Download 125 years more health - Boehringer Ingelheim

125 years
more
health
1885 – 2010
Corporate Magazine 2010
content
innovation
05
Extracts from our Leitbild*
06
In conversation with
Christian Boehringer and
Andreas Barner
10
125 years more health:
The jubilee year 2010
* guiding principles
12
the company history:
12
1885 ― 1912 | how it all started
14
1912 ― 1948 | innovative beginnings
16
1948 ― 1988 | internationalisation
19
1988 ― 2010 | value through innovation
22 corporate responsibility
CR
24
Be respected. Be encouraged. Be innovative.
28
Our employees
38
Sustainability
46
Corporate Citizenship
66
Be first. Be best. Be focused.
74
Medical innovation
78
Be first. Thrombo-embolic diseases
84
Be best. Diabetes
90
Be focused. Oncology
99
Idiopathic pulmonary fibrosis
64 research and development
R&D
100
Hepatitis C
104
Be committed. Be reliable. Be successful.
106
Human Pharmaceuticals *
108
Prescription Medicines
102 our businesses
BIZ
118
Consumer Health Care
126
Biopharmaceuticals
136
Operations
152
Animal Health
* The patient reports are authentic reports which refer to personal experience only. Please note that other patients may experience different
treatment results. Individual treatment regimes have always to be discussed between patient and physician case by case.
Content
125 years more health
The jubilee year 2010
For the past 125 years our basic principles and claim have remained to be
outstanding in innovation and technology. It is our endeavour to translate
groundbreaking discoveries concerning the causes and course of human
diseases into ever-improving methods of treatment.
Guarantors of this are our employees. They form the core of our distinctive
corporate culture that lives out its responsibility and builds on mutual respect
and fairness.
Read more about the jubilee year
page 10
Extracts from our Leitbild *
Boehringer Ingelheim has been a successful, family-owned business
for 125 years and intends to remain so for the second century of its existence. Although it is impossible to predict the future precisely, we are
actively and creatively facing the changing tasks and challenges, building on our experiences and achievements. This gives us the strength,
direction and confidence to shape our future. We have committed ourselves to the goal of serving humankind through research into diseases
and the development of new drugs and therapies. In this endeavour the
future of our company will depend on its innovative capability.
In all our activities we safeguard our employees, facilities and the
environment from harmful influences, conserve natural resources and
promote environmental awareness. Parallel to pursuing these goals we
seek to foster economic and social well-being in the countries and communities where we do business. In order to realise our goals, we must
be financially successful, be willing to make the necessary changes, and
be critically receptive to new ideas and developments. Maintaining and
improving the performance of the company take precedence over maximising earnings in the short term.
* guiding principles
Extracts from our Leitbild
5
innovation
In conversation
Be entrepreneurial.
Improve the established.
Develop the new.
As in the past, it will also be true in the future that continual
but steady changes will be necessary in order be equipped
at any time for the future. And here it is important for us to
have a constant – our values and culture of togetherness for
researching, developing, producing and marketing innovative
medicines – borne by a family-owned company.
christian boehringer
chairman of the shareholders’ committee
6
Boehringer Ingelheim annual report 2010
andreas barner
chairman of the board of managing directors
In conversation
7
In conversation
innovation
What are Boehringer Ingelheim’s corporate goals?
christian boehringer: “In 2010, we celebrated a special jubilee: the 125-year existence
What does being entrepreneurial mean for
Boehringer Ingelheim?
christian boehringer: “For this we have
of our family-owned company, Boehringer Ingel-
clear framework conditions: we, the shareholder
heim. In conjunction with this we were able to
family, today, as before, set a reliable financial
experience how strong and vital the basic princi-
framework and provide continuity in the strate-
ples and claim of the shareholder family also
gic orientation of the company. We thereby create
remain, having taken form when the company
the preconditions for the stability, profitability
was founded in 1885: to be outstanding in inno-
and sustainable growth of the company.
vation and technology – Value through Innovation.
I like to use the image of a tree. The roots of the
Boehringer Ingelheim tree give the tree nutrients
What in the years since the company was founded
and hold. The nutrients are the capital which the
in 1885 with the production and opening up of new
shareholders make available to the company, via
markets for lactic acid, has continually developed
the profit, the bulk of which is reinvested, so that
further and is today a modern, highly innovative
the company can grow. The hold is the share-
pharmaceutical company in family hands.”
holders‘ long-term strategy to develop innovative
medicines for people and animals and to avoid
andreas barner: “This corporate goal of
short-term trends or divergencies from our
Boehringer Ingelheim runs like a theme through
course. On this solid fundament stands the
its 125-year history. It is the endeavour to trans-
trunk, that is all the employees who in the spirit
late groundbreaking discoveries concerning the
of a stable partnership with the shareholders im-
causes and course of human diseases into ever-
plement stable our strategy. Only in this way do
improving methods of treatment. Boehringer
the branches bear fruit, our products that we can
Ingelheim concentrates on innovation in all
successfully bring to the market. The shareholders
areas, not only in human medicine, but also in
are, on the one hand, engaged at the operative
veterinary medicine and allied technology.
level with Hubertus von Baumbach on the Board
of Managing Directors. On the other hand, the
With innovative research and development
six shareholders on the Shareholders’ Commit-
projects the company wishes to close the thera-
tee, as well as all the other shareholder too, have
peutic gaps with new medicines that improve the
a great interest in the employees and matters of
survival chances and quality of life of patients.
importance at the company.”
Where medical need exists today – and we see
this in many places – we deploy our research
How does Boehringer Ingelheim want to improve
efforts. pradaxa®, our innovative thrombin in-
what it has already established?
hibitor, is an example in which this has succeeded
in a particularly convincing way.
christian boehringer: “We, the shareholders, regard ourselves as trustees of the lasting
success of company. The family-owned company
In implementing this endeavour, Boehringer
Boehringer Ingelheim should continually be in a
Ingelheim has always followed its own course:
position to research, develop, produce and market
the company has traditionally confronted change
innovative medicines for the benefit of people
and successfully practiced continuity in change
and animals.
with persistence and patience.”
8
Boehringer Ingelheim annual report 2010
The relationship of trust between the shareholders
tung (charitable foundation) provides funding
and the Board of Managing Directors provides
totalling EUR 100 million over 10 years for the
us shareholders with far-ranging informational
Institute of Molecular Biology (IMB), which
opportunities. It promotes the understanding
should open up new possibilities for diagnoses
of the individual businesses and has the advantage
and therapies through basic research. In addi-
when decisions are faced that one has a good
tion, the company has established the Boehringer
shared knowledge beforehand and a grasp of
Ingelheim Venture Fund with an initial contribu-
the opportunities and risks.
tion of EUR 100 million. Our approach is to gain
broad access to the newly emerging therapy con-
Decisions are then taken jointly with the Board
cepts and new technology platforms, and thereby
of Managing Directors in our corporate bodies.
participate in the therapeutic opportunities of to-
This is in keeping with the culture, deeply rooted
morrow. Thus, as a company, we think very long
in the company, of mutual trust and fairness
term and in doing so must always be up-to-date
between the shareholder family, the Board of
and mobile in order to be able at the same time to
Managing Directors and our employees.
remain traditional and constant.
We want to safeguard this special culture for
As in the past, it will also be true in the future
the future, so that our employees continue to
that continual but steady changes will be neces-
find Boehringer Ingelheim attractive, and, at
sary in order be equipped at any time for the fu-
the same, gain new employees for the family-
ture. And here it is important for us to have a
owned company and creating the future.”
constant for the next 125 years – our values and
culture of togetherness for researching, develop-
What does developing the new mean for
ing, producing and marketing innovative medi-
Boehringer Ingelheim?
cines – borne by a family-owned company.”
andreas barner: “This is how we will continue to grow: the shareholders and the Board of
Managing Directors jointly discuss possible social
changes and openly and prepared address the
signed by
changes of the future. Developments in medicine
christian boehringer
and in society must be anticipated so that we
chairman of the shareholders’ committee
in the company can, specifically where long
research and development cycles are concerned,
develop the company in a targeted way, thereby
securing the supreme goal of independence for
signed by
the next generation.
andreas barner
chairman of the board of managing directors
Three examples show our long-term thinking
clearly: Boehringer Ingelheim supports the Research Institute of Molecular Pathology (IMP) in
Vienna, Austria, where more than 200 scientists
from 30 countries conduct basic research with
the focus on oncology. And at the University of
Mainz, Germany, the Boehringer Ingelheim Stif-
In conversation
9
125 years more health
The jubilee year 2010
125 years more health:
The jubilee year 2010
We know that Boehringer Ingelheim faces a world full of challenges.
Our celebrations in the 125th year of our existence were therefore designed
to meet the coming changes with self-confidence and to concentrate
ourselves where we best can: giving the world more health.
More than a pharmaceutical company –
More than a logo
Hello, I’m Me/We:
Boehringer Ingelheim is a company
I am the symbolic figure that accompanies all the jubilee
celebrations at Boehringer Ingelheim around the globe.
I stand at the same time for the great importance of the
individual and the teams in our company: without “Me”
no “We”, and the reverse.
with a special history that has in 125
Welcome to 125 years more health.
years enabled it to become the world’s
largest family-owned pharmaceutical
company. Just as special to the company
jubilee is the symbolic figure Me/We.
This is not just a simple logo, but
an attempt to portray the spirit of
Boehringer Ingelheim.
10
Boehringer Ingelheim annual report 2010
This symbol stands for the success, joy
Christian Boehringer, as Chairman of
and pride at the celebrations around
the Shareholders’ Committee, opened
this special year. Me/We lives, as it
a colourful and attractive programme
derives directly from the symbolic
in front of thousands of guests. Be-
world of the corporate programme of
sides many entertainment options for
many years, Vision and Leadership,
young and old, the whole of the Boeh-
as well as Lead & Learn, making
ringer Ingelheim world was to be
them three-dimensional. Its reference
brought primarily before the eyes of
to the world of chemistry and pharma-
family members. To be discovered
ceutical research is unmistakeable.
were highlights from the company his-
Me/We should enter the real world.
tory on display walls, production with
The symbolic figure has therefore since
examples of machine presentations,
the jubilee year been found worldwide
and pharmaceutical research.
as a sticker, display, 3D figure or giant
projection at buildings on Boehringer
Ingelheim sites.
The title of the Boehringer Ingelheim
company history With people – for
people, that was published for the
company’s 125-year jubilee, can also
Organisational structures and processes
must be designed to facilitate and promote entrepreneurial thinking and action,
flexibility and responsibility.
The core element of corporate culture is
set out in the company’s vision Value
through Innovation. In order to ensure
perpetual innovation throughout the
company, Boehringer Ingelheim relies on
flexible, mobile employees with selfconfidence, accountability and the ability
to think and act in a global context.
The motto of our corporate responsibility
Living our values refers to our pledge to
create a working environment that promotes entrepreneurial thinking and action,
continual knowledge-building, further education and employee identification with the
company.
be conveyed totally in terms of Boehringer Ingelheim’s fundamental social
awareness, at the start of the worldwide celebrations on 3 – 4 September
2010 in Ingelheim. At the official
Rhineland-Palatinate Minister-Presi-
The company’s efforts are aimed at creating medicines and treatments that offer significant therapeutic benefits to patients.
Highly skilled, motivated employees are
the company’s key asset and a guarantee
of its innovative power and performance.
And all employees help to ensure that
Boehringer Ingelheim can meet its responsibilities and fulfil its tasks.
With people – for people
reception, attended by Kurt Beck, the
Our guiding principles
for 2010
Watch our special Jubilee website:
www.jubilee125.com
dent, and Cardinal Karl Lehmann, the
Bishop of Mainz, the speech of the
well-known futurist Matthias Horx
stood out particularly, dealing with
social change and the consequences
for the healthcare system. Horx predicted that a new healthcare system –
from hi-tech to hi-care medicine, to
which Boehringer Ingelheim can certainly make its contribution.
The celebrations had a very special
value for all employees with their
families in Germany.
125 years more health
11
The company history
125 years more health
1885 ― 1912
| how it all started
On 24 July 1885, a small tartaric acid factory in Ingelheim, in the Rhinehessen region of
Germany, changed hands. On 31 July, the following entry was recorded in the trade register
of the nearby town of Bingen: “Albert Böhringer, chem. Fabrik vom 1. Aug. 1885 ab”.
At the age of nearly 24, Albert Boehringer had decided to become an entrepreneur.
[ 1885 ]
Ernst Boehringer purchases
in the name of his brother
Albert, a small tartaric acid
factory in Ingelheim in the
Rhinehessen region of
Germany, noted in the trade
register as “Albert Boehringer,
chemical factory from
1 August 1885”.
[ 1893 ]
(Picture: Albert Boehringer)
In memory of his father Christoph Heinrich, Albert
Boehringer changes the company’s name to C.H.
Boehringer Sohn (CHBS) as of 1 January and appoints his mother as a limited partner. He plans
and builds his own house in Ingelheim, subsequently known as the Founder’s Villa. Whilst attempting to produce citric acid, an unwanted fermentation leads to the creation of lactic acid. Not
abandoning this process, Albert Boehringer now
possesses a method to produce lactic acid on an
industrial scale.
[ 1886 ]
Albert Boehringer
starts producing
tartaric acid.
1885
1890
1895
Successful research and development
Innovation as a corporate task
special direction of a family-owned
that leads to the production and mar-
On 3 September 2010, some hundred
company runs as recurrent theme
keting of innovative medicines has a
guests sat at Boehringer Ingelheim’s
through Boehringer Ingelheim’s histo-
long tradition at Boehringer Ingelheim,
official 125-year celebration in Ingel-
ry. In the vision Value through Inno-
totalling 125 years in 2010. In this peri-
heim, Germany. This special day was
vation the idea of a special company,
od, a highly innovative pharmaceutical
possible because one man – Albert
which always applied to Boehringer
company developed from its Ingelheim
Boehringer – had 125 years earlier a
Ingelheim, has since 1885 found con-
tartaric acid factory embryo.
vision and bought a small tartaric acid
cise expression. When Albert Boeh-
factory in Ingelheim. Since then, the
ringer, under the then company name
unconditional will to innovate and the
C.H.Boehringer Sohn (CHBS), began
12
Boehringer Ingelheim annual report 2010
[ 1910 ]
[ 1895 ]
The 25th anniversary of CHBS.
The company now has 156 employees.
Paid holidays, based on the length of
company service, are introduced.
Lactic acid is produced on
an industrial scale. CHBS
registers its first patent – for
a lactic acid-based baking
powder.
[ 1907 ]
A benefit fund for retired
workers is set up.
[ 1902 ]
The first company
health insurance
system is established.
[ 1912 ]
[ 1905 ]
laudanon®, a painkiller based on
six alkaloids of opium, is the first
pharmaceutical specialty product
by CHBS.
For the first time, the
company logo displays
an image of Charlemagne’s imperial palace
in Ingelheim.
1900
1905
producing tartaric acid he could not
to think about financial support and
imagine that his factory would turn
social benefits for his employees and
into the world’s largest family-owned
their families. Where possible, he had
pharmaceutical company. But he rec-
certainly already been helping people
ognised the existential significance of
in need. But now he could, as it were,
innovation for both his factory and
institutionalise the contributions. Key
the first employees. After the nascent
here were the establishment of a com-
economic success of the industrial
pany insurance scheme in 1902 and
production process for lactic acid,
the setting up of a benefit fund for re-
Albert Boehringer was now also able
tired workers in 1907.
1910
How it all started
13
The company history
125 years more health
1912 ― 1948
| innovative beginnings
Important decisions had to be made for Boehringer Ingelheim. It was a matter of reorganising the
company and surviving the consequences of two world wars. The death of Albert Boehringer in 1939
brought the founding era to an end, but not the history of Boehringer Ingelheim. Both his sons and
his son-in-law seamlessly continued his work.
[ 1923 ]
[ 1920 ]
On 11 August – Albert Boehringer’s
62nd birthday – CHBS provides
emergency funds in response to
hyperinflation.
The cardiovascular drug cadechol®, a camphor-based product made water-soluble
through bile acid, is launched.
[ 1915 ]
During World War I,
Albert Boehringer is on
military service until
1917. His nephew,
Robert Boehringer,
takes charge of CHBS.
[ 1921 ]
[ 1917 ]
Following the advice of
the chemist Heinrich
Wieland (1877 – 1957),
a cousin of Albert Boehringer, the first research
department is founded.
1915
Heinrich Wieland and his brother, pharmacologist Hermann Wieland (1885–1920), isolate
the pure alkaloid lobelin from the Lobelia
inflata plant. It is launched in the same year
under the scientific name lobelin®. In 1936,
it will be produced synthetically and on an
industrial scale.
1920
Being innovative also means identify-
matter of filling the pipeline. In the
ing the opportunities of new business
following years, a whole row of medi-
areas at the right time. Two years after
cines for different purposes came on
the company’s 25-year jubilee in 1910,
the market: the cardiovascular drug
the launch began on the first pharma-
cadechol® (1920), the stimulant lo-
ceutical preparation laudanon®, an
belin® (1921) and the asthma medica-
analgesic, which was important to the
tion aludrin® (1941).
decisive transition from chemicals to
pharmaceuticals in the later development of the company. Now it was a
14
1925
Boehringer Ingelheim annual report 2010
[ 1941 ]
Work begins on the production of citric acid from citrate
calcium for the foodstuffs,
drinks and tobacco industry.
aleudrin®/aludrin®, the innovative broncholytic, which belongs to the sympathomimetics
group, is launched. aludrin® is the first CHBS
asthma drug and paves the way for betablockers. After World War II, the allied forces
confiscate the patent.
[ 1930 ]
Heinrich Wieland is
awarded the Nobel
Prize for chemistry.
The cardiovascular medication sympatol®, an
adrenaline derivative is launched. The
baking and nutrition department is opened.
[ 1932 ]
562
[ 1927 ]
[ 1941 ]
CHBS now
employs 1,500
people.
[ 1946 ]
The new company Dr. Karl Thomae GmbH is formed in
Biberach on Riss, employing 70 people. The painkiller
thomapyrin® is launched.
CELA, Agricultural Chemicals GmbH, is formed to produce pesticides to fight the Colorado beetle infestation.
The number of employees
drops to 562 during the
global economic crisis.
1930
1,500
[ 1933 ]
1935
1940
Under the sign of totally synthetic
After the end of World War II, it was
Cie. in Winnenden, southern Garmany.
production
important for the company to again
This company was re-established in
In 1921, the natural alkaloid lobelin
make available to patients medicines
1946 in Biberach, where, under the
was iolated from the plant Lobelia in-
to meet medical needs. In this situa-
name Dr. Karl Thomae GmbH, 70
flata. The same year saw for the first
tion, employees at a subsidiary also
employees, starting that year, produced
time successful wholly synthetic pro-
demonstrate once again their ability to
and marketed the painkiller thomapy-
duction. This step was an important
innovate.
rin®, still a self-medication classic
precursor of the first wholly syntheti-
today.
cally produced asthma medication
In 1928, Albert Boehringer acquired
aludrin®.
the chemical company Dr. Karl Thomä &
Innovative beginnings
15
125 years more health
The company history
1948 ― 1988
| internationalisation
For a long time, the owner family wanted to expand its business abroad, but circumstances,
world political events, and also the lack of available capital, had repeatedly stopped them from
doing so. The decades following the end of World War II opened up opportunities to realise
the dream of internationalisation, supported by skillful planning and a corporate world vision.
[ 1956 ]
[ 1949 ]
Boehringer de Angeli
Quimicia e Farmaceutica Ltda, São
Paulo/Brazil, is established.
After mediation by Robert Boehringer, a long
and fruitful collaboration with the Swiss
Pharmaceutical company J.R. Geigy AG in
Basel begins. Thomae takes over the production and sole distribution of all Geigy pharmaceutical products in Germany. effortil®,
the cardiovascular medication, is launched.
[ 1948 ]
[ 1951 ]
The first foreign subsidiary,
Bender & Co Ges. mbH is formed
(Today Boehringer Ingelheim RCV
GmbH u. Co. KG.
buscopan®, a painkiller and antispasmodic
medication, is launched.
finalgon® is the first product for percutaneous heat-impulse therapy, resulting from research carried out by Thomae in Biberach.
Olivin, a subsidiary for selling
cosmetic products, is set up.
1945
1950
1955
At the end of the 1940s, the interna-
internationalisation had an impact,
off and enabled, among other things,
tional markets gained increasing im-
especially on the development of turn-
the establishment in 1955 of the Ingel-
portance for the chemical-pharmaceu-
over. In 1950, it still stood at 11.6 mil-
heimer Wohnungsgesellschaft mbH
tical industry. CHBS also established
lion German marks, climbing to a con-
housing organisation for employees in
its first subsidiary outside Germany in
siderable 3.3 billion German marks in
which Boehringer Ingelheim was the
Vienna, Austria, today incorporated as
1986, over 80 % of which was generated
majority shareholder.
Boehringer Ingelheim Regional Center
outside Germany.
Vienna (RCV) GmbH & Co. KG. In the
following year, further branches were
International marketing of medicines
opened in Europe and overseas. And
the company had developed itself paid
16
Boehringer Ingelheim annual report 2010
[ 1971 ]
Boehringer Ingelheim,
Ridgefield/USA,is established.
[ 1972 ]
berotec®, the asthma
medication, is
launched.
[ 1958 ]
9,300
Impression of the Ingelheim plant in the 1950s
[ 1961 ]
C.H. Boehringer
Sohn Ltd, Toronto
Canada is established.
alupent®, the asthma
medication, is launched.
[ 1965 ]
9,300 employees
worldwide generate
revenue of 543 million
German marks.
[ 1960 ]
[ 1966 ]
Boehringer Ingelheim is
75 years old.
silomat®, for dry cough,
is launched.
1960
catapresan®, a medication
to fight high blood pressure,
is launched.
1965
Advantage diversity
tria, the USA and Canada. Some 900
Internationalisation does not only
people are today employed at the
mean new markets, but also new ideas
international corporate headquarters
and stimulation. Boehringer Ingelheim
in Ingelheim, Germany.
1970
has for decades used cultural diversity
to increase the flow of innovations.
The research centres of such importance to the company are spread
around the world, in Germany, Aus-
Internationalisation
17
125 years more health
The company history
22,254
[ 1975 ]
atrovent®, for the treatment
of chronic obstructive
respiratory disease (COPD),
is launched.
[ 1985 ]
Boehringer Ingelheim and its 22,254 employees, 8,784 of whom are based in Germany,
celebrating the company’s 100th anniversary,
generate revenues of 4.5 billion German
marks.
[ 1986 ]
The biotechnical center in Biberach opens its doors.
With an investment of 150 million German marks, it is
the largest production plant in Europe for biopharmaceuticals derived from cell cultures.
[ 1978 ]
Boehringer Ingelheim
Vetmedica GmbH is formed
from the department for
veterinary medicine.
[1979]
mexitil®, against heart arrhythmia, and mucosolvan®
(Thomae), to treat bronchitis,
are launched.
1975
1980
[ 1987 ]
actilyse®, the first biotechnologically produced
medication by Thomae / Boehringer Ingelheim
to treat acute heart attack, gains approval
1985
Biotechnology – the market of
This amounted to the final farewell to
Ingelheim is one of the leading com-
the future
organic acids that stood for economic
panies in the field of biotechnology in
While over the years a giant corporate
success in the company’s early years.
Europe, thanks to its ability to inno-
network emerged in the computer de-
On the other hand, Boehringer
vate.
partment, there was again a paradigm
Ingelheim in 1986 opened the first
change in production that was once
biotechnological production plant
more closely connected with innova-
in Germany. actilyse®, the first bio-
tion-driven transformation. This
technologically produced medicine,
transformation caused the termina-
used to treat acute heart attacks,
tion in 1982 of citric acid production.
followed in 1987. Today, Boehringer
18
Boehringer Ingelheim annual report 2010
1988 ― 2010
| value through innovation
By the end of the 1980s, Boehringer Ingelheim found itself caught in the tensions between economic,
industrial, health and social politics. From 1991, all activities dedicated to research and development,
were restructured in order to use resources more efficiently, to develop more target-orientated substances
and to steer the company more successfully through a global market. With in-house R&D resources in
place and an explicit dedication to innovation, Boehringer Ingelheim commits itself to one ambition:
To create Value through Innovation. These efforts lead to the launch of new and successful products.
[ 1996 ]
[ 1999 ]
5.2bn
viramune®, for HIV/AIDS treatment, and
alna®/flomax®, for the treatment of benign prostate enlargement, are launched.
1999 sees the
launch of micardis®,
a product used in
the treatment of hypertension.
[ 1991 ]
[ 1997 ]
Boehringer Ingelheim now employs 24,347
people worldwide and generates revenue of
5.2 billion German marks.
A new company logo is launched.
mobec®, the anti-rheumatism
medication, and sifrol®, to combat Parkinson’s disease, are
launched.
1990
1995
2000
Concentrating strengths
already initiated finally led in 1994 to
bate the basic assumptions of the vi-
At the beginning of the 1990s, Boeh-
the direction-giving corporate pro-
sion, that true value for patients, for
ringer Ingelheim faced the challenge
gramme Vision and Leadership, the
the society, and, finally, for the compa-
of reorganising the whole group of
vision of which, Value through Inno-
ny, arise when there is continuous suc-
companies with its then 25,000 em-
vation, remains a core element of the
cess in new development and in opti-
ployees. Research and production
corporate culture to this day.
mising established approaches.
were clearly divided up by function
and location, the whole innovation
Since 1995, an annual Value though
process was to operate in a more tar-
Innovation Day is held at all sites. On
geted way. The many change processes
that day, the employees constantly de-
Value through Innovation
19
125 years more health
The company history
1988 ― 2010 | value through innovation
[ 2000 ]
[ 2004 ]
2000 sees the
launch of metalyse®,
a drug used in the
treatment of heart
attacks.
The micro-technology company microParts GmbH in Dortmund, with which
Boehringer Ingelheim developed the innovative inhaler respimat®, is acquired.
[ 2005 ]
Lead & Learn is the next step towards the
overall vision of creating Value through Innovation. The official signal to start the process is
given on VTI-Day. Lead & Learn emphasises
comprehensively how the importance of each
individual, as well team effort and in-depth
understanding, can contribute the company’s
success.
[ 2002 ]
The new active ingredient production plant in Ingelheim is opened. This EUR 180 million plant is
one of the largest individual investments in the
company’s history.
spiriva®, for the treatment of chronically obstructive pulmonary disease (COPD) is launched.
[ 2003 ]
Opening of the new biopharmaceutical
production plant G104 in Biberach. The
more than 255 million euro plant is the
biggest individual investment in the company’s history.
2000
20
2005
The Lead & Learn initiative from
All these programmes and initiatives
2005 emphasises the further develop-
also had a direct effect on product
ment of the leadership principles, how
launches, such as alna®, for the treat-
important both the individual and the
ment of benign prostate hyperplasia
team are for Boehringer Ingelheim’s
(1996), sifrol®, for Parkinson’s dis-
corporate success. The Me/We con-
ease (1997), or the product spiriva®,
cept was again taken further in the
today the most prescribed medication
reporting year with the Me/We figure
for the treatment of chronic obstruc-
for the company’s 125th jubilee.
tive pulmonary disease (COPD).
Boehringer Ingelheim annual report 2010
42,224
[ 2008 ]
pradaxa® for the prevention of
thrombosis is launched.
The LogiPack centre in Ingelheim is
opened. Its 14 production lines can
produce up to 250 million items of
packaging per year.
[ 2010 ]
Boehringer Ingelheim
now employs 42,224
people worldwide.
[ 2007 ]
[ 2010 ]
The new company
restaurant is opened
in Ingelheim.
Boehringer Ingelheim
celebrates its 125th
anniversary.
[ 2009 ]
The Boehringer Ingelheim Foundation announced that
it will support the operation of the Institute of Molecular Biology (IMB) at the Johannes Gutenberg-Universität in Mainz with EUR 100 million spent over a tenyear period.
[ 2010 ]
pradaxa® launch in
stroke prevention in
patients with atrial
fibrillation.
2010
From generation to generation
the reporting year was authorised in
to grow with new, innovative medi-
It is the right mix of preservation and
the USA and Canada and recently in
cines that offer patients convincing
change that make a company fit for
Japan for the prevention of stroke in
therapeutic advantage in the treat-
the future. It is thinking with the far-
patients with atrial fibrillation. Fur-
ment of their diseases.
sightedness of generations that also
ther promising candidates are in the
allows the company to overcome
product pipeline. The ability to inno-
challenges, such as the loss of exclu-
vate of Boehringer Ingelheim is undi-
sivity in the past business year. In
minished and the foundations for fur-
2010, the company received market
ther success of the company are laid.
authorisation for pradaxa®, which in
Boehringer Ingelheim will continue
Value through Innovation
21
corporate responsibility
Living our values:
For 125 years, people have engaged themselves at our
company in the pursuit of more health. They thereby take
on responsibility for the quality of life and prospects
of patients. In our jubilee year, we renewed our commitment
to our company values as well as to our readiness for
change.
As early as 1902, C.H.Boehringer Sohn
(CBHS) established its own company
health insurance plan.
A benefit fund for retired workers is
set up.
1902
1907
22
Boehringer Ingelheim annual report 2010
CR
Corporate Responsibility
Be respected. Be encouraged. Be innovative.
24
Our employees
26
Sustainability
38
Corporate Citizenship
46
More than 2 million mother-child pairs participated at the Viramune® Donation Programme for
the prevention of mother-to-child transmission
of HIV/AIDS.
The Boehringer Ingelheim Stiftung is supporting
with EUR 100 million the operation of the Institute
of Molecular Biology (IMB) at the Johannes Gutenberg-University of Mainz, Germany over a ten-year
period.
> 2m
EUR 100 m
Corporate Responsibility
23
corporate responsibility
Be respected. Be encouraged. Be innovative.
Be respected.
Be encouraged.
Be innovative.
With their knowledge, efforts and ideas, our employees make possible the
innovations with which we create value. It was always thus.
24
Boehringer Ingelheim annual report 2010
[ corporate responsibility at boehringer ingelheim ]
“Boehringer Ingelheim is for us a very good
employer and offers stability, good personal
development and jobs. We have already
become family with Boehringer Ingelheim
and we would like to continue this cooperation for many decades to come.”
the hadamik family,
working for boehringer ingelheim for three generations
Be respected. Be encouraged. Be innovative.
25
corporate responsibility
Be respected. Be encouraged. Be innovative.
Our employees:
It is our employees, with their commitment, their knowledge and their ideas,
who enable us to come up with innovations. They are constantly enquiring about
processes and procedures and are helping us to introduce improvements. Our
ambition to be innovative applies in equal measure to all divisions.
[ canada ]
“I love it that Boehringer Ingelheim
is big enough to tackle interesting
things but small enough that if
you want to reach something
you just have to talk to a few
people.”
[ usa ]
ontario
ridgefield
ross scarrow,
information technology
“We are making
pharmaceuticals
that improve the
quality of life.”
kimberly kellermann,
flow operations
guadalajara
[ mexico ]
“Boehringer Ingelheim is a
learning-orientated company
which challenges us all the
time to achieve greater
results as a team.”
alessandro de leonardis,
environment, health and safety &
engineering
42,224
The commitment, competence and creative power of our
people, sustained for well over a century, have made
Boehringer Ingelheim a first-class, fast-growing pharmaceutical corporation. This is reflected in the energy and
innovation of 42,224 employees.
13,491
Workforce in the
Americas
26
Boehringer Ingelheim annual report 2010
21,016
Workforce in
Europe
[ sweden ]
“Working for Boehringer Ingelheim
makes me a part of an international
team that clearly defines
targets and works hard and
consistently to reach them.”
edgar dagrup,
customer relations management
stockholm
[ china ]
“Boehringer Ingelheim offers plenty of
possibilities and challenges.
I can develop myself.”
ingelheim
haiyan liu,
logistics
[ germany ]
“Boehringer Ingelheim is an ideal
combination: a research-driven
company, innovative and
international, and yet at its
core a family company with
traditional values.”
shanghai
mumbai
dr ingo presser,
biopharma operations
[ india ]
“Boehringer Ingelheim is a
place full of opportunities
and challenges, where I
can develop my skills.”
7,717
charmaine braganza,
regulatory affairs / cmc
Workforce in Asia,
Africa, Australasia
(AAA)
[ australia ]
“Boehringer Ingelheim means
support, encouragement,
excellence and value.”
james smith, district sales,
prescription medicines
Our employees
27
corporate responsibility
Our Employees
Our Employees
Employees who innovate - the future of our company depends
directly on its innovative capability. Our employees are the
guarantors of this and our most important corporate asset. They
form the core of our distinctive corporate culture as a familyowned company that lives out its responsibility and builds on
mutual respect and fairness.
28
Boehringer Ingelheim annual report 2010
Values with staying power
Value through Innovation – for us at Boehringer Ingelheim this is no
mere motto, but an internal commitment. This vision drives us forward
and is the basis of our success
This commitment to innovation is re-
Boehringer Ingelheim is and will re-
alised in all areas at Boehringer Ingel-
main a family-owned company that
heim:
strongly believes in continuity and
prepares early and consistently for
First and foremost, we create new
challenges ahead.
medicines that truly help people. We
research and develop, manufacture
We think long term. Our strategy has
and market them.
been and will continue to be to secure
Boehringer Ingelheim’s development
Secondly, we work continuously on
through sustained economic growth
optimising own processes or aim to
based on the productivity of its re-
find completely new solutions.
search and development.
Thirdly, we support our employees and
develop their competencies with the
means of talent management. What always takes us forward is the commitment of our employees – they are our
most important success factor. We aim
to make it easier for them to maintain
a balance between their contribution
to Boehringer Ingelheim and their private life.
Fourthly, we seek to permanently verify whether we are using natural and
economic resources efficiently and responsibly.
These four pillars are the basis of our
future ability to innovate and our contribution to progress in medicine to
benefit patients.
Our employees are our most important corporate asset.
Picture from the 125 years jubilee party in 2010.
Values with staying power
29
Our employees
corporate responsibility
Talent management as a strategic priority
Talent management is a strategic priority for Boehringer Ingelheim to
build and sustain a competitive advantage in a fast-moving and
highly competitive environment.
In 2010, Boehringer Ingelheim contin-
The overall talent management cycle
ued to roll out and implement its
of Boehringer Ingelheim is comprised
globally integrated talent management
of several core elements. (see graph)
approach.
To date, around 2,500 employees
The aim of talent management is that
worldwide have been discussed at
all employees should be able to devel-
cross-validation meetings. As a result,
op within their job or towards new
actionable development plans aligned
roles. They shall be enabled to grow
with business needs have been initiated,
through new challenges and the com-
relevant staffing decisions have been
pany will achieve improved results.
made, and cross-moves have been
o
er Ingelhe im
ehring
Tale
f Bo
nt M
o
s
t
an
en
ag
m
e
em
performance
El
e
e
r
potential
nt
C
implemented or planned.
succession
o
pe
right
needs &
actions
ce
BI Talent
Management
pla
mag
g
ht
evaluation
feedback
alignment
our overall objective of having the best
time.
ri
e
ment will bring us closer to meeting
people in the right position at the right
cross
validation
pl
We are convinced that talent manage-
development
[ south africa ]
rig
ht time
implementation
staffing
decision
”Boehringer Ingelheim has supported
me in developing me to various positions. I started in the warehouse as an
order clerk. Most recently, I joined sales
as a representative.”
bethuel ramadiro
marketing and sales
30
Boehringer Ingelheim annual report 2010
hip Compe
Leaders
tenc
bal
o
ies
l
G
Deliver
Results
Leadership development
Set
Direction
To realise
our vision
and live
Lead & Learn
Developing people and leading innovation.
In order to drive talent management,
Lead
Innovation
all leaders focus on the development
Lead &
Manage
Change
Lead
People
of our employees. They identify high
potential employees early and develop
them. With the implementation of
new worldwide structures and our
governance model resulting in a higher
number of cross-country reporting relationships, our leaders need to be true
global leaders.
Leadership competencies
Based on Lead & Learn – our philosophy on how we work together – we introduced five global leadership compe-
[ singapore ]
tencies.
A new standard of our expectations
has hereby been set and the leaders in
the organisation are evaluated against
these expectations (leadership competencies). The evaluation is based on
the following questions:
Ω How do we get results?
Ω How do we lead change and
innovation?
”Boehringer Ingelheim continuously gives
me challenges and opportunities for
development. After 13 years of experiences
in various positions in the IS organisation
in Japan, I had the opportunity to work in
the IS organisation in Germany where I was
able to participate in global projects. I have
now taken on a new role in Singapore “
yasuhiro nishimi
regional chief information
officer asia pacific
Ω How do we attract, develop and retain
high potential and high professional
employees?
Ω How do we communicate together
with the results on core job and
individual goals equal performance?
Talent management / Leadership development
31
Our employees
corporate responsibility
For those employees who do not lead
other employees, our Lead & Learnquestions will be the standard they
are measured against (see graph).
[ spain ]
With talent management including
“Boehringer Ingelheim supported
me in my career path, in identifying
the appropriate balanced match
between the company’s and my
professional interests.”
dr teresa rodó
head of production site pharma
spain
performance management the evaluation of leadership and results of core
job and individual goals determine
development needs and give an indication of individual potential as a basis for growth in future roles.
To support the development of the
global leadership competencies, we
have developed a leadership development landscape. Global, regional and
local leadership development programmes will be available to leaders at
all levels in the organisation. Our
leadership capability will be a strategic differentiator for Boehringer Ingelheim.
Our Lead & Learn questions
For those employees who do not lead other employees, our Lead & Learn questions will be the standard they are measured against.
Are we taking the initiative?
32
Are we connected?
Boehringer Ingelheim annual report 2010
Are we growing together?
Are we getting results?
Develop
visions
Organisational development
bi
change
model
Leading and managing change.
Cultivate
change
Boehringer Ingelheim has successful-
Nevertheless, this process will need
ly implemented a systematic approach
time and it would not be possible
to manage change at Boehringer In-
without full commitment and dedicat-
gelheim. This well-structured change
ed support of the Animal Health Man-
process will help and support all em-
agement Team.
Change implementation
ployees to better understand the common Boehringer Ingelheim culture,
values and the overall company vision.
One example for a successful change
management process is the integration
of employees from Fort Dodge Animal
Health.
One year has passed since Boehringer
Ingelheim Animal Health together
Integration meeting of Fort Dodge
and Boehringer Ingelheim staff
with Boehringer Ingelheim Vetmedica
Inc., acquired certain assets and facilities from Fort Dodge.
It has been a time full of energy and
efforts in the process of integrating
the various parts. Most importantly,
Boehringer Ingelheim welcomed
about 900 new colleagues working
in highly motivated teams in all
functions, be it R&D, sales force or
production.
“The one thing that stands out is the willingness from both
the St. Joseph site and Fort Dodge sites of the Animal
Health business to work together to make the transition
work seamless. Although there were some bumps in the
road early on, overall, the transition is continuing to be
successful. I believe Boehringer Ingelheim Vetmedica Inc.
is a strong and healthy company which will continue to
grow. I’m looking for greater things to come to pass
in the future.”
An overall change process has been
put in place to facilitate mutual understanding and create a joint workforce to be prepared for a successful
bob lentsch,
manager, security and site services, usa
future. All colleagues are pulling together and are willing to contribute.
Organisational development
33
corporate responsibility
Our employees
A lot has been achieved during the
past months like product transfers and
adaptation of manufacturing systems
showing that we are connected.
On a regular basis, feedback is ob-
[ japan ]
tained from all colleagues. This is very
“Boehringer Ingelheim has always
provided me of the good working
environment, where I can develop my
competencies through various assignments,
and experienced supervisors.
Challenging targets as well
as opportunities enhanced
my capabilities.“
important in order to ascertain where
we need to give more support and to
improve activities so that our overall
success will be accomplished in the
best way. The approach which has
been chosen has proved to be successful and brings us closer to our aim to
move through the times of change and
to develop into one Animal Health
dr seiji yamasaki
plant manager
boehringer ingelheim seiyaku
business in the future.
[ china ]
“A company with a human face, strongly
focused on people, has been for me the
perfect place to develop myself and even
more, to develop others.”
sebastien blang
director, quality & environment
health & safety
34
Boehringer Ingelheim annual report 2010
[ germany ]
Employer of choice
The attractiveness of Boehringer Ingelheim as an employer of choice has for
some years been widely acknowledged.
in highly regarded, independent surveys.
The attractiveness as a workplace is not
a matter of chance, but reflects the distinctive, innovative corporate culture
“Boehringer Ingelheim has constantly
enabled me to develop my technical and
managerial skills by giving me the
opportunity to lead challenging projects
and diverse teams, both locally and
abroad, combined with excellent
coaching and mentoring.”
g.”
oliver sluke
head of is service management
nt
and a working environment built on
mutual respect and fairness that Boehringer Ingelheim has fostered throughout its 125-year history.
It also confirms the scientific community’s appreciation of the company’s
long-term commitment to research and
development.
Sample of Awards 2010
Country
Ranking
Austria
Denmark
Survey
Certification berufundfamilie gGmbH
15
Germany
Great Place to Work
Recertification berufundfamilie gGmbH
2
Japan
Corporate Health Award 2010 (Initiative of Handelsblatt, EuPD Research and TÜV SÜD Life Service)
JMA (Japan Management Association)
HRD Excellence Award
Great Place to Work
South Korea
1
Netherlands
UK
Korea-EU Awards
Top Employer (CFR Institute)
1
USA
PharmaField Survey
Best Places to Work for LGBT Equality - 100% Corporate
Equality Index (Human Rights Campaign Foundation)
Working Mother 100 Best Companies
Gold Award
Our apprentices
Boehringer Ingelheim’s human resources programmes also focus on apprenticeships. To
ensure and develop bench strength for the
future, Boehringer Ingelheim Germany gave
699 young people vocational training within
the company’s highly regarded and well-established apprenticeship programmes.
American Health Association
Organisational development
35
corporate responsibility
Our employees
Evolution of the workplace
Implementation of a new workplace model and
new office structures.
What will the future workplace look
While assistants in the group offices
viduals (Me space) arranged more
like at Boehringer Ingelheim?
will continue to work in clearly desig-
flexibly and the additional common
Answers to this question should be pro-
nated offices and serve as an anchor
areas (We space), such as meeting
vided by the initial experiences gained
point, other employees will take part
rooms, touchdowns and lounge areas,
from the introduction of a new work-
in desk-sharing. The great advantage
benefitting all employees and also
place model by our Corporate Prescrip-
is that the available offices are used
fostering informal exchanges and
tion Medicines Marketing Division and
more efficiently and that additional
greater interaction. Part of the work-
a new office space structure in the Re-
space is gained. The 13 additional
places in the new function Regional
gional Business Services Europe De-
meeting rooms and the videoconfer-
Business Services Europe are located
partment in Ingelheim, Germany.
ence room in particular have proved
in open space structures in which
very popular. The lounge area has also
each employee is designated a fixed
been well-received as a meeting point
place, as previously. The model is
for informal exchanges.
based on a flexibly adjustable workplace form from which very different
Overall, the workplace model adheres
spatial formations can be produced.
to Boehringer Ingelheim’s Me/We
Thus, an individual configuration can
concept, with the workplaces for indi-
be developed for each team.
A significant component of the new
office design models are the cubes,
New office structures at
Boehringer Ingelheim.
which represent a mixture of meeting
room and teamwork room. These
cubes are partially glazed spaces
which are arranged between the openform workplaces. They offer teams
variable working options, from
planned meetings to informal, spontaneous communication and intensive
project work.
36
Boehringer Ingelheim annual report 2010
Combining job and family
At all times, Boehringer Ingelheim has set great importance on being
a family-friendly company. Successfully combining work and family
is very important for our employees with family responsibilities, as
well as for Boehringer Ingelheim.
Attracting and keeping employees is
The programme of the BI-Ferienakade-
becoming increasingly important for
mie supports the childrens’ education
Boehringer Ingelheim. Demographic
and provides relief for their mothers
change with a constantly aging popu-
and fathers. A comprehensive range of
lation and a simultaneously declining
projects offers something for every-
birthrate, leads to a consequent de-
one, from fostering language or artis-
cline in skilled workers.
tic skills to sporting activities.
Successfully combining work and
Through play, linking care and educa-
family is at the same time becoming
tion, the knowledge of the children
very important for employees with
taking part is expanded and their com-
family responsibilities, as well as for
petence fostered. The choices for the
employers like Boehringer Ingelheim.
children also provide the opportunity
At our German locations we support
to be involved in natural science sub-
our employees in a variety of ways, for
jects, which are often given short
example with the BI-Ferienakademie
shrift in the regular school day.
school holiday academy for employees’ children.
Family-friendliness – berufundfamilie
gGmbH (career and family) certification
Holiday academy as a learning
At all times, Boehringer Ingelheim has
opportunity
attached great importance to being a
During the long summer school holi-
family-friendly company. To continue
days, combining job and family
to ensure that we are enabling our em-
presents a particular challenge for
ployees a good work-life balance, we
parents, to cover the care needs of
have subjected our personnel policy to
their children.
a recurring external audit. In 2010,
Boehringer Ingelheim was
audited and again awarded a
certificate by the berufundfamilie
gGmbH foundation.
Boehringer Ingelheim was audited and
At the Ingelheim site, Boehringer In-
again awarded a certificate of the high-
gelheim, in cooperation with the town
ly respected berufundfamilie gGmbH
of Ingelheim, offers an exciting and
foundation.
interesting course for 340 children in
various age groups.
Evolution in the workplace / Combining job and family
37
corporate responsibility
Sustainability
Sustainability
In all our endeavours, we safeguard our employees,
facilities and the environment from harmful influences.
38
Boehringer Ingelheim annual report 2010
Environment, health
and safety
As with any type of production, the manufacture of medicinal products
inevitably has an impact on the environment. It is thus the express aim
of our Leitbild (guiding principles) to keep this impact to a minimum. At
the same time, we make every endeavour to guarantee the protection of
our employees
Protection of employees’ health:
In the last few years, Boehringer Ingel-
rollout of new safety culture –
heim’s accident statistics have shown
Zero by Choice
stagnation. Zero By Choice makes the
2010 marked the start of the interna-
reduction of work related accidents
tional roll-out of the new Boehringer
one of our most important goals. In
Ingelheim safety culture Zero by Choice
2010, we committed ourselves to the
covering our worldwide organisation.
following roadmap for the ahead
years: to reduce the safety indicator
Zero by Choice
Zero by Choice is our new approach to
Accident Frequency Rate (number of
safety, involving management and em-
accidents per million working hours)
ployees as key players. Both manage-
from above 3 in 2009 to a rate of less
ment and employees are asked to pro-
than 1 by 2014. The first step towards
actively take on the responsibility of
this medium-term goal was to reach an
their own well-being and also look out
accident frequency rate of 2.6 in 2010.
An example how our US site in
Petersburg, Virginia, reinforced our
Zero by Choice culture and increased the safety awareness of
our employees was the sponsoring
of Safety Pit Stops. As employees
arrived at work, they were given
the option of driving through the
pit and having basic safety items
on their private cars checked.
for others working around them. The
vision of Zero by Choice is to move to
How will we make the change?
an organisation where safety is one of
Management has committed itself to
our true values.
being on the frontline and gives the
new safety culture its full support. Em-
Choice or chance
ployees are being encouraged to be-
On a daily basis, employees encounter
come more proactive, talk about the
multiple situations where they have
topic of safety and voice their points of
the opportunity to make a decision
view.
about the safety of a task at hand. Do I
take a short-cut, or do I take the extra
time to do the job safely? In order to
reduce the number of accidents, we
need to shift our ‘by chance’ culture to
one of ‘by choice’.
Environment, health and safety
39
corporate responsibility
Sustainability
At a site level, the initiative was rolled
and will foster talent management. In
out in four countries in 2010. Further
2011 this model is planned to be ex-
countries will follow within the next
tended to Marketing & Sales.
few years, according to our rollout
plan. Functions at the sites will go
Energy efficiency
through a workflow comprised of vari-
As a pharmaceutical company, Boeh-
ous steps, such as self-assessments to-
ringer Ingelheim does not operate in
gether with management and setting
an energy-intensive sector. However,
up specific improvement plans.
we consider reducing energy consumption and greenhouse gas emissions to
EHS management approach
be one of our important goals, and we
Protecting our employees and the en-
thereby contribute to preventing cli-
vironment is a crucial cornerstone of
mate change. In addition, energy being
our business. This is reflected by our
a growing cost factor, we see efficiency
Leitbild, as well as our safety, quality
improvements as an important driver
and environmental protection princi-
for cost reduction.
ples. We regularly set out policies, procedures and objectives for environ-
In order to maximise energy efficiency
mental protection, health and safety
and the use of renewable resources,
(EHS) at corporate level. Environmen-
the scope of the Boehringer Ingelheim
tal protection and safety at our pro-
Working Group on Sustainable Use of
duction plants is organised within
Energy was in 2010 reviewed and re-
management systems established ac-
defined. The working group was as-
cording to international standards.
signed to create a comprehensive
Regular internal audits serve to check
framework for a sustainable and sys-
the status of environmental protection
tematic energy management at all levels
and safety at our sites as well as to ex-
of our organisation. Based on this
change and align different views. In
framework, we are going to set our-
addition, specific projects and site per-
selves an ambitious goal for reduction
formances are tracked by a systematic
of our CO2 emissions. A main objective
approach built on key performance in-
of the working group is to set up a cor-
dicators.
poration-wide greenhouse gas reporting system in accordance with the
In 2010, a new EHS governance model
Greenhouse Gas Protocol and energy
was been established combining re-
audits are planned. The working group
gional and functional EHS manage-
will implement and evaluate future en-
ment structures. Existing networks
ergy concepts at our sites and will foster
within Operations were extended to
the initiation and realisation of at least
further operational as well as research
one major energy-saving project per
and development functions. This ap-
production site per year.
proach will ensure the transfer of EHS
knowledge best practices within the
Boehringer Ingelheim organisation
40
Boehringer Ingelheim annual report 2010
Examples of ongoing energy efficiency
waste and energy consumption. Meas-
projects
ures realised in 2010, such as optimi-
At our site in Ingelheim, Germany, opti-
sation of the steam supply, are expect-
misation of air-conditioning systems in
ed to reduce local CO2 emissions by
2010 is expected to yield an estimated
2%. For 2011, an additional decrease
annual reduction of 2,000 tonnes of
of CO2 of 4% is expected to be
CO2 and EUR 1 million worth of energy
achieved.
The new approach to safety culture was
discussed among Boehringer Ingelheim
employees at the rollout event for the
Zero by Choice initiative.
costs.
Campaigns such as the 3rd Annual
At corporation level, the project Green
Green Fair at our site in Ridgefield,
Building was initiated to provide sug-
USA, highlight actions employees and
gestions for investment projects to in-
the company can and are undertaking
crease energy efficiency. In addition, a
to save energy and resources. Green
classification in terms of profitability
alternatives to a variety of daily activi-
and costs for reduction of CO2 emis-
ties are promoted. The focus of this
sions is going to be introduced.
fair is to inform employees and feed
suggestions and improvement ideas
In cooperation with local authorities,
from employees back to the company
our site in Vienna, Austria, started
for evaluation. Such initiatives help
Ökoprofit® (Eco-profit) projects with
raise the general awareness of the im-
the focus on measures for reduction of
portance of saving energy.
Environment, health and safety
41
corporate responsibility
Sustainability
What we expect from our suppliers
ing measures for 2011 are planned to
From our suppliers and contract man-
increase the efficiency and capacity of
ufacturers, we expect certain require-
the treatment. Our pharmaceutical site
ments to be met in terms of environ-
in Mexico implemented additional tech-
mental protection and safety and with
nical equipment at its sewage treatment
regard to social topics. These aspects
plant (aeration and disinfection devices),
are taken into consideration when we
improving the treatment efficiency. The
evaluate our suppliers. In 2010, we es-
effluent of this plant is used to irrigate
tablished new supplier qualification
green areas, thus saving 31,000 m3 of
processes by, for example, introducing
drinking water per year.
a risk-based approach for auditing our
business partners.
Pharmaceuticals in the environment
Product responsibility requires the
At the annual Green Fair at our
site in Ridgefield, USA, employees are encouraged to bring in
their ideas and suggestions regarding environmental topics
such as energy efficiency.
Conserving water quality and
implementation of environmental risk
availability
assessments for all newly launched
The availability of safe water is essential
drugs. Going beyond the official re-
for a healthy and successful society.
quirements for the authorisation of
Boehringer Ingelheim strives to protect
medicines, we voluntarily publish in-
the environment by minimising the im-
formation of environmental risk for our
pact of its operations on fresh water. Our
existing products via the Swedish Doc-
production sites keep their sewage treat-
tors Prescribing Guide (www.fass.se)
ment plants working efficiently to en-
using the disclosure system of the
sure a good water quality of effluents
Swedish Association of the Pharma-
reaching water sources. For example, our
ceutical Industry.
plant in Indonesia reconditioned its
treatment plant in 2010. Further upgrad-
Crisis management
Boehringer Ingelheim has a crisis
management system implemented on
a worldwide basis. Our proactive approach is designed to examine potentially critical situations, prevent incidents and keep them from escalating
to critical levels. Specific risks are
identified and evaluated on the basis
of various crisis scenarios. Crisis team
members are constantly trained to
maintain and extend their readiness
and skills, all emergency management
plans are reviewed and technical facilities are checked regularly. There were
no major incidents within the Corporation in 2010.
42
Boehringer Ingelheim annual report 2010
Awards and certifications
In 2010, the environmental manage-
Work accidents
ment system at our chemical site in
Total work-related accidents: 195 (fatality: 2)
Lost labour days: 2.997
Petersburg, Virginia, USA, received
100
ISO 14001 certification, following in
80
the footsteps of our other chemical
60
sites in Spain, France and Italy. During
2010, our chemical site in Spain additionally received certification accord-
40
5
4
ing to OSHA 18001. Our pharmaceuti-
3
cal production site in Bogota, Columbia,
2
was certified according to ISO 14001
1
for the first time. Our plant in Columbus, US, has been awarded the 2010
ENERGY STAR® by the US Environ-
2006
2007
2008
2009
2010
Frequency rate (= accidents x 1 million hours/total labour hours)
Severity rate (= lost labour days x 1 million hours/total labour hours)
mental Protection Agency for superior
energy management. The ENERGY
STAR® is the distinguishing mark of
energy efficiency for pharmaceutical
to less than 1 in 2014. Our roadmap
manufacturing plants in the United
towards this goal required us to reach
States and identifies our plant’s status
an accident frequency rate of 2.5 in
among the most energy-efficient based
2010. We almost achieved this goal,
on its performance in EPA’s National
achieving a rate of 2.6.
Energy Performance Rating System.
Boehringer Ingelheim Indonesia re-
With regard to energy efficiency and
ceived an award from the Ministry of
carbon footprint, we intend to set our-
Manpower and Transmigration for
selves an ambitious goal for reducing
having succeeded in operating without
our global CO2 emissions.
a lost-time workplace accident from
July 2007 to December 2009. Our sites
Facts and figures
in Petersburg and Fornovo, Italy, re-
The graphs show our performance re-
ceived a Safety Excellence Award pre-
lated to the environment and worker
sented by Jacobs Engineering in recog-
safety for the last five years. The im-
nition of the high level of commitment
pact on the environment is described
to safety demonstrated by the project
both in absolute figures as well as nor-
teams on two complex construction
malized in relation to the annual sales
projects.
volumes (indices with 2006 as base
year). To evaluate our environmental
Our goals
performance, we considered our pro-
Our target for worker safety is the
duction as well as research and devel-
reduction of the accident frequency
opment sites. The figures for 2010 re-
rate (number of accidents per million
flect changes relating to our sites. Our
working hours) from above 3 in 2009
pharmaceutical production facilities
Environment, health and safety
43
corporate responsibility
Improvement of efficiency and flexibility and
a maintenance of our good chemical oxygen
demand (COD) degradation rates was made
possible, even for higher production, by the
expansion of the wastewater treatment plant
in Ingelheim, Germany.
Sustainability
in the United Kingdom and Colombia
as water consumption, indirect CO2
were therefore no longer included in
emissions and hazardous waste slight-
the consolidation, whereas, for the
ly increased compared to 2009. This
first time, our new Animal Health pro-
can be attributed to the inclusion of
duction site in Fort Dodge, USA, is re-
our new production site in Fort Dodge
flected in the figures.
in the consolidation.
The key parameter for our perform-
The indirect CO2 emissions presented
ance in occupational safety is the acci-
in the graph refer to the emissions
dent frequency rate (work related acci-
generated due to the consumption of
dents with one or more absence days
purchased electricity. The CO2 emis-
in relation to hours worked). Over the
sions attributable to our company car
last few years, this rate remained
fleet were estimated to be approxi-
slightly above three. By obtaining a
mately 86,000 tonnes. Currently, we
frequency rate of 2.6 in 2010, we suc-
are setting up a revised approach how
ceeded for the first time in reaching a
to calculate our corporate carbon foot-
rate of below 3. This is an important
print, with the aim of including addi-
achievement made possible by the roll-
tional indirect emissions in our calcu-
out of our new safety culture.
lations in future.
In 2010, the levels of most of our environmental indicators were kept in the
same order of magnitude compared to
previous years. Some indicators, such
44
Boehringer Ingelheim annual report 2010
Water
Energy
100
100
90
90
80
80
70
70
60
60
8
8
6
6
4
4
2
2
2006
2007
2008
2009
2010
2006
Water consumption (in millions of m3)
Water consumption index (in %, relative to sales volume)
2007
2008
2009
2010
Energy consumption (in millions of gigajoules)
Energy consumption index (in %, relative to sales volume)
Wastewater – chemical oxygen demand (COD)
Disposed waste
120
120
100
100
10,000
80
28,000
80
60
24,000
60
40
20,000
8,000
16,000
6,000
12,000
4,000
8,000
2,000
4,000
2006
2007
2008
2009
2010
2006
2007
2008
2009
2010
Domestic waste (in tonnes)
Hazardous waste index incl. pharmaceutical waste
Disposed waste index (in %, relative to sales volume)
Recycling rate (in %)
COD load before treatment (in tonnes)
COD load after treatment (in tonnes)
COD load (after treatment) index
(in %, relative to sales volume)
Volatile organic carbon (VOC)
Carbon dioxide (CO2)
100
100
90
80
80
60
40
70
1000
20
200
800
0
150
600
100
400
50
200
250
60
2006
2007
2008
2009
CO2 indirect emissions (in 1,000 tonnes)
CO2 direct emissions (in 1,000 tonnes)
CO2 emissions index, direct emissions
(in % relative to sales volume)
2010
2006
2007
2008
2009
2010
VOC emissions, non-halogenated (in tonnes)
VOC emissions, halogenated incl. Chlorofluorocarbons
(in tonnes)
VOC emissions index (in %, relative to sales volume)
Environment, health and safety
45
corporate responsibility
Corporate Citizenship
Corporate Citizenship
We seek to foster economic and social well-being in the countries
and communities in which we do business. Our activities embrace patients, neighbouring communities and society at large.
Corporate citizenship is an integral part of our corporate culture.
46
Boehringer Ingelheim annual report 2010
Cooperations and projects
Throughout the world, Boehringer Ingelheim employees, as individuals,
and the company, as a good corporate citizen, are engaged in many
activities, including child protection, healthcare projects, educational
programmes, environmental protection and emergency aid.
Access to medicines
preserving the health of more than
Boehringer Ingelheim is committed to
two million babies born to HIV-posi-
improving access to medicines in least
tive mothers throughout the develop-
developed countries. In particular, the
ing world. In the intervening decade,
company has an overarching commit-
medicine sufficient for the manage-
ment to combating the devastating
ment of more than two million moth-
AIDS pandemic through its engage-
er-child pairs in 171 programmes
ment for the prevention of mother-to-
stretching over 71 countries were do-
child transmission (MTCT) of HIV/
nated to PMTCT projects throughout
AIDS.
the world. For the baby dose, oral dis-
> 2m
More than 2 million mother-child
pairs were donated to PMTCT
projects.
pensers and pouches for the filled disThe Viramune® Donation Programme
penser were included in the package.
On the occasion of World AIDS Day in
2000, Boehringer Ingelheim publicly
During this period, Boehringer Ingel-
announced that its antiretroviral vira-
heim has been proud to work closely
mune® (active ingredient nevirapine)
with governments, medical experts
would be offered free of charge for a
and NGOs in various parts of the
period of five years, as part of a dona-
world to prevent the transmission of
tion programme to developing coun-
HIV from the HIV-positive mother to
tries for the prevention of mother-to-
her offspring.
child transmission (PMTCT) of HIV-1.
The donation would be provided within
The medical evidence for the success-
reliable, local projects on MTCT, with
ful use of viramune® in the prevention
voluntary counselling and testing
of PMTCT indicated that viramune®, a
(VCT), to health facilities for pregnant
potent non-nucleoside reverse tran-
women and healthcare for mothers and
scriptase inhibitor, when given as a
babies. The initiative was called the vi-
single dose to the mother during la-
ramune® Donation Programme (VDP).
bour and to the infant within 72 hours
of birth, could significantly reduce the
Since its inception, the viramune® Do-
transmission of HIV from the positive
nation Programme has contributed to
mother to her baby.
Cooperations and projects
47
corporate responsibility
Corporate Citizenship
This recommendation was included
Additionally, the 240 ml pack of vira-
early on the World Health Organiza-
mune® oral suspension will now be of-
tion (WHO) List of Essential Drugs for
fered for use in PMTCT programmes at
use in the reduction or prevention of
a not-for-profit price.
MTCT of HIV-1.
Since inception, Boehringer Ingelheim
Over the ten years since the start of
has been proud of its viramune® Do-
the viramune® Donation Programme,
nation Programme and the pioneering
there have been new developments
contribution it has made to controlling
and new insights into the therapies
the transmission of HIV-1 from moth-
that can be offered to reduce PMTCT
er to child. It has valued the partner-
of HIV-1 even further.
ships it has developed and the support
it has received from healthcare work-
Single-dose nevirapine, as employed in
ers and governments throughout the
the viramune® Donation Programme
world involved in this very worthwhile
and included in the earlier WHO
programme. The company is fully com-
guidelines, is no longer considered as
mitted to continuing supporting ef-
an appropriate approach for this pur-
forts to eliminate MTCT.
pose.
Extended access to nevirapine through
In the light of these modified guide-
the non-assert declaration policy
lines, Boehringer Ingelheim will pur-
Products containing the active ingredi-
sue its commitment, but in a modified
ent nevirapine are widely available in
form.
the developing world from a number
of generic manufacturers. Over the
71
The PMTCT programme
stretches over 71
countries.
Where countries experience difficulties
last four years, Boehringer Ingelheim
in the transition to the new guidelines,
has granted non-assert declarations to
Boehringer Ingelheim will provide in-
generic manufacturers pre-qualified by
terim assistance, on request, to the
the WHO, to manufacture products
sites the company has supported in
containing nevirapine. The policy ap-
the past, with supplies of viramune®
plies to all low-income countries, all
tablets and suspension until the end of
least developed countries (LDC) and all
2013.
African countries, 78 countries in total. It has led to an increase in patients
The decision to transform the current
being treated with medicines contain-
approach to PMTCT will not cause sup-
ing nevirapine.
ply problems. Other products contain-
48
ing the active ingredient nevirapine,
The policy stipulates that patents will
both tablets and oral suspension, are
not be enforced, that no royalties
now widely available in the developing
have to be paid and, most important-
world from a number of appropriately
ly, that high product quality will be
qualified generic manufacturers.
ensured.
Boehringer Ingelheim annual report 2010
Physician at work at the medical office of the
Inkanyezi catholic missionary station, Orange
Farm, South Africa.
Patients at the medical office of the missionary station.
Technology transfer and human
Further developments related to the
resources development
Access to Antiretroviral Drugs (ARVs)
In addition, Boehringer Ingelheim en-
In the area of research and develop-
gages in healthcare-supporting activi-
ment, Boehringer-Ingelheim has de-
ties, such as human resources develop-
veloped and launched an extended re-
ment and capacity building through
lease form of its HIV drug, viramune®
training and education in various
(nevirapine), in 2010 (see chapter Our
ways, including:
Business). Additionally, a pediatric ver-
Prevention of MTCT is the aim of the Viramune® Donation Programme.
sion of its other antiretroviral (ARV),
• Training of paramedical/
laboratory staff
• The Boehringer Ingelheim Endowed
Chair in Clinical Pharmacology
aptivus® (tipranavir), has been available since 2009 (see glossary). Both
medications qualify for the non-assert
scheme.
• The Botswana Clinical Trial
Programme
• The Boehringer Ingelheim
Facilitation and Training Centre
• Pharmacy Students at Rhodes
University
• The Boehringer Ingelheim Lung
Institute
External recognition by the Access to
Medicine Foundation
In the 2010 survey and ranking of
the Access to Medicine Foundation,
Boehringer Ingelheim ranked 12th
out of 20 pharmaceutical companies
under review for its viramune® Dona-
• BI Medical Students Programme
tion Programme, its non-exclusive
• Clinical Epidemiology Fellowship
voluntary licensing actvities and its
• ICEM Aids workplace programme in
non-assert declaration policy.
India
The Access to Medicines Index is
an initiative of the Access to
Medicine Foundation.
www.accesstomedicineindex.org
For more information, see
corporateresponsibility.boehringeringelheim.com
Cooperations and projects
49
corporate responsibility
Corporate Citizenship
Local cooperations and projects
Our employees in the operating units cooperate with local
organisations. The following are examples of some of our
regional activities.
Cooperation partners Cliniclown
Cooperation with Banco Farmaceutico
In Belgium, Boehringer Ingelheim
In Italy, Boehringer Ingelheim has for
employees helped a local much-loved
many years been supporting Banco
and highly respected organisation,
Farmaceutico, a non-profit association
Cliniclowns, whose motto is “laugh-
which collects pharmaceutical products
ing is recovering”. Since 1994, this or-
from pharmaceutical companies and
ganisation’s professional clowns have
individuals for distribution to various
been visiting children in hospitals to
institutions that assist people in need.
bring some joy and happiness to
young patients in difficult circum-
Boehringer Ingelheim Italia helps in
stances.
particular by providing winter season
products, such as treatments for influ-
Boehringer Ingelheim employees col-
enza and coughs.
lected money for Cliniclowns by tak-
Belgium:
Laughing is recovering with
Cliniclowns.
ing part in different activities, from
Cooperation with DREAM
car-washing to selling gadgets, and by
Additionally in Italy, the company
making certain savings.
cooperates with DREAM (Drug Resources Enhancement against Aids and
Cooperation with St John Ambulance
Malnutrition), an AIDS therapy pro-
In the UK, Boehringer Ingelheim
gramme promoted by the christian
teamed up with its local newspaper,
community of Sant’Egidio aimed at
The Bracknell News, and the leading
preventing, treating and reducing the
first aid charity, St John Ambulance,
prevalence of this infection in coun-
to sponsor a series of free Child Life-
tries in Africa. The programme also
saver workshops for parents, grand-
provides training to local doctors,
parents and carers in the local com-
nurses and other specialised health-
munity. The free workshops covered
care personnel. Boehringer Ingelheim
lifesaving topics, including uncon-
Italia’s support is specially devoted to
scious, choking and non-breathing in-
a ten-year scholarship programme for
fants. All attendees got the chance to
two local researchers.
practice cardio-pulmonary resuscitation on life-size baby and toddler
Cooperation with Fundació Ictus
manikins.
In Spain, Boehringer Ingelheim,
along with Fundació Ictus, and the
50
Boehringer Ingelheim annual report 2010
Government of Catalonia’s Depart-
was sufficient to purchase ten modern
ment of Health and Barcelona City
multimedia class boards and 20 laptop
Council, organised a conference
computers . One-year scholarships for
aimed at offering citizens an educa-
four students were also funded and
tional explanation of what our brain
the cooperation with the school is on-
is and how to look after it, as well
going.
knowing how to act in situations
where there a risk of ictus. The inter-
Cooperation with Cadena de Ayuda
active exhibition Què tens al cap?
In Mexico, Boehringher Ingelheim
(What’s in your head?) was organised
was part of the initiative Cadena de
at the Plaça Nova in front of Barcelo-
Ayuda (Aid Chain), supporting some
na cathedral.
institutions in the implementation of
Hungary:
more than 3,000 houses in three
villages were damaged by the
toxic flood.
initiatives to fight malnutrition in
Cooperation with Agaliazo Group
children up to five years of age. Mal-
Volunteers Against Cancer
nutrition in this context also includes
In Greece, Boehringer Ingelhiem pro-
children suffering from overeating. In
vided funds to the Agaliazo Group
Mexico, it is estimated that one in eight
Volunteers Against Cancer for confront-
children have impaired life chances
ing patient problems and informing
due to malnutrition. Two projects
people about cancer prevention.
were given funds to benefit thousands
of children who face malnutrition.
Cooperation with the Hungarian
Ecumenical Charity Service
Cooperation with Transparencia
In Hungary, Boehringer Ingelheim
Mexicana
employees, via the Hungarian Ecu-
Additionally, Boehringer Ingelheim
menical Charity Service, helped vic-
cooperated with the intervention of
tims of the toxic sludge catastrophe in
Transparencia Mexicana, a civil society
Veszprém County, donating pharma-
organisation that fights corruption in
ceuticals to local hospitals and finan-
Mexico.
Mexico, Cadena de Ayuda:
fight against malnutrition in
children.
cial assistance to towns affected by the
catastrophe.
Cooperation with flood-hit school
In response to devastating floods,
Boehringer Ingelheim employees
raised funds to buy cleaning products
and dry food, delivering them to the
community of Wilków in southeast
Poland. Boehringer Ingelheim also
made a financial donation to the
Wilków public school complex for
buying new equipment for the chemistry and language labs. The support
Local cooperations and projects
51
corporate responsibility
Corporate Citizenship
Cooperation with Associação Arte
Cooperation of Cares Foundation with
Despertar
Direct Relief International
In Brazil, Boehringer Ingelheim en-
As part of it’s ongoing commitment to
tered into a partnership to support
helping individuals and families in
Associação Arte Despertar, a non-
times of natural disaster, Boehringer
profit organisation, through a project
Ingelheim Cares Foundation (BICF)
that aims at “health humanisation” in
partnered with Direct Relief Interna-
two major hospitals serving the lower
tional (DRI) to provide products for
income population in São Paulo: Insti-
DRI’s Hurricane Preparedness Pro-
tuto do Coração do Hospital das Clíni-
gram in 2010.
cas da Faculdade de Medicina da Universidade de São Paulo and Irmandade
Boehringer Ingelheim products were
da Santa Casa de Misericórdia de São
packaged with other manufacturers’
Paulo.
products and pre-positioned at 30 preselected clinics in the US Gulf Coast to
Four times a week, two art teachers, a
support DRI’s healthcare provider
psychologist and a pedagogist work in
partners that care for vulnerable pop-
the different areas of the hospital,
ulations in hurricane-prone areas.
bringing music, storytelling and visual
Each of the US packs was stocked with
arts to patients, caregivers and health
enough materials to treat 100 patients
professionals.
for 3-5 days.
DRI has been pre-positioning emergency supplies for hurricane season
and assisting in emergency planning
since 2007 in partnership with the
Texas Association of Community
Health Centers, the Louisiana Primary
Care Association, the Mississippi Primary Health Care Association, and
long-time partners in the Caribbean.
Medical facilities receiving packs are
selected for their location, past experience with emergency response, vulnerability of patient population, and
capacity to treat victims during a disaster. If a hurricane hits, resources are
already in place so that healthcare
providers have immediate access to
medicines and supplies in their greatest time of need.
Brazil: project for “health humanisation” in two major hospitals.
52
Boehringer Ingelheim annual report 2010
United Way Day of Caring in the USA:
employees of Boehringer Ingelheim packed
medications to help people impacted by
natural disasters.
Boehringer Ingelheim Cares Volunteer
Day of Caring. In 2010, more than 125
Match
employees spent the day engaged in
Boehringer Ingelheim employees
projects that helped improve the lives
across the USA volunteered more than
of individuals and families in our
13,100 hours of their time in 2010 to
community.
help individuals and families in the
community, exceeding the company’s
Activities for the 2010 Day of Caring
2010 goal of 10,000 volunteer hours.
included clean-up and repair of local
parks and hiking trails, painting and
The goal was set in April 2010 during
home repair at a local safe-house for
National Volunteer Week as the com-
women and children, and painting
pany introduced Boehringer Ingelhe-
and gardening at a facility that helps
im Cares Volunteer Match – an online
families and children cope after the
employee engagement system that
loss of a loved one.
measures and tracks employee volunteer activity and provides access to lo-
Across the USA, employees volun-
cal volunteer opportunities.
teered their time to help various nonprofit organisations during the United
United Way Day of Caring
Way Day of Caring. They built more
Each year, teams of Boehringer Ingel-
than 50 bicycles for needy children,
heim Pharmaceutical Inc. employees
painted 20 murals that will decorate
take part in the annual United Way
the hallways of hospitals in the USA,
Local cooperations and pojects
53
corporate responsibility
Corporate Citizenship
United Way Day of Caring in the USA:
Boehringer Ingelheim employees assembled
more than 50 bicycles for needy children.
assembled and donated 2,000 person-
ees quickly made donations in money
al care kits to help people impacted by
and in kind, delivering materials to two
natural disasters, served more than
middle schools in the quake-hit areas
10,000 meals to hungry families in
through a local charity organisation. A
the community, helped build new
substantial cash donation raised by the
homes, raised funds for breast cancer,
staff and the company was donated to
diabetes and childhood obesity
Shanghai Red Cross Society to help the
awareness programmes and supplied
victims in Yushu.
backpacks and other school supplies
to needy children.
In September 2010, a new hospital,
now named Lingxing Boehringer
Employees also donated their time to
Ingelheim Hospital, was inaugurated
help the Regional Hospice of Western
in Lingxing Town, Mian Yang City in
CT raise funds to help patients and
Sichuan Province. It was constructed
their families and provided medical
with the help of donations from
services at Boehringer Ingelheim
Boehringer Ingelheim China and its
AmeriCares Free Clinic. In total,
employees. The original municipal
Boehringer Ingelheim employees do-
hospital was badly damaged in the
nated their time and talents to more
2008 earthquake.
than 400 different non-profit organisations across the country.
China:
Lingxing Boehringer Ingelheim
Hospital was constructed with
the help of donations of employees from Boehringer Ingelheim
China.
Cooperation with Shanghai Red Cross
Society
Boehringer Ingelheim China employees responded rapidly to the magnitude 7.1 earthquake that struck Yushu
in Qinghai Province in April 2010,
leading to a great loss of life. Employ-
54
Boehringer Ingelheim annual report 2010
Partnership with academic research
Boehringer Ingelheim regards its cooperation with academic research
and its involvement in public-private partnerships as active citizenship,
as service to society.
Pharmaceutical biotechnology –
Ten of the graduates have decided to
cooperation with a German university
enter the profession. One of the female
In the pharmaceutical biotechnology
pharmaceutical biotechnology gradu-
faculty of Biberach University of Ap-
ates, Martina Stehmer, has already been
plied Sciences in Biberach, Germany,
employed at Boehringer Ingelheim. She
the bachelor degree course in pharma-
did her practical semester and her sub-
ceutical biotechnology has since 2006
sequent graduate work at the company.
been orientated towards the development and production of biopharma-
Graduates can now also pursue fur-
ceuticals. As a public-private partner-
ther qualification in the field of phar-
ship, with Boehringer Ingelheim as its
maceutical development and produc-
industrial partner, the study pro-
tion. In a cooperation with Biberach
gramme remains unique in Germany.
University and Ulm University, a joint
In the winter semester 2010, 211 stu-
masters programme in pharmaceutical
dents were enrolled.
biotechnology was established in 2010.
Twenty-two students enrolled for the
Biberach University held its first grad-
winter semester 2010.
uation ceremonies in 2010, with a total of 56 biotechnologists receiving
Based on a good bachelor-level educa-
their bachelor of science degrees at ac-
tion in pharmaceutical biotechnology,
ademic celebrations.
biochemistry and biology with a focus
on molecular biology, or a study
Pharmaceutical Biotechnology
graduates 2009/2010
Good networking between the university and industry from the outset
has provided students with many insights into practices involved, in lectures by representatives of industry,
site visits , and finally a practical semester in which students can, among
other things, show their ability at
Boehringer Ingelheim’s research site
in Biberach.
Partnership with academic research
55
corporate responsibility
Now a Boehringer
Ingelheim employee,
Martina Stehmer,
pharmaceutical biotechnology graduate
from the first batch
of graduates, winter
semester 2009/10.
Corporate Citizenship
course with essentially the same con-
Some 150 years ago, Rudolf Virchow,
tent, the masters study programme is
the German biologist , sometimes
orientated towards research, develop-
called the father of social medicine,
ment and production. The academic
established that every organism con-
goal of the programme, lasting four
sists of cells – omnis cellula e cellula –
consecutive semesters, is a master of
and that the only source for a living
science (M.Sc.) qualification in the
cell is another living cell. Just how a
field of pharmaceutical biotechnology
cell manages to divide flawlessly time
which, among other things, paves the
after time has fascinated biologists
way to studying for a doctorate.
ever since.
At Biberach University, the Institute
It is of vital importance for a living or-
for Pharmaceutical Biotechnology,
ganism that the process of cell division,
founded in 2007, is at the disposal of
or mitosis, is tightly controlled by the
the masters degree programme. In
cells’ internal mechanisms. The slight-
close cooperation with Boehringer In-
est mistake can result in a tumour, or, if
gelheim as their industrial partner,
it occurs during reproduction, be the
and with national and international
cause of infertility or birth defects.
universities, the institute handles research projects in biopharmaceutical
Leading European cell cycle research
production processes.
For over 20 years, scientists at the
IMP, have been investigating cell divi-
The Institute of Molecular Pathology
sion, acquiring a wealth of expertise
The IMP is a basic biomedical research
and gaining an international reputa-
centre sponsored largely by Boehringer
tion in the field of molecular cell biol-
Ingelheim. Internationally regarded as
ogy.
a centre of excellence in molecular biology and genetics, the institute focus-
MitoCheck - coordinated by the IMP
es its research on molecular and cell
In 2004, the European Commission
biology, including structural biology,
launched MitoCheck, an international
disease mechanisms, and the emerging
research initiative on cell cycle regula-
field of circuit neuroscience. It further
tion, coordinated by the IMP.
aims to promote interdisciplinary research, bringing together expertise in
The project brought together leading
optical engineering, computation, and
scientists from eleven research insti-
bioengineering.
tutes, universities and industry in Austria, Germany, the UK, Italy and
56
At its site in Vienna, Austria, the IMP
France. Under the guidance of Jan-
cooperates closely with the Institute of
Michael Peters, Senior Scientist at the
Molecular Biotechnology of the Aus-
IMP, they joined forces to address a
trian Academy of Sciences (IMBA) and
question that no single research group
other research institutions of the Cam-
could have tackled, namely to find
pus Vienna Biocenter.
each and every gene and protein in-
Boehringer Ingelheim annual report 2010
volved in the process of cell division.
The project was successfully terminated after five years and its results were
published by the esteemed journals
Nature and Science in spring 2010. In
total, 22,000 human genes had been
”The remarkable thing about MitoCheck is
that technologies had to be developed
which in turn led to new questions being
addressed. So science and technology were
fruitfully pushing each other along.”
screened with 600 found to play a
role in cell division. The results are
now freely available to the scientific
community (www.mitocheck.org), cre-
jan-michael peters,
senior scientist,
institute of molecular pathology,
vienna, austria
ating a valuable resource on which future research can draw.
One of the new methods developed is
high-throughput imaging of living
up the challenge of tackling mitosis
cells. Using RNA-interference, all
from a systems biology perspective.
22,000 genes from a human cancer cell
line were inactivated one by one. The
Over the next five years, MitoSys will
cells were then recorded for 48 hours
attempt to develop quantitative assays
under a microscope. This generated al-
for the behaviour of mitotic proteins,
most 200,000 time lapse movies, each
to use these assays to build mathemat-
of them showing what happens when a
ical models for key aspects of mitosis
particular gene is silenced.
in human cells, to experimentally test
predictions of these models, and ulti-
To process this vast amount of infor-
mately to merge the individual models
mation in an automated way, advanced
of mitotic processes into a first com-
computer software had to be created.
prehensive model of mitotic division
The technique developed for systemat-
in human cells.
ically silencing all genes in an organism was a success in itself. A year after
Achieving these ambitious goals will
it had been published, it was already in
involve the collaboration of interna-
use by more than ten research groups
tionally leading mathematicians, bio-
across Europe.
chemists, biophysicists and biologists
working at 13 research institutes, uni-
The MitoSys project
versities, international organisations
But knowing the genes and proteins
and companies in eight European
involved in mitosis is not the end of
countries. After the IMP’s successful
the story. The scientists have yet to un-
coordination of the MitoCheck project,
cover how these players act and inter-
Jan-Michael Peters will stay on to head
act at the molecular level. A follow-up
MitoSys.
project, MitoSys, which started in June
2010 under the European Union’s seventh framework programme, will take
Partnership with academic research
57
corporate responsibility
Corporate Citizenship
The Boehringer Ingelheim foundations
The Boehringer Ingelheim foundations are independent, not-for-profit
organisations. By supporting research and science, they provide a
fundamental service to society.
Today’s research is the basis of tomor-
Boehringer Ingelheim Foundation:
row’s developments. The scientific
fostering excellence in sciences.
sponsorship programmes of the Boeh-
The foundation was established by
ringer Ingelheim foundations are a
Hubertus Liebrecht (1931 – 1991) in
bridge to the future. Their vision: by
1977. This non-profit organisation
promoting outstanding scientific
promotes the medical, biological,
achievements, important develop-
chemical and pharmaceutical sciences.
ments can be encouraged - thus add-
Activities aim at funding basic re-
ing, in the long run, to our quality of
search, for example with the Plus
life.
3-Perspectives Programme for young
leaders of independent research
groups.
Also, from 2011 onwards, the foundation will honour outstanding research
with the celebrated Heinrich Wieland
Prize. What is more, the foundation
can support scientific events that act
as a platform for an exchange of ideas
between different generations of scientists.
As a sign of its strong bond to the
founder’s native region, the foundation has been devoting special attention to the University of Mainz. For
instance, it awards the Boehringer
Ingelheim Prize to outstanding young
researchers at Mainz University’s medical school.
The ribosome, the cell’s protein synthesising factory (left), “fishes“ for helper
proteins – the so-called elongation factors. Photo by Dr Niels Fischer, former PhD
fellow of the Boehringer Ingelheim Fonds.
58
Boehringer Ingelheim annual report 2010
Institute of Molecular Biology (IMB)
The founding director of the IMB,
The pledge to support the Institute of
Professor Christof Niehrs, is one of the
Molecular Biology (IMB) at the Uni-
world’s leading cell and developmen-
versity of Mainz with EUR 100 million
tal biologists. The official opening cer-
for a period of ten years represents a
emony of the IMB was conducted in
milestone in the history of the Boe-
March 2011.
hringer Ingelheim Foundation. The
purpose of this donation is to foster an
institute for top-level research that
will complement the research already
being run in Mainz, with scientists
and facilities that meet international
standards of excellence.
Questions to Professor Christof Niehrs, founding director of the Institute of Molecular Biology
Prof. Niehrs, you have left behind a
repair. We need a broad range of dis-
on the key issues of epigenetics and
highly attractive environment – the
ciplines and methods if we are to
DNA repair. And we have chosen an
German Cancer Research Centre – to
answer the key questions – for ex-
area that holds much promise for
come to Mainz and set up the Insti-
ample, how genes are regulated,
the future, an area that looks at
tute of Molecular Biology (IMB) as
switched on and off, during certain
some of the currently most exciting
its founding director. What do you
phases of development and in the
issues in bioscience. Our institute
find most exciting about this new
stem cells. We have known about the
can create synergies that will foster
challenge?
book of life, the DNA Code, since ge-
research significantly, taking it far
nome sequencing. But we still need
beyond what existing epigenetic re-
to read it better.”
search centres have achieved.”
prof. christof niehrs: “I see
this as a unique opportunity in a scientist’s life: having the chance to set
up an institute and realize my own
vision and goals. The IMB will not
How will the institute be structured?
prof. christof niehrs: “The
be the usual type of research centre,
institute offers space for three research
but an institute with an exceptional
departments and up to 12 indepen-
degree of flexibility and – thanks in
dent groups of scientists. This is
particular to the Boehringer Ingel-
complemented by state-of-the-art
heim Foundation – outstanding re-
technology with the most efficient
search conditions.”
equipment available today.”
What type of research will be carried
What are the goals of the IMB?
out at the IMB?
prof. christof niehrs: “The
prof. christof niehrs
(photo: peter pulkowski)
prof. christof niehrs: “Our
mission is top-level basic research.
focus of our work is on epigenetics,
We aim to become one of the world’s
developmental biology and DNA
landmark institutes concentrating
The Boehringer Ingelheim foundations
59
corporate responsibility
Corporate Citizenship
Boehringer Ingelheim Fonds: passion
ual basis. They do not only receive a
for science
competitive stipend, but also seminars
This foundation for basic research in
and personal support.
biomedicine has been in existence
Nobel Prize winner Prof. Venkatraman
Ramakrishnan (3rd from left). B.I.F. Fellow
Dr James Ogle (1st from left).
since 1983. In its largest programme,
Top-class science at the Titisee
it supports up-and-coming scientists
Twice a year, the Boehringer Ingelheim
studying basic phenomena of human
Fonds invites scientists of worldwide
life as part of their PhD project. Only
repute to its International Titisee Con-
the best applicants are accepted after
ferences. Since 1962, experts from all
an extremely rigorous application
nations have been meeting in the Black
process. Some 140 grant holders have
Forest (southern Germany) to discuss
already been appointed professor and
the latest results and developments in
four have gone on to win Germany’s
different areas of the molecular life
most prestigious award, the Leibniz
sciences. The conference traditionally
Prize. In 2009, the Boehringer Ingel-
brings together the leading scientists of
heim Fonds (B.I.F.) could proudly an-
two to three different fields to stimu-
nounce that Dr James Ogle, a B.I.F. fel-
late discussion across disciplines. For
low, made a key contribution with his
example, the Titisee Conference in
doctoral thesis to the work of Prof.
October 2010 was opened by Dr Mar-
Venki Ramakrishnan, one of 2009’s
tin Chalfie, winner of the Nobel Prize
Nobel Laureates in chemistry.
for Chemistry in 2008.
In 2010, the Boehringer Ingelheim
Fonds broke an important sound
barrier, awarding the 1,000th PhD
fellowship. The PhD programme sponsors 120 young scientists on a contin-
Participants of the 102nd International Titisee
Conference in October 2010.
60
Boehringer Ingelheim annual report 2010
Cultural commitment of
Boehringer Ingelheim
Bros. Boehringer Ingelheim Foundation for the Humanities and
the Internationale Tage in Ingelheim, Germany.
The Bros. Boehringer Ingelheim Foun-
Internationale Tage Ingelheim
dation for the Humanities
The Internationale Tage (International
The oldest of the three Boehringer
Days) exhibitions in Ingelheim have
foundations originated as an idea for
for more than 50 years provided
a gift to mark the 65th birthdays of
special insights into the cultural tradi-
Albert Boehringer Sr. and Julius
tions of other countries, important
Liebrecht, as well as the 60th birthday
trends in art and the work of individu-
of Dr Ernst Boehringer. In fact, the
al artists. This ongoing cultural com-
foundation was established in 1957 –
mitment is an expression of the spirit
“in gratitude for the achievement of
of patronage to which Boehringer In-
our fathers and in the binding knowl-
gelheim’s shareholder family has dedi-
edge that our culture has grown from
cated itself since 1959.
Photographer Axel Hütte at the exhibition of
the Internationale Tage.
intellectual vigour …”
Albert Renger-Patzsch – Axel Hütte
As it sponsors the humanities, the
Rheingau* - Photographs
foundation is quite different from the
In 1953, C.H.Boehringer Sohn initiat-
Boehringer Ingelheim Fonds and the
ed and published “Lob des Rheingaus”
Boehringer Ingelheim Foundation,
(In Praise of the Rheingau), the first
both of whom were established later
illustrated book with photographs of
and support basic research in the life
Albert Renger-Patzsch. A further three
sciences. It underlines the founders’
should follow: “Hohenstaufenburgen
commitment for culture and the liber-
in Süditalien”(Hohestaufen Castles
al arts.
in Southern Italy) - 1961, “Bäume”
(Trees) – 1962, and “Gestein” (Rocks) –
Dr Robert Boehringer, a close friend of
1966.
Axel Hütte
Burg Rheinstein, 2009
60 x 45 cm
© Axel Hütte.
the famous lyricist Stefan George, was
appointed to the first scientific adviso-
This cooperation over many years was
ry council of the foundation. Today,
based on the friendly association be-
the foundation exclusively grants sub-
tween the photographer and Dr Ernst
sidies for the printing costs of research
Boehringer.
literature – e.g. doctoral theses – in the
field of humanities.
125 years of Boehringer Ingelheim’s
existence was the occasion for the
Cultural commitment of Boehringer Ingelheim
61
corporate responsibility
Albert Renger-Patzsch:
view upstream into the Rhine valley,
around 1950, 30 x 40 cm
© Albert Renger-Patzsch Archive/
Ann and Jürgen Wilde /VG BildKunst, Bonn 2011.
Corporate Citizenship
shareholder family, and their fourth
preciated exhibition of the Interna-
generation in particular, to take up the
tional Days – the company’s cultural
Rheingau theme once again and to re-
commitment for the last 50 years –
interpret it: the company’s home, as
in the Old Town Hall in Ingelheim,
seen through the eyes of a photogra-
Germany, in September 2010. Albert
pher - then and now, almost 60 years
Renger-Patzsch’s original prints, pre-
later.
pared for the publications “In Praise
of the Rheingau” and “Trees”, also in-
Albert Renger-Patzsch (1897–1966) is
cluding unpublished prints, stand op-
regarded as a pioneer of new function-
posite Axel Hütte’s large format pic-
alism in Germany. His direct, relevant
tures created for this project and here
photographic style formed the basis of
shown publicly for the first time.
modern photography. Axel Hütte (born
1951), the well-known German pho-
Parallel to the special exhibition, the
tographer and former pupil of Becher
Internationale Tage has published a
at the Kunstakademie in Düsseldorf,
corresponding publication – a splen-
is today considered as the uncontested
did illustrated book which the interna-
master of analogue landscape photo-
tional experts are calling a milestone
graphy. In the project, as stimulating
in photographic publishing.
as it is informative, Hütte combines
the Renger-Patzsch pictures from the
(*The Rheingau, facing Boehringer In-
1950s with historic postcards and his
gelheim’s headquarters across the Riv-
own works created between autumn
er Rhine, is one of Germany’s most fa-
2009 and spring 2010.
mous wine-growing regions ).
A selection of the most beautiful pho-
For more information, visit
www.internationale-tage.de
tographs was presented in a highly ap-
62
Boehringer Ingelheim annual report 2010
The Boehringer Ingelheim employee
The quality of the work submitted by
photography contest
our employees over the years has been
excellent, producing a successful exhi-
Tradition stimulates
For more information on the photography
group, go to
www.fotogruppe-ingelheim.com
bition every year.
The photography contest goes back a
long way at Boehringer Ingelheim. Ini-
The themes of past contests reflect the
tiated by Dr Ernst Boehringer in 1954,
wide range of topics provided, while
it is now firmly established.
the number of contestants taking part
is clear evidence of their commitment.
Right from the beginning, the share-
Past mottos have included “People at
holder family was interested in “Peo-
work“ (1960), ”After work” (1962),
ple and Employees.” What do employ-
“Get fit” (1973), “Sport and us” (1982),
ees do in their spare time, what are
“People and their hobbies“ (1986),
their hobbies? This philosophy is the
“Seasons” (1994), and the “Pharma-
basis of the annual selection of topics.
cist” (1995).
Even now, it is always exciting to see
The motto for the 2010 photo contest
how the selected topic stimulates
was “What living healthily means to me”
employees’ creativity and the way in
The following pictures were chosen as
which the topics are turned into reality.
winners from among many entries.
The three winning photos of the employee photo contest
2010: “What living healthily means to me”.
Cultural commitment of Boehringer Ingelheim
63
research and development
Driving Innovation:
How do we help treat diseases to achieve better
therapeutic outcomes? Research and development
has laid the foundations for Boehringer Ingelheim’s
success and remains the driving force for new and
innovative medicines.
In 2010, Boehringer Ingelheim invested EUR
2,306 million in research and development in
Human Pharmaceuticals, which corresponds
to a share of 23.8 % of Prescription Medicines’
sales.
Over the last 10 years, Boehringer Ingelheim has
conducted or funded 1,320 clinical studies with
106 substances in 87 countries in all regions of
the world.
23.8 %
1,320 studies
64
Boehringer Ingelheim annual report 2010
R&D
Research & Development
Be first. Be best. Be focused.
66
Medical innovation
74
Be first.
78
Be best.
84
Be focused.
90
Idiopathic pulmonary fibrosis
99
Hepatitis C
100
Boehringer Ingelheim carries out drug
discovery and development in six therapeutic
areas at four major R&D sites and three
smaller specialised sites.
Globally, we in 2010 employed on average 7,093
highly qualified staff in research, development,
and medicine.
7 R&D sites
7,093
Research and Development
65
research and development
Be first. Be best. Be focused.
Be first.
Be best.
Be focused.
What drives innovation at Boehringer Ingelheim? What R&D strategy is
required to ensure the future success of Boehringer Ingelheim in providing
innovative medicines to meet unmet medical needs? The answers
define the core of Boehringer Ingelheim’s R&D innovation and revolve
around three recurring objectives: Be first. Be best. Be focused.
66
Boehringer Ingelheim annual report 2010
[ research and development at boehringer ingelheim ]
Our employees in R&D continue
every day to translate visions into
experiments, into clinical trials, and
in the end into marketed drugs.
in the laboratory:
dr wolfgang baiker, corporate senior vice president development (left)
prof. klaus dugi, corporate senior vice president medicine (middle)
prof. wolfgang rettig, corporate senior vice president research (right)
Be first. Be bast. Be focused.
67
research and development
Be first. Be best. Be focused.
medicines. Our scientists are also not alone in
“Innovation is not an event.
Innovation is an ongoing process
and a mindset.”
charting new territory. They have built a tradition of trust and collaboration with researchers
at universities and basic research institutes who
best understand disease mechanisms and who
prof. wolfgang rettig,
corporate senior vice president research,
ingelheim, germany
are eagerly looking for means to change faulty
mechanisms at the molecular level.
With teams and tools in place, the focus goes
back to being first. The courage and aspiration to
Why is the daily challenge to be first so important
dedicate years of hard work, scientific alacrity, a
to our R&D scientists?
big portion of trial and error, and a little pinch of
wolfgang rettig: To be first in drug discovery does not mean to run fast. It is not about
luck before arriving at the ultimate blueprint for
an innovative medicine.
cutting corners. It is all about courage and aspirations. It is the courage to take on daunting scien-
klaus dugi: A good example for being first
tific challenges, which do not come from an ivory
on the market is our new oral anticoagulant
tower but directly from daily living. It is the aspi-
pradaxa® (dabigatran etexilate). pradaxa® repre-
ration to change people’s lives.
sents an alternative to oral vitamin K antagonists
which have been used in various indications for
Why do central neurons decay in the brain,
more than 50 years. pradaxa® is the first oral
memory circuits go awry and mental functions
thrombin inhibitor representing a novel mecha-
deteriorate in people struck by Alzheimer’s dis-
nism of action and is therefore a revolution for
ease? What makes lung tissue stiff and unable to
patients suffering from atrial fibrillation who are
pick up enough oxygen? Why do hidden clusters
at risk for developing an ischaemic stroke.
of cancer cells lie dormant for years and show
up many years after surgery or chemotherapy to
For the 150 mg twice daily dosage regimen, it
form metastases? How to design medicines to
was shown in the RE-LY® trial that this dose of
prevent this process? Why is the control of blood
dabigatran etexilate was safer than the estab-
pressure, blood sugar and blood lipids still una-
lished standard warfarin with regard to intracra-
ble to eliminate all heart diseases and risk of
nial, life-threatening and any bleeding events,
stroke?
more efficacious with regard to the reduction of
stroke risk and more convenient, because there
Questions like these lead our R&D scientists into
was no need for monitoring of pradaxa®.
uncharted territory. When they start the journey,
they are well-equipped. State-of-the-art technol-
68
wolfgang baiker: Innovation should be
ogies allow studies of genetic disease factors in
viewed as a continuum rather than a discrete
minute detail, visualise the role of receptors and
one-off quality. Depending on existing, or not
signals in living cells, bridge the gap between
existing medication, the degree of innovation can
clinical research findings and molecular struc-
in the end only be judged by patients, prescribers,
tures, and provide a richness of chemical struc-
and payers. In some cases, it can take some time
tures to be screened, redesigned, and fine-tuned
until an innovation is appreciated by the market.
in the laboratory as blueprints for innovative
In the case of pradaxa®, Boehringer Ingelheim is
Boehringer Ingelheim annual report 2010
certain that the excellent results of our clinical
“Innovation should be viewed as a continuum
rather than a discrete one-off quality.”
trials are so convincing that the degree of innovation of pradaxa® should be appreciated soon.
dr wolfgang baiker,
corporate senior vice president development,
ingelheim, germany
Why to be best shows our R&D scientists’ commitment to sustained innovation for patients?
wolfgang baike r: Being best refers to a
variety of parameters, which add value to the patient. As mentioned, innovation can have different degrees, depending on different needs and
burden for patients with several illnesses may in-
perspectives. We at Boehringer Ingelheim do not
crease compliance and lead to better treatment
only focus on breakthroughs, we ask ourselves in
outcomes.
many ways how to add value with our medication. Being best means comparing existing medi-
wolfgang re ttig: Being best in drug dis-
cation and treatment regimens and adding better
covery research is all about a sustained commit-
medication. This could be reflected in better effi-
ment to better health. Instead of asking ques-
cacy, fewer side effects, better treatment for a
tions simply about treatment options, like ‘Is
subgroup of patients or simply more convenience
there a medicine for this disease?’, R&D scien-
in usage. For example, lowering the so-called pill
tists look harder.
Dabigatran etexilate (Pradaxa®)
A good example of being first on the market is our new oral anticoagulant pradaxa® (dabigatran etexilate). pradaxa® represents an
alternative to oral vitamin K antagonists which have been used
in various indications for more than 50 years.
CH2
NH2
[ dabigatran etexilate ]
Molecule structure
NH
EtOOC
Carbon
Oxygen
Nitrogen
CH2
NH2
EtOOC
CH2
[ dabigatran etexilate ]
Last step of the synthesis of the substance
Be first. Be best. Be focused.
69
research and development
Be first. Be best. Be focused.
Can a new medicine be more selective in treating
Often, R&D projects take unexpected turns and
the disease and avoiding adverse effects, by tar-
teams are challenged repeatedly to find the right
geting a different receptor, a newly discovered
way. Ultimately, it will be the patients, the pre-
receptor subtype, or by avoiding unwanted recep-
scribers, and the payers, who decide whether a
tors? Can a new medicine target a second recep-
novel medication does indeed address a clinically
tor and strengthen the therapeutic effect? Can a
relevant unmet medical need.
new medicine be paired with a new diagnostic
test? Do new medicines avoid cumbersome labo-
Why are our R&D scientists wide open to many
ratory checks and visits to the doctor’s office?
sources of inspiration and insight, but need to be
focused every step of the way?
The goal to be best in drug discovery is always
klaus dugi: Even though there is still a
challenging when it comes to deciphering the ge-
very large number of diseases with significant
netic and molecular details of disease, the design
unmet medical need, it is important for any
of smarter molecules, and the fine-tuning for
pharmaceutical company to focus on areas of
highly ambitious goals.
special expertise, due to the natural limitations
in capacity and budget.
klaus dugi: Being best means, you have to
be able to define how the added value of the nov-
Boehringer Ingelheim, for instance, has a long-
el medication can be demonstrated to patients,
term expertise in respiratory diseases. However,
physicians, and payers.
after a past decision to address unmet medical
needs in newer therapeutic areas, we now also
New compounds from Boehringer Ingelheim have
focus on oncology, immunology and inflamma-
to be investigated in clinical trials to define how
tion as well as metabolic diseases.
they provide additional benefit to patients compared to currently available drugs. The quality of
wolfgang baiker: Today, the blueprint of
the clinical development programme is of utmost
the human genome or mutations in the genome,
importance. It may be reflected by focusing on the
which can lead to cancer, are known. In oncolo-
indications with the highest unmet medical need,
gy, Boehringer Ingelheim develops substances
by testing more than one dose in large-scale clini-
that are effectively targeting various tumours re-
cal trials or by defining the dosage based on the
sulting from different mutations.
pharmacokinetic properties of the compound.
Innovative technologies have enabled scientists
to look at disease in a holistic way. Given these
“Ultimately, it will be the patients, the
prescribers, and the payers, who decide
whether a novel medication does
indeed address a clinically relevant
unmet medical need.”
developments, our scientists can even focus on
sub-groups of patients, where new medication is
best suited for treatment. Personalised medicine
describes this new approach aptly. Our focus on
personalised medicine ensures that the patient
receives the right medication with high efficacy
prof. klaus dugi,
corporate senior vice president medicine,
ingelheim, germany
and safety.
Growing knowledge on the physiological and
pathophysiological context of diseases and on
70
Boehringer Ingelheim annual report 2010
Being best means comparing existing medication and
treatment regimens and adding better medication.
New compounds from Boehringer Ingelheim have to be investigated in
clinical trials to define how they provide additional benefit to patients
compared to currently available drugs. The quality of the clinical
development programme is of utmost importance.
[ linagliptin ]
molecule structure
1) CF3COOH
2) K2CO2, H2O
Carbon
Oxygen
Nitrogen
NH2
[ linagliptin ]
last step of research synthesis
molecular pathways also enables us to use bio-
There are more opportunities to design and cre-
markers. These biological markers serve as indi-
ate unique chemical and protein molecules in the
cators for a normal biological state versus patho-
laboratory, to serve as potential new medicines,
genic processes. They allow us to diagnose a
than stars in the universe.
disease in a patient, to determine disease risk, or
to judge whether treatments are successful.
The daily work in cross-functional teams brings
together very diverse professional experience to a
wolfgang rettig: At times, the sheer
numbers involved are difficult to comprehend.
single task: working in one team to design the
one innovative molecule to reach patients.
A human genome has 5 billion base pairs and
25,000 genes, endless DNA sequence polymorphisms and protein modifications. There are
hundreds of human diseases in medical registries
and thousands of disease genes. Myriad permutations of signalling pathways exist inside cells and
between cells.
Be first. Be best. Be focused.
71
research and development
Be first. Be best. Be focused.
Research & Development
In accordance with our research and development (R&D) strategy, we
carry out drug discovery and development in six therapeutic areas at
four major R&D sites and three smaller specialised sites
13
It takes on average 13 years to
develop a new medication.
laval, canada
ridgefield, usa
7 R&D Sites
[ research and development sites ]
Our major research and development centres are located
in Biberach (Germany), Laval (Canada), Ridgefield (USA)
and Vienna (Austria), supported by units in Buenos Aires
(Argentina), Kobe (Japan), and Milan (Italy).
These R&D activities are supported by alliances in North
America and Europe as well as China, India and Russia.
We are also engaged in a broad array of collaborations
with leading universities and basic research institutes.
72
Boehringer Ingelheim annual report 2010
buenos aires, argentina
94
[ research areas ]
Boehringer Ingelheim has 94 projects in development
(as of 31 December 2010). Of these, 40 are in pre-clinical
development, 9 are in clinical development phase I, 19 in
phase II, 13 in phase III and 13 are either in registration or
have recently been launched and continue to be profiled
clinically.
Major R&D sites
Smaller, specialised R&D sites
biberach and ingelheim, germany
vienna, austria
milan, italy
kobe, japan
Research areas
research areas
examples of disease areas
sites
Respiratory
diseases
Asthma
COPD
Idiopathic pulmonary fibrosis
Biberach (Germany)
Cardiometabolic
diseases
Atherosclerosis
Diabetes
Metabolic syndrome
Obesity
Thrombo-embolic diseases
Biberach (Germany)
Ridgefield (USA)
Oncology
Lymphoma
Leukaemia
Solid tumours
Vienna (Austria)
Neurological
diseases
Alzheimer’s disease
Chronic pain
Migraine
Parkinson’s disease
Biberach (Germany)
Immunology
Multiple sclerosis
Psoriasis
Rheumatoid arthritis
Ridgefield (USA)
Infectious
diseases
Hepatitis C
HIV/AIDS
Laval (Canada)
Research & Development
73
Be first. Be best. Be focused.
research and development
Medical innovation
R&D is all about meeting unmet medical needs. At Boehringer Ingelheim, networks of specialised
scientists collaborate at seven sites around the world to translate their ideas into medications. In 2010,
R&D investments in biotherapeutics were increased to ensure that the best-suited type of molecule
can be chosen to modify the disease. We are focused on very different diseases, which have one theme
in common: patients need new and/or better medications
Cardiometabolic diseases
regard to metabolic diseases, the company fo-
Metabolic diseases are complex, chronic diseases,
cuses on new strategies for the treatment of dia-
which can affect the entire population, regardless
betes, lipid disorders/atherosclerosis, and obes-
of age. One example of a metabolic disorder is
ity. Together with the treatment of hypertension,
obesity. Obesity is the most important cause of type
these therapies complement each other to reduce
2 diabetes, which can lead to hypertension and dis-
the risk of cardiovascular mortality and morbid-
orders of the lipid metabolism. This combination of
ity.
disorders of all of the above increases the risk of
suffering or dying from a cardiovascular event.
Central nervous system (CNS) diseases
The likelihood of a neurological disease increas-
Chronic kidney disease is characterised by a pro-
es with age. In most of these diseases, such as
gressive loss in renal function over time period of
Parkinson’s or Alzheimer’s disease, the patient
months or years. It is often associated with diabe-
eventually needs long-term care, which places a
tes, hypertension, and glomerulonephritis, and is
significant strain on the caretakers in the family
often poorly managed with current therapies.
or in nursing homes.
Boehringer Ingelheim’s research efforts in the field
Progressive degeneration of the nerve cells is
of cardiovascular and chronic kidney diseases are
typical for all chronic neurological diseases. Our
designed to develop treatments that will influence
scientists are investigating ways of identifying
the course of these life-threatening diseases. With
and developing new treatments which can intervene in the process. The aim is to provide patients and doctors with improved treatments to
The Boehringer Ingelheim pipeline in 2010
address the symptoms of these diseases, and to
(94 projects in development)
find ways of inhibiting the basic pathological
processes, which are responsible for disease pro-
Respiratory
Oncology
gression.
19
26
Immunology
In addition, we are actively involved in research
9
11
CNS
Infectious diseases
into novel analgesics, which are believed to be
22
7
Cardiometabolic
diseases
effective in the prevention and treatment of pain.
The company is investigating compounds to specifically inhibit fundamental mechanisms of pain
74
Boehringer Ingelheim annual report 2010
Rheumatoid arthritis
is a chronic, lifelong disease that has significant impact on patients’ lives.
Our researchers are working to establish effective therapies that target
inflammation and joint destruction via novel mechanisms.
Picture: © DR P. MARAZZI / SPL / Agentur Focus
transduction in a multitude of chronic pain con-
Multiple sclerosis is a chronic immune-mediated
ditions. Such new drugs are expected to provide
inflammatory disease of the central nervous
physicians with effective new treatment options
system and is a common cause of neurological
with fewer side effects for millions of patients.
disability already in young and middle-aged
adults. Although several drugs have recently
Most recently, we extended our research efforts into
become available to treat this disease, many
psychiatric diseases, the largest segment of CNS dis-
carry a significant risk of serious side effects that
orders in terms of prevalence, by ways of subtly
may increase with time. Boehringer Ingelheim’s
modulating neurotransmitter systems, which are
research in multiple sclerosis is focused on
believed to be out of balance in these diseases.
identifying drugs that protect the patient from
the progressive disability that results from this
Immunology and inflammation
chronic disease.
We are also engaged in the discovery and development of new therapeutic agents for the treat-
Infectious diseases
ment of autoimmune and chronic inflammatory
The introduction of new treatments for infec-
diseases. The major focus in this field includes
tious diseases has accelerated in recent decades
rheumatoid arthritis, psoriasis and multiple scle-
and this trend is projected to continue in the
rosis. In addition, inflammation is an important
coming years. The engines for this growth have
mechanism underlying many diseases and there-
been, on the one hand, technological advances
fore research in this area may have therapeutic
resulting in the discovery of new pathogens
benefit in a wide range of diseases also in other
associated with human diseases, and on the other
therapeutic areas.
hand, understanding of how to target these
pathogens with highly specific agents that have
Autoimmune diseases, such as rheumatoid ar-
good tolerability as well as efficacy. The result
thritis, are chronic, lifelong diseases that have
has been a number of innovative drugs for per-
significant impact on patients’ lives. Although
sistent infections, for which no effective therapy
some efficacious therapies are available, there re-
had previously existed. Nevertheless, the emer-
mains a significant unmet medical need, because
gence and transmission of drug-resistant patho-
many patients do not respond to these drugs or
gens creates a continuing demand for new
other patients lose therapeutic benefit over time.
agents with different cross-resistance profiles.
Thus, our researchers are working to establish effective therapies that target inflammation and
In spite of the advances of the last two decades,
joint destruction via novel mechanisms.
exemplified by the enormously improved
Medical innovation
75
research and development
Be first. Be best. Be focused.
Respiratory diseases
HIV/AIDS treatment
Boehringer Ingelheim is one of the leading
Advances in R&D are exemplified by the
enormously improved management of
HIV-infected patients as the result of
combination antiretroviral therapy.
pharmaceutical companies worldwide in the
treatment of airway diseases. Research and development are focused particularly on asthma,
chronic obstructive pulmonary diseases (COPD),
and idiopathic pulmonary fibrosis.
Picture: HI virus
The respiratory disease asthma is a chronic allergy which can be life-threatening. In industrialised countries, 5 – 10% of the population suffers
from asthma and the prevalence is increasing.
COPD is the fifth most common cause of death in
management of HIV-infected patients as the re-
industrialised countries, and the prevalence is
sult of combination antiretroviral therapy, many
also increasing as well.
infectious diseases remain poorly treated. Our
focus of infectious diseases research is on patho-
Our scientists are investigating and developing
gens responsible for very significant human dis-
new substances for the treatment of airway dis-
eases where effective therapy is lacking. The goal
eases with the aim of being able to offer patients
is to introduce the next generation of innovative
and doctors improved therapies with high effica-
new therapies to address the continually evolv-
cy, few side effects and convenient dosage forms
ing unmet medical need presented by infectious
and regimens.
diseases.
Inlicensing and partnering
Oncology
Boehringer Ingelheim has continued to strength-
Opportunities for effective drug discovery in on-
en its Research & Development programmes in
cology have never been better. Blueprints of the
biopharmaceuticals through external partner-
genetic and biochemical workings of cancer cells
ships. As in previous years, one focus of our
allow scientists in our laboratories to rapidly
in-licensing and partnering activities was on
home in on promising targets for innovative
biopharmaceuticals, in particular monoclonal
drugs. The impact of modern cancer genetics, bi-
antibodies.
ochemistry and biology is beginning to change
the practice of medicine in oncology, with both
The company entered into a long-term collabora-
biopharmaceuticals and small-molecule drugs
tion with the Swiss biotech company 4-Antibody
providing a growing repertoire of therapies.
AG to discover and to develop fully human therapeutic antibodies for a number of targets in var-
76
Drug discovery at Boehringer Ingelheim aims to
ious disease indications. With the US-based com-
develop new cancer medicines with clear thera-
pany Micromet, Inc a partnership was started
peutic benefit. We pursue the search for new can-
with the goal to research, develop and commer-
cer drugs along several fronts, including cell sur-
cialise a new BiTE antibody for the treatment of
face receptor signalling pathways, cell cycle
multiple myeloma. Furthermore, Boehringer In-
regulation, cancer cell survival and drug resist-
gelheim entered into a global alliance with an-
ance as well as tumour angiogenesis.
other US-based partner company, Macrogenics
Boehringer Ingelheim annual report 2010
Inc, covering antibody-based therapeutics, which
structure is a human tumour suppressor pro-
may span multiple therapeutic areas, including
tein. This therefore represents an interesting
immunology, oncology, respiratory, cardiometa-
new approach to the treatment of various onco-
bolic and infectious disease. Additionally, a col-
logical indications. Finally, in the field of diabe-
laboration and license agreement with the Aus-
tes indications, Boehringer Ingelheim entered
trian biotech company f-star Biotechnologische
into a collaboration with the US-based Neuro-
Forschungs- und Entwicklungsges. m.b.H was
crine Biosciences Inc regarding the research and
signed for the joint discovery of new antibody-
development of low-molecular-weight GPR119
derived therapeutic products based on f-star’s
agonists. This new mechanism stimulates both
modular antibody technology.
the production and secretion of the body’s own
insulin and thus forms an ideal complement to
In the field of small molecule therapeutics, we
our growing pipeline in the area of diabetes.
have also expanded our portfolio via partnering
activities. Boehringer Ingelheim and Priaxon
AG, Germany, entered into a worldwide partnership focusing on the research and development of MDM2-/p53 inhibitors in the treatment
of cancer. Priaxon AG will contribute its innovative expertise in the field of discovering drugs
with low molecular weight, which is particularly important in researching the inhibition of
protein-to-protein interaction. The p53 target
Collaboration with biotechnology
companies
Boehringer Ingelheim enters into collaborations
with biotechnology companies to, inter alia, discover
and to develop therapeutic antibodies for
a number of targets in various disease indications.
(Structure of a monoclonal antibody)
Picture: © LAGUNA DESIGN / SPL / Agentur Focus
Medical innovation
77
research and development
Be first.
Be first.
pradaxa® offers patients and doctors the first new treatment option for stroke
prevention in atrial fibrillation for more than 50 years. The medication represents
a breakthrough innovation that has the potential to transform the anticoagulant
market for patients and prescribers.
First
new treatment option for stroke
prevention in atrial fibrillation.
[ stroke prevention ]
“The design and scope of the RE-LY® study
yielded a revolution for patients and physicians
alike-treatment with PRADAXA® results in
better stroke prevention, less bleeding into the
brain, and simple dosing, without monitoring,
all at the same time!”
dr paul reilly,
clinical program director,
clinical research, cardiovascular and metabolic diseases,
ridgefield, usa
78
Boehringer Ingelheim annual report 2010
How atrial fibrillation affects the heart
atrial fibrillation
normal heart
sinoatrial node
left atrium
atrioventricular
node
right atrium
sinoatrial node
What are the risk factors for
atrial fibrillation (AF) ?
left atrium
atrioventricular
node
left ventricle
right ventricle
right atrium
left ventricle
• Family history of AF
• Cardiovascular disease at
advancing age
• History of heart disease
• Echo-cardiographic
abnormalities
• Thyroid disorders
• Sleep apnoea
• Excessive alcohol intake
right ventricle
Picture: © PASIEKA / SPL /
Agentur Focus
Epidemiology of atrial fibrillation
Pathophysiology and symptoms of atrial fibrillation
Atrial fibrillation (AF) is the most common heart
In patients with atrial fibrillation (AF), the nor-
rhythm condition, affecting around 1% of the to-
mal control of heart rhythm is disrupted, leading
tal population, rising to 10% in people over the
to rapid and irregular electrical signals, which
age of 80. A total of 6.3 million people in the
cause the atria to quiver rather than contract in a
USA, Japan, Germany, Italy, France, the UK and
coordinated fashion. This reduces the efficiency
Spain were living with AF in 2007 and this is ex-
with which blood is pumped from the atria to the
pected to increase to 7.5 million by 2017 prima-
ventricles and blood stasis (pooling) can occur.
rily due to the ageing population.
Symptoms of AF include palpitations, dizziness,
chest pains and breathlessness. Although some
people with AF can experience the symptoms on
a regular basis, others may never, or rarely, experience symptoms.
+ 60 %
Hospital admissions caused
by AF increased 60 % in the last
20 years.
Read more about dabigatran:
page 82
Be first.
79
Be first.
research and development
How atrial fibrillation (AF) leads to stroke
AF is associated with several serious consequences. The rapid and irregular atrial activity in AF reduces the
efficiency with which blood is pumped from the atria to the ventricles. Blood clots (thrombi) can form in the
atria following the pooling of blood (stasis) that can dislodge and travel in the bloodstream, potentially
blocking blood vessels in the brain and leading to ischaemic stroke.
5 Brain starved of oxygen
leading to stroke and brain
damage
4 Embolus blocks
blood flow to
part of the brain
Internal carotid artery
Common carotid artery
3 Embolus (clot) enters blood
stream and travels towards
Brain
1 Atrial fibrilation in
the left atrium
Aorta
2 Embolus (clot)
forms
Heart
80
Boehringer Ingelheim annual report 2010
Stroke is the leading complication of AF
Furthermore, the reduction in cardiac output ob-
AF increases the risk of stroke approximately
served in AF can precipitate heart failure, leading
five fold. It is responsible for nearly one-third of
to accumulation of fluid in the legs (peripheral
all strokes and is the leading cause of embolic
oedema) and lungs (pulmonary oedema), or dys-
stroke. As many as three million people world-
pnoea, fatigue and chest pain. AF has also been
wide have an AF-related stroke every year; equiv-
associated with poorer clinical outcomes in pa-
alent to one person every 12 seconds. One in four
tients suffering a myocardial infarction and in
people aged 40 years or older develop AF during
patients with acute coronary syndromes.
their lifetime, making it the most common heart
rhythm abnormality. Three out of four AF-related strokes can be prevented, but many patients
are not aware of their risk and do not take action
to prevent stroke.
AF-related stroke is associated with a heavy burden of morbidity and mortality. For example,
stroke is more likely to be fatal in patients with
AF, and those who survive face persistent neu-
5x
The risk of stroke is five times
higher with atrial fibrillation.
rological deficits, persistent disability and poorer
functional performance.
[ stroke prevention ]
“These remarkable conclusions were
only achieved through the dedication
and hard work of the thousands of
employees, investigators, nurses, and
patients who managed or took part in
RE-LY®.”
dr janet schnee,
executive director and medical leader,
cardiovascular medical affairs,
ridgefield, usa
Be first.
81
research and development
Be first.
Our research and development in
thrombo-embolic diseases
Dabigatran etexilate is at the forefront of a new generation of oral
anticoagulants/direct thrombin inhibitors (DTIs) targeting a high
unmet medical need in the prevention and treatment of acute and
chronic thrombo-embolic diseases.
Pradaxa® - a direct thrombin inhibitor
patients (150 mg bid, twice daily,
Potent anti-thrombotic effects are
75 mg for patients with severe renal
achieved with direct thrombin inhibi-
impairment). In Canada, dabigatran
tion. Thrombin is the central enzyme
etexilate was also approved (150 mg
in the process responsible for clot
bid/110 mg bid for patients older than
(thrombus) formation. Dabigatran
80 years) in this indication.
etexilate provides effective, predictable
35 %
Dabigatran etexilate significantly
reduced the risk of stroke and
systemic embolism by 35%.
and consistent anticoagulation with a
RE-LY® - the basis for approving da-
low potential for drug-drug interac-
bigatran etexilate
tions and no drug-food interactions,
The approvals of dabigatran etexilate
without the need for routine coagula-
were based on the landmark RE-LY®
tion monitoring or dose adjustment.
(Randomized Evaluation of Long-term
anticoagulant therapy) trial, which
First indication for Pradaxa®
was published in 2009 in the New
In its first indication, dabigatran etexi-
England Journal of Medicine.
late is approved in more than 75 countries under the trademark pradaxa®
The pivotal phase III RE-LY® trial was
for the primary prevention of venous
the largest completed trial of its kind,
thrombo-embolic events (blood clots)
with over 18,000 patients worldwide.
in adults who have undergone elective
It compared the efficacy and safety of
total hip or knee replacement surgery.
two doses of dabigatran etexilate with
warfarin (titrated to INR 2.0 to 3.0) for
A breakthrough treatment for stroke
the prevention of stroke and systemic
risk reduction in non-valvular AF
embolism in patients with AF.
In the USA, the US Food and Drug
82
Administration (FDA) has approved
RE-LY® results
pradaxa® for stroke risk reduction in
Results from RE-LY® showed that in
patients with non-valvular AF, mark-
patients with AF, dabigatran etexilate
ing the first approval of a new oral an-
150 mg bid significantly reduced the
ticoagulant in the USA for more than
risk of stroke and systemic embolism by
50 years. The approval made pradaxa®
35% compared to warfarin, with com-
available to a broad spectrum of
parable rates of major bleeding.
Boehringer Ingelheim annual report 2010
Dabigatran etexilate 110 mg bid dem-
The dabigatran etexilate clinical trial
onstrated similar reductions in stroke
programme
and systemic embolism, while deliver-
Boehringer Ingelheim’s clinical trial
ing a reduction in major bleeding rates
programme encompasses studies to-
compared to warfarin. Additionally,
talling more than 18,000 patients in:
both doses showed a significant reduction in haemorrhagic stroke and a significant reduction in life threatening,
• Treatment of acute venous thromboembolism (VTE)
intracranial and total bleeding com-
• Secondary prevention of VTE
pared to warfarin.
• Secondary prevention of cardiac
events in patients with acute coro-
Implications of RE-LY®
pradaxa® offers patients and doctors
the first new treatment option for stroke
nary syndrome (ACS)
1960
wafarin
2010
pradaxa
prevention in AF for more than 50
years. It represents a breakthrough innovation (first-in-class) that has the potential to transform the anticoagulant
pradaxa® offers patients and
doctors the first new treatment
option for stroke prevention in
AF for more than 50 years.
therapy for patients and prescribers.
Sources Atrial Fibrillation p.78—81: 1. Lin HJ, Wolf PA, Kelly-Hayes M, et al. Stroke severity in atrial fibrillation: the Framingham Study. Stroke 1996; 27:1760-4 2. Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Viewed July 2009 at http://www.who.int/cardiovascular_disease/en/cvd_atlas_15_burden_stroke.pdf. 3. Wolf PA, Abbott
RD, Kannel WB. Atrial fibrillation as an independent risk factor for stroke: the Framingham Study. Stroke 1991; 22(8):983-8. 4. Lloyd-Jones DM, Wang TJ, Leip EP, Larson MG, Levy D,
Vasan RS, et al. Lifetime risk for development of atrial fibrillation: the Framingham Heart Study.  Circulation 2004; 110:1042-6. 5. Stewart S, Murphy N, Walker A, et al. Cost of an
emerging epidemic: an economic analysis of atrial fibrillation in the UK. Heart 2004; 90:286-92. 6. Fuster V, Rydn LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation – executive summary. Circulation 2006; 114:700-52. 7. Kannel WB, Abbott RD, Savage DD, et al. Coronary heart disease and atrial fibrillation: the
Framingham Study. Am Heart J 1983; 106:389-96. 8. Collony SJ et al. Dabigatran versus Warfarin in Patients with Atrial Fibrillation. N Engl J Med 2009;361:1139-1151. 9. Hart RG et al.
Meta-analysis: Antithrombotic Therapy to Prevent Stroke in Patients Who Have Nonvalvular Atrial Fibrillation. Ann Intern Med 2007;146:857-867.
Sources Graphic p.80: 1. What is Atrial Fibrillation? National Heart Blood and Lung Institute Diseases and Conditions Index, October 2009. Last viewed July 2010 at http://www.nhlbi.
nih.gov/health/dci/Diseases/af/af_what.html. 2. Atrial Fibrillation Factsheet, Patient UK, March 2008. Last viewed July 2010 at http://www.patient.co.uk/health/Atrial-Fibrillation.
htm 3. Atlas of Heart Disease and Stroke, World Health Organization, September 2004. Last viewed June 2010 at http://www.who.int/cardiovascular_diseases/en/cvd_atlas_15_burden_stroke.pdf
Treatment of thrombo-embolic diseases
83
research and development
Be best.
Be best.
The investigational compound linagliptin is a dipeptidyl peptidase 4
(DPP 4) inhibitor in late stage development for the treatment of type 2
diabetes with a unique pharmacokinetic profile
[ diabetes ]
“I am proud of having followed linagliptin
from the project idea to its current status.
Linagliptin, as you can imagine, is therefore close to my heart. This compound will
help to reduce the consequences of diabetes, which is a real health burden for the
patient, but also for humankind, given the
exploding numbers of patients worldwide.”
dr michael mark,
global head of cardiometabolic diseases research,
biberach, germany
285m
People are suffering from
type 2 diabetes worldwide.
84
Boehringer Ingelheim annual report 2010
Proportion of population with diabetes
2010
Type 2 diabetes is a pandemic of the modern
era affecting approximately 285 million people worldwide. Over the next 20 years, the
number of type 2 diabetes patients is expected to increase by 50 percent to 438 million.
2030
>4 %
4-5 %
5-7 %
7-9 %
9-12 %
Diabetes
cose levels such as heart disease, stroke, renal
There are approximately 285 million people with
impairment and nerve damage.
diabetes in the adult population worldwide. The
International Diabetes Federation estimates that
In most instances, type 2 diabetes is a dual-defect
the number of people with diabetes will increase
disease characterised by insulin resistance and
by 50 percent to 438 million people worldwide
impaired ß-cell function. Type 2 diabetes results
by 2030.
from an imbalance between insulin sensitivity
12 %
40 %
of type 2 diabetes
patients already
present with some
form of tissue damage at diagnosis.
and insulin secretion. Glucose production fails to
Nearly four million people within the 20-79 age
be regulated adequately by insulin, leading to he-
group are predicted to die from diabetes and its
patic glucose overproduction and diminished
complications in 2010. Approximately 50% of
glucose uptake by muscle tissue.
people with diabetes die of cardiovascular disease and more than 8% die of renal causes.
Over time, the impaired glucose metabolism
leads to a loss of ß-cells and the remaining ß-
Type 2 diabetes
cells eventually fail to maintain their high rate of
Type 2 diabetes is a chronic progressive disease
insulin secretion, leading to glucose intolerance,
and the most common form of diabetes, respon-
insulin resistance, and overt type 2 diabetes. In
sible for 90 to 95 percent of diabetes cases.
addition, accelerated gastric emptying and excessive lipolysis in adipose tissue also contribute to
At diagnosis, approximately 40% of type 2 diabe-
the development of type 2 diabetes. High blood
tes patients already present with some form of
glucose levels can lead to disease-related long-
tissue damage resulting from elevated blood glu-
term complications.
Read more about linagliptin:
page 88
Be best.
85
research and development
Be best.
Obesity as a risk factor for type 2 diabetes
Renal impairment and hypertension
Obesity is a major risk factor for developing type
There is a proven link between renal impairment
2 diabetes and is estimated to be responsible for
and increased risk of cardiovascular disease. The
80% of all newly diagnosed cases. Obesity can
relationship between high blood pressure and
cause increased insulin resistance that, in people
renal impairment is complex and interrelated:
with a certain genetic susceptibility, may develop
renal impairment can cause high blood pressure
into diabetes.
and, in turn, high blood pressure is a risk factor
for developing renal impairment.
Renal impairment in type 2 diabetes
In diabetes, high levels of blood glucose can
High blood pressure is very common in people
damage the kidneys’ filters. This leaves people
with type 2 diabetes at diagnosis. All people with
with type 2 diabetes at risk of developing renal
type 2 diabetes are at a greater risk of cardiovas-
impairment. When the kidneys are damaged, the
cular disease, but the risk is up to three times
protein albumin leaks out of the kidneys into the
higher for those patients with renal impairment.
urine. This is one of the first signs of early stage
renal disease.
Treatment implications
As kidney disease progresses, diabetes treatment
+50 %
Diabetic nephropathy, a complication of diabe-
choices become more and more limited. Many
tes, is a chronic and progressive disease of the
current type 2 diabetes treatments are either con-
Over the next 20
years the number
of type 2 diabetes
patients is expected
to increase by 50%
to 438 million.
kidneys which occurs in about one third of all
tra-indicated in type 2 diabetes patients with re-
people with diabetes. Diabetic nephropathy is as-
nal impairment or not recommended in this pa-
sociated with an increased risk of other diabetic
tient population.
complications including a greater risk of cardiovascular disease and is associated with a lower
Linagliptin - DPP-4 inhibitor
than average life expectancy.
The compound linagliptin, a DPP-4 inhibitor in
late stage development for the treatment of type
Symptoms of diabetic nephropathy are often
2 diabetes, has a primarily non-renal route of ex-
non-existent in the early stages of chronic kidney
cretion. Data to date suggest that for linagliptin
disease which means people may be unaware
no dose adjustment would be required, regardless
they have the condition until a later stage in the
of the degree of renal impairment.
disease.
Sources Diabetes: 1. International Diabetes Federation. Available at: www.idf.org. Last accessed: April 2010. 2. World Health Organization. Available at: www.who.int. Last accessed:
April 2010. 3. Goldstein B. Understanding Type 2 Diabetes. Medscape Diabetes & Endocrinology, 2006. Last accessed: April 2010. 4. Copeland C. et al. Type 2 Diabetes in Children and
Adolescents: Risk Factors, Diagnosis, and Treatment. Clinical Diabetes 2005; 23:4: 181-185. 5. Kaul S, et al. Thiazolidinedione Drugs and Cardiovascular Risks - A Science Advisory From
the American Heart Association and American College of Cardiology Foundation. Circulation. February 2010. 6. International Diabetes Federation, International Society of Nephrology.
Diabetes and Kidney Disease. Time to Act. 2003. 7. American Diabetes Association. Available at: www.diabetes.org. Last accessed: April 2010. 8. Jeerakathil T, Johnson JA, Simpson SH,
Majumdar SR. Short-term risk for stroke is doubled in persons with newly treated type 2 diabetes compared with persons without diabetes. Stroke. 2007; 38(6):1739-43. 9. World Heart
Foundation. Cardiovascular Risk Factors – Diabetes. www.worldheart.org/cardiovascular-health/cardiovascular-disease-risk-factors/diabetes/. Accessed June 2010. 10. Hovind P, Rossing P, Tarnow L, Smidt UM, Parving HH. Progression of diabetic nephropathy. Kidney Int. 2001; 59(2):702-9. 11. Fong DS, Aiello LP, Ferris FL 3rd, Klein R. Diabetic retinopathy. Diabetes
Care. 2004; 27(10):2540-53. 12. Dang CN, Boulton AJ. Changing perspectives in diabetic foot ulcer management. Int J Low Extrem Wounds. 2003; 2(1):4-12. 13. Brown JB, et al. The
Burden of Treatment Failure in Type 2 diabetes. Diabetes Care. 2004: 27: 7;1535-1540. 14. Pratley R and Salsali A. Inhibition of DPP-4: a new therapeutic approach for the treatment of
type 2 diabetes. Current Medical Research and Opinion. 2007; 23: 4: 919–931.
86
Boehringer Ingelheim annual report 2010
Major diabetes complications:
Microvascular damage to the
retina from diabetes (diabetic
retinopathy)
The risk of stroke in newly treated
type 2 diabetes is more than
doubled
Risk factors that contribute to
type 2 diabetes include:
People with diabetes are two to
four times more likely to have
cardiovascular disease
Picture: © Brian Evans /
Photo Researchers /
Agentur Focus
• Family history
• Obesity, diet and inactivity
• Ethnicity
• Insulin resistance
• Gestational diabetes
Damage to the kidney filtering
systems from diabetes (diabetic
nephropathy)
High levels of blood glucose can
damage the kidneys’ filters.
This leaves people with type 2
diabetes at risk of developing
renal impairment.
3.8m
Each year, 3.8 million deaths
are linked directly to diabetesrelated causes.
Characteristic symptoms of
type 2 diabetes:
• Excessive thirst
• Constant hunger
• Irritability
• Extreme fatigue
• Breathing difficulties
• Blurred vision
• Weight loss
Damage to the nerves from
diabetes (diabetic neuropathy) is
a leading cause of foot wounds
and ulcers
Be best.
87
research and development
Be best.
Our research and development in
diabetes
Metabolism is one of Boehringer Ingelheim’s core R&D areas and
diabetes one of the indications at the centre of interest within the
company’s global research network
Picture upper right:
exocrine and endocrine pancreas tissue
(Picture by Lennart Nilsson)
Boehringer Ingelheim is committed to
Boehringer Ingelheim diabetes portfolio.
researching and developing new dia-
Linagliptin is being investigated as an
betes compounds with novel modes of
oral once-daily tablet for the treat-
action to improve patients’ health and
ment of type 2 diabetes, as mono-
increase overall quality of life. These
therapy and as combination therapy.
include:
Linagliptin has a primarily non-renal
route of excretion (only approx. 5 %
DPP-4 inhibitor
linagliptin
SGLT-2 inhibitor
excreted via the kidneys). Data from
The compound BI 10773, a sodium-
late-stage clinical trials added to the
dependent glucose transporter-2
large body of clinical evidence demon-
(SGLT-2) inhibitor, blocks renal glu-
strating that linagliptin cannot only
cose absorption in the kidneys, there-
achieve significant and sustainable re-
by improving glycaemic control. The
ductions in blood glucose, but that
inhibition of SGLT-2 has been seen to
based on its unique pharmacokinetic
have a positive effect on body weight
profile, linagliptin may not require
loss and reduction in blood pressure
dose adjustment even in patients with
The phase II clinical trials with the
type 2 diabetes, with any degree of re-
compound have been concluded.
nal impairment.
11β-HSD1 inhibitor
DPP-4 inhibitors: a novel class of treat-
Inhibition of 11ß-HSD1 offers a novel
ment in type 2 diabetes
potential therapy for the management
DPP-4 inhibitors represent an innova-
of diabetes by lowering intracellular
tive approach to type 2 diabetes treat-
cortisol concentrations resulting in im-
ment with a unique mechanism of ac-
proved insulin sensitivity, blood lipid
tion compared to other classes in this
levels and vascular function. The 11ß-
therapeutic area.
HSD1 inhibitor compound currently
being studied by Boehringer Ingelheim
The inhibition of DPP-4 is beneficial
is in early stage of clinical development.
for type 2 diabetes patients to control
blood glucose levels, a primary goal of
88
DPP-4 inhibitor
type 2 diabetes management. A dose-
The DPP-4 inhibitor linagliptin is the
finding period (up-titration period) at
most advanced compound in the
the beginning of therapy is not needed
Boehringer Ingelheim annual report 2010
when treating with a DPP-4 inhibitor.
This is because of their rapid mode of
• Linagliptin as monotherapy (exercise
and diet alone),
• Linagliptin as an add-on to met-
action and the fact that their favourable tolerability profile does not cause
formin,
• Linagliptin as an add-on to met-
nausea and vomiting, in addition to
formin plus a sulfonylurea,
having a low risk of drug-drug interactions. This makes them appropriate
• Linagliptin in combination with pioglitazone.
as monotherapy or in combination
with other commonly used anti-diabe-
Linagliptin phase III data showed that
tes drugs.
this investigational compound
Linagliptin pivotal trials
achieved significant, sustained and
Four multi-center, randomised, place-
clinically meaningful reductions in
bo-controlled, double-blind phase III
blood glucose as measured by haemo-
studies were conducted to investigate
globin A1c (HbA1c), fasting plasma
the efficacy, safety, and tolerability of
glucose, and postprandial glucose con-
linagliptin (5 mg once daily) versus
centrations. Furthermore, these phase
placebo, administered over 24 weeks
III studies exhibited an outstanding
in type 2 diabetes mellitus patients
safety and compatibility profile.
with insufficient glycaemic control.
The overall HbA1c range for these
In 2010 too, applications for market ap-
studies was ≥ 7.0% and ≤ 11%, with
proval of linagliptin were submitted to
the following background therapy:
a number of authorities worldwide.
The mechanism of action of DPP-4 inhibitors
Mixed meal
Intestinal
GLP-1 release
• Glucose-dependent
insulin secretion
• Glucagon suppression
By binding to the DPP-4 enzyme, the breakdown of the two incretin hormones, glucagon-like peptide (GLP)-1 and glucose-dependent insulinotropic peptide (GIP) is inhibited. GLP-1 and GIP are
naturally occurring hormones, which are released by the gut after
meals and target the pancreas by increasing glucose-dependent
insulin secretion and suppressing glucagon secretion. DPP-4 inhibitors increase the GLP-1 plasma concentrations within the
physiological range.
GLP-1 (7-36)
active
DPP-4
Exogenous analogs
of GLP-1
DPP-4
inhibitor
GLP-1 (9-36)
inactive
Metabolism and diabetes
89
research and development
Be focused.
Be focused.
Boehringer Ingelheim has a long-term commitment to deliver tomorrow’s cancer
therapies by discovering and developing novel treatment options, both new
chemical entities (NCEs) and new biological entities (NBEs), that combine groundbreaking science with high therapeutic value for patients
[ cancer therapies ]
“Understanding the molecular biology and pathogenesis
of non-small cell lung cancer (NSCLC) has given rise to
the identification of targeted therapies. Two processes
have been identified as major contributors to the pathology of NSCLC – tumour cell signal transduction and the
initiation of tumour angiogenesis.”
dr matthias mueser,
deputy therapeutic area head oncology,
global clinical development/medical affairs,
ingelheim, germany
26.4m
By the year 2030, the cancer burden is set to
more than double: there will be 26.4 million
cancer cases, 17 million deaths and 75 million
people living with the disease.
Cancer
Cancer is a major global public health problem
and despite considerable advances in disease
awareness, diagnosis, and treatment, it remains
an area of significant unmet medical need.
Cancer - the facts
One out of every two men, and one out of every
three women, will have some type of cancer at
some point during their lifetime.
90
Boehringer Ingelheim annual report 2010
Cancer is one of the leading causes of death in
the world and represents a tremendous burden
Lung cancer
on patients, families and societies. In 2008, there
were 12.4 million new cases of cancer diagnosed
1,6 million
1,38 million
and 7.6 million deaths from the disease. The most
NEW LUNG CANCER CASES ANNUALLY
common cancers in terms of incidence were lung
(1.61 million), breast (1.29 million) and colorectal (1.15 million). Based on projections, cancer
LUNG CANCER DEATHS ANNUALLY
deaths will continue to rise. By the year 2030, the
burden is set to more than double: there will be
0
1.5
MILLION
26.4 million cancer cases, 17 million deaths and
75 million people living with the disease.
7%
Lung cancer
of lung cancer patients in Europe
Lung cancer is the most common and most dead-
alive 5 years
after diagnosis
ly form of cancer in the world. It accounts for
1.61 million new cancer cases annually and, beTODAY
cause of its poor prognosis, 1.38 million deaths
+1 YEAR
+2 YEARS
+3 YEARS
+4 YEARS
+5 YEARS
each year are attributable to lung cancer. More
than two-thirds of lung cancers are diagnosed at a
late stage and only 7% of lung cancer patients survive for at least five years after diagnosis.
All other
new
cancers
All other
cancers
Overall lung cancer is the cause of nearly 20% of
all cancer deaths. 13% of all new cases of cancer
are lung cancers and smoking is attributed as the
main cause in 90% of these cases.
13%
LUNG CANCER
13% of all new cancers
are lung cancers
90%
LUNG CANCER
90% of all lung cancer
smoking as cause
20%
LUNG CANCER
Lung cancer is in 20% cause
of all cancer deaths
Lung cancer – high unmet medical need
Lung cancer remains an area of high unmet need,
especially in its advanced stages where it is particularly aggressive and patients have limited treat-
Targeted cancer therapies for lung cancer
ment options. In general, there are three types of
New treatments may become available that are
treatment used in the management of lung cancer
targeted and selective to specific molecular
that can be used separately or in combination.
markers or structures on tumour cells. Two processes have been identified as major contributors
These are surgery, radiotherapy, and chemother-
to the pathology of NSCLC – tumour cell signal
apy. However, small-cell lung cancer (SCLC) and
transduction and the initiation of tumour angio-
non-small cell lung cancer (NSCLC) behave and
genesis.
respond to treatment quite differently. To determine the most appropriate treatment, cancers are
Understanding the molecular biology and patho-
staged to determine the severity of a patient’s
genesis of NSCLC has given rise to the identifica-
disease.
tion of targeted therapies. The epidermal growth
Be focused.
91
research and development
Be focused.
Lung cancer
Lung cancer remains an area of high unmet need. Especially, there is a high unmet medical need in advanced stages of lung
cancer, where the tumour is particularly aggressive and patients have limited treatment options. In general, there are three
types of treatment used in the management of lung cancer that can be used separately or in combination. These are surgery,
radiotherapy, and chemotherapy.
[ diagnosis ]
Computertomography of
lung cancer
[ treatment option ]
Surgical resection
Picture: © Medical Body Scans /
Photo Researchers / Agentur Focus
[ treatment option ]
Radiotherapy
[ treatment option ]
Chemotherapy
Picture: © picture-alliance/
Ronald Wittek
factor receptor (EGFR) family is a group of recep-
Given as monotherapy in combination with
tors implicated in the development of NSCLC.
classical chemotherapy, these new agents may also
provide a higher efficacy that is urgently needed
By focusing on molecular and cellular changes
in this patient population. These targeted therapies
that are specific to the cancer, these targeted can-
offer personalised treatment depending on a
cer therapies may be more effective than current
patient’s genetic make-up.
treatments and less harmful to normal cells,
thereby reducing unwanted treatment side effects.
[ cancer therapies ]
“I’m now able to bring to Boehringer Ingelheim
the experiences I gathered as a senior physician
treating cancer patients. The special fascination
for me in working in Global Medical Affairs is
being able to contribute to the further development of new cancer treatments to extend life
with a improved quality of life, thereby serving
a greater patient population.”
dr claudia-nanette gann,
senior global medical advisor medical affairs,
ingelheim, germany
92
Boehringer Ingelheim annual report 2010
Ovarian cancer
Breast cancer
204,000
1.5 million
NEW OVARIAN CANCER CASES ANNUALLY
NEW BREAST CANCER CASES ANNUALLY
125,000
500,000
OVARIAN CANCER DEATHS ANNUALLY
BREAST CANCER DEATHS ANNUALLY
0
0
210.000
1.5
MILLION
Breast cancer is the most common cancer among women worldwide
40%
alive 5 years
after diagnosis
alive 5 years
after diagnosis
+4 YEARS
tom
ymp
PTO
al s
stin
ms
inte
ar y
Urin
ss
t lo
Wei
gh
ue
Fati
g
sym
pto
trogas
and
Pain
+5 YEARS
TODAY
abn
orm
al v
agin
al b
om
leed
ina
ing
l or
bac
k pa
in
Lac
k of
ene
rgy
+3 YEARS
+1 YEAR
+2 YEARS
+3 YEARS
+4 YEARS
+5 YEARS
Probability of developing breast cancer
within the next 10 years
BY AGE 20
BY AGE 30
BY AGE 40
BY AGE 50
Abd
+2 YEARS
s
MS
+1 YEAR
SYM
g
CER
ellin
CAN
l sw
AN
ina
om
Abd
OVA
RI
of breast cancer patients in Europe
Occ
asio
nall
y
TODAY
90%
of ovarian cancer patients in Europe
1 OUT OF
1,985 229
1 OUT OF
1 OUT OF
68 37
1 OUT OF
Ovarian cancer
Breast cancer
Ovarian cancer is ranked as the sixth most com-
Breast cancer is the leading cause of cancer
mon cancer in women worldwide, with an esti-
deaths in women globally, resulting in more
mated 125,000 dying of the disease each year. The
than 411,000 deaths each year. HER2-positive
highest incidences of ovarian cancer are found in
breast cancer is a particularly aggressive form of
the USA and Northern Europe and lowest in Af-
the disease and is associated with a greater risk
rica and Asia.
of disease progression and death compared to
BY AGE 60
BY AGE 70
1 OUT OF
26 24
1 OUT OF
women with HER2-negative tumours. It is
The risk of ovarian cancer increases with age, as
thought that in approximately 30% of advanced
more than four out of five cases are diagnosed in
breast cancer cases, women over-express the
women over 50 years of age.
HER2 protein.
Be focused.
93
research and development
Be focused.
Our research and development in
oncology
Boehringer Ingelheim is committed to the clinical development of
pioneering treatments for cancer, with the aim of developing treatments, which will make a difference to the lives of patients and their
families.
Picture: Lung cancer
(by Lennart Nilsson)
Focus of research in oncology
plays a critical role in tumour growth
Boehringer Ingelheim is conducting a
and metastasis. Boehringer Ingelheim
broad clinical programmes (LUME
is developing new treatments that tar-
and LUX) involving various pipeline
get and inhibit these key biological
products in several cancer indications.
pathways involved in stimulating ang-
The current focus of research includes
iogenesis, thereby preventing growth
compounds in three areas:
and spread of the tumour.
Ω Angiogenesis inhibition,
Ω Signal transduction inhibition and
BIBF 1120 – triple angiokinase inhibitor
Ω Cell-cycle kinase inhibition.
BIBF 1120 (planned trade name
vargatef™) is a novel triple angiokinase
Angiogenesis inhibition
inhibitor that acts on three endothelial
Angiogenesis, the formation of new
growth factors simultaneously: vascular
vessels for the blood supply of tissue,
endothelial growth factor receptor
BIBF 1120 is a triple
angiokinase inhibitor
that blocks three
growth factor receptors
simultaneously: vascular
endothelial growth
factor receptors
(VEGFR 1-3), platelet
factor receptors
(PDGFR alpha and beta)
and fibroblast growth factor
receptors (FGFR 1-3).
[ bibf 1120 ]
• Small molecule, oral
• Targets FGFR, PDGFR, VEGFR
Angiogenesis inhibition
94
phase
patient population
III
Non-small cell lung cancer
III
Ovarian cancer
II
Ovarian cancer
II
Hormone-refractory prostate
cancer
II
Hepatocellular carcinoma
II
Renal cell carcinoma
II
Colorectal carcinoma
I
Solid Tumours
Boehringer Ingelheim annual report 2010
fgfr
pdgfr
vegfr
bibf 1120: Triple Angiokinase Inhibitor
EGF ligands
[ afatinib - bibw 2992 ]
Heregulins
• Small molecule, oral
• Targets EGFR, HER2
Signal transduction inhibition
phase
patient population
III
Non-small cell lung cancer
III
Breast cancer
IIb/III
Non-small cell lung cancer
II
Non-small cell lung cancer
II
Hormone-refractory prostate
cancer
II
Glioblastoma
II
Squamous-cell head and
neck cancer
II
Breast cancer
I
Solid tumours
egfr / her3
egfr / her4
egfr / egfr
egfr / her2
her2 / her2
her2 / her3
her2 / her4
Afatinib is a next generation tyrosine kinase inhibitor, which is an irreversible inhibitor of the epidermal growth factor receptor (EGFR) and the human epidermal
growth factor receptor 2 (HER2) kinases. Both receptors are involved in cell proliferation, differentiation and apoptosis (programmed cell death) and their inhibition
may play a critical role in the prevention of tumour growth and spread.
(VEGFR), platelet-derived growth fac-
Afatinib - BIBW 2992
tor receptor (PDGFR) and fibroblast
Afatinib (planned tradename Tomto-
growth factor receptor (FGFR) – all cru-
vok®) is an oral compound (taken as a
cially involved in the formation of
tablet), a next generation inhibitor of
blood vessels. As angiogenesis plays a
the epidermal growth factor receptor
pivotal role in the growth of all solid
(EGFR) and human epidermal recep-
tumours, BIBF 1120 is being investigat-
tor 2 (HER2) tyrosine kinase (TK) and,
ed in a number of other solid tumours
unlike first generation TK inhibitors,
including advanced non-small cell lung
irreversibly binds to EFGR/HER2 and
cancer (NSCLC), ovarian cancer, color-
irreversibly inhibits both, the epider-
ectal, hepatocellular, and renal cancer.
mal growth factor receptor (EGFR/
HER1) and the human epidermal re-
Signal-transduction inhibition
ceptor HER2, which are involved in
Cell proliferation, differentiation and
tumour growth and spread. The com-
programmed cell death (apoptosis) are
pound is under development in several
tightly regulated in healthy tissues by a
solid tumour types.
variety of external signals working via
receptors that activate intracellular sig-
Afatinib is currently in phase III clini-
nal-transduction pathways. Cancer cells
cal development in NSCLC.
acquire genetic mutations that alter these
signal-transduction pathways, resulting
In 2010, Boehringer Ingelheim also
in malignant cells that proliferate uncon-
initiated a phase III clinical trial to in-
trollably and do not respond to the sig-
vestigate afatinib for the treatment of
nals that normally activate apoptosis.
patients with advanced (metastatic)
Oncology
95
research and development
Be focused.
breast cancer. Furthermore, BIBW
Volasertib - BI 6727
2992 is being investigated for various
Volasertib represents the latest step in
additional cancer indications, includ-
Boehringer Ingelheim’s programme to
ing head and neck cancer and colorec-
develop the most effective, potential
tal cancer.
first-in-class specific Plk1 inhibitor.
Volasertib specifically inhibits Plk1,
Cell-cycle kinase inhibition
a key regulator in the process of cell
The cell cycle describes the series of
division. It may be associated with dis-
events between one cell division (mi-
ruption of the mitotic spindle check-
tosis) and the next. It is the process by
point activation, and prolonged mitot-
which a single cell forms identical sets
ic arrest (polo arrest), which then
of daughter cells. Disruption of this
leads to cell death. Due to much high-
process is a fundamental feature of
er levels of Plk1 in tumour cells com-
cancer.
pared to healthy tissues, BI 6727 preferentially targets the dividing cancer
Apoptosis of a
tumour cell.
[ volasertib - bi 6727 ]
• Small molecule, intraveneous/oral
• Targets Plk1
cells.
Plk-1 Inhibition
In the area of cell-cycle kinase inhibition, Boehringer Ingelheim is develop-
Based on the encouraging efficacy and
ing inhibitors of polo-like kinase 1
safety results from a phase I study, vo-
(Plk-1), a protein that is involved in
lasertib is being advanced further in
the processes of cell division. These
clinical development. The phase II pro-
molecules are in the earlier stages of
gramme assesses the efficacy and safety
clinical development.
of volasertib in several tumour types.
Volasertib specifically inhibits Plk1, a key
regulator in the process of cell division. It may
be associated with disruption of the mitotic
spindle checkpoint activation and prolonged
mitotic arrest (polo arrest), which then leads
to cell death.
Cell-cycle kinase inhibition
Metaphase
Prometaphase
Anaphase
Prophase
phase
patient population
II
Ovarian cancer
II
Urothelial cancer
II
Non-small cell lung cancer
I/IIa
Acute myeloid leukaemia
I
Solid tumours
PLK1
Interphase
Cytokinesis
96
Boehringer Ingelheim annual report 2010
Telophase
The LUX trial programme
The LUX clinical trial programme in-
The LUX trial programme
vestigates afatinib in a number of dif-
Overview of ongoing clinical trials
ferent cancer patient populations.
BIBW 2992
Clinical
phase
Medication in the treatment
and control arm
Cancer type
LUX Lung 3
III
Afatinib
vs
Cisplatin/pemetrexed
Potential first-line
NSCLC with EGFR
mutation
LUX Lung 6
III
Afatinib
vs
Cisplatin/gemcitabine
Potential first-line
NSCLC with EGFR
mutation
LUX Lung 5
III
After afatinib:
Afatinib + combination
chemotherapy
NSCLC progressing after chemotherapy and erlotinib or gefitinib
LUX Breast 1
III
Afatinib + vinorelbine
vs
Trastuzumab + vinorelbine
Metastatic HER2positive breast
cancer
LUX Lung 1 trial programme
LUX Lung 1 is a clinical phase IIb/III
randomised, double-blind study evaluating afatinib plus best supportive
care (BSC) versus placebo plus BSC in
patients with advanced NSCLC. Patients’ disease has progressed after prior chemotherapy and first generation
epidermal growth factor receptor
(EGFR) tyrosine kinase inhibitor gefitinib or erlotinib treatment. Due to the
study inclusion criteria, a high proportion of patients that may have mutated EGF receptors in their tumours
were included.
LUX Lung 1 trial results
Afatinib has been shown to prolong
The LUX Lung 1 trial results (2010)
progression free survival from 1.1 to
3.3 months, even though the primary
Independent review
endpoint has not been met. The pro-
Afatinib
Controlled
gression-free survival in this trial was
Partial response regardless of confirmation
13 %
0.5 %
confirmed by independent review.
Partial response confirmed
7%
0.5 %
These results are supported by a sig-
Stable disease
51 %
18 %
nificant increase in disease control
Disease control rate
58 %
19 %
rate (the share of patients with stabilised tumours or tumour shrinkage)
and objective response rate (share of
patients with tumour shrinkage or absence of tumour) compared to placebo.
Progression-free survival is a measure
of the clinical benefit from a specific
therapy.
LUX Lung 2 trial
LUX Lung 2 is a multicenter phase II,
open-label, single arm trial of afatinib;
in patients with advanced lung cancer
Our R&D activities in oncology
97
research and development
Be focused.
who were untreated or progressed after
one course of chemotherapy. Patients
The LUX Lung 2 trial results (2010)
were tested for activating EGFR muta-
Remarkable progression-free survival rates were reported for patients with the activating EGFR mutations that were treated with afatinib:
tions prior to the trial.
All patients N = 120
The LUX Lung 2 trial results
There were remarkable progressionfree survival of 14 months and a sur-
Overall response rate
61 %
vival of two years for patients with
Disease control rate
86 %
EGFR mutations who were treated
Median progression free survival
14 months
with afatinib. In addition, the data
Median overall survival
24 months
from the LUX Lung 2 trial showed
that, the majority of patients (61%)
have significant tumour shrinkage
(measured as partial response) when
The LUME trial programme
treated with afatinib as assessed by in-
Overview of ongoing clinical trials
dependent review.
BIBF 1120
Clinical
phase
Medication in the treatment
and control arm
Cancer type
Lume Lung 1
III
BIBF 1120 + doxetaxel
vs
doxetaxel
Stage III/IV or
recurrent NSCLC
LUME Lung 2
III
BIBF 1120 + pemetrexed
vs
pemetrexed
Stage III/IV or
recurrent NSCLC
Lume Ovar 1
III
BIBF 1120 + carboplatin
vs
carboplatin/paclitaxel
Advanced ovarian
cancer
The LUX Breast 1 trial is an open-label
randomised phase III trial to investigate the efficacy and safety of afatinib
plus vinorelbine compared to trastuzumab plus vinorelbine in patients
with metastatic HER-2 positive breast
cancer who received prior treatment
with trastuzumab.
The LUME Lung trial programme is investigating BIBF 1120 in combination
with standard second-line chemotherapy treatments for patients with advanced NSCLC.
The LUME Ovar 1 trial
LUME Ovar 1 is a multicentre, randomized, double-blind Phase III trial to
investigate the efficacy and safety of
BIBF 1120 in combination with carboplatin and paclitaxel compared with
placebo plus carboplatin and paclitaxel in patients with advanced ovarian
cancer.
98
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Available at: http://www.hospitalmanagement.net/features/feature648 [Last Accessed April 2009] 2. American Cancer
Society 2009. Who gets cancer? [Online] Available at: http://www.cancer.org/docroot/CRI/content/CRI_2_4_1x_Who_
gets_cancer.asp?sitearea [Last Accessed February 2009] 3. The World Health Organization 2005. Strategies that prevent,
cure and care. The World Health Organization’s Fight Against Cancer. [Online] Available at: http://www.who.int/cancer/
publicat/WHOCancerBrochure2007.FINALweb.pdf [Last Accessed February 2008] 4. Boyle P. et al. World Cancer Report
2008. International Agency for Research on Cancer. 5. Stewart B.W. and Kleihues P. World Cancer Report. International
Agency for Research on Cancer 2003.
Sources Lung Cancer p. 91: 1. The World Health Organisation. Global cancer rates could increase by 50% to 15 million
by 2020. Last accessed March 2010 (http://www.who.int/mediacentre/news/releases/2003/pr27/en/ ). 2. Cancer Research UK. CancerStats - Key Facts on Lung Cancer and Smoking. [Online] Available at: http://info.cancerresearchuk.org/
cancerstats/types/lung/. [Last accessed 30 September 2010]. 3. Allen J et al. J Natl Compr Canc Netw 2008; 6 (3): 28593. 4. Ferlay, J., Parkin, D.M., Steliarova-Foucher, E., Estimates of cancer incidence and mortality in Europe in 2008. European Journal of Cancer 46 (2010) 765-781.
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International Agency for Research on Cancer. Lyon: 2008 2. American Cancer Society. “Ovarian Cancer Detailed Guide.”
Atlanta: 2008. Available at: http://documents.cancer.org/114.00/114.00.pdf. Accessed on 5 May 2009.
Sources Breast Cancer p. 93: 1. Garcia M et al. Global Cancer Facts & Figures. Atlanta, GA: American Cancer Society,
2007. 2. WHO Cancer Factsheet N°297 – updated February 2009. [Online] Available at: http://www.who.int/mediacentre/factsheets/fs297/en/index.html [Last accessed 7 July 2010] 3. US National Cancer Institute. Cancer Advances in Focus [Online] Available at: http://www.cancer.gov/cancertopics/cancer-advances-in-focus/breast [Last accessed 7 July
2010] 4. American Cancer Society Breast Cancer Facts & Figures, 2005-2006 [Online] Available at: http://www.cancer.
org/acs/groups/content/@nho/documents/document/caff2005brfacspdf2005pdf.pdf [Last accessed 8 July 2010]
5. WHO. Breast Cancer Burden [Online] Available at: http://www.who.int/cancer/detection/breastcancer/en/index1.html
[Last accessed 8 July 2010] 6. Penault-Llorca F et al. 2005 ‘Incidence and implications of HER2 and hormonal receptor
overexpression in newly diagnosed metastatic breast cancer (MBC)’, Journal of Clinical Oncology, vol. 23, S69. © 2010
Boehringer Ingelheim GmbH. All rights reserved.
Boehringer Ingelheim annual report 2010
Our research and development in
idiopathic pulmonary fibrosis
Idiopathic pulmonary fibrosis (IPF) is a progressive and severely debilitating lung disease, for which there are no approved treatments and
there is an unmet clinical need for effective licensed medications.
Idiopathic pulmonary fibrosis
from these receptors, it is hypothe-
IPF is characterised by fibrosis (stiff-
sised that BIBF 1120 inhibits one of
ening) of the tissue between the alveo-
the pathogenic processes in IPF.
Alveoli of the lung.
(Picture by Lennart Nilsson)
li in the lungs, which causes coughing
and breathing difficulties and limits
Tomorrow study
physical activity. Unpredictable acute
The TOMORROW (to improve pulmo-
exacerbations of the disease occur in
nary fibrosis with BIBF 1120) study
some patients and may be fatal. The
was a 12-month, randomised, double-
mean age at diagnosis is 66 years.
blind, placebo-controlled trial designed to evaluate the effect of oral
IPF has a survival rate similar to many
BIBF 1120 on decline in forced vital
cancers, with a mean survival time
capacity in patients diagnosed with
following diagnosis of 3 to 5 years. At
IPF.
3-5 years
The mean survival time following
diagnosis of IPF is 3 to 5 years.
present, there are no licensed pharmacological treatments for IPF in the
Results from the phase II TOMOR-
USA or Europe.
ROW study showed that 12 months of
treatment with BIBF 1120 resulted in
BIBF 1120 – triple kinase inhibitor
a clinically important reduction in the
Boehringer Ingelheim’s investigation-
rate of decline in lung function in pa-
al compound BIBF 1120, a triple ki-
tients with IPF.
nase inhibitor, may provide significant
clinical benefit in patients with IPF.
These results were evaluated to be
very encouraging. Using an innovative
Apart from IPF, Boehringer Ingelheim
approach to treating IPF, an effect has
is investigating BIBF 1120 also in
been shown on clinically relevant
phase III clinical studies for the treat-
study endpoints. Taken together, these
ment of cancer patients in different
data provided a solid and promising
cancer types (see oncology).
platform for the development of a
phase III programme.
Receptors blocked by BIBF 1120 have
been shown to be involved in fibrosis
of the lungs. By blocking the signalling pathways that lie downstream
Idiopathic pulmonary fibrosis
99
research and development
Be focused.
Our research and development in
hepatitis C
New anti-viral therapies with novel mechanisms of action are muchneeded advancements in the treatment of hepatitis C virus (HCV)
infections. HCV research at Boehringer Ingelheim is directed toward
identifying inhibitors targeting essential viral enzymes, such as the
HCV serine protease and RNA polymerase.
Picture: Hepatitis C viruses
© AMI IMAGES / SPL / Agentur
Focus
Hepatitis C
ment landscape and potentially im-
Hepatitis C is an infectious disease
prove cure rates for a wider patient
of the liver and is a leading cause of
base. In addition, with any antiviral
chronic liver disease and liver trans-
therapy, viral resistance is a potential
plant. The number of individuals
issue.
chronically infected with hepatitis C
virus (HCV) globally has been estimat-
New antiviral therapies with novel
ed at 170 million, with 3–4 million
mechanisms of action are much-needed
new infections occurring each year.
advancements in the treatment of hep-
170m
Only about 20–45 % of patients clear
atitis C.
The number of individuals
chronically infected with HCV
globally has been estimated at
170 million.
maining chronically infected patients,
Our hepatitis C portfolio
20 % will develop cirrhosis within a
Hepatitis C research at Boehringer In-
mean of 20 years. The mortality rate
gelheim is directed toward identifying
after cirrhosis has developed is 2-5 %
inhibitors targeting essential viral en-
per year. End-stage liver disease due to
zymes, such as the HCV serine pro-
HCV infection currently represents the
tease and RNA polymerase.
the virus in the acute phase. Of the re-
major indication for liver transplantation in the western world.
Such novel mechanisms offer the potential for new therapies with im-
Treatment of hepatitis C
proved tolerability compared to cur-
Therapeutic options for hepatitis C are
rent treatments of chronic hepatitis C.
currently limited. The standard of
These approaches may lead to the de-
care, pegylated interferon and ribavi-
velopment of novel classes of antivi-
rin, is often challenging for patients
rals for the treatment of chronic hepa-
due to significant treatment duration
titis C.
of typically 48 weeks and with side ef-
100
fects that impact treatment adherence
The two lead investigational com-
and low response rates. A successful
pounds in the Boehringer Ingelheim
interferon-saving regimen could sig-
hepatitis portfolio are BI 201335 and
nificantly change the hepatitis C treat-
BI 207127.
Boehringer Ingelheim annual report 2010
Oral HCV NS3/4A protease inhibitor
PegIFN sparing combination therapy
BI 201335 is an investigational oral
Boehringer Ingelheim has conducted a
HCV NS3/4A protease inhibitor, dis-
phase Ib study, SOUND-C, that
covered from Boehringer Ingelheim’s
showed that the combination of two
own research and development, which
oral hepatitis C compounds, the pro-
has completed clinical trials through
tease inhibitor BI 201335 and the
phase IIb (SILEN-C) studies.
polymerase inhibitor BI 207127, with
ribavirin reduced viral load to the
NS5B RNA-dependent polymerase
lower limit of quantifiable levels in
inhibitor
HCV treatment-naïve patients. The
BI 207127 is a polymerase inhibitor
regimen did not include interferon
that has completed phase I clinical tri-
through the first 28 days of treatment.
als. HCV NS5B is believed to be the
central enzyme responsible for HCV
Planning is currently underway to
replication. BI 207127 works by
begin phase II trials of BI 207127 with
blocking a specific step in the viral li-
BI 201335 in interferon-saving regimens
fecycle, targeting the polymerase en-
both with and without ribavirin.
zyme and consequently preventing
HCV from replicating.
“Early data of the Sound-C study suggest that there is
the potential for the combination of oral anti-hepatitis C
virus therapies to reduce the viral load in a more tolerable,
interferon-sparing regimen. The current standard of care,
is challenging for hepatitis C patients due to side effects
that impact treatment adherence and has suboptimal
response rates, An interferon-saving regimen
could provide an important treatment option
for patients with chronic hepatitis C.”
professor stefan zeuzem,
department of medicine at the johann wolfgang
goethe university hospital,
frankfurt, germany
Our R&D activities in hepatitis C
101
our businesses
Our drive for innovation:
Boehringer Ingelheim is a company committed to
the goal of serving humankind. Innovative medicines
are the basis of our success as an independent,
family-owned company. Our businesses are Human
Pharmaceuticals and Animal Health.
Boehringer Ingelheim’s total net sales amounted
to EUR 12,586 million in 2010, close to the
level of the previous year.
Prescription Medicines, which represents
Boehringer Ingelheim’s most important
business area, achieved net sales of EUR
9,702 million, corresponding to 77% of the
company’s overall net sales.
12,586m
9,702m
102
Boehringer Ingelheim annual report 2010
BIZ
Our Businesses
Be committed. Be reliable. Be successful.
104
Human Pharmaceuticals
106
Prescription Medicines
108
Consumer Health Care
118
Biopharmaceuticals
126
Operations
136
Animal Health
152
Our Consumer Health Care business in
over-the-counter medications recorded net
sales of EUR 1,318 million, an increase
of 4.5%.
With net sales of EUR 921 million, our
Animal Health business was able once
again to register exceptional successes
in 2010. This corresponds to an increase of
+51% on the previous year.
1,318m
921m
Businesses
103
our businesses
Be committed. Be reliable. Be successful.
Be committed.
Be reliable.
Be successful.
The success of our innovations is measured by the great number
of patients who are helped by our medicines.
104
Boehringer Ingelheim annual report 2010
[ human pharmaceuticals ]
“A medication, such as dabigatran etexilate, prevents the complications of atrial
fibrillation, I mean the risk of blood clots
and strokes.”
dr john digby,
specialist in internal medicine,
toronto, canada
Be committed. Be reliable. Be successful.
105
Be committed. Be reliable. Be successful.
our businesses
Human Pharmaceuticals
Human Pharmaceuticals is our prime business area and accounts for nearly 93 % of our
net sales. All our medications in various therapeutic areas are of special medicinal importance for our patients and thereby of great significance to Boehringer Ingelheim.
How aware are you of the disease?
“I am 80 and thriving. I swim half a kilometre
twice a week, I work out in the gym and
play golf. Oh, I feel great.”
dr digby: “I don’t have it all the time, but
I’d get bursts of this irregularity from time to
time. I’d be quite aware something was sort of
puttering away within, like a faulty electric or
outboard motor, or something like that, that
seemed to be going a little faster and a little irregular.”
dr john digby,
specialist in internal medicine,
toronto, canada
How was your atrial fibrillation treated?
dr digby: “I started on dabigatran etexilate
in August 2007, as part of a trial of this drug that
was being conducted by my cardiologist, and I’ve
Quality of life despite atrial fibrillation
continued on that medication until the present. I
Dr John Digby, 80, a retired specialist in internal
knew that AF could be controlled with medica-
medicine, has enjoyed a fulfilling life with his
tions and to prevent the complications of atrial
wife Donna for many years, despite being diag-
fibrillation with a drug, such as dabigatran etexi-
nosed with intermittent atrial fibrillation.
late, I mean the risk of strokes and blood clots.”
What has also made this possible is the active in-
How do you feel taking the medication?
gredient dabigatran etexilate, which, as a novel
a kilometre twice a week, I work out in the gym
danger of a stroke in this special type of cardiac
and play golf. Oh, I feel great.”
dysrhythmia. In the USA and in Europe alone, six
million people suffer from atrial fibrillation (AF).
When was your AF diagnosed?
dr digby: “Well, it was rather dramatic. I had
a cataract operation. Then I went home. And
suddenly I collapsed. She (Donna) thought I was
dead, I wasn’t breathing, I was pale, just lying
there on the bed. Subsequently, the doctors followed it up and realised that I had what they
called paroxysmal atrial fibrillation.”
106
dr digby: “I am 80 and thriving. I swim half
oral anticoagulant, helps to prevent the typical
Boehringer Ingelheim annual report 2010
Atrial fibrillation – an increasing problem
[ usa ]
[ europe ]
[ worldwide ]
5.1m
4.5m
+ 100 %
Patients with AF in USA
in 2010
Patients with AF in Europe
in 2010
The number of people with AF is expected to
more than double by 2050
Sources: 1. Miyasaka Y et al. Circulation 2006;114:119-25 2. Fuster V et al. Circulation 2006;114:e257-354
ropace 2008;10:403-11 5. Coyne KS et al. Value Health 2006;9:348-56
3. Friberg J et al. Epidemiology 2003;14:666-72
4. Ringborg A et al. Eu-
Managing atrial fibrillation (AF)
vantageous than controlling heart
Need for new anticoagulation
The management of AF has two broad
rate, and criteria favouring rhythm-
Due to the limitations of current anti-
objectives. These are the prevention of
control include patients being young-
coagulant therapy with vitamin-K-an-
complications, including stroke and
er and the existence of troublesome
tagonists and/or acetylsalicylic acid,
heart failure, and the relief of symp-
symptoms of AF, despite treatment
there is a need for an effective, safe
toms from the arrhythmia itself.
with rate-control.
and convenient oral anticoagulant
Symptom relief can be achieved by
with predictable effects, fewer drug-
either controlling the heart rate or re-
A majority of patients with AF should
drug interactions, no drug-food inter-
storing sinus rhythm, which is only
receive anti-thrombotic therapy
actions and no requirement for rou-
possible in rare cases.
For stroke prevention, anti-thrombotic
tine coagulation monitoring.
therapy is recommended for all paTreatment strategies should be tailored
tients with AF and at least one risk
to the patient
factor for stroke, other than those
The goals of therapy need to be indi-
with lone AF or contra-indications.
vidualised for each patient. Studies
Risk factors for thrombo-embolism and
have demonstrated that rate-control
bleeding must be considered when de-
has similar efficacy to rhythm-control
ciding on a stroke prevention strategy.
and that rate-control is generally bet-
Risk stratification schemes such as
ter tolerated. Consequently, rate-con-
CHADS2 and haemorrhages can be
trol is recommended as the first-line
used in clinical practice to stratify a
strategy for many patients. Restora-
patient’s risk of stroke and bleeding
tion of sinus rhythm is still more ad-
respectively.
Human Pharmaceuticals
107
our businesses
Prescription Medicines
Prescription Medicines
Within our Human Pharmaceuticals business,
Prescription Medicines represents the focus of our
activities. Our key products, such as pradaxa®,
spiriva®, micardis® and mirapex®/sifrol®, made a
significant contribution to our growth in 2010.
Thrombo-embolic diseases –
a novel oral anticoagulant
Dabigatran etexilate (pradaxa®) represents a new generation of oral
anticoagulants targeting a high unmet medical need in the prevention
and treatment of acute and chronic thrombo-embolic diseases.
[ pradaxa®, pradax®, prazaxa® ]
is approved for stroke prevention in
atrial fibrillation in the USA, Canada
and recently in Japan.
The medication is also approved for
the primary prevention of venous
thrombo-embolic events (blood clots)
in adults who have undergone elective
total hip or elective total knee replacement surgery.
Approval for stroke prevention in
Market authorisation in USA
atrial fibrillation (AT)
Approval in the USA made pradaxa®
After 50 years without any major
available to a broad spectrum of pa-
therapeutic innovations being intro-
tients, with the 150 mg twice-daily
duced to the market, pradaxa® is
dose approved for all patients, except
the first novel oral anticoagulant to
for a small subset with severe renal
have been approved for stroke preven-
impairment, where the approved dose
tion in AT in the USA, Canada and
is 75 mg twice-daily.
recently in Japan. Market approval
in other major markets is expected
Market authorisation in Canada
during 2011.
In Canada, pradax® is available to
AT patients with the flexibility of two
108
This approval of pradaxa® marks
dosing regimens. While overall the
an important step in advancing care
150 mg twice daily dose is recom-
for patients with AT. pradaxa® repre-
mended, the 110 mg twice daily dose
sents a breakthrough innovation that
is specifically available for elderly pa-
has the potential to transform the an-
tients aged 80 years and above as well
ticoagulant market place for patients
as for patients at increased risk of
and prescribers.
bleeding.
Boehringer Ingelheim annual report 2010
Market authorisation in Japan
Prevention of venous thromboembo-
In Japan, the medication was approved
lism after orthopaedic surgery
under the brand name pradaxa® for
pradaxa® is already approved in 75
the prevention of ischaemic stroke and
countries for the primary prevention
systemic embolism in patients with
of venous thrombo-embolic events
non-valvular AF. The medication is
(blood clots) in adults who have un-
available with 150 mg bid (given as
dergone elective total hip or elective
2 capsules of 75 mg) recommended
total knee replacement surgery.
as the standard dose and 110 mg bid
available for specific patient types
considered to be at a higher risk of
bleeding.
Atrial fibrillation (AF) - Cost burden and need for treatment
[ af and stroke ]
[ managing af ]
As many as three million people worldwide have an AF-related stroke every year; equivalent to one person every 12
seconds. One in four people aged 40 years or older develop
AF during their lifetime, making it the most common heart
rhythm abnormality.
A majority of patients with AF should receive antithrombotic therapy. For stroke prevention, antithrombotic therapy is recommended for all patients with AF and at least
one risk factor for stroke, other than those with lone AF or
contraindications.
Three out of four AF-related strokes can be prevented, but
many patients are not aware of their risk and do not take
action to prevent stroke.
[ usa ]
[ europe ]
[ af-related stroke ]
6.65bn
6.2bn
3m
EUR per year costs treating AT
EUR per year costs treating AT
Three million people worldwide have an
AT-related stroke every year.
Sources: 1. Fuster V, Rydn LE, Cannom DS, et al. ACC/AHA/ESC 2006 Guidelines for the management of patients with atrial fibrillation. Circulation 2006; 114:e257-e354 2. Bruggenjurgen B et al. The impact of atrial fibrillation on the cost of stroke: The Berlin Acute Stroke Study. Value Health 2007;10:137-43 3. Coyne KS, et al. Assessing the direct costs of treating
nonvalvular atrial fibrillation in the United States. Value Health 2006; 9:348-56 4. Ringborg A, et al. Costs of atrial fibrillation in five European countries: results from the Euro Heart
Survey on atrial fibrillation. Europace 2008; 10:403–411
Thrombo-embolic diseases
109
our businesses
Prescription Medicines
COPD treatment - sustained improvement
in lung function
spiriva®, a long-acting inhaled anticholinergic medication, is the first
inhaled treatment to provide significant and sustained improvements
in lung function with once-daily dosing.
Picture: Loading the spiriva® respimat®
with active ingredient
Spiriva®, a long-acting inhaled anti-
leads to significant improvements in
cholinergic medication, is the first in-
lung function (FEV1) and to signifi-
haled treatment to provide significant
cant reductions in the risk of exacer-
and sustained improvements in lung
bations and hospitalisations, delay
function with once-daily dosing. The
in time to first exacerbation and it
unique mechanism of action of the
preserves quality of life for up to four
medication provides 24-hour airway
years. Furthermore, it has demonstrated
patency and optimal treatment flex-
significant improvements in patients’
ibility and the treatment benefits prov-
exercise tolerance.
en in a broad patient population with
or without concurrent respiratory
spiriva® has a favourable safety pro-
medications.
file as demonstrated in the uplift®
Spiriva® Respimat®
cluding a 16 % reduced risk of mortality
The delivery system spiriva® respimat®
on treatment and a reduced cardiac
relies on energy released from a spring,
and respiratory morbidity, including
rather than propellants, to produce a
reduced respiratory failures.
trial with spiriva®handihaler®, in-
[ spiriva® ]
Once-daily dosing,
24-hour airway patency
Most prescribed maintenance
therapy for COPD
long-lasting, slow-moving soft mist.
The delivery system respimat®
produces a long-lasting, slow-moving
soft mist
spiriva® is the essential COPD treatThe innovative design makes spiriva®
ment for earlier intervention, since it
respimat® easy to use and results in
provides efficient symptom relief, sus-
reduced deposition in the mouth and
tained benefits and a favourable long-
throat compared to a pressurised me-
term safety profile for all patients re-
tered-dose inhaler (pMDI) without a
quiring maintenance therapy.
spacer device.
Results of the POET® Study
110
Impact on the clinical course of COPD
The POET® study tested the frequency
spiriva® impacts positively the clinical
of exacerbation of COPD in compari-
course of chronic obstructive pulmo-
son with salmeterol. For a year, more
nary disease (COPD), helping to change
than 7,000 patients took part in this
the way patients live with their disease.
class comparison of the long-acting
It is the most prescribed maintenance
anticholinergenic tiotropium with the
therapy for COPD worldwide. spiriva®
long-acting beta agonist/salmeterol.
Boehringer Ingelheim annual report 2010
COPD - spiriva® recommended as a first-line maintenance
treatment option for patients with moderate to severe COPD.
Stage I (mild)
Mild airflow limitation
Stage II (moderate)
Shortness of breath on exertion;
cough and sputum
Stage III (severe)
Repeated exacerbations that
impact Qol
Stage IV (very severe)
Greatly impaired Qol,
life-threatening
exacerbations
Differential diagnosis –
asthma versus COPD
Asthma
• Onset at an early age
(often in childhood)
• Symptoms vary from day to day
• Symptoms often occur at night/
early morning
• Allergy, rhinitis, and/or eczema also
present
• Family history of asthma
• Largely reversible airflow limitation
COPD
• Onset in mid-life (usually 40+)
• Symptoms slowly progressive
• History of smoking
• Breathlessness during exercise
• Poorly reversible airflow limitation
Diagnosis of COPD includes an assessment of risk factors, such as smoking and
exposure to pollutants, and symptoms,
including persistent cough and breathlessness. It is then confirmed by spirometry.
Source: GOLD: Pocket Guide to COPD Diagnosis, Management, and Prevention, December 2010
spiriva® reduced the risk of COPD ex-
symptoms can restrict a patient’s abil-
Differential diagnosis of COPD
acerbation significantly by 17 % versus
ity to perform normal daily activities.
and asthma
COPD is often mistaken for asthma, yet
salmeterol. Furthermore, the risk of severe exacerbations requiring hospitali-
Importance of early and accurate
these are very different diseases with
sation were significantly reduced by
diagnosis of COPD
different underlying causes and out-
28 %. The study strengthened the posi-
Due to its progressive nature, the early
comes, and therefore require different
tion of spiriva® as the first choice for
diagnosis and treatment of COPD is
treatment. Accurate diagnosis to distin-
COPD therapy.
essential to prevent complications and
guish between asthma and COPD is es-
exacerbations (worsening of symp-
sential to ensure that all patients re-
toms) associated with the condition.
ceive the best therapy and avoid
COPD
COPD is a preventable lung disease
further deterioration (see table).
caused by the long-term inhalation of
The Global Initiative for Chronic Ob-
pollutants, most commonly cigarette
structive Lung Disease (GOLD) inter-
Treatment of COPD
smoke, that progressively and perma-
national consensus guidelines recom-
A stepwise approach to treatment de-
nently reduces the ability of adults to
mend that patients are identified as
pending on international treatment
breathe well and maintain active lives.
early in the course of the disease as
guidelines like GOLD is recommended.
COPD is characterised by shortness
possible. (see figure)
Maintenance therapy with long-acting
of breath (or dyspnoea), coughing,
bronchodilators is recommended first
wheezing and increased sputum (mu-
line for patients with moderate to very
cus or phlegm) production. These
severe COPD (GOLD stages II - IV).
Respiratory diseases
111
our businesses
Prescription Medicines
Extended-release formulations
increase adherence to therapy
Once-daily formulations make a difference in the treatment of
Parkinson’s disease and HIV/AIDS.
Why once-daily formulations make a
heim research to date available in over
difference
90 countries across the globe for the
Poor adherence to therapy regimens is
treatment of the signs and symptoms
common, leading to significant wors-
of early and advanced idiopathic PD,
ening of quality of life and increased
as monotherapy or in combination
health care costs. This is of impor-
with levodopa.
tance especially for neurodegenerative
conditions, such as Parkinson’s dis-
Mirapexin®/Sifrol® extended release
ease, but also for life-threatening dis-
Following the marketing authorisation
eases, such as HIV/AIDS.
by the European Commission in October 2009, a once-daily, extended re-
By switching from more complex
lease formulation of pramipexole
[ mirapexin/sifrol® extended
release/ mirapex er® ]
treatments, such as two or even three
(trade name mirapex er® in the USA)
times daily medications, improve-
was granted market authorisation by
Symptomatic treatment of
Parkinson’s disease
ments in adherence can be expected.
the US Food and Drug Administration
Market authorisation in EU and
the USA
(FDA) for the treatment of early in
Parkinson’s disease
February 2010 and in March 2010 for
Parkinson’s disease (PD) is a chronic
advanced PD.
neurological disorder. Its worldwide
prevalence is estimated to be approxi-
Benefit for the patient:
reduction of the pill burden. This may
increase compliance and may improve PD patients’ quality of life.
mately 1-2 % of those over 65 years.
In June 2010, Boehringer Ingelheim
Although PD is traditionally associat-
received European approval of two
ed with motor symptoms, such as
new tablet strengths (2.25 mg and
tremor, rigidity, slowed motion, imbal-
3.75 mg) of the mirapexin®/sifrol®
ance, shuffling gait, loss of facial ex-
extended-release, once-daily formula-
pression, the non-motor symptoms,
tion for the treatment of early and ad-
including depressive symptoms, pain,
vanced idiopathic PD.
cognitive impairment and sleep disorders, can be significant.
The new dosages will offer PD patients to take only one mirapexin®/
112
Pramipexole for treatment of PD
sifrol® tablet once a day. This may in-
Pramipexole (trade names mirapex-
crease compliance and may improve
in®, sifrol®, mirapex® and pexola®)
PD patients’ quality of life. The new
is a compound from Boehringer Ingel-
extended release formulations will
Boehringer Ingelheim annual report 2010
also offer an efficacy and safety profile
Clinical efficacy results at 48 weeks
comparable to the immediate release
confirm that once daily nevirapine is
tablet taken three times daily as dem-
non-inferior to the already licensed
onstrated in recent studies
viramune®.
HIV/AIDS Treatment – Viramune®
The 400mg once-daily nevirapine ex-
viramune® (nevirapine) is a member
tended release formulation demon-
of the non-nucleoside reverse tran-
strated adequate drug exposure
scriptase inhibitor (NNRTI) class of
through 48 weeks, and efficacy was
anti-HIV drugs and is indicated for
consistent across gender, baseline viral
the treatment of HIV-1 infection in
load and country of origin. Both for-
combination with other antiretroviral
mulations demonstrated a similar ad-
agents.
verse event profile and no new side ef-
[ viramune® extended release]
Treatment of HIV/AIDS.
Extended release formulation
submitted to regulatory authorities
for approval.
verxve study results
demonstrated safety and efficacy
of once-daily viramune® extended
release.
fects were identified.
Viramune® prolonged release
With the once-daily formulation of our
HIV medication viramune® , patients
will be able to reduce their pill burden
without foregoing the effectiveness,
which will also be highly appreciated
by their caregivers, as it is expected that
a once daily administration can improve patient adherence to their treatment regimen.
In 2010, the viramune®prolonged release formulation, including paediatric
formulations, was submitted to the regulatory authorities in various countries.
The VERXVE study
The verxve study demonstrated efficacy and safety of 400mg once-daily
nevirapine prolonged release formulation.
The study was designed to compare
the clinical efficacy of a new, once-
“Most people with Parkinson’s disease take many
different pills on a daily basis, to manage their
PD symptoms and other concomitant conditions.
Particularly newly diagnosed PD patients may
experience more ease in coping with their illness
when they are introduced to a simpler, oncedaily dosing regimen.”
daily, single 400mg tablet of nevirapine prolonged release with the currently available version of viramune®,
professor angelo antonini,
director of the parkinson unit at the research institute
irccs san camillo venice, italy
which is 200mg taken twice a day.
Parkinson’s disease - HIV/AIDS
113
our businesses
Prescription Medicines
Hypertension and cardiovascular
protection
Boehringer Ingelheim offers a portfolio of medications to support
physicians to manage hypertension and to provide protection beyond
blood pressure control.
Hypertension
hypertension with the introduction
High blood pressure (hypertension) is
of micardis® (telmisartan), an angi-
a primary risk factor for a serious car-
otensin II receptor blocker (ARB).
diovascular event such as a heart at-
[ micardis® ]
Highly effective, well-tolerated blood
pressure lowering
Over the full 24 hours in a single once
daily dose
Additionally protects patients against
severe cardiovascular events, such as
myocardial infarction and stroke
tack or stroke. Cardiovascular disease
With twynsta®, micardisplus® and
is the number one cause of death
micardis®, Boehringer Ingelheim now
worldwide. Well tolerated treatment
has a portfolio of options, that all con-
options that reduce the pill burden
tain the ARB telmisartan. This range of
for patients may lead to better man-
products has been developed to support
agement of their hypertension and
phyisicians in managing hypertension
lead to better outcomes. This is espe-
and to provide cardiovascular protection
cially important in patients who are
beyond blood pressure control.
particularly at risk of these serious
cardiovascular events because their
Telmisartan - efficacy and safety
hypertension is severe, or they suffer
Telmisartan is a modern ARB and has
from diabetes or metabolic syndrome.
been investigated in the most ambitious
and far-reaching research programme
There are now many treatments for
conducted with an ARB. In the clinical
high blood pressure yet control of
trial programmes ontarget™, tran-
hypertension around the world is still
scend® and profess®, over 50,000 pa-
low (see table). In most of the coun-
tients were enrolled to investigate the
tries surveyed, more than 40 % of
efficacy in cardiovascular prevention of
adults aged between 35 and 64 years
telmisartan (for more information please
had hypertension above the recom-
visit www.news-landmarktrials.com).
mended worldwide blood pressure
level of <140/90 mmHg.
Convincing safety data for patients
with a high cardiovascular risk were
114
A portfolio of options for treatment of
also collected in the three long-term
hypertension
outcome trials ontarget™, profess®
Boehringer Ingelheim has established
and transcend® which followed some
itself at the forefront of treatment for
of the patients for up to five years.
Boehringer Ingelheim annual report 2010
micardis® offers an excellent safety
profile, which has been confirmed also
Hypertension: low awareness, treatment and control
in a market exposure of 34.5 million
patient years.
Proportion of patients in the population (%)
Country
Aware
Treated
Controlled
Telmisartan was discovered and de-
Japan
16.0
–
4.1
veloped by Boehringer Ingelheim.
UK
35.8
24.8
10.0
Under the trademarks micardis® and
Germany
36.5
26.1
7.8
micardisplus® (combination with
Spain
38.9
26.8
5.0
hydrochlorothiazide) Boehringer In-
Sweden
48.0
26.2
5.5
gelheim markets telmisartan in 84
Italy
51.8
32.0
9.0
countries around the world, includ-
USA
69.3
52.5
28.6
Micardis®, MicardisPlus®
ing the USA, Japan and European
countries. Telmisartan is marketed in
BP < 140/90 mmHg
Wolf-Maier et al. Hypertensions. 2004; 43:10-17 / Sekikawa, Hayakawa. J Hum Hypertens. 2004; 18:911-912 /
Telmisartan Plus Amlodipine Medical Education Slide Resource: Final Version 1.0 (7.-July-2010
cooperation with Astellas Pharma
Inc. in Japan, Bayer HealthCare in
Europe and GlaxoSmithKline in selected markets.
treatment of hypertension. At least two
micardis® provides highly effective,
thirds of patients need more than one
well-tolerated blood pressure-lower-
drug alone to control their blood pres-
ing over the full 24 hours in a single
sure. Many treatment guidelines suggest
once-daily dose and is widely used as
that combination therapy be initiated if
medication to lower blood pressure. In
a patient’s blood pressure is more than
addition, micardis® is proven to pre-
20/10mmHg above their goal.
vent patients at high risks from events,
such as myocardial infarction and
Twynsta®
stroke.
twynsta® is a new highly effective
and well tolerated single pill combina-
micardis® fulfils the medical need to
tion therapy of the ARB telmisartan
protect patients, especially older pa-
and amlodipine, a calcium channel
tients, from cardiovascular risks such
blocker, for the treatment of hyperten-
as myocardial infarction or stroke. It is
sion.
the only ARB which has cardiovascular prevention in its label and has be-
twynsta® consistently reduces blood
come a valuable treatment option in
pressure in a broad range of patients
the management of cardiovascular
including those with mild, moderate
risk.
and severe hypertension. In particular,
it is effective in hypertensive patients
Unmet need in hypertension treatment
with added risk such as those with
Data from recent patient studies show
obesity, metabolic syndrome and dia-
that there are still unmet needs in the
betes (see figures).
Hypertension and cardiovascular protection
115
Prescription Medicines
our businesses
[ twynsta®/micamlo® ]
Telmisartan plus amlodipine
Since October 2009, telmisartan plus
ment therapy in adult patients receiv-
amlodipine (marketed as twynsta®)
ing telmisartan and amlodipine from
has been approved by the US Food and
separate tablets containing the same
Drug Administration (FDA) for use in
component doses.
the treatment of hypertension alone,
Approved for treatment of hypertension alone, or in combination with
other antihypertensive agents, and as
initial therapy in patients likely to
need multiple drugs to achieve their
blood pressure goals
or with other antihypertensive agents,
Both telmisartan and amlodipine
and as initial therapy in patients likely
have a proven evidence base in cardio-
to need multiple drugs to achieve their
vascular outcomes.
blood pressure goals.
Twynsta® – trials overview
Approved in the USA, EU and Japan
Twynsta®/Micamlo® – market authorisa-
The approval of twynsta® by the
tion in Japan and the EU in 2010
European Commission followed a re-
In Japan, telmisartan plus amlodipine
view of three pivotal clinical trials.
is marketed as micamlo® and was ap-
Results from these studies demon-
proved for the treatment of hyperten-
strated that twynsta® provided con-
sion in July 2010.
sistent and significantly greater blood
pressure reduction compared to the
In October 2010, the European Com-
respective monotherapies with the
mission confirmed the positive opin-
40-80mg/5-10mg formulations. The
ion of the European Medicines Agency
medication allowed 82.7 % of patients
(EMA) approving twynsta®.
to achieve their 24 hour blood pressure goal (<130/80 mmHg according
twynsta® is indicated for the treat-
to the AHA criteria) with the
ment of hypertension in adults whose
80mg/10mg formulation.
blood pressure is not adequately controlled on amlodipine or as replace-
twynsta® - Substantial and sustained 24-hour blood pressure lowering
Patients achieving 24-hour ABPM goal* (%)
Mean systolic blood pressure reductions after eight weeks of treatment with TWYNSTA®
Diabetes
p < 0.0001
100
82.7
80
60
40
Obese
00
n = 68
n = 188
Metabolic
syndrome
n = 36
Severe HTN
n = 379
-10
-20
37.9
-30
20
-40
0
-50
A10 (n = 58)
T80/A10 (n = 52)
- 43.2
mmHg
- 46.3
mmHg
- 44.2
mmHg
- 47.5
mmHg
* AHA criteria for 24h BP goal
Mean SBP reductions from baseline (mmHG)
Figure 2. TWYNSTA® provides superior 24-hour ambulatory blood pressure monitoring (ABPM) goal rate achievement (<130/80 mmHG*) in 82 % of patients
Figure 3. TWYNSTA® delivers powerful blood pressure reductions for patients with
added risk
116
Boehringer Ingelheim annual report 2010
“The latest data confirm that combination therapies provide a valuable treatment option for patients, including those with severe hypertension. The results
demonstrate that the combination of telmisartan and amlodipine provides reliable reduction in blood pressure and offers a more favourable safety profile
than the respective individual therapies – an important consideration for improving adherence, which is often a barrier to effective
blood pressure control.”
professor michael böhm,
department of internal medicine and cardiology,
university of saarland, germany
In addition, results from a recent double-blind, randomised, controlled trial
in patients with severe hypertension
(teamsta severe hypertension) showed
that twynsta® reduced systolic blood
pressure by a mean of nearly 50
mmHg. This powerful reduction, observed in nearly half of patients, is
among the highest blood pressure reduction achieved in antihypertensive
trials.
Related links:
www.ontarget-telmisartan.com
www.micardis.com
Hypertension and cardiovascular protection
117
our businesses
Consumer Health Care
Consumer Health Care
Consumer Health Care (CHC) is one of the core
businesses of Boehringer Ingelheim. CHC strives to
serve consumers worldwide with top-quality pharmaceuticals for self-medication.
Innovation – a major driver for CHC
The market for over-the-counter (OTC) healthcare is undergoing
constant change. This is influenced by regulatory, competitive
and technological factors, as well as by the growing consumer trend
towards taking personal responsibility in addressing healthcare
and well-being.
Key drivers of consumer trends
fast access to healthcare information.
Aging populations and cost pressure
Disease, treatment, product and price
on healthcare systems change the
information is at the tip of their fin-
landscape of the markets in which
gers and experiences and evaluations
Boehringer Ingelheim CHC is compet-
are shared via web portals, blogs and
ing. Cost pressure leads to govern-
social networks. In order to create and
ments no longer supporting reim-
maintain sustainable growth in the
bursement of all medications. This has
OTC market, innovation is therefore
led to an increase in preventative med-
key for Boehringer Ingelheim CHC.
icines and an increasing willingness of
Core sources of innovation are:
regulators to consider switching prescription medicines to OTC brands.
New business opportunities (NBOs) RX to OTC switches
118
The way consumers seek and use in-
The CHC new business opportunities
formation is also changing. The mod-
process delivers continuous improve-
ern consumer wants to be well in-
ments in terms of line or brand exten-
formed and self empowered to be able
sions. It typically represents new pres-
to take care of their health and well-
entations of the international core
being. New information technology
brands, such as formulations, tastes,
enables consumers to have easy and
e.g. mucoangin® Cassis and Lemon.
Boehringer Ingelheim annual report 2010
Providing this type of change keeps
OTC products need ongoing scientific
our core business modern and rele-
support and news. Within the special-
vant.
ist disciplines of CHC, the groups of
Development, Medical and Regulatory
Brand extensions aim to grow the cus-
Affairs (DMRA) are centres of excel-
tomer base of the international core
lence and have an extensive and inti-
brands by moving it into new areas of
mate knowledge of the medical and
business, such as new indications and
scientific support of our brands.
areas of medical need. For example,
[ chc highlights 2010 ]
• Six out of seven CHC international
core brands grew above their categories.
• Our key brands hold over 50 local
category leader positions around
the world.
buscofem® using ibuprofen extends
Recent clinical study results have con-
buscopan® into the area of menstrual
firmed the efficacy and safety of our
pain and opens the international core
brands.
• Obtaining 100% of SSP shares in
Japan in 2010 has resulted in
Boehringer Ingelheim being the
only multinational in Japan’s top
10 OTC companies.
Innovation in execution
• With SSP, CHC now has the largest
OTC cough business in the world.
brands to a new target market to build
incremental sales.
As Boehringer Ingelheim moves into
• Creation of RX-to-OTC switch unit
In order to further expand and max-
2011, specific programmes for sales
imise the trends described above, CHC
excellence and launch excellence will
will also strive to enter in new upcom-
be started in early 2011 and be rolled
ing OTC categories.
out across the year.
• alesion® (epinastine, allergic
rhinitis) switch approval Japan
This will be done by pioneering RX
By addressing all sources of innova-
(prescription medicines) to OTC
tion, CHC is prepared to benefit from a
• Successful rollout of “Got
mucus” TV campaign for bisolvon®
switches which are fostered by the
lively and fast-changing environment
changing regulatory environment ex-
and continue to provide consumers
perienced in many countries. As of
with new options to take care of their
2010, CHC has a fully dedicated RX-
health and well-being.
• Excellent clinical trial results for
dulcolax® and antistax®
• Successful launches and brand
extensions under pharmaton®,
dulcolax® and buscopan®
to-OTC switch unit to clearly dedicate
resources to assess and exploit this
promising opportunity.
Communication-driven innovation
In line with the fast development of
communication patterns and related
technology, CHC has to adapt its communication tools accordingly. Classic
TV and print campaigns still represent
an important part of the communication mix, however new media also have
Read more about
RX-to-OTC switch unit
page 120
to be targeted in order to reach target
groups even more efficiently. Medical support-driven innovation
Read more about
clinical study results
for DULCOLAX®
page 124
Boehringer Ingelheim’s established
Innovation – a major driver for CHC
119
our businesses
Consumer Health Care
The new RX to OTC switch unit
Bringing more self-care solutions to patients.
250m
The overall buscopan®
franchise today comprises sales
of close to EUR 250 million.
Given the progressive ageing of the
OTC switches as a strategic tool to
population and the accompanying in-
open up new OTC categories, it is
crease in chronic diseases, the health-
worth pointing out that Boehringer
care systems of the developed world
Ingelheim’s CHC has switched its
face fundamental and profound
own compounds in the past with
changes. The growing shortage of phy-
great success.
sicians reduces the time for professional consultation. State budget cuts,
The switch of Buscopan®
coupled with rising health costs, re-
An excellent example is buscopan®,
lentlessly raise the financial pressure.
which has been switched step-by-step
This can lead to restricted accessibility
in many regions – over decades. Still,
to existing and effective treatment op-
as of today, some combination prod-
tions and thus endanger overall public
ucts sold under the brand buscopan®
health.
have not yet been switched to OTC
and buscopan® is thus a brand com-
[ buscopan® ]
RX to OTC switches
Has been switched step-by-step in
many regions.
Many diseases are self-treatable with
prising both RX and OTC products at
good OTC medicines, supported by
the same time (dual status).
appropriate educational and awareness
campaigns. This is both welcomed by
The medical, advertising and promo-
most consumers and reduces the de-
tional efforts of the CHC business
mand on healthcare systems. Trans-
have enabled both the RX and the
buscopan® is a brand comprising
ferring former prescription me-dicine
CHC products to grow significantly
both RX and OTC products at the
same time (dual status).
products to self-medication status in-
over the last couple of years under the
creases consumer access to treatment
common brand buscopan® (see chart
options, reduces overall healthcare
below – buscapina® in Latin America).
A dual status strategy has proven to
be successful.
costs and can, with the right support,
significantly increase the awareness of
The overall buscopan® franchise to-
the respective health condition and
day comprises sales of close to EUR
the independence of the individual in
250 million. And the story has just be-
treating themselves.
gun. This case shows that a dual strategy (brand exists in different dosages
120
While current market dynamics and
or formulations in RX and OTC in
competitor activities clearly underpin
parallel) after patent expiry proves to
the increasing importance of RX to
be very successful. As the chart below
Boehringer Ingelheim annual report 2010
shows, RX and OTC business, i.e. in
tion of Boehringer Ingelheim as one of
Latin America, subsequently are grow-
the world’s leading self medication
ing steadily in parallel, driven by CHC
companies with high-level marketing
marketing efforts.
and sales capabilities as well as a
[ flomax® relief ]
First-in-class switch of flomax®
in the UK.
unique global coverage.
The RX to OTC switch unit
The complexity of new switches,
A significant achievement by Boe-
particularly those from chronic and
hringer Ingelheim, the first switch for
symptomless conditions, requires
a chronic condition, came at the end
pioneering regulatory and marketing
of 2009, with the first-in-class switch
approaches - a need also recognised
of flomax® (tamsulosin) in the UK. As
by other global pharmaceutical com-
of the beginning of 2010, flomax re-
panies. This has led to the decision to
lief® mr has been sold OTC in UK
establish a fully dedicated RX to OTC
pharmacies. This marks an entry into
switch group within CHC.
a completely new self-medication cat-
Available in UK since first quarter
2010.
Entry into a new self-medication
category.
egory and will serve as a reference or
The switch group will focus on two
learning case for further switches in
strategies. First, to switch mature Boe-
the UK and other countries.
hringer Ingelheim products, thus extending their life cycle well beyond
patent protection and offering consumers new self-care solutions. Secondly, it will position CHC as a partner of choice for external switch
candidates through the strong posi-
buscapina® Americas
CHC investments drives overall buscopan® growth
Sales in
EUR
80,000
70,000
60,000
50,000
40,000
CAGR PM:
30,000
+ 6.9 %
20,000
CAGR CHC:
10,000
+ 23.1 %
0
2004
2005
Prescription Medecines (PM)
2006
2007
2008
Consumer Health Care (CHC)
2009
2010
CAGR=
Compound
Annual
Growth Rate
The new RX to OTC switch unit
121
our businesses
Consumer Health Care
Innovative social media campaigns
in CHC
Reflecting changing consumer behaviour regarding information
searches leads to integrated advertising campaigns using both social
and classical media.
People spend more and more time on
Digital activity - Poland
the internet, especially on social net-
In Poland, a successful digital cam-
works. A consumer-orientated busi-
paign was executed in 2009 for
ness like Boehringer Ingelheim’s CHC
buscopan® without any TV support.
must therefore reflect changing con-
A market share increase from 2 % to
sumer behaviour regarding informa-
4 % was achieved. The campaign was
tion searches. Classical advertising
executed throughout 2010, support-
patterns using only mass media, such
ed by booster phases on TV which
as TV, are no longer the best and most
doubled the market share to 8 %.
effective methods of communication.
Digital activity - Brazil
Today, both social media campaigns
The CHC team in Brazil was one of the
and classical advertising campaigns (TV
first willing to take a calculated risk by
or any other media) exist in parallel and
using social media as one pillar of their
are being aired as integrated campaigns.
360° communication to consumers.
Various campaigns for international
brands such as buscofem®, mucosolvan®, mucoangin® and pharmaton® were developed. Whenever
someone in Brazil was talking about
sore throats (mucoangin®) on Twitter,
Orkut or Facebook, the team was
available to answer the consumer’s
questions in real time.
For the cough market (mucosolvan®),
the team created a variety of tools for
educating as well as entertaining consumers.
For menstrual cramps (buscofem®), a
www.123livredatosse.com.br
122
Boehringer Ingelheim annual report 2010
highly personalised platform was cre-
“It is important to listen and learn from our consumers and
finally engage and entertain them in the right places at the right
times. Today, many of our consumers are spending a lot of time
on social media platforms.”
benni boruchowski,
marketing chc, brazil
ated to help younger women deal with
their problems.
To encourage the consumer to think
about their vitality (pharmaton®), the
Brazilian CHC team established events
in the offline world that are highly
connected to the web and delivered a
portal where all Brazilians are able to
track their mental and physical performance.
Further links of social media campaigns:
buscofem®
www.buscofem.com.br
www.dicadeamiga.com.br
mucoangin®
www.mucoangin.com.br
www.tratadordegarganta.com.br
mucosolvan®
www.mucosolvan.com.br
www.123livredatosse.com.br
pharmaton®
www.pharmaton.com.br
www.clubepharmaton.com.br
Especially for product launches, the
broader use of digital and social
media can be highly effective to test
bisolvon®
www.bisolvon.com.br
future communication strategies on
a lower cost level.
The Polish and Brazilian experiences
serve as case studies for other countries. Today, CHC runs digital media
campaigns all over the world.
In 2010, CHC reached more than 300
million consumers through digital
media campaigns.
CHC runs more than 250 websites
around the world with more than 15
million visitors per year in more than
40 countries.
www.clubepharmaton.com.br
Innovative social media campaigns
123
our businesses
Consumer Health Care
Dulcolax® – innovation through
state-of-the-art clinical studies
Boehringer Ingelheim Consumer Health Care (CHC) is committed to
progressing scientific knowledge about its products and has conducted
clinical studies on dulcolax® tablets and dulcolax® drops.
Boehringer Ingelheim’s international
Innovation through new clinical trials
core brand, dulcolax®, offers consum-
To demonstrate the commitment of
ers worldwide a range of effective and
Boehringer Ingelheim to progressing
well-tolerated products for intestinal ir-
scientific knowledge about its prod-
regularity and disruption.
ucts, the company conducted two randomised, double-blind, placebo-con-
[ dulcolax® ]
Flagship brand:
range of products for intestinal
irregularity and disruption.
50 years on the market:
sold in 60 countries across the world.
Franchise is worldwide market leader:
Net sales: EUR 159 million in 2010
Market share: 6.6 %.
The dulcolax® range includes dulco-
trolled, parallel group clinical trials in
lax® tablets and suppositories (bisa-
accordance with ICH-GCP guidelines
codyl), dulcolax® pearls, drops and
and in patients with functional consti-
syrup (sodium picosulfate) , dulcolax®
pation. One trial assessed bisacodyl
balance (macrogol), dulcofiber® (glu-
and the other assessed sodium pico-
comanan), and, in selected countries
sulfate.
additionally, dulcoease® (docusate sodium) and dulcoenema® (glycerine).
Efficacy and safety confirmed –
Dulcolax® – a success story
The clinical studies were conducted
With a history of over 50 years on the
on dulcolax® tablets (bisacodyl) and
market, dulcolax® is today sold in
dulcolax® drops (sodium picosulfate)
more than 60 countries across the
and clearly demonstrated efficacy by
world, generating net sales of EUR
increasing the frequency and regular-
159 million. The franchise is the
ity of bowel movements.
quality of life improved
worldwide market leader in the irregularity field with a market share of
Study design
6.6 %.
• Objective: to determine the efficacy
and safety of four weeks of treat-
The success of dulcolax® is based not
ment with oral bisacodyl tablets 10
only on sound consumer insight, mar-
mg (2x 5mg dulcolax® tablets), or
keting and sales, well-defined product
10mg sodium picosulfate (drops)
ranges and new product development,
• Patients with chronic constipation
but also on a solid scientific founda-
(defined by ROME III criteria), once
tion which was significantly enriched
daily dosing.
by two recent clinical trials.
124
Boehringer Ingelheim annual report 2010
• Bisacodyl trial: 368 patients were
randomised and treated, 247 with
ferers’ everyday well-being, measured
A foundation for further growth
bisacodyl, 121 with the placebo.
by the constipation-related PAC-QoL®
The sodium picosulfate trial was pub-
questionnaire.
lished in the American Journal of Gas-
• Sodium picosulfate trial: 367 patients
were randomised and treated, 233
troenterology in 2010. The results of
with sodium picosulfate and 134 with
One of the most important questions a
the two trials were also presented at
the placebo.
consumer with constipation faces is
both the leading European (UEGW)
related to efficacy. The answer to this
and North American (Digestive Dis-
question determines whether a partic-
ease Week) scientific congresses in the
ular drug will be used again or not. In
gastroenterology field.
• Efficacy data were recorded daily in
an electronic diary by patients.
Study results
these trials, the final global efficacy
During the four weeks of treatment, the
was assessed by the patient after a
The above studies further confirm the
mean number of complete spontaneous
four-week treatment period and the
leading position of dulcolax® not only
bowel movements (CSPM) per week
outcome was very positive. This recon-
in the laxative market, but also in the
(primary efficacy variable) was statisti-
firmed why consumers worldwide rely
related scientific arena. Ultimately, this
cally significantly higher in the bisa-
on dulcolax®:
will lead to the further strengthening
codyl and sodium picosulfate group
than in the placebo group (p<0.0001).
of Boehringer Ingelheim’s scientific
• 79.5 % of the patients taking bisa-
• 87.7 % of the patients taking sodium
[Gastroenterology 2010, 138 (5): 228;
picosulfate rated the efficacy of the
Am J Gastroenterol 105 (4), 897 - 903
drug as good or satisfactory.
(2010)].
For the first time, it was shown that
treatment with dulcolax® (bisacodyl
and consumers worldwide.
as good or satisfactory.
proved to be an effective, well-tolerated
treatment for patients with constipation.
reputation with doctors, pharmacists
codyl rated the efficacy of the drug
Oral bisacodyl and sodium picosulfate
• The comparisons to the evaluations
tablets and sodium picosulfate drops)
done by patients in the placebo group
in patients suffering from constipation
resulted in statistically significant
results in an increase of quality of life
differences in favour of dulcolax®.
as well as an improvement in the suf-
Quality of life of patients treated with dulcolax®
Percentage of patients
Percentage of patients
60
60
Patient
50
40
40
30
30
20
20
10
10
0
Patient
50
0
Good
Placebo
Satisfactory
Sodium picosulfate
Not satisfactory
Bad
Good
Placebo
Satisfactory
Not satisfactory
Bad
Bisacodyl
Innovation through state-of-the-art clinical studies
125
our businesses
Biopharmaceuticals
Biopharmaceuticals
Innovation helps us to be successful and to maintain our technological leadership in biopharmaceutical development and manufacturing for both in-house research projects and our contract
manufacturing business.
126
Boehringer Ingelheim annual report 2010
What is a TIM? What is
innovation in Biopharmaceuticals?
Our goal is to open new horizons for health and healing. This is achieved through innovative modes of action, product enhancement or a fresh approach to well-known issues.
Who are your customers in the biopharmaceutical
“Innovation in technology is
turning ideas into commercially
viable opportunities.”
business?
dr jung: “Our customers are both our internal R&D colleagues as well as our external contract manufacturing customers. For all our cus-
dr wolfgang buchinger,
technology innovation manager,
vienna, austria
tomers, we develop and transfer processes for the
entire, wide-ranging field of biopharmaceutical
compounds, from small protein scaffolds to large
antibodies in all clinical stages from early development up to phase II/III and market supply.
Our innovation programme basically addresses
What is the key function of a technology and
both product and process-related improvements
innovation manager (TIM)?
which have the potential to generate higher val-
dr buchinger: “Our role as innovation
managers is really multifunctional. As a tech-
ue. This enables us to offer unique, cutting-edge
services to all our customers.”
nology scout, we are continuously searching for
attractive innovations which are complementa-
What are the major achievements of the
ry to our in-house technologies. Internally, we
technology and innovation programme?
serve as facilitators to support our scientists
dr jung: “The production of a biopharma-
who are the ideal source for creative ideas and
ceutical product from DNA to bulk filling reflects
innovations for our biopharmaceutical business.
a value chain. Along this value chain, there are
This includes guidance for the scientists on
many starting points for innovation which in-
managing the technology portfolio, ensuring
clude enhancement of productivity, shorter de-
highest scientific and technical quality in the
velopment timelines, robust processes as well as
programme. Furthermore, we assist in the de-
high product stability during storage.
DNA as the carrier of
genetic information
also encodes for
biopharmaceutical
drugs such as monoclonal antibodies
or recombinant proteins.
velopment of strategies and the active implementation of new technologies as part of our
Our recent achievements include molecular and
customer services.
cellular improvements of our BI-HEX® cell culture platform as well as our integrated lean
We are also responsible for translating the high
downstream platform, which we call BI-PurEx®.
level technology strategy into an operative im-
These innovations have led to titers of up to 8 g/L
plementation plan together with the scientists.”
and yields greater than 90% after purification.
Biopharmaceuticals
127
our businesses
Biopharmaceuticals
The available technologies include, for example,
“Innovation in technology is
to create value for users.”
high titer processes in E. coli with superior fermentation yields of up to 20 g/L. Our refolding
platform enables the production of several scaffold molecules as inclusion bodies in E. coli with
dr alexander jung,
technology innovation manager,
biberach, germany
outstanding yields.
In addition to these process innovations, we have
established product technologies which improve
the half-life of those scaffold molecules and
These innovations, together with excellent proc-
make them more convenient for patient dosing.
ess quality control, lead to a very high success
The broad range of technologies covers PEG-yla-
rate and product quality in development and
tion, HES-ylation and HSA-fusions.
clinical material supply.”
For efficient purification of high protein
dr buchinger: “For microbial expression
amounts, we have established large-scale pro-
systems, a number of powerful platform technol-
tein crystallisation with a systematic develop-
ogies and a versatile development toolbox have
ment approach for both cell culture and micro-
been established to continuously succeed in a
bial technologies.”
challenging market environment. Besides inhouse development, scientific collaborations
with universities and other external partners as
How do you deliver continuous innovation?
dr jung: “We have established a continuous
well as in-licensing are also utilised to improve
technology innovation process which identifies
technologies, drive innovation and provide com-
our internal technology needs. The process in-
petitive advantages to our customers.
cludes prioritisation of the different internal objectives, benchmarking existing external technologies and their value potential and due diligence
of selected technologies with regard to feasibility
in routine development and manufacturing processes.
Together with our function Competitive Intelligence, we constantly screen the outside world for
technology trends and future customer needs.
This approach helps us to offer cutting-edge
technologies to our customers.”
E. Coli microorganisms
can be used to produce
non-glycosylated biopharmaceuticals.
dr buchinger: “Out of the large pool of internal and external ideas and opportunities, the
technologies that will help to achieve this goal
are the highest priority in our innovation pro-
Picture: © DR LINDA STANNARD,
UCT/ SPL / Agentur Focus
128
Boehringer Ingelheim annual report 2010
grammes. These innovations incorporate both
solutions for short-term development projects, as
Crystals of recombinant interferon gamma
well as ideas for a long-term technology strategy.
cytotoxicity (CDC) or antibody-dependent cell-
The innovation managers at the manufacturing
mediated cytotoxicity (ADCC) for specific medical
sites play an important role here in ensuring the
applications. To be able to offer these technolo-
link of the technology development to strategic
gies makes a big difference for a manufacturer,
goals and business benefits.”
because it offers an added value to the customers’ projects and helps them to be more success-
How will future service in biopharmaceuticals
ful in clinical development. A lower attrition rate
production look?
thus means a more likely market product for
dr jung: “As we are seeing a competitive sit-
Boehringer Ingelheim.”
uation, together with a continued vigorous
growth on the market in biopharmaceuticals, it is
dr buchinger: “Additionally, a short time-
important to be able to offer unique advantages
line for process development and thus minimised
to all our customers.
time-to-clinic is also crucial to be competitive in
the contract manufacturing market.”
Beyond the quality and process technologies that
I have already mentioned, I think that it is also
important to have a unique selling proposition
that helps our customers to get access to product
improvements through the development of the
production process.
At Boehringer Ingelheim, we deal with technologies that help address issues wit the molecules in
the medical application profile, such as half-life,
immunogenicity, aggregation, but also mechanism of action, such as complement-dependent
Read more about
protein crystals:
page 132
Biopharmaceuticals
129
our businesses
Biopharmaceuticals
Orchestrating innovation
New expression systems and recent improvements available for
current systems have the potential to revolutionise the biopharmaceutical industry. Lower costs and efficiencies of newer expressionsystems are driving these changes.
Being at the cutting-edge, Boehringer
antibodies or recombinant proteins,
Ingelheim constantly develops new
Boehringer Ingelheim’s proprietary
technologies to offer our customers a
high-expression system BI-HEX® en-
competitive advantage.
ables fast-track development of highquality combined with high titers
The high demand for biopharmaceuti-
from CHO (Chinese hamster ovary)
cals has led to the development of
cells. The BI-HEX® platform meets
large-scale manufacturing processes
both demands for a fast time-to-clinic
and technologies to improve produc-
as well as the scalability for later
tivity in manufacturing. One area that
large-scale manufacturing. The plat-
has increased productivity is the gen-
form addresses all important features,
eration of high-expression cell lines.
including process performance, product quality, safety and comparability.
BI-HEX® - your best match
Boehringer Ingelheim has further-
For the industrial production of bio-
more extended the CHO host cell port-
pharmaceuticals, such as monoclonal
folio within the BI-HEX® platform.
This gives our customers the opportunity to select from different glycoprofiles which best fit their product. This
variety of different CHO cell lines is
sufficient to meet targeted glycoprofiles and quality, especially in second
generation processes.
One strategy to further improve productivity, cell growth, product quality
and cell stability, is cell line engineering. Since most biopharmaceutical
products are proteins that are secreted
from the cells, the secretory transport
machinery of the production cell line
is an important target for novel cell
engineering strategies.
Chinese hamster ovary cells.
130
Boehringer Ingelheim annual report 2010
ConCERT™ is an innovative, genetical-
molecule) in biopharmaceutical pro-
ly optimised BI-HEX® CHO cell line
duction processes. This important fea-
which overexpresses the CERamide
ture reduces the cost of goods to gen-
transport protein (CERT).
erate material for clinical trials or
market supply. conCERT™ thereby
CERT is a cytoplasmic lipid transfer
makes production more economical
protein which simultaneously facili-
and speeds up drug development
tates both lipid and protein transport.
through faster delivery of sufficient
The conCERT™ cell lines show im-
material for pre-clinical studies.
proved secretion characteristics. These
cells are therefore ideal host cell lines
for recombinant protein production,
as they have an improved secretory capacity as well as good growth characteristics. The enhanced secretion of recombinant proteins from conCERT™
cells lead to up to 100% higher product titers (depending on the product
The key to the conCERT™ technology
• The human CER-amide Transport protein (CERT) is a cytoplasmatic transfer protein that transports single lipid molecules
from the endoplasmatic reticulum to the plasma membrane via
the Golgi apparatus.
• CERT is also a substrate of protein kinase D, a known regulator
of protein secretion. This results in simultaneously facilitating
both lipid and protein transport.
er
golgi
cert
CERT shuttles lipids
and facilitates
secretory transport.
Orchestrating innovation
131
Biopharmaceuticals
our businesses
Protein crystallisation
Micro-scale crystallisation of proteins is widely used as a tool for
structure determination. Preparative crystallisation may be an alternative to costly unit operations.
Picture: Crystals of a monoclonal
antibody
Two decades of intensive development
can fulfil the increasing market de-
of novel expression systems for mam-
mand for biopharmaceutical proteins.
malian cells and microorganisms have
led to a significant increase of fermen-
Preparative crystallisation of biophar-
tation titers in the biopharmaceutical
maceutical proteins has the potential
production of proteins (more than
to dissolve bottlenecks in large-scale
20 g/L in microbials and more than
downstream processes and may be an
4 g/L in mammalian cell culture).
alternative to costly unit operations,
However, dynamic binding capacity of
such as liquid chromatography.
chromatography resins is often limited
and very large chromatography col-
Since there is a general lack of knowl-
umns are needed to purify such large
edge about multi-kilogram cystallisa-
amounts of target proteins. New paths
tion processes, substantial efforts have
for cost-efficient purification are
been made at Boehringer Ingelheim’s
therefore needed which include down-
Process Science department to over-
stream processing steps that can cope
come the limitations. A very efficient
with high fermentation titers and that
systematic development approach has
therefore been set up for bulk crystallisation processes that have been prac-
Crystallisation of proteins
tically approved with a wide variety of
While highly diffracting single crystals are required for structure analysis, the objectives for bulk crystallisation processes are different: scalability up to a several thousand litre scale, fast growth kinetics, cheap and pharmaceutically acceptable compounds, as well as high recovery rates are the major characteristics of efficient bulk
crystallisation processes.
proteins.
Successful scale-up
To date, using this systematically and
practically approved approach, a wide
variety of biopharmaceutical proteins,
X-Ray / Understanding
interactions
Screening for crystallisation
Different
conditions
crystals
such as single chain antibody fragments, growth factors and interferons,
were successfully crystallised from
downstream intermediates, in particular from crude homogenate, resulting
Purification /
Formulation
in high product purity. Yields in the
range of 95 %, with highest quality
and process robustness, can be
132
Boehringer Ingelheim annual report 2010
achieved even from crude cell lysates.
gelheim was able to crystallise an IgG
At our production facility in Vienna,
antibody with a yield of 98 % under
Austria, we have successfully up-
optimised conditions, resulting in no
scaled this process to several kilo
measurable loss of binding activity in
grams per batch. This development en-
the redissolved antibody. Crystallisa-
ables the implementation of down-
tion is therefore an innovative path to
stream processes whereby several time
purify biopharmaceuticals during
-consuming and expensive chromato-
downstream processes in a fast and
graphic steps can be replaced by crys-
economically valuable way.
tallisation.
In addition, protein crystallisation has
Crystallisation of monoclonal
the potential to become a new eco-
antibodies
nomical tool for the stable formula-
At our mammalian cell culture facility
tion and storage of biopharmaceuti-
in Biberach, Germany, the department
cals. Crystallisation of macromolecule
of Downstream Development works
pharmaceuticals can offer significant
on the challenge of crystallising anti-
advantages, such as high stability, con-
bodies which are made up of large,
trolled release of activity and high
complex molecules. Although crystal-
doses at the delivery site, which are at-
lisation of full-length monoclonal an-
tractive for mAb therapies and recom-
tibodies (mAbs) has been a subject of
binant proteins.
[ objectives ]
• Evaluation of crystallisation as an
economic purification step in
downstream processing.
• Evaluation of crystallisation as an
economic and stable formulation
and storage step.
• Co-crystallisation of mAbs with
different receptors to gain a better
understanding of the protein interactions.
• New ideas on how to improve
the interactions between IgG and
receptors.
significant interest for the last three
decades, very few intact mAbs have
ever been crystallised. Boehringer In-
Picture: Crystals of scaffold proteins
Protein crystallisation
133
our businesses
Biopharmaceuticals
Production platform for affinity scaffolds
in microorganisms
Platform technologies in process science are of great importance for
simplifying the development of commercially viable production processes in a time and cost-effective way.
Beyond antibodies
tibodies. In order to broaden the port-
Over the last few years, many compa-
folio of Boehringer Ingelheim Regional
nies have developed their own affinity
Center Vienna (RCV) as a contract
scaffold platform and are now trying
manufacturer, the application of its
to validate in clinical studies. Affinity
E. coli production platform was in-
scaffolds represent a very promising
vestigated for two further affinity scaf-
novel class of ligand-binding proteins.
folds: single-chain antibodies (scFv)
They are derived either from antibod-
derived from human monoclonal anti-
ies or other human proteins that pro-
bodies and anticalin®s, derivatives of
vide variable regions on top of a con-
natural lipocalins.
served framework. The advantages of
these next generation protein thera-
Single-chain antibodies
peutics that are much smaller than
Single-chain antibodies are the fusion
monoclonal full length antibodies are
of the variable light (LC) and the vari-
their stability, high tissue penetration,
able heavy chain (HC) of a monoclonal
high affinity and target selectivity and
human antibody. The two chains are
individual control of their serum half-
connected via a peptide linker and can
life. Their format flexibility – scaffolds
be arranged in two different ways:
can form bi or trivalent dimers or
HC-linker-LC or LC-linker-HC. We
trimers – enables the development of
have investigated the influence of the
new, innovative drugs.
arrangement of the chains, as well as
the nature of the linker peptide on the
Compared to monoclonal full-length
fermentation titer, the quality of the
antibodies, many of these affinity scaf-
inclusion bodies and the refolding
folds can be produced in microorgan-
yield. Thus, our platform for produc-
isms because of their small size, stabil-
tion of scFv combines production and
ity and no need for glycosylation.
product properties. ScFv can now be
expressed in E. coli as insoluble inclu-
134
Nanobodies
sion bodies (IBs) at outstanding titers
In recent years, Boehringer Ingelheim
of 8-10 g/L at short cultivation times
RCV has developed a manufacturing
of less than 32 hours. The production
toolbox for nanobodies®, scaffolds
process of scFv further comprises a
derived from camelid heavy-chain an-
very efficient purification step by sim-
Boehringer Ingelheim annual report 2010
Three-dimensional nanobody® structure
ply washing the IBs that contain the
for refolding. Thus, a simple purification
desired protein already with a purity
process, comprising an effective step for
of more than 70 %. Refolding yields in
endotoxin and DNA removal and only
the range of 60 – 80 % therefore ena-
two chromatography steps, could be ap-
ble an efficient production process.
plied. Starting from the cDNA of an
anticalin®s, about 100 mg of this
Anticalin®s
anticalin®s were provided, thereby
anticalin®s were also integrated suc-
meeting all quality criteria within four
cessfully into our E. coli platform for
months.
the production of affinity scaffolds.
For anticalin®s, we developed a basic
We thus showed that Boehringer Ingelhe-
production process in less than four
im RCV’s E. coli manufacturing technol-
months, applying our E. coli produc-
ogy is an attractive tool for our customers
tion platform. anticalin®s were ex-
for the large-scale GMP production of af-
pressed in a soluble state in E. coli at
finity scaffolds.
high titers (~ 10 g/L) without the need
Production platform
135
Operations
our businesses
Operations
Operations at Boehringer Ingelheim ensures reliable supply
of high-quality advanced intermediates, active pharmaceutical
ingredients (APIs) and final drug products for both internal and
all external markets.
136
Boehringer Ingelheim annual report 2010
High quality and supply at
competitive cost
The global divisions Launch & Strategic Products and Established
Products form two important cornerstones in manufacturing by
Operations at Boehringer Ingelheim. They are complemented crossfunctionally by corporate quality and supply chain management.
Launch & Strategic Products (LSP) en-
well-established products which re-
sures launch excellence through the
quire cost-effective processes and
implementation of robust analytical,
management of the product life cycle.
chemical and pharmaceutical processes. It launches new products on the
Both divisions serve internal and ex-
markets and ensures continuous sup-
ternal customers who benefit from
ply of a product in the beginning of its
Boehringer Ingelheim’s launch capa-
life cycle. Once launched and in a
bility, innovative technology and
more mature phase, responsibility will
thinking and of course a cost-effective
be transferred to the Established Prod-
mindset.
ucts network.
Established Products (ESP) leads the
internal and external production network to ensure smooth and stable market supply of already launched and
Operations: joint responsibility of LSP and ESP throughout the product life cycle
Development
Industrialisation
Launch
Routine
Life Cycle Phases
LSP
LSP
LSP
ESP Sites
Product
Allocation
ESP/3rd Party Production Sites
Operations
137
Operations
our businesses
Interplay between production
and logistics
From the production of basic materials to actually reaching the patient, each new medicine that Boehringer
Ingelheim brings to the market first requires years of effort from our employees and heavy investment.
In conjunction with the launch of new medicines, there are other challenges to overcome besides those in
routine production. Despite all of that, all production technology and logistics inputs, involving hundreds
of employees worldwide, must mesh smoothly.
LSP responsible for launches
tween researchers and process developers is
Each new product also demands new production
therefore started at a very early stage.
processes. Launch & Strategic Products (LSP) is
responsible worldwide for the development of
LSP employees are integrated when possible new
robust, economic processes for launching new
raw materials are involved. As soon as the possi-
products.
bility for success of a development project are evident, LSP gets involved.
LSP’s services form the bridge between innovation at small-scale and local market require-
Early preparation is necessary and that is because
ments, ultimately ensuring that the volumes
international marketing often starts the day after
needed can be manufactured. Reliable supply of
authorisation. Considerable investments are thus
the whole world market with a medication dif-
already activated in advance: the production
fers considerably from manufacturing it under
plants are built, personnel taken on and product
test and research conditions. The cooperation be-
and packaging pre-produced.
From raw material to product to patient: our value and supply chain
[ chemical production ]
[ active pharmaceutical ingredient ]
[ pharma production ]
Intermediates
Core substances
Finished goods
138
Boehringer Ingelheim annual report 2010
Each new medication fundamentally presents
cause from translation of the packaging label to
the LSP team with completely new challenges.
transportation, the whole process chain benefits
A new active ingredient and appropriate excipi-
from proximity to the market.
ents must be brought together in a stable process. Depending on whether it involves a syrup,
Logistics processes decisive for time factor
tablets, capsules, suppositories or inhalers, the
Research-driven pharmaceutical companies,
demands on production, and thereby on the
such as Boehringer Ingelheim, activate enormous
team, differ.
investments before a product enters the market.
As soon as the medication is granted authorisa-
ESP optimises established products
tion, time becomes a significant success factor.
Besides of local launches, Established Products
For this reason, logistics and sales planning also
(ESP) ensures that products already established
commences in parallel to clinical studies.
on the market can be manufactured efficiently
on a sustained basis, in high quality and close to
Boehringer Ingelheim’s medications are market-
market.
ed in 138 countries, which leads to complex demands on logistics, and fast logistics processes
The complete production process is again tested
are necessary.
for efficiency and a competitive site is selected.
Each step of the process and every plant detail
Long before regulatory approval of a new medi-
have to be transferred to the new site and then
cation, our coordinated teams get to work on the
adapted to the new local conditions. These can
logistics and marketing schedules for the launch.
vary considerably from the previous conditions.
From storing semi-finished goods to purchasing
A medication should, as much as possible, be
blister packs, through to printing packaging ma-
manufactured on a sustained basis in the region
terial, every single step is gone through in detail
where it will also be sold. That is the concept that
and in several variants.
ESP implements at Boehringer Ingelheim, be-
[ supply chain management ]
[ marketing & sales ]
[ the patient ]
Transportation and distribution
Key account management
Medicines for the benefit of humankind
Interplay between production and logistics
139
our businesses
Operations
Launch & Strategic Products
Launching a new product requires cutting-edge technology in each
segment of the manufacturing process. LSP ensures reliable market
supply of new and existing products for its global customers.
The global division Launch & Strategic
Transforming to large-scale production
Products operates locations in the
Within Operations, LSP owns the in-
USA (Columbus, Ohio and Petersburg,
terface to development through its
Virginia), in France, Italy, Spain and
Global Function Launch unit. Here,
Germany, as well as in China. It is well-
LSP receives newly discovered active
positioned to meet the demands of a
pharmaceutical ingredients (APIs) and
global market. It is committed to pro-
formulated drug products from R&D
viding superior products and services
which need to be transformed into a
to its internal and external customers
robust, large-scale chemical and phar-
at competitive cost and on time.
maceutical manufacturing process.
Being at the interface between drug
LSP consists of several important func-
development and routine production,
tions, which include product and proc-
the acquired and growing technical
ess development, manufacturing, qual-
know-how and process understanding
ity control and assurance, supply chain
obtained with each new project ena-
management, and operational process
bles the team in Global Function
excellence to continuously bring inno-
Launch to become increasingly more
vative thinking to our day-to-day work.
effective and efficient in making a
contribution to the future success of
Boehringer Ingelheim.
Pradaxa® launch
“Prudent scenario planning and benefitting from what we
learned from our multi-source launches ensured
the fast availability of Pradaxa® for the US
market. This was a result of an innovative
supply chain approach which considered
pre-approval on risk shipments.”
An example of such coordination was
the pradaxa® (dabigatran etexilate)
launch. Already at the beginning of
the development launch, colleagues
from Operations were active members
of the R&D sub-teams which were
working on the development of the
iris mann,
launch manager pradaxa®,
ingelheim, germany
future drug pradaxa® and its readiness for transfer into the LSP manufacturing network.
140
Boehringer Ingelheim annual report 2010
A true highlight in 2010 was the rapid
introduction of pradaxa® to the US
markets within seven days after approval from the US Food and Drug Administration (FDA). This was a benchmark performance for a product that is
“Behind the successful development of efficient
synthetic routes are many years of hard work.
It goes without saying that teamwork and
interdisciplinary collaboration have been
essential in our operational achievement.”
manufactured in Europe but launched
first in the USA. Such a transcontinental task was only possible through
dr frieder gnad,
global function launch,
ingelheim, germany
close and extremely flexible cooperation between the responsible LSP sites
in Ingelheim, Germany and Columbus,
Ohio in the USA.
manufacturing location. The associated activities can be quite complex and
More successful launches
challenging. A highlight in 2010 was
For mirapex er®, which received ap-
the network expansion of the pradaxa®
proval in the USA, we managed a rap-
chemical production capability. The
id-response process to include all last
Petersburg, VA site was chosen to sup-
minute changes to ensure readiness.
ply significant volumes of intermedi-
Our product twynsta®, which gained
ates and bulk API for pradaxa®.
approval in the USA in 2009, was also
launched last year successfully after
Flexibility, agility and teamwork be-
Boehringer Ingelheim had received
tween various functions and different
marketing authorisation also for the
sites characterised the transfer work
European Union.
from Ingelheim to Petersburg. A modular approach through multi-product
In the face of strong international
plants created the needed flexibility,
competition, the need to ensure that
allowing a rapid scale-up of volumes
products are made as cost-effectively
while minimising the risk associated
as possible is more pressing than ever
with dependence on a mono-site con-
before. This important task is embed-
cept.
ded in the group’s Process Development.
Dabigatran etexilate molecule
attached in thrombin domains
active binding site
Innovation in Operations – production,
quality & regulatory management
Continuous optimisation efforts of the
process development teams prepare
the new API and drug product for its
final transfer into full-scale commercial production. The transfers often
include a site shift from the developing or launch location to a receiving
Launch & Strategic Products
141
our businesses
Operations
“Fluid bed coating is a much more efficient and effective process than the
drum coater process that was initially developed. The new process is a huge
milestone for pharmaceutical production. We will continue to optimise further
wherever we can to find every possible improvement, however small and
without compromising the quality of our processes.”
dr guido radtke,
responsible for developing the process for pradaxa®,
ingelheim, germany
New ideas and technologies needed
Launching a new product also means
Launching a product often means in-
quality in each step of the process.
vestment in state-of-the-art or new
The fruits of our efforts were high-
technologies. In the centre of the
lighted during the FDA inspection last
launch and manufacturing site Ingel-
year. The successful pre-approval in-
heim is an impressive, new pharma-
spection by the authorities is a man-
ceutical production plant. It is here
datory prerequisite for supplying the
where pellets for encapsulation are
US market. Our two German sites,
produced for pradaxa®. The pellets
Biberach and Ingelheim, were audited
are coated with the API and then air-
by the FDA in early 2010 to verify
dried in a fluid bed coater. This unique
regulatory compliance and current
production is an in-house, tailor-made
good manufacturing practice (cGMP)
manufacturing process for the oral
for our pradaxa® production process-
thrombin inhibitor pradaxa®.
es. The result of the inspection was
“As a member of the project team, it was clear to
everyone that Dabigatran is seen as a priority
across the entire company. This project
exemplifies the seamlessness and alignment
among our manufacturing network.
It highlights our ability to deliver high
impact results in a short period of time.”
The Boehringer Ingelheim FDA audit team
celebrating the successful visit and review
of the US authority FDA
142
Boehringer Ingelheim annual report 2010
vonzella vincent,
project team member,
petersburg, usa
very gratifying. The FDA did not file
spiriva® respimat® was launched in
any relevant findings and the inspec-
15 additional countries, including Ja-
tion report was finished without ob-
pan and Spain. To anticipate and meet
servations. The results of the evalua-
market demand, investments of ap-
tion demonstrated once again the
proximately EUR 70 million have been
high level of quality at work at Boe-
made in an additional, highly auto-
hringer Ingelheim, our understanding
mated production facility.
[ respimat® ]
EUR 70 million
Market demand investments
From 10 million to 20 million
Manufacturing capacity doubled
of required processes and the competence and skills exercised in our Operations network.
+ 30 %
Increased productivity
More innovation
Innovation at Boehringer Ingelheim
can go beyond an API or drug product
development. We aim to bring innovatiove technologies to the market. Such
innovative technology can be found in
our respimat® soft mistTM inhaler.
The precision inhalation device is
manufactured in Dortmund and the
cartridge and medicine in conjunction
with the LSP site Ingelheim. This environmentally friendly technology is
characterised by long lasting, slowmoving nebulised product release
which can easily be taken up by a patient. 2010 was a rather important
year for respimat®.
Boehringer Ingelheim microParts production
location in Dortmund, Germany, the home of
our respimat® technology
Launch & Strategic Products
143
our businesses
Operations
Established Products
The majority of the Boehringer Ingelheim production portfolio (80 %) is
produced within the global internal and external production network of
Established Products (ESP), which is present in all regions of the world
and has the flexibility to react to local requirements.
Established Products (ESP)
(produces 80% of the production portfolio of
Boehringer Ingelheim)
Our main established products are
quality-focused and providing robust
viramune® and mobic® in Prescrip-
manufacturing processes, we are able
tion Medicines and the Consumer
to deliver the right product at the
Health Care (CHC) products under
right time and the right place with
the brands dulcolax®, buscopan®,
good quality and at competitive costs.
mucoangin®, mucosolvan®, bisolvon®,
antistax® and pharmaton®.
For the treatment of
cramping pain
[ viramune® ]
For the combination
treatment of HIV/AIDS
Each ESP site consists of several important functions – manufacturing,
[ buscopan® ]
This product portfolio is based on
engineering, quality, supply chain
many different technologies: tablets,
management and operational process
capsules, liquids and injectables.
excellence.
Global production network
In addition, we rely on robust supply
The vision of the Established Prod-
chain and risk management strategies
ucts network is to be the first choice
throughout the Boehringer Ingelheim
to deliver globally competitive estab-
sourcing network. Our business proc-
lished products by providing innova-
ess excellence mindset is not only fo-
tive and fast solutions to new busi-
cused on operational excellence, but
ness opportunities.
goes hand in hand with maintaining
the required environmental and safety
A clear mission of reliably delivering
[ dulcolax® ]
Laxative for use by
constipation sufferers
established products fulfilling our business partners’ (PM, CHC, Animal
Health and also Industrial Customer
Business (ICB)) expectations regarding
quality, flexibility and speed, through
our lean internal and external network.
Key to our success is our world-class
global production network, which is
structured in regional clusters to serve
specific market requirements alongside global hubs able to address all
markets. Being flexible, cost-efficient,
144
Boehringer Ingelheim annual report 2010
standards all over the world.
Network and product competitiveness
Marketed products are continuously challenged during their life cycle
with respect to cost, quality and optimal supply chains.
The performance-orientated mindset
Product competitiveness
of the internationally experienced
A clear priority of the management of
people in the ESP network, and being
mature products is the cost competi-
globally located, enables ESP to act in
tiveness of the product portfolio. A
highly dynamic markets.
Product Competitiveness Unit (PCU)
was therefore created within ESP to
Network competitiveness
manage the continuous cost improve-
In a global world with very fast
ments regarding the ESP product port-
changing business and regulatory en-
folio and the product life cycle. The
vironment, it is crucial to constantly
unit’s responsibilities are:
improve and adjust competitiveness of
the Boehringer Ingelheim production
• To continuously align a priority list
sites with respect to quality, supply re-
of products to be consistent with
liability and costs. The Network Competitiveness unit is achieving these
goals by:
business needs
• To define and implement cost improvement measures in collaboration
with the local manufacturers in the
• Continuously comparing the site’s
performance with regional and international benchmarks
• Defining, implementing and execut-
Boehringer Ingelheim production
network
• To follow up and measure cost effects in a yearly cycle
Boehringer Ingelheim do Brasil
won the Industry of the Year
award for the second year running for the involvement of their
employees in meetings, working
groups and lecturers at ISPE
events, contributing to the development of the life science industries in Brazil.
ing optimisation programmes following a holistic approach, covering
management system, operational setup and mindset and behaviour
• Defining specific initiatives, such as
product transfer excellence or NBO
projects together with business management
Site competitiveness is complemented
by product competitiveness.
Established products / Competitiveness
145
Operations
our businesses
The Operations network
Being flexible, cost-efficient, quality-focused and providing robust
manufacturing processes, our Operations network is able to deliver high
quality products at the right time and the right place at competitive
costs.
bedford, ohio, usa
20
columbus, ohio, usa
petersburg, virginia, usa
Productions sites
in 13 countries
mexico city, mexico
•
Contract
manufacturing
Injectables
Inhalants
Liquids
Semi-solids
Solids
Pharmaceutical production
Columbus, Ohio, USA
• • •
• • • •
•
• •
•
•
•
•
Ingelheim &
Biberach, Germany
•
•
•
•
•
• •
•
•
•
•
•
•
St. Cugat, Spain
•
•
•
•
•
Yamagata, Fukushima* & Narita,
Japan
•
•
•
Bedford, Ohio, USA
Bogor, Indonesia
Bogota, Colombia
Itapecerica, Brazil
Koropi, Greece
Mexico City, Mexico
Shanghai, China
* Production discontinued after
natural disaster (March 11, 2011)
146
Boehringer Ingelheim annual report 2010
bogota, colombia
itapecerica, brazil
Chemical production
Biopharmaceuticals
dortmund, germany
Pharmaceutical production
ingelheim and biberach,
germany
Medical device production
vienna, austria
blanquefort, france
fornovo, italy
malgrat, spain
sant cugat, spain
koropi, greece
yamagata, japan
fukushima*, japan
narita, japan
shanghai, china
Fornovo, Italy
Ingelheim, Germany
Malgrat, Spain
Petersburg, Virginia, USA
•
•
•
• •
• • • •
•
• •
•
• •
The Operations network
Toxicology process safety
Regulatory registration support
Process development
Synthesis API
Blanquefort, France
Phytochemicals
bogor, indonesia
•
EUR 576m
Investments in tangible
and intangible assets in 2010
Chemical production
•
Biberach, Germany
Vienna, Austria
Mammalian cell culture
Microorganism and
Yeast fermentation
Biopharmaceuticals
•
•
•
•
•
147
our businesses
Operations
Expansion in the Asian markets
Participating in the growth market Asia will be of utmost importance to
Boehringer Ingelheim in the future. Stepping up our presence will bring
opportunities for growth.
The next step for Operations, and as
ity Control department (QC). The main
part of our corporate strategy, is the
function of the PD is to focus on the
expansion of our global presence. In
production process optimisation and
August 2010, Boehringer Ingelheim
the corresponding technology transfer
celebrated the inauguration of its new
to partners. Similarly, the QC unit will
Center of Competence (CoC) at the
provide full analytical support for PD
Waigaoqiao Free Trade Zone in Pu-
for the testing and release of chemical
dong, Shanghai, China. The CoC will
products originating in China to en-
support the optimisation of process
sure that the quality of the products
development for our active pharma-
sourced will match Boehringer Ingel-
ceutical ingredients and intermediates.
heim standards for intermediate or
In addition, the CoC will secure future
API synthesis.
supply chain options for Boehringer
Ingelheim for potential intermediates.
China - global core plant
Our investments and commitment will
At Boehringer Ingelheim Shanghai
give us an increased presence in the
Pharmaceuticals Limited (BISPL), the
important growth region of Asia.
mission is to expand and transform the
current plant into a Boehringer Ingel-
The CoC consists of a Process Devel-
heim global core plant, focused on
opment department (PD) and a Qual-
manufacturing and packaging stand-
New colleagues at Boehringer
Ingelheim China – a science
team in the new Center of Competence at the Waigaoqiao Free
Trade Zone in Pudong, Shanghai,
China
148
Boehringer Ingelheim annual report 2010
Members of the inauguration
ceremony committee for our new
Center of Competence at the
Waigaoqiao Free Trade Zone in
Pudong, Shanghai, China
ard solids and liquids. This will phase
During this period, the expansion will
its supply from the current main focus
take advantage of the opportunity to
of China in the mid to long term to in-
launch new products onto the market,
clude the whole Far East. This must be
either as imported then packed, or as
delivered with a key focus on a lean,
full production.
flexible and cost-competitive operation.
Over and above the expansion of the
In additon to the pharmaceutical
BISPL plant, opportunities exist to
plant, we will also increase our activi-
grow the whole operations network in
ties to secure the sourcing of APIs
China.
from third parties in China to the
Shanghai plant as well as the global
network of Boehringer Ingelheim
sites.
Plant expansion project
The plant expansion project (PANDA)
will see the plant more than double in
size and will accommodate nearly three
times the staff as compared to present
numbers. This will support the increased
volume and changes to the portfolio
for the China market up to and around
the year 2020. It is expected that the
current percentage of locally packed/
manufactured product, versus imported
product, will switch from the current
figure of 80% (47 million pack units)
to 91% (220 million pack units) by 2015.
Expansion in the Asian markets
149
our businesses
Operations
Growing with external partners –
the Industrial Customer Business
Our expertise in development and launch of new APIs or drug
products is sought after around the world by our external partners
and customers.
Our unique technical capabilities and
tion facilities offer unique expertise,
superior product quality at Boehringer
flexibility and a service mindset to
Ingelheim are also offered to exter-
our internal and external partners.
nal partners. These contract manufacturing capabilities and services are
The consolidated expertise in
part of our technology and research-
handling both, complex chemistry or
driven organisation, offering clients
demanding pharmaceutical formula-
customised end-to-end solutions for
tions assures each customer of a se-
active pharmaceutical ingredients
cure and robust, just-in-time supply
(APIs) and respective drug formula-
for their project. Key to our success is
tions.
our ability at Boehringer Ingelheim to
deliver reliable product solutions
Our comprehensive range of technolo-
backed by analytical and regulatory
gies enables us to develop drug sub-
assurance along the product life cycle,
stance (DS), drug product (DP), or inte-
from the clinical phase through
grated DS&DP solutions in our global
launch to market supply.
operations network for our clients.
Methyldigoxin for external customers
The sites can easily upscale from
Methyldigoxin is an example of an al-
small quantities to large demands of
ready existing API being newly devel-
API or final drug product. Our state-
oped and launched for a group of cus-
of-the-art development and produc-
tomers. The API has a long-standing
“Our integrated approach assures customers
of the best possible time-to-market
combined with reduced total costs of
ownership.”
takahiro shinagawa,
manager of customer relations,
nippon boehringer ingelheim, japan
150
Boehringer Ingelheim annual report 2010
Our pharmaceutical production plant in Columbus, Ohio, USA.
as a valuable cardiac drug with a
technology network, we were able to
significant global market reach.
develop a new synthetic route for the
Boehringer Ingelheim was approached
API. The first commercial shipments
in 2010 with the idea of newly devel-
to our customer are scheduled for
oping the synthesis and market supply
2011.
of methyldigoxin. The selection of
Boehringer Ingelheim as the supplier
was obvious, as the company already
manufactures the related compound
digoxin.
Dr Franz-Dietrich Klingler, responsible in our Global Function
Launch group for developing new
synthetic methodologies
The major hurdle to overcome in
launching this known product was
the lack of a modern, commercially
viable and environmentally sound
process. Operating within our strong
Growing with external partners
151
our businesses
Animal Health
Animal Health
The vision of our Animal Health business is to foster the health
and well-being of mankind by contributing to an adequate supply
of safe, nutritious food and by promoting the emotional and
physical benefits arising from the human animal bond.
152
Boehringer Ingelheim annual report 2010
Marc Eichmeyer –
a view from the lab
Marc Eichmeyer, a leading scientist at Boehringer Ingelheim Animal Health,
explains what is needed to develop a successful market-leading solution.
What were the challenges in the Ingelvac
al needed for the virus to replicate and cause
circoflex® project?
disease. This translates into a vaccine that is
marc eichmeyer: “The early stages of the
safe, due to the fact that it is a protein and not
pre-development and development of ingelvac
an infectious virus. The vaccine is also very
circoflex® met with several challenges. There
effective at generating a protective immune re-
were no established models to evaluate the dis-
sponse, given that it is the major protein ex-
ease or vaccine prototype efficacy and there really
pressed by the virus.”
was very little known about the virus. The team
was faced with several obstacles that would need
Did the use of technology trigger questions from
creative solutions.”
the regulatory authorities?
What role did innovation play?
technology to generate an innovative vaccine was
marc eichmeyer: “The opportunity to utilise
marc eichmeyer: “Porcine circovirus type 2
not the last challenge for the development team.
(PCV2) had been present in swine globally for
Given the methods used to generate the prospec-
years. Disease associated with PCV2 infection
tive vaccine, the defined registration process
was first reported in Europe and then in North
would be another challenge that had not been en-
America. It became known that problems were
countered previously. Through extensive sup-
the result of a disease complex in which an im-
portive data and proactive team efforts, the con-
mune stimulation event was necessary to trigger
cerns of the regulatory authorities were addressed
the PCV2 virus to replicate uncontrolledly. One
and the vaccine registration was achieved.”
of the first concerns was whether traditional vaccinology methods would work for a PCV2 vac-
Which improvements have been made in
cine. The PCV2 virus is very small and ubiqui-
convenience and application of the vaccine?
tous in nature. The nature of the virus itself
marc eichmeyer: “Boehringer Ingelheim
lends it to be resistant to physical or chemical
has not only developed innovative products,
neutralisation.”
such as ingelvac circoflex® and enterisol®
ileitis for control of disease in the swine indus-
Which solutions were found to overcome these
try, but has also developed delivery systems that
hurdles?
allow ease of vaccine delivery. For example, the
marc eichmeyer: “This was an area of op-
low volume and ease of administration are well-
portunity to develop an innovative vaccine using
received by customers. This translates into a pos-
a virus-like particle of PCV2. The result is essen-
itive reputation for Boehringer Ingelheim among
tially a natural virus without the genetic materi-
swine producers and veterinarians.”
Animal Health
153
our businesses
Animal Health
Prevention is better than cure –
innovative vaccines – milestones in
animal health
Boehringer Ingelheim Animal Health provides leading swine
vaccine solutions.
Boehringer Ingelheim Animal Health
of target pathogens. The company fur-
is the leading company in the field of
ther believes that the early identifica-
swine vaccines. The company is com-
tion of emerging diseases, coupled
mitted to continuously bringing inno-
with tools for their control, will help
vation to farmers, veterinarians, and
to protect animals and farmers in the
animals to assure that they have avail-
future.
able the best possible tools for the pre-
The European Porcine Circovirus
(PCV2) Research Award is presented annually in recognition of
research proposals in the area of
applied immunological PCV2 research. With this award, Boehringer Ingelheim Animal Health
aims to promote further scientific progress to better understand
and ultimately control this devastating swine disease.
vention of diseases. At the same time,
A growing world population makes
there is growing public concern about
the need for safe and nutritious food
the widespread use of antibiotics in
even more urgent. Sustainability is
animals.
one of the leading topics in public discussion and business decisions are
The maxim “prevention is better than
evaluated as to whether activities and
cure” rightly endorses the idea that,
tools are sustainable. Carbon foot-
wherever possible, prevention is pref-
print, animal welfare, residues and de-
erable to therapeutic intervention.
velopment of resistance are features
Thus, the need for antibiotic treatment
also relevant for the animal health
can be reduced. As a result, vaccines
business.
are gaining significantly in importance
for all species. This includes the inte-
The value of vaccination is without
gration of sophisticated molecular bi-
doubt contributing to these require-
ology and the decoding of the genome
ments. Boehringer Ingelheim Animal
Health provides leading swine vaccine
solutions, such as ingelvac circoflex®,
ingelvac mycolflex®, ingelvac®
prrs mlv and enterisol® ileitis.
Great atmosphere at the FLEXcombo® launch event for the European sales force in Ingelheim,
Germany, in 2010
154
Boehringer Ingelheim annual report 2010
Animal well-being – a major topic
on the animal health agenda
There is no need for animals to feel unnecessary pain. That is why there
should be solutions for effective pain relief.
Boehringer Ingelheim Animal Health
Originally, the concept of pain therapy
has always been ambitious about de-
was successfully transferred from
veloping solutions to improve animal
companion animals to lifestock. It sig-
well-being, and not only with their
nificantly improves the quality of life
swine vaccines, where reduction of
for animals.
the number of injections means less
stress for animals, as for example in
the FLEXcombo® concept.
Of course not all diseases can be prevented, but pain management is also
of major concern for Boehringer Ingelheim Animal Health activities, being a major topic in animal welfare.
There is no need for animals to feel
unnecessary pain. That is why there
should be solutions for effective pain
relief. Boehringer Ingelheim Animal
Health is one of the leading companies in the field of effective treatment
of painful mastitis in dairy cows.
metacam®, a very effective nonsteroidal anti-inflammatory drug
(NSAID) for the treatment of chronic
pain, is available for swine and cattle
as well as for horses, cats and dogs.
The speakers of the “3rd International Expert Forum on Animal Well-Being” in Barcelona, Spain
Prevention is better than cure / Animal well-being
155
our businesses
Animal Health
Gaining knowledge through our
global research network
A growing global business requires a more diversified R&D environment
to better serve customers in key markets and to expand the global network with scientific institutions to bring innovations to market.
With our own research sites in North
the global network with scientific in-
America and Europe, as well as nu-
stitutions necessary to continuously
merous international collaborations in
bring innovation to the marketplace.
this field, Boehringer Ingelheim Ani-
Consequently, we will accelerate the
mal Health is a business where re-
growth of our international R&D or-
search plays an important role.
ganisation, predominantly in vaccines.
Prominent examples include the es-
World distribution of our Animal
health products.
At six sites throughout the world,
tablishment of the Boehringer Ingel-
more than 340 highly qualified and
heim Veterinary Research Center
highly motivated scientists are in-
(BIVRC) in Hanover, Germany, and
volved in research and development,
the Asian Veterinary Vaccine Research
registration of new medicines and
Center (AVVRC) in Shanghai, China.
treatment methods. Most work closely
with universities and private research
In October 2010, Boehringer Ingelhe-
institutions all over the world.
im laid the foundation stone for its
new research site in Hanover, Germa-
At the same time, a growing global
ny. The ultra-modern European vac-
business requires a more diversified
cine research center is being built in
R&D environment to better serve cus-
the vicinity of the internationally rec-
tomers in key markets and to expand
ognised University of Veterinary Medicine. In this attractive scientific environment, Boehringer Ingelheim will,
“We are committed to making our innovative products
globally available to as many patients as possible. In order to
register our products successfully in emerging markets, we
are gearing up for the country-specific challenges,
thereby making sure that animals in emerging
countries receive the best possible treatment.”
as a first step, provide 50 new jobs for
scientists in a diverse environment. In
close cooperation with their academic
colleagues, they will identify and develop innovative vaccines against livestock diseases. Furthermore, this research center will also enhance our
dr suzin choi,
regulatory affairs, boehringer ingelheim animal health,
ingelheim, germany
ability to further strengthen the relationship and collaboration with the
major EU academic research institutes
in the field of veterinary vaccines.
156
Boehringer Ingelheim annual report 2010
Manufacturing excellence globally –
production at the highest level
The Boehringer Ingelheim Animal Health organisation understands
that it takes much more than new facilities to achieve manufacturing
excellence.
St. Joseph, Missouri, USA, plays a dis-
and communicating in a global envi-
tinctive role for Boehringer Ingelheim
ronment,” says Dr Christian Klessen,
Animal Health. It harbours the compa-
Head of Global Operations at Boe-
ny’s newly expanded GMP (good man-
hringer Ingelheim Animal Health.
ufacturing practice) certified production site in which a multitude of global
His colleagues know that manufactur-
vaccines are manufactured, including
ing excellence is achieved through con-
the swine health products ingelvac
tinually increasing process knowledge,
circoflex® and ingelvac mycoflex®.
continually making process improve-
This state-of-art plant is managed by a
ments, and continually linking the way
proactive team, that works in close con-
we work. The organisation is convinced
tact with the R&D team also represent-
that in addition to reliable supply and
ed on site. This connection guarantees
high quality products, creativity, com-
that the latest research findings are im-
mitment, the desire to learn and the ne-
plemented in the production processes
cessity for change are indispensable to
in the shortest possible time.
sustainable growth and to remaining a
strong competitor in the marketplace.
The newly expanded vaccine manufacturing facility, one of the world’s
“We are prepared for the future and
largest in the animal health industry,
our employees are proud to be part of
features technologies for bacterial,
a global ambitious team,” adds Dr
mammalian and insect cells and rep-
Klessen. “It is the culmination of the
resents Boehringer Ingelheim Animal
actions of the entire organisation,
Health’s most recent example of excel-
working together, that drives excel-
lent international team work. The or-
lence in manufacturing.” The new
ganisation understands that it takes
Boehringer Ingelheim Animal Health
much more than new facilities to
operations network is designed to en-
achieve manufacturing excellence.
sure maximum effectiveness in all
“Investment in new facilities alone
functions by taking advantage of syn-
does not automatically provide a com-
ergies within the other US sites, in
petitive advantage; we also need qual-
Fort Dodge, Iowa, as well as Guadala-
ified, talented people organised in ef-
jara, Mexico, and within Corporate
fective structures, capable of working
Operations.
The newly expanded GMP
(good manufacturing practice)
certified production plant in St.
Joseph, USA, plays a distinctive
role for Boehringer Ingelheim
Animal Health
Gaining knowledge / Manufacturing excellence globally
157
our businesses
Animal Health
Building an industry leader – building on
our strengths
The year 2010 was characterised by further actions to enable
Boehringer Ingelheim Animal Health to successfully face challenges
in the future.
Within the past five years, Boehringer
cattle positions. “These achievements
Ingelheim Animal Health has signifi-
were an important step to successfully
cantly improved its competitive and fi-
compete in an industry that has been
nancial position, while making dispro-
characterised by rapid consolidation
portionately large investments in R&D.
in the past few years,” says Dr Joachim
In 2010, Boehringer Ingelheim ranked
Hasenmaier, Managing Director,
6th among the global animal health
Boehringer Ingelheim Animal Health
companies, with a market share of 5.9
(picture above).
%. Its investment in R&D reached EUR
92 million on total sales of EUR 891
Boehringer Ingelheim Animal Health
million.
can look more optimistically than
ever to its future. The company is in-
[ our mission ]
Based on our own research and the
synergy with our group’s human
pharmaceutical expertise, Boehringer
Ingelheim Animal Health delivers
leading solutions to prevent, treat
and cure animal diseases.
We have consciously decided to focus on specific diseases and animal
species, such as small animals, cattle, pigs, horses and poultry, and
strive to set standards and provide
for unmet medical needs. We are
driven by the desire to improve animal welfare as an integral part of a
healthy future for mankind.
This clearly reflects the tremendous
vesting EUR 75 million in its manu-
change Boehringer Ingelheim Animal
facturing capacity in St. Joseph, Mis-
Health has been going through in re-
souri, USA. Furthermore, Boehringer
cent years. The basis for this success
Ingelheim is investing EUR 45 million
was internal organic growth, mainly
in its new European R&D centre for
in the vaccine, but also in the pharma-
vaccine research in Hanover, Germa-
ceutical segment. A clear reflection of
ny. This is an important step forward
this success is ingelvac circoflex® –
to building a truly global R&D infra-
the first truly global launch which
structure. A highly attractive interna-
quickly translated into a leading glo-
tional working environment will be
bal brand. It has just recently been
established for scientists who are
strengthened by the addition of its
striving to conduct state-of-the-art re-
partner product ingelvac mycoflex®.
search in this field.
Furthermore, Boehringer Ingelheim
Animal Health was able to acquire
important assets of the former Fort
Dodge business and successfully integrate them, thereby strengthening especially the North American market
presence as well as the global pet and
158
Boehringer Ingelheim annual report 2010
Highlights in innovation 2010
Success in the marketplace is a consequence of our strength in
continually developing innovative solutions against animal
diseases.
Another first – a flexible swine vaccine
European countries. For the first time
combination reduces stress and labour
in Europe, protection against two of the
Prevention of disease is better than
most threatening swine diseases can be
cure – this maxim leads to an im-
achieved with a single injection instead
provement in animal well-being as
of up to four. This is a big step forward
well as to enhanced efficiency and
in animal welfare. The mixed use of
sustainability. Vaccines are the most
ingelvac circoflex® and ingelvac
common tools in prevention. Today,
mycoflex® is already registered and
more and more pigs are vaccinated. To
widely used in North America and Asia.
allow an optimal vaccination scheme
It is globally the first and only pro-
for each farm situation, scientists from
duct combination of its kind, another
Boehringer Ingelheim Animal Health
Boehringer Ingelheim first.
developed an innovative adjuvant system for their swine vaccine: impran-
Vetmedin® - driving innovation in
flex®, which enhances the immune re-
canine cardiology
sponse and leads to a faster onset and
vetmedin® continues to revolutionise
longer duration of protection. Further-
the treatment of congestive heart fail-
more, vaccines based on impranflex®
ure (CHF) in dogs as the most clinically
are mixable without compromising
validated treatment option in this cat-
safety or efficacy.
egory. More and more dogs and their
A flexible swine vaccine
combination reduces
stress and labour..
owners are benefitting from the visible
Today, more than 70% of commercially
improvement in quality of life and lon-
raised pigs are vaccinated against por-
gevity that vetmedin® produces in
cine circovirus disease (PCVD) and en-
dogs with heart failure. The ground-
zootic pneumonia (EP). Boehringer In-
breaking quest™ study, confirming the
gelheim’s ingelvac circoflex® is the
superiority of vetmedin®, paved the
global market leader in PCVD vaccines,
way and continues to drive strong
and ingelvac mycoflex® is the global-
growth in all markets. The position of
market leading product in EP vaccines.
vetmedin® in veterinary cardiology
Both are based on impranflex® and
was further reinforced by a prestigious
therefore are mixable. By July 2010, the
group of veterinary cardiologists in
EU Commission had approved the mix-
the recently published American Col-
ing of these two swine vaccines in 27
lege of Veterinary Internal Medicine
The global vetmedin® trial, EPIC
(Evaluating Pimobendan In Cardiomegaly), officially started in
October 2010.
Building an industry leader / Innovation
159
Animal Health
our businesses
(ACVIM) treatment consensus for ca-
the world teamed up with Boehringer
of combinations, protecting horses
nine mitral valve disease (MVD), the
Ingelheim to produce data that will un-
against all major disease from the age
most common heart condition in dogs.
doubtedly help practitioners around the
of four months onwards. The conven-
According to the consensus, Vetmed-
globe better manage dogs with heart
ience of a vaccine solution to protect
in® is considered an essential treat-
disease.
against up to eight diseases is a major
ment for both the acute and chronic
advantage especially if this can be
phases of congestive heart failure due
Vetera® – a breakthrough in equine
achieved with only one injection. This
to mitral valve disease in dogs.
vaccines
is a truly innovative idea behind vet-
In 2010, Boehringer Ingelheim Ani-
era®. Fewer injections also mean less
Two additional major studies are un-
mal Health successfully launched its
potential for site reactions and less
derway to assess the question both
new vetera® vaccine concept in the
stress for animals and veterinarians.
practitioners and experts are asking:
United States and in the Canadian
does vetmedin® delay the onset of clin-
market. In the equine segment, vet-
Up to now, large combination vaccines
ical signs of heart failure in dogs with
era® is the first vaccine line which
have been known to be highly reactive
pre-symptomatic heart disease? There
comprises all relevant antigens in one
whilst providing only limited protec-
are currently over 40 experts around
shot. It also includes multiple choices
tion. Two important steps in the production process have been incorporated to solve that problem: ultrafil™
Research and development of a new veterinary vaccine
purification technology is applied, involving a series of purification processes that filter out all unwanted substances which could distract the
immune system. This purification
Pathogen
Idea and concept
Research
process does not only minimise reactions but also improves the quality of
the immune response.
Furthermore, carbimmune™ is added
Prototype
Determination of dose,
Development of
duration of immunity and
manufacturing process
appropriate age for vaccination
in the lab
in the experimental/laboratory
setting
which is a proprietary adjuvant formulation designed to optimise protection and
ensuring a rapid initial and a prolonged
immune response after vaccination.
Controlling influenza in poultry –
Volvac® AI
Field application of
developed product
Compilation of dossier
for registration
Registration approval
Poultry is and will remain the fastest
growing source of animal protein in
large parts of the world, especially in
• Registration approval is a prerequisite for commercial
production and distribution of a vaccine
• Duration of development process to license: 5–7 years
• Research and development costs: 30–50 million Euros
per vaccine
the developing countries. Avian influenza severely affects the supply situation of animal protein if it is not conApplication
trolled. A number of cases have
reminded humankind in the recent
160
Boehringer Ingelheim annual report 2010
past that avian influenza is not only a
Successful development of cattle
threat to animals, but to humans as
biologicals in the USA
well. Several reports provide evidence
In 2010, Boehringer Ingelheim Vet-
that the virus has the ability to mutate
medica Inc. had the greatest market
and jump from, for example, birds (to
share growth in cattle biologicals in
pigs) to humans. In order to control
the USA, establishing a leadership po-
avian influenza, most of the countries
sition in the respiratory and pasteurel-
are trying to control the disease by re-
la markets. The key product groups
moving the infected animals. However,
that have led to this growth are the
this policy has its limitations and is ex-
pyramid®, presponse®, and express®,
tensively discussed from the animal
vaccine lines. Another success factor
welfare point of view as well.
was the rapid integration of the sales,
Disease control of avian
influenza in countries such as
Mexico and Egypt.
professional service and marketing
Preventive vaccination of the animals
teams. Smaller territories allow for
is the only other known approach to
greater customer reach and increased
controlling the disease. At its R&D
frequency of customer interactions.
and production site in Guadalajara,
These interactions include face-to-face
Mexico, Boehringer Ingelheim Animal
visits between customers and sales rep-
Health has successfully developed and
resentatives, as well as consultations
is producing two different vaccines,
with the expanded professional service
which are contributing to the control
veterinary team.
of avian influenza in countries such as
Mexico and Egypt.
The Fort Dodge portfolio, which was
combined with the legacy Boehringer
The quality of the volvac® avian influ-
Ingelheim product line, afforded the
enza range is uncompromisingly high
NAFTA region the opportunity to posi-
to achieve good immune response pro-
tion these products to bring the greatest
tection under difficult field conditions.
value to our customers in terms of dis-
Boehringer Ingelheim technical service
ease prevention and therapy. The larger
staff, together with their partners, are
product portfolio gives Boehringer In-
working with poultry producers in the
gelheim a greater presence in the dairy
field to secure the correct use and appli-
industry, as well as a more complete
cation of the vaccine.
product offering for beef cattle producers. Boehringer Ingelheim is looking to
In collaboration with international or-
the future with confidence that it will be
ganisations and scientific institutions,
able to further expand its cattle product
we assure the continuous efficacy of
portfolio by strengthening its efforts in
our vaccine. Boehringer Ingelheim
R&D.
Animal Health is thus offering a successful solution for the prevention of
avian influenza, thus contributing to
animal welfare.
Innovation
161
www.boehringer-ingelheim.com
www.boehringer-ingelheim.com
125 years
more
values
1885 – 2010
Business Year 2010
content
05 our company
06
Shareholders’ perspective 2010
10
Key aspects 2010
15
Corporate bodies
16
group management report 2010
18
Business and operating environment
31
Results from operations, financial position and net assets
35
Report on post balance sheet date events
36
Risk report
37
Report on expected developments
39
consolidated financial statements 2010
40
Overview of the major consolidated companies
42
Consolidated balance sheet
43
Consolidated profit and loss statement
44
Cash flow statement
45
Statement of changes in group equity
46
Notes to the consolidated financial statements 2010
64
auditor’s report
Flap
comparison of balance sheets / financial data 2001–2010
68 branded prescription medicines
68
Respiratory diseases
70
Diseases of the central nervous system
72
Cardiovascular diseases
76
Infectious diseases
76
Urological diseases
78
Cough and cold
78
Sore throat
80
Gastrointestinal diseases
82
Vitamins and supplements
82
Urological diseases
84
Leg vein health
84
Pain
86
Food producing animals – swine
88
Food producing animals – cattle
90
Companion animals – small animals
90
Companion animals – horse
78 consumer health care
86 animal health
Content
Top 4 products — Prescription Medicines
Top 4 products — Consumer Health Care
Our company
Boehringer Ingelheim is a research-driven company dedicated to researching and developing, manufacturing and marketing pharmaceuticals that
improve health and quality of life.
Our businesses are Human Pharmaceuticals and Animal Health. We
focus on innovative drugs and treatments that represent major therapeutic
advances.
Excellence in innovation and technology guides our actions in all areas.
Our products have long been highly successful in the treatment of respiratory, cardiovascular, central nervous system, urological and infectious
disorders. In addition, we have successfully advanced our research in
thrombo-embolic, cardio-metabolic and oncological diseases.
We have more than 42,000 employees in 145 affiliated companies and
operate global networks of research and development (R&D) facilities at
seven sites and 20 production sites in 13 countries. R&D expenditure
in the business area Prescription Medicines corresponds to 23.8% of its net
sales.
Our headquarters is at Ingelheim, the German town where the familyowned company was founded in 1885.
Our company
5
shareholders’ perspective 2010
Shareholders’ perspective 2010
christian boehringer
chairman of the shareholders’ committee
In 1885, our great-grandfather, Albert Boehringer, acquired a tartar factory in Nieder-Ingelheim,
Germany. This was the start of his own, independent entrepreneurial activity and, at the same time,
the embryo of today’s Boehringer Ingelheim group of companies.
With gratitude, acknowledgment and humility we view what employees and shareholders of the participant generations have achieved since its foundation 125 years ago – a modern, highly innovative
pharmaceutical company in family hands.
To be outstanding in innovation and technology today remains, as 125 years ago, Boehringer Ingelheim’s
leitmotif – Value through Innovation.
Today, as then, the shareholders, set a reliable financial framework and create continuity in the strategic orientation for the family-owned Boehringer Ingelheim. We thereby establish the fundamental
conditions for stability, profitability and sustainable growth of our family firm.
What are the success factors of a family-owned company? For this, one can symbolise the company
using the analogy of forestry and the construction of a tree:
First, the company’s historical roots are the motivation and obligation for the shareholders. And
what roots typically do – they give a tree hold. Translating this hold to the company are our values
and the long-term strategy that we, the shareholders, together with the Board of Managing Directors,
can transfer to this company.
6
Boehringer Ingelheim annual report 2010
Hold also comes from a closeness between the shareholders and the company. And, what is just as
important for the protection of Boehringer Ingelheim as a family-owned company, is the unity lived
out within the shareholder family.
Nutrients for the tree, and thus the company, are the capital and retained profit which is again made
available so that the the tree can grow strongly. We, the shareholder family, regard ourselves as trustees of the company’s sustainable success. We want to the company entrusted to us to remain for the
benefit of our family, patients as well as our employees, for generations to come.
The tree trunk is the employees who together with us wish to realise the same vision of developing
and marketing medicines for people and animals.
At the same time, the soul of this company, which truly drives us forward, is the well-educated and
committed workforce who share and live these common values. These employees thereby contribute
to Boehringer Ingelheim remaining an independent and successful family-owned company for the
coming 125 years too.
In researching and developing new medicines there is a further parallel with forestry. For the company,
whose 125th jubilee we had the honour of celebrating in 2010, was planted by people long before as
saplings. These are the basis for us to work our way forward. Our thanks are thus due to the third
generation of the shareholder family and our pensioners for handing on to us, the fourth generation
of the shareholder-family, a sound and successful company.
The successes and therapeutic progress achieved so far are the visible results of the common efforts
of everybody over generations.
The shareholder family balances its own interests and company interests; it never puts its own interests above company interests – one of the strengths in Boehringer Ingelheim’s long history.
All these values form part of the social canon to which we commit ourselves and which has built up
the solid foundation of over 125 years. We want sustainable organic growth and have no commitment to short-term profit.
With our Leitbild (stated guiding principles) we declare our support for two goals: one is that we
want to serve humankind by developing medicines for people and animals; the other, that we want to
do this as an independent company.
Shareholders’ perspective 2010
7
shareholders’ perspective 2010
This independence was extremely helpful, especially during the latest economic crisis. With a focus
on competitiveness and future viability, instead of maximising profit, we were better prepared for the
crisis. In this phase, we were able as a family-owned company to plan quite differently, finding a
sphere of future activity for all employees.
Six key figures for the company are important for us as the shareholder family. These indicators are
used by the Board of Managing Directors to evaluate Boehringer Ingelheim’s substance and prospects.
First is the company’s market position. What determines the market position for us? It is the relative
customer benefit and relative market share in therapeutic areas of relevance to us rather than world
market share. With this we measure the company’s growth. Precisely through reliability and a good
relation with physicians, patients and authorities Boehringer Ingelheim has been able to grow on a
sustained basis as a well-established company.
Innovation performance is a parameter that indicates to us how much value we create through innovation. With this we span the bridge between today and tomorrow. In concrete terms, this innovation
performance at Boehringer Ingelheim reflects the share of net sales generated by new new products,
the development and potential of our product pipeline, the continued renewal of processes, systems
and methods, as well as structures and technologies.
Of very special importance to our company’s future is its attractiveness to employees: the ability to be
an attractive employer to talented people and to retain employees in the company. Precisely when a
company is going through a phase of change, a family–owned company has the opportunity to show
a special degree of respect and fairness to employees.
Under finance parameters, the following are of particular importance: the productivity of work, as
well as the productivity of capital. Just as important is liquidity which measures the company’s solvency. For us, this parameter still takes priority over profit. Regarding profit, we, as the shareholder
family, attach value to achieving a minimum profit. This means how much profit we require to at
least be able to provide medicines to the benefit of people and animals in the future too.
The fourth generation regards the company for which it has been given responsibility as a duty. But it
is also an opportunity and a huge challenge, as we can still develop values which we took over from
the previous generation.
8
Boehringer Ingelheim annual report 2010
We, the fourth shareholder generation, understand ourselves to be trustees for the fifth generation.
That means that we are now creating the preconditions that will give the fifth generation the opportunity to take over a healthy company. We thereby maintain our commitment to a long-term perspective.
Boehringer Ingelheim serves humankind. Successful research and development of progressive and
pioneering medicines has a long tradition at the company. A scientific department was established as
early on as 1917 and successfully conducted in-house research and development.
This focus on continuous innovation has ensured our current strong market position and opens the
way to good opportunities in the future.
As already explained, we feel, as shareholders, that we are trustees of our company’s lasting success.
It is also this sustainability aspect which offers our family-owned company other opportunities for
success than those open to companies listed on the stock exchange. For us, short-term success counts
less than the long-term perspective. Only a high degree of stability provides the necessary space for
innovation and creativity.
Our employees today decide on tomorrow’s success. All are guarantors of our innovative strength
and efficiency. They thereby contribute to Boehringer Ingelheim remaining an independent and successful company for the coming 125 years too.
We, Boehringer Ingelheim’s shareholders, together with the Board of Managing Directors and our
employees, will continue to work with heart and commitment for Boehringer Ingelheim’s success
and to live our common values.
signed by
christian boehringer
chairman of the shareholders’ committee
Shareholders’ perspective 2010
9
key aspects 2010
Key aspects 2010
andreas barner, hubertus von baumbach, wolfram carius,
engelbert tjeenk willink, (from left to right)
the board of managing directors
10
Boehringer Ingelheim annual report 2010
In 2010, we had the pleasure of celebrating our company’s 125th jubilee. It is with joy and respect
that we look back on what was achieved.
For Boehringer Ingelheim, 2010 was a year of transition with many challenges which, thanks to
the performance of all our employees, we were once again able to take on successfully. In 2010, an
important foundation was laid for the future: now, it is time to take advantage of the opportunities
of 2011. We are satisfied with what has been achieved and look ahead to the new tasks in 2011 with
optimism and confidence.
The consistent implementation of our long-term orientated strategy in order to secure sustainable
company success was one of the central tasks in 2010. For the next ten years, our corporate strategy
envisages Boehringer Ingelheim successfully researching, developing, producing and marketing innovative medicines for patients worldwide. We will reach this goal if we continue to concentrate on
our organic growth supported by inlicensing, selected acquisitions and alliances.
In doing this, one of the main goals is the international positioning of the company with new innovative medicines in indications in which there is actual therapeutic need, and also in areas in which
Boehringer Ingelheim has so far not been represented. Our ability to achieve this has been given
enduring proof by our employees in Research, Development and Medicine, with the registration of the
innovative coagulation inhibitor pradaxa® in the new indication prevention of stroke in patients with
atrial fibrillation.
pradaxa® in stroke prevention not only achieved a medical breakthrough for the first time in over
50 years, but also represented a therapeutic simplification and therapeutic progress.
The clinical development of our substances in the indications diabetes, oncology and hepatitis C
was also highly successful. Clinical phase III studies were completed for the oral diabetes medicine
linagliptin. After the international submission in 2010, we expect to receive the first approvals by
mid-2011.
Key aspects 2010
11
key aspects 2010
These successes in research and development are further important milestones in our 125-year history.
In 2010, we have for the first time worked with a new organisation structure that, while retaining
our values and corporate culture, will help the company to achieve a better alignment, higher productivity and more flexibility.
In the conjunction with the implementation of the corporate strategy, proactive change and talent
management was established within the company in order through targeted employee development
to better face the challenges of the future.
As in the past, it will also be true in the future that continual but steady changes will be necessary in
order to be equipped for the future at any time. And here it is important for us to have a constant in
the future – our values and culture of togetherness – borne by a family-owned company.
A good starting point
After a 10-year period of above-market growth, Boehringer Ingelheim’s business development in
2010 was, as expected, not easy, due to the planned loss of exclusivity for important products, but the
results were nevertheless satisfactory overall.
Net sales of the group of companies were EUR 12,586 million. With a decline of 1.1% in net sales,
this was only slightly below the previous year level. Operating income, at EUR 1,896 million, was, as
expected, below the previous year level, as was the return on net sales of 15.1%. Sustained success
and securing the company’s independence long term are, however, more important to us than optimising short-term profit.
Prescription Medicines
Prescription Medicines form the main focus of our commercial activities and the core of our Human
Pharmaceuticals business. Net sales of EUR 9,702 million represented a – 3.5% decline compared to
the previous year. The loss of exclusivity on flomax® and mirapex® in the USA, as well as the ending
of the agreement for duloxetine (cymbalta®/xeristar®), depressed net sales.
Adjusted for these extraordinary components, business performance was, nevertheless, quite
gratifying, as shown especially in the positive growth rates of our established products spiriva®,
micardis® and combivent®.
12
Boehringer Ingelheim annual report 2010
Consumer Health Care
Consumer Health Care is our business in over-the-counter medications. Despite a declining market
in Japan, as well as a low-turnover cold season at the beginning of the year, we were able to register
net sales of EUR 1,318 million, representing growth of + 4.5%.
Industrial Customer
The Industrial Customer business showed negative development due to the effects of the economic
crisis. Net sales dropped to EUR 638 million, a decline of – 18.7% compared to the previous year.
Animal Health
Our Animal Health business, also reflecting the successful integration of parts of the Fort Dodge animal health business, once again proved extraordinarily successful and its net sales rose to EUR 921
million, an increase of + 51%. Thanks to the success of swine vaccines, solid progress was achieved in
the strategic core segments.
New products – top priority
In 2010, Boehringer Ingelheim applied for the registration of new and medically important products.
They were the slow-release formulations of viramune® and sifrol®/mirapex®. These were already
registered in a number of countries and have already initiated a growth phase. Thanks to the new
products, Boehringer Ingelheim will again commence a new period of growth in 2011 – first with
pradaxa®, subsequently also with substances in the diabetes area, and, in coming years, in oncology
and other therapeutic areas.
The successful launch of these new products will be our top priority in 2011 – all disciplines within
the company will be contributing – and we are convinced that our organisation is well-equipped for
this challenge.
Outlook
Our strategy for the next 10 years foresees Boehringer Ingelheim continuing to research and develop
successful, innovative medicines for patients worldwide. We will achieve this goal if we continue to
concentrate on our organic growth, supported by inlicensing and selected acquisitions and alliances.
Key aspects 2010
13
key aspects 2010
Within the framework of the corporate strategy, Boehringer Ingelheim and the pharmaceutical company Eli Lilly and Company in 2011 concluded a global agreement on the joint development and
commercialisation of their diabetes portfolios in mid and late-stage development. With this intended
long-term alliance, which is broad and strategic in the therapeutic area diabetes, Boehringer Ingelheim
combines its row of innovative products in the pipeline with Lilly‘s expertise in diabetes marketing
and its late-stage portfolio.
In addition in 2011, Boehringer Ingelheim has from Amgen Inc. acquired a development and production site for biopharmaceuticals in Fremont, California, USA. The Amgen site in Fremont comprises a modern production plant, development facilities and laboratories for process development.
Boehringer Ingelheim is one of the leading companies in the contract manufacturing of biopharmaceuticals. The technical know-how and modern facilities in the biotechnology center in the San
Francisco Bay area will enable Boehringer Ingelheim to further expand its global contract manufacturing business, including activities in the field of process development and production of new biological active ingredients.
We will also address the future in our Animal Health business. With the laying of the foundation
stone for the new European Animal Research Center in Hanover, Germany, we took a further step in
the long-term expansion of this exceptionally successful business.
Everything that we undertake will also in 2011 demand a great deal of effort, commitment and creativity from all of us. A precondition is our readiness, together with all employees, to actively deploy
our full working capacity in this process. This distinguished us from oters in the past and justifies
our optimism for the future.
14
signed by
signed by
andreas barner
hubertus von baumbach
signed by
signed by
wolfram carius
engelbert tjeenk willink
Boehringer Ingelheim annual report 2010
Corporate bodies
Shareholders’ Committee
Board of Managing Directors
christian boehringer
prof.* dr dr andreas barner
Chairman of the Shareholders’
Chairman of the Board
Committee
Corporate Board Division Pharma Research,
Development and Medicine
albert boehringer
hubertus von baumbach
christoph boehringer
Corporate Board Division
Finance and Animal Health
erich von baumbach jr.
prof. h.c. dr wolfram carius
ferdinand von baumbach
Corporate Board Division
Human Resources and Operations
dr mathias boehringer
engelbert tjeenk willink
Corporate Board Division
Advisory Board
Marketing and Sales Human Pharma
prof. dr michael hoffmann-becking
Attorney at Law, Düsseldorf
Chairman of the Advisory Board
egbert appel
Trustee, Martin Hilti Family Trust
Member of the Board
and Managing Director
Hilti Foundation
dr andreas kreimeyer
Member of the Board of
Executive Directors
and Research Executive Director
BASF SE
prof. dr fredmund malik
Chairman of the Board
Malik Management Zentrum St. Gallen AG
*Republic of Austria
Key aspects 2010 / Corporate bodies
15
group management report
16
Boehringer Ingelheim annual report 2010
2010
Group Management Report
Business and operating environment
18
Results from operations, financial position and net assets
31
Report on post balance sheet date events
35
Risk report
36
Report on expected developments
37
Group Management Report 2010
17
group management report
Group management report 2010
Business and operating
environment
nomic upturn in Germany was accompanied by a high
level of employment. The number of people in employment reached a new high of around 40.5 million,
while the number of unemployed was temporarily re-
Whereas 2008 and 2009 were shaped by the consequenc-
duced to fewer than 3 million. The German govern-
es of the financial and economic crisis, 2010 was influ-
ment expects this positive trend to continue in 2011,
enced by a recovery in the global economy. The world-
although it has forecasted slightly lower economic
wide economy grew by 3.9 % in 2010. In particular, the
growth of 2.3 %.
substantial rise in global trade and strong growth in
emerging countries made a significant contribution to
The inflation rate in Germany (measured using the
the recovery of the markets in 2010. China achieved eco-
consumer price index) was around 1.1 % on average in
nomic growth of around 10 %. The economy of the entire
2010. This was a considerable increase on the previous
Asia/Pacific region grew by 9.3 % last year.
year, although it was still at a relatively low level in a
multiple year comparison over several years. Looking
For 2011, the World Bank expects global economic
at Europe as a whole, we can see that inflation rates in
growth to slow slightly to about 3.3 %, mainly owing to
the expiry of economic stimulus packages set up by various governments during the financial and economic
Net sales by businesses (in millions of EUR)
crisis. Worldwide growth will be bolstered again in
2011 by above-average growth in emerging and developing countries (expected value around 6 %). However
for large industrialised nations, the World Bank expects
Prescription Medicines
9,702
10,058
2010
2009
an increase of only 2.4 % in economic output in 2011.
Consumer Health Care
In the eurozone, a very mixed picture emerged in 2010.
The countries with large budget deficits in particular
are still regarded as problematic. The restrictive finan-
1,318
1,261
2010
2009
Biopharmaceuticals
cial policy had a braking effect on economic recovery
in some countries, particularly in the second half of
2010
2009
422
553
the year. As a result, current estimates assume economic growth of only 1.7 % in 2010 and around 1.3 % in
2011 for the eurozone.
Pharma Chemicals and Pharmaceuticals Production
2010
2009
216
233
In contrast, the German economy grew substantially in
2010, achieving positive economic growth of 3.6 %.
Following the crisis year of 2009, the positive impetus
in 2010 came mainly from stronger foreign trade and
an appreciable increase in domestic trade. The eco-
18
Boehringer Ingelheim annual report 2010
Animal Health
2010
2009
921
610
The global pharmaceutical market showed stable de-
Net sales by regions (in millions of EUR)
velopment in 2010. At a growth rate of 4 %, however,
worldwide market growth was slightly lower than in
the previous year (6.5 %). This development was influenced by the loss of exclusivity for major pharmaceutical products, which was not offset by the introduction
of product innovations. Furthermore, health policy
Europe
Americas
5,724
6,257
2010
2009
4,089
3,980
2010
2009
measures in Europe and the USA had a significant
Asia,
Australasia,
Africa
(AAA)
2,773
2010
negative impact on the pharmaceutical sector, particularly in established industrialised nations, and led to
2,484
2009
drops in sales. Growth in the worldwide pharmaceutical market was therefore largely driven, as expected, by
high growth rates in emerging markets (including China, Brazil, Russia, India, Mexico and Turkey). Particularly the Chinese pharmaceutical market is showing
the various European countries vary considerably. The
dynamic growth.
European Central Bank is pursuing the target of an inflation rate of under 2 % (based on the eurozone). Al-
For 2011, market researchers are anticipating slightly
though this level was exceeded occasionally, the aver-
higher growth once again for the global pharmaceuti-
age inflation rate for the eurozone in 2010 was 1.6 %,
cal market, within a range of around 5 % to 7 %. How-
well below this threshold.
ever, the experts expect growth rates to continue to
vary widely on the different pharmaceutical markets
The foreign exchange markets showed considerable
around the world.
volatility in the last financial year, with the US dollar
and the Japanese yen, currencies of importance to
Business at Boehringer Ingelheim
Boehringer Ingelheim, developing along different
For the Boehringer Ingelheim group of companies, the
lines. In relation to the US dollar, the EURO fluctuated
year 2010, in which we celebrated our 125th anniver-
over the course of the year between 1.19 USD/EUR
sary, was a year of transition to a new growth phase.
and 1.45 USD/EUR . At the beginning of the year, the
Against the background of the loss of exclusivity, prep-
exchange rate against the US dollar still stood at 1.43
arations for the launch of new products and regulatory
USD/EUR, but it then dropped significantly in the first
changes on the markets, as expected, Boehringer Ingel-
half of the year to a low of 1.19 USD/EUR in June,
heim did not achieve the high growth rates of previous
before rising again in the second half of the year and
years. As announced in advance, Boehringer Ingelheim
closing in 2010 at 1.34 USD/EUR.
recorded significant shortfall in sales as a result of the
loss of exclusivity for key sales drivers on the US phar-
The exchange rate of the EURO against the Japanese
maceutical market and the associated competition
YEN also declined significantly in the first half of 2010;
from generic drugs (around EUR 1.4 billion after ad-
however, in contrast to the exchange rate with the US
justments for currency effects). Adjusted for this one-
dollar, this trend continued in the second half of the
off effect, the development of business in 2010 was
year. The 2010 financial year began at an exchange rate
positive. Driven by the growth in the rest of our range
of 134 JPY/EUR (also the annual high). The annual low
of prescription medicines (around +5.5 % after adjust-
of 106 JPY/EUR was reached in September at the end of
ments for currency effects), the successful launch of
2010, the exchange rate stood at 108 JPY/EUR.
new products and the growing Animal Health business
Business and operating environment
19
group management report
we were almost able to compensate for the anticipated
products and production capacity into our Animal
drop in sales. Boehringer Ingelheim generated sales of
Health business and the integration of the new em-
EUR 12,586 million in 2010. With the slight decline of
ployees into the Boehringer Ingelheim group of com-
– 1.1 %, sales were down only marginally on the previ-
panies progressed as planned.
ous year’s figure of EUR 12,721 million.
As in previous years, Boehringer Ingelheim’s strategic
Lasting success and ensuring the company’s independ-
focus will remain on in-house research and development
ence in the long term are more important to us than
of innovative medicines in future. We are thus concen-
short-term optimisation of results. Boehringer Ingel-
trating on our own strengths and laying the foundations
heim is to enter a new phase of growth in 2011 with
for sound and sustainable organic growth. In areas
new medicines and a well-filled product pipeline.
where we require new expertise or if suitable-looking
market opportunities arise, Boehringer Ingelheim will
Last year, we worked for the first time in a new or-
also make use of opportunities for external growth.
ganisational structure, which will significantly
strengthen us for the future and will help our company
Owing to the effects described above, there was a slight
to achieve both greater market penetration and higher
shift in the regional distribution of our sales compared
productivity and flexibility.
with the previous year. As expected, the Americas region recorded a drop in sales of 8.5 % last year, owing
As part of our corporate strategy, we are focusing our
to the loss of exclusivity, which primarily affected the
business activities on the successful development and
US market. The positive development of the rest of the
market launch of our promising product pipeline.
product range could not fully compensate for the de-
Against this background, Boehringer Ingelheim reached
cline in sales in this region in connection with the loss
an amicable agreement last year with Eli Lilly to end
of exclusivity. However, the Americas region is still
our existing collaboration in connection with duloxe-
Boehringer Ingelheim’s largest region in terms of sales,
tine (cymbalta®/ariclaim®). Eli Lilly reacquired the
accounting for around 46 % of our total sales. In line
exclusive worldwide development and marketing
with expectations, the Asia /Australasia /Africa region
rights to duloxetine for all indications and is to contin-
registered the strongest growth year-on-year, at a
ue marketing duloxetine through its own organisation.
pleasing 11.6 %. As a consequence, around 22 % of our
total sales came from this increasingly important re-
Since 2001, Boehringer Ingelheim has been the ma-
gion. In Europe, solid growth of 2.7 % was achieved,
jority shareholder in SSP Co. Ltd. (SSP), a long-
giving this market a share of 32 % in total sales.
established Japanese company. In 2010, Boehringer
Ingelheim acquired the outstanding shares of SSP, a
Net sales by region
(in millions of EUR)
2010
2009
Change
Americas
5,724
6,257
— 8.5%
in the company. In doing this, Boehringer Ingelheim is
Europe
4,089
3,980
+ 2.7%
showing a clear strategic commitment to the Japanese
Asia, Australasia, Africa (AAA)
2,773
2,484
+ 11.6%
listed company, as part of a public tender offer followed by a squeeze out, and now owns 100 % of shares
market.
Sales in our Human Pharmaceuticals business were
After taking over parts of the Animal Health business
down around 4 % year-on-year in 2010. This develop-
of Pfizer/Fort Dodge at the end of 2009, Boehringer
ment was expected and is mainly due to the loss of
Ingelheim began implementing a long-term integration
exclusivity for the prostate drug alna®/flomax® and
concept last year. The incorporation of the acquired
the Parkinson’s disease product sifrol®/mirapex®,
20
Boehringer Ingelheim annual report 2010
along with competition from generic drug manufactur-
loss of exclusivity, which confirms our strategy. On the
ers for the anti-hypertensive medicine catapresan®
basis of the positive development of our established
TTS in the USA. Added to this were the terminations of
products and the promising product innovations in our
the contractual agreement for duloxetine (cymbalta®/
pipeline, we will embark on a new growth phase fol-
xerista®) and a licensing agreement for Herceptin
lowing the transition year of 2010.
with Roche/Genentec. With adjustments for these oneoff factors, the development of business was very posi-
Our employees and positive results in research and
tive, which is reflected above all in the positive growth
development form the basis for the continuation of our
rates for our established products spiriva®, micardis®
long-term growth. On the strength of the success of
and combivent®. In addition to the established prod-
our research and development activities, we deliberate-
ucts, the new launches pradaxa® and twynsta® also
ly maintained our high levels of investment in R&D in
made a positive contribution to sales development in
the transition year of 2010. At EUR 1,896 million,
the Human Pharmaceuticals business. At EUR 11,665
Boehringer Ingelheim’s operating income correspond-
million, the Human Pharmaceuticals business accounts
ed to a return on net sales of 15.1 %.
for 92,7 % of Boehringer Ingelheim’s total sales. Within
the Human Pharmaceuticals business, EUR 9,702 mil-
Key figures (in millions of EUR)
lion relates to Prescription Medicines (– 3.5 % com-
Net Sales
pared with the previous year) and EUR 1,318 million
Operating income
to our Consumer Health Care business (+ 4.5 % com-
Return on net sales
2010
2009
Change
12,586
12,721
— 1.1%
1,896
2,239
— 15.3%
15.1%
17.6%
pared with the previous year).
Research and development (R&D)
The Animal Health business also performed very suc-
In line with Boehringer Ingelheim’s corporate mission
cessfully in the 2010 financial year. With sales of EUR
statement, our primary objective is to develop inno-
921 million, the share of this business in our total sales
vative medicines and treatments for diseases that can-
has increased to a substantial 7.3 %. This positive
not yet be treated in a satisfactory manner. In this
development is based both on organic growth (particu-
way, we hope to help people affected by these diseases.
larly for our pig vaccine ingelvac circoflex®) and on
We are constantly striving to make an important con-
the products acquired from Pfizer/Fort Dodge at the end
tribution in areas where the need for treatment is high
of 2009. The sales of our Animal Health business have
and to attain a leading position in the major indication
thus risen by 51 % compared with the previous year.
areas. In order to achieve this goal, we ensure that we
are always up-to-date with strategically important
Net sales by businesses (in
millions of EUR)
2010
2009
Change
Prescription Medicines
9,702
10,058
— 3.5%
Consumer Health Care (CHC)
1,318
1,261
+ 4.5%
Biopharmaceuticals
422
553
— 23.7%
Pharma Chemicals and
Pharmaceutical Production
216
233
— 7.3%
Animal Health
921
610
+ 51.0%
technologies and systematically research new key technological approaches.
Boehringer Ingelheim’s successful research and development activities and our associated innovative
strength have always provided the basis for our positive development in previous years. This will not
change in the years to come. In-house research and
Overall, we are satisfied with the development of our
development will remain a top priority in the future.
sales in 2010, given the difficult general conditions.
It represents the cornerstone of the Boehringer Ingel-
We consider it a success that we were able to compen-
heim group of companies and will continue to be our
sate almost entirely for the drops in sales caused by
main growth driver in future.
Business and operating environment
21
group management report
In 2010, we employed an average of 7,093 staff at
body technology, which could be used in the fields of
our large R&D sites in Germany (Biberach), the USA
oncology, respiratory diseases, cardiometabolic disor-
(Ridgefield), Austria (Vienna) and Canada (Laval).
ders and infectious diseases. In addition, we signed a
With a total investment of around EUR 2,453 million
cooperation and licensing agreement last year with the
in research and development activities, Boehringer In-
Austrian company f-star Biotechnologische Forsc-
gelheim once again significantly increased its invest-
hungs- und Entwicklungsgesellschaft for the develop-
ment in this field compared with the previous year. In
ment of pharmaceuticals based on antibodies. As part
total, Boehringer Ingelheim thus invested 19.5 % of
of this agreement, Boehringer Ingelheim can apply the
group sales in the research and development of new
modular technology developed by f-star for the pro-
medicines in 2010.
duction of antibodies and functional antibody fragments against up to seven target structures from vari-
At Boehringer Ingelheim, in-house research and devel-
ous therapeutic areas and can use it to develop new
opment activities are a high priority. In addition, we
medicines. A cooperation agreement with German-
regularly supplement our product range with targeted
based company Priaxon AG was launched last year for
licensing and cooperation agreements.
the research and development of innovative cancer
treatments. The aim is to jointly develop an mdm2-/
In the last financial year, for example, we entered into
p53 inhibitor against various types of tumours. We
a long-term cooperation agreement with 4-Antibody
concluded a worldwide cooperation agreement with
AG (Switzerland) for the development of fully human,
the US company Neurocrine Biosciences for the re-
therapeutic antibodies for a series of targets in various
search and development of the GPR119 agonist for the
indications. 4-Antibody AG is to use its proprietary
treatment of type 2 diabetes. The mechanism aims to
Hu-PAC(R) and Retrocyte Display(R) technologies to
stimulate the production and secretion of the body’s
develop fully human antibodies against new targets
own insulin and thus represents an addition to our
designated by Boehringer Ingelheim. We have conclud-
own diabetes pipeline. Furthermore, Boehringer Ingel-
ed a cooperation agreement with the US company
heim signed an agreement with the engineering and
Micromet Inc. for the research, development and mar-
technology company VTU regarding cooperation in
keting of a new BiTE antibody for the treatment of
technological development. As part of this agreement,
multiple myelomas. Although some progress has been
Boehringer Ingelheim will obtain access to VTU’s own
made recently in the treatment of multiple myelomas,
expression system (methodology for protein expression).
this disease is still regarded as being largely untreatable. Boehringer Ingelheim also entered into a coopera-
Boehringer Ingelheim set up its own venture capital
tion agreement with the company Macrogenics Inc.,
fund last year – the Boehringer Ingelheim Venture
also based in the USA. The aim of this collaboration is
Fund GmbH (BIVF). This fund will invest in biotech
to research, develop and market a DART™-based anti-
and start-up companies that research promising ap-
Research and development
2010
2009
2008
2007
2006
Expenditure in millions of EUR
2,453
2,215
2,109
1,900
1,574
19.5
17.4
18.2
17.3
14.9
2,306
2,100
2,016
1,818
1,501
– as % of net sales
Prescription Medicines expenditure in millions of EUR
– as % of Prescription Medicines net sales
Average number of employees
Investments in tangible assets (without investments in infrastructure) in millions of EUR
22
Boehringer Ingelheim annual report 2010
23.8
20.9
22.1
21.0
18.1
7,093
6,934
6,788
6,405
6,003
83
125
145
157
125
proaches to treatment and technologies, in order to
over, the enormous restrictions associated with the
promote innovation in medical science. The initial vol-
standard treatment used until now are no longer nec-
ume of funds to be invested by Boehringer Ingelheim
essary with pradaxa®. Atrial fibrillation is the most
totals EUR 100 million. The first investments were
common type of arrhythmia, affecting approximately
made in the last financial year.
1 % of the total population and 10 % of those aged over
80. They have an increased risk of blood clots and are
At the four large research sites of Boehringer Ingelheim,
therefore up to five times more likely to suffer a stroke.
referred to above, we have focused our research and de-
pradaxa® therefore represents innovation in an area
velopment activities on the following therapeutic areas:
where the need for treatment is high and is simultaneously an excellent example of our mission statement
• Respiratory diseases
“Value through Innovation”.
• Immunology
• Infectious diseases
In October last year, pradaxa® received the Galenus
• Cardiometabolic disorders (cardiovascular and
von Pergamon prize in the “Primary Care” category,
metabolic diseases)
a prize for top-level pharmacological research. This
• Neurological diseases
award confirms once again the highly innovative na-
• Oncology
ture of pradaxa®. In April 2010, Boehringer Ingelheim
was selected as one of the three finalists for the “Ger-
In the last financial year, Boehringer Ingelheim once
man Innovation Award” in the category of large com-
again made significant progress with clinical research
panies for the development of dabigatran etexilate. In
into new substances. In particular, we should highlight
September 2010, German GPs, practitioners and inter-
our innovations in the field of cardiometabolic disor-
nal specialists chose the medicine as the “most innova-
ders with our substance dabigatran etexilate (pradaxa®)
tive product of 2010” in a survey conducted by the pe-
and in the field of type 2 diabetes with our active in-
riodical “PharmaBarometer”. The clinical results of the
gredient linagliptin.
study, the market approvals and the numerous awards
that have been received attest to the innovative strength
In October 2010, our new product pradaxa® (dabigat-
of pradaxa® and confirm once again the success of our
ran etexilate) obtained approval in the USA and Cana-
research and development strategy.
da for the indication of the prevention of strokes in
patients with atrial fibrillation. Further approvals are
Metabolic diseases have also been among the key areas
expected for this innovative oral direct thrombin in-
of research and development at Boehringer Ingelheim
hibitor in 2011, including in Japan and Europe.
for many years. Diabetes is one of the indications on
which our global research network focuses. Almost
pradaxa® has already been approved for the preven-
four million people aged between 20 and 79 are esti-
tion of venous thromboembolism (VTE) following hip
mated to have died of diabetes or related complications
and knee replacement operations in 75 countries since
in 2010. Around 50 % of people with diabetes die of
2008. The approvals that have now been granted for
cardiovascular diseases and over 8 % of kidney failure.
the indication of the prevention of strokes represent a
Within our research and development of new active in-
therapeutic breakthrough from a medical point of view.
gredients for diabetes with innovative mechanisms of
In the USA, this is the first approval for an oral coagu-
action, our DPP-4 inhibitor linagliptin is the most ad-
lation inhibitor for over 50 years. Treatment with
vanced active ingredient in Boehringer Ingelheim’s
pradaxa® will improve the lives of many patients, as it
diabetes range in terms of development. Linagliptin is
offers a high level of protection against strokes; more-
being developed as a tablet to be taken once daily for
Business and operating environment
23
group management report
the treatment of type 2 diabetes (as a monotherapy) and
non-small-cell bronchial carcinoma, breast cancer
as a combination therapy. The phase III data presented
and carcinoma of the head and neck). Our substance
in 2010 for linagliptin as part of the 70th Scientific
afatinib is an innovative oral tyrosine kinase inhibitor,
Sessions of the American Diabetes Association (ADA)
the effect of which is based on the irreversible inhibi-
showed a substantial, lasting and clinically significant
tion of two tyrosine kinases involved in the growth
reduction in the blood glucose level. The phase III ap-
and spread of the tumours.
proval studies also showed a very favourable safety
profile for linagliptin, with an overall rate of adverse
Lung cancer is the most common type of cancer world-
concomitant symptoms at the same level as a placebo.
wide and also the most common cause of death linked
Moreover, linagliptin showed no effects on body
to cancer. Boehringer Ingelheim made further progress
weight and no increased risk of interactions with other
with development in this area in 2010. Our substance
pharmaceuticals. What is particularly significant is
afatinib is currently being tested in the treatment of
that no increased risk of hypoglycaemia occurred in
lung cancer as part of the LUX-Lung clinical trial pro-
connection with linagliptin as a monotherapy or in
gramme.
combination with metformin or pioglitazone. At the
autumn 2010 conference of the German Diabetes As-
This programme includes a series of studies, most of
sociation in Berlin, Boehringer Ingelheim presented
which are now in clinical phase III.
further study results, which supplemented the results
already known from the phase III study programme.
In the clinical phase III study LUX-Lung 1, the study
The new data shows a significant and lasting reduction
results last year confirmed, for example, the activity and
in the blood glucose level and also demonstrates that
clinical benefits of afatinib in advanced, non-small-
linagliptin could be used at an early stage for all pa-
cell bronchial carcinoma for the overall population.
tients with type 2 diabetes without adjusting the dose,
Patients treated with afatinib showed significantly
even with patients who have kidney damage, as it has a
higher rates for tumour control or reduction in the size
unique pharmacokinetic profile among DPP-4 inhibi-
of the tumour than patients who received a placebo.
tors. Boehringer Ingelheim is proud of these positive
These results were confirmed by an independent party.
development results and expects to receive the first
The study results also showed that the active ingre-
market approvals for linagliptin over the course of 2011.
dient afatinib leads to a statistically significant improvement in the central symptoms associated with bron-
In the field of oncology, Boehringer Ingelheim has de-
chial carcinoma (cough, dyspnoea and pain). In
voted itself to the research and development of innova-
addition, afatinib significantly delayed the time taken
tive active ingredients for the treatment of cancer,
for the cough, dyspnoea and chest pain to reduce.
which will mean significant therapeutic benefits and
an improvement in the quality of life for patients. This
In September last year, we also announced the beginning
commitment is based on scientific progress in the de-
of a clinical phase III study in which afatinib is to be
velopment of a series of targeted treatments for solid
tested in the treatment of patients with advanced
tumours and haematological cancers with a high treat-
breast cancer. Breast cancer is the most common cause
ment requirement.
of cancer-related deaths in women worldwide, with
over 411,000 deaths every year. The clinical phase III
Our comprehensive and robust LUX study programme
study, which is labelled “LUX-Breast 1” and is of rele-
consists of over ten studies taking place worldwide
vance to approval, is the first to assess afatinib in the
to assess our active ingredient afatinib (BIBW 2992) in
treatment of breast cancer. This study expands the
the treatment of various solid tumours (including
potential range of applications for which Boehringer
24
Boehringer Ingelheim annual report 2010
Ingelheim’s oncology pipeline could be suitable. It thus
tor) with Ribavirin reduces the viral load of previously
represents an important milestone on the path towards
untreated HCV patients to unquantifiable levels. Dur-
extending our developments in oncology beyond lung
ing the study, the new protease-polymerase inhibitor
cancer.
combination produced a rapid virological response
even without PEGy-lated Interferon. At Boehringer In-
Alongside afatinib, BIBF 1120 (planned trade name
gelheim, we are proud of our research findings in this
vargatef®) is the second leading substance in the on-
area. Therapy foregoing the use of interferon and its
cology pipeline at Boehringer Ingelheim. This triple
associated side effects for patients with chronic hepati-
kinase inhibitor is currently in clinical phase III devel-
tis C may well prove an important treatment option.
opment for the treatment of patients with advanced
non-small-cell bronchial carcinoma, as well as patients
Our research and development activities in the area of
suffering from ovarian cancer. Furthermore, in Novem-
cardiovascular medication have helped us to develop
ber 2010, Boehringer Ingelheim published the results
our product twynsta®, a highly effective pill combin-
of the clinical phase II TOMORROW study. In the
ing the angiotensin receptor blocker telmisartan
study, our substance BIBF 1120 produced very promis-
(micardis®) with the calcium channel blocker am-
ing results in patients with idiopathic pulmonary fi-
lodipine. This product is aimed at the treatment
brosis (IPF). The trial results clearly indicate that this
of essential hypertension in adult patients whose
substance may prove of significant benefit to IPF pa-
blood pressure cannot be sufficiently controlled by
tients, since it reduces the rate of lung function decline
amlodipine alone. It is also designed as an alternative
associated with this disease. These results are most en-
therapy for adults who have previously been taking
couraging and serve to build a solid base for the devel-
both micardis® and amlodipine as separate pills in
opment of further clinical programmes.
the same dosage. High blood pressure is the greatest
risk factor for cardiovascular disease, and is responsi-
In the therapeutic area of infectious diseases,
ble for more fatalities than any other risk factor. Our
Boehringer Ingelheim’s research and development ac-
successful development studies led to twynsta® being
tivities are focused on viral diseases with high, previ-
approved for the US market in 2009, while the finan-
ously unmet medical needs. Last year, we made further
cial year just closed saw twynsta® gain market approv-
significant progress in our HCV (hepatitis C virus) re-
al for both Japan and Europe.
search programme. Our BI 201335 substance is an oral
HCV NS3/4A protease inhibitor (test substance), which
Boehringer Ingelheim’s pipeline projects are subject to
was developed by our research and development team
regular review. In this regard, we made the decision
and has already undergone clinical trials up to phase
last year to discontinue the development of flibanserin,
IIb (SILEN-C studies). Our BI 207127 substance, on
an active ingredient for the treatment of hypoactive
the other hand, is an NS5B RNA-dependent polymer-
sexual desire disorder (HSDD). In June 2010, the Re-
ase inhibitor which has successfully completed phase I
productive Health Drugs Advisory Committee of the
clinical trials. Plans for phase II studies with both BI
US Food and Drug Administration (FDA) met in order
207127 and BI 201335 are currently underway in ther-
to deliberate over the application for approval of fli-
apies without Interferon, both with and without Riba-
banserin for the treatment of HSDD in premenopausal
virin. In October 2010, Boehringer Ingelheim pub-
women. The answer given by the regulatory authority,
lished the promising results of our phase Ib study
together with the complexity and scope of further
“SOUND-C1”, from which it emerged that the combi-
questions which would have to be addressed in order
nation of the oral hepatitis C ingredients BI 201335
to gain approval for flibanserin, led us at Boehringer
(protease inhibitor) and BI 207127 (polymerase inhibi-
Ingelheim to decide that we would focus our attentions
Business and operating environment
25
group management report
on other projects in our product pipeline. This was a
established itself very successfully as a reliable partner
difficult decision, particularly since we remain con-
for both internal group customers and external indus-
vinced of the value of flibanserin for women suffering
trial customers.
from HSDD. Therefore, it is important to us that we
have made a significant contribution to a better under-
In the 2010 financial year, we reorganised the manage-
standing of HSDD, both by investing in research and
ment of our global production locations, thereby fur-
development and by engaging in educational activities
ther enhancing our competitive edge.
concerning the disorder.
We merged our chemical and pharmaceutical plants,
The main research focus of Boehringer Ingelheim’s
which are responsible for the market launch of innova-
Animal Health business is the research and develop-
tive new drugs, to form the new Launch & Strategic
ment of innovative vaccines, primarily to protect food-
Products (LSP) division. The primary objective of this
producing animals. During the financial year just
division is to ensure that product launches meet the
closed, Boehringer Ingelheim invested roughly EUR 92
highest quality standards, while safeguarding the tech-
million in the research and development of new prod-
nologically and procedurally challenging manufacture
ucts. This represents approximately 10 % of the over-
of these innovative products during the first years of
all sales generated by our Animal Health business.
their life cycle. LSP thus represents an interface between production and our development activities. It is
In 2010, Boehringer Ingelheim laid the foundations of
also responsible for taking on preparatory tasks for the
its European research centre for animal vaccines in
market launch of new products at a very early stage.
Hanover. More than EUR 40 million is to be invested in
One particularly successful example in 2010 was the
the Boehringer Ingelheim Veterinary Research Center,
launch of our product pradaxa® in the USA. It was
where a staff of 50 will be involved in developing in-
possible to enhance the manufacturing process in the
novative vaccines in the first phase of expansion. Op-
initial phases of production, with the result that a sta-
erations are to get underway at the end of at the end of
ble, high-quality manufacturing process was already
2011, while scientific work is scheduled to begin in
ensured at the product launch.
2012. We are building a truly modern research centre,
encompassing 50 laboratories with animal accommo-
Around 80 % of our production volume relates to es-
dation facilities. This substantial investment will firm-
tablished products in the advanced stages of their life
ly establish our research and development activities in
cycle. Manufacture of these products is the responsibil-
the area of animal vaccines for food-producing ani-
ity of our Established Products (ESP) division. A solid
mals in Europe, while also expanding our internation-
presence in all regions of the world allows us maxi-
al reputation.
mum flexibility in our production network, so that we
can react optimally to varying local requirements. Our
Production
production network means that we are always in a po-
In 2010, our Human Pharmaceuticals production net-
sition to produce not only our proprietary drugs, but
work comprised 22 operative units, spread over 20 sites
also products commissioned by external industrial
worldwide (in 13 countries): 14 pharmaceutical, five
customers, with cost-efficient manufacturing process-
chemical, two biopharmaceutical and one for medical
es, high quality standards and reliability.
devices. Boehringer Ingelheim’s many years of experience at these production sites mean that we can be sure
Boehringer Ingelheim’s biopharmaceutical production
of reliable and high-quality product supply, even when
sites in Vienna, Austria, and Biberach, Germany, have a
using modern technology. Our production division has
global reputation. In addition to producing our own
26
Boehringer Ingelheim annual report 2010
proprietary drugs (actilyse®, metalyse®, imukin® and
gelheim announced plans to invest EUR 100 million in
beromun®), Boehringer Ingelheim is also a leading
China, with the aim of increasing production capaci-
contract manufacturer spanning the entire biopharma-
ties at our plant in the Shanghai-based Zhangjiang
ceutical process chain, from genetic development of
High-Tech Park. In 2010, as part of this broad expan-
the cell, to manufacturing, and right through to pro-
sion project, we injected roughly EUR 10 million into
ducing market-ready drugs on a commercial scale for
the creation of a new Center of Competence in Shang-
external industrial customers.
hai. This new facility will specialise in quality control
for pharmaceutical active ingredients and chemical in-
Ongoing investment in our production network over
terim products procured in China. The new Center of
many years means that we can secure access to having
Competence comprises two departments, process de-
access to the most innovative and ultramodern produc-
velopment and quality control. Process development is
tion technologies.
in charge of optimisation of production processes and
the associated transfer of technology to our Chinese
In 2009, we had already invested roughly EUR 64 million
business partners. This helps to increase production
in the first module of the new production facilities
efficiency and precision. By helping to optimise our
for the manufacture of active ingredient pellets for our
partners’ production processes, as well as guaranteeing
new oral thrombin inhibitor pradaxa® at our Ingelhe-
the quality of interim products, we can ensure that
im location. In 2010, this was followed by a EUR 119
China plays a stronger role in our global procurement
million investment in the expansion of this innovative
activities in the future.
production plant. The facilities are to be completed by
2011 and will be linked to the creation of a further 120
Environmental and employee protection
jobs at our head office in Ingelheim. This additional
An important element of our corporate mission state-
investment means that we can increase capacity signif-
ment, and of key concern to Boehringer Ingelheim, is
icantly, with 1.5 billion capsules to be manufactured
the protection of our employees, our facilities and the
annually in the future. In this way, Boehringer Ingel-
environment. This goes hand in hand with conserving
heim can guarantee that the expected global demand
natural resources and promoting environmental aware-
for dabigatran etexilate (pradaxa®) is met.
ness. We have long taken care to ensure that social and
ecological concerns are firmly anchored at the heart
With a further investment of approximately EUR 70
of our corporate philosophy. Everything we do at
million in a highly automated atomisation factory at
Boehringer Ingelheim must meet the twin objectives of
the Dortmund-based Boehringer Ingelheim microParts
sustainability and concomitant respect for the environ-
for the manufacture of our respimat® inhaler, we have
ment. In all of our activities, we do our utmost to pro-
doubled production capacity to 20 million inhalers per
tect our employees, neighbouring communities and the
year. With the help of this investment, we are in a po-
environment. The company is deeply committed to con-
sition to make available to patients a highly efficient
serving natural resources and working hard to promote
and innovative atomiser in the form of the respimat®
environmental awareness both internally and externally.
Soft Mist inhaler at a time of rising world demand for
preparations for treating chronic obstructive pulmo-
We have drawn up binding standards, applicable
nary disease (CODP).
throughout the group, for the areas of environmental
protection and occupational safety. These standards
At Boehringer Ingelheim, we are always working to
do not merely meet, but go far beyond country-specific
optimise our production network. This includes ex-
legal requirements. Implementation of and compliance
panding our presence in Asia. In 2009, Boehringer In-
with these environmental and occupational safety
Business and operating environment
27
group management report
standards is ensured through established processes in
Virginia, USA. In gaining this certificate, the Peters-
our Environment, Health and Safety (EHS) division.
burg plant is following in the footsteps of our certified
Regular internal audits serve to ensure compliance
chemical plants in Spain, France and Italy.
with our standards, while helping us to identify and
realise potential for improvement. In the last financial
As with any type of production, the manufacture of
year, we again voluntarily carried out 14 internal envi-
pharmaceutical products inevitably has an impact on
ronmental protection and occupational safety audits at
the environment. It is thus our express aim to keep
12 of our sites worldwide. This global auditing process,
this impact to a minimum. A concrete example of this
along with a systematic investigation on the basis of
commitment is illustrated in our ambitious targets for
carefully defined data, is firmly established at the heart
the reduction of CO2 emissions. Last year, for instance,
of our business processes. It has a vital part to play in
we optimised the air-conditioning system at our
ensuring the high standards that have become synony-
Ingelheim plant, resulting in an annual reduction of
mous with our activities in the areas of environmental
2,000 tonnes of CO2. Boehringer Ingelheim has been
protection, health and occupational safety.
involved with the world-renowned environmental
project Ökoprofit® for a number of years. This ecologi-
When it comes to occupational safety and environmen-
cal initiative, developed in Graz, Austria promotes in-
tal protection, we have high expectations not only of
tegrated environmental technology. In effect a coopera-
ourselves, but also of our suppliers. During the 2010
tive project between local authorities and businesses,
financial year, we undertook a detailed revision and
the initiative encourages companies to take concrete
improvement of our supplier selection process. To take
measures to reduce their consumption of energy and
one example, we developed a risk-based approach for
water, as well as cutting down on waste. Dramatic re-
auditing our external business partners. Boehringer
ductions in consumption have already been achieved at
Ingelheim will not enter into a business relationship
our plants in Ingelheim and Dortmund, Germany in re-
with a supplier until all of our defined requirements
cent years. In the last financial year, however, we iden-
have been met. For this reason, a comprehensive on-site
tified considerable potential for the reduction of CO2
inspection is always the first step in a new partnership.
emissions at our plant in Vienna, Austria.
Since 1995, Boehringer Ingelheim has adhered to
The health and safety of our employees is of the high-
guidelines laid down by responsible care®, a global
est priority at Boehringer Ingelheim. Last year, build-
initiative of the chemicals industry (World Chemical
ing on the foundation of our high safety standards and
Association). For our company, responsible care®
guidelines, we implemented our new global safety cul-
means working continously to improve health, safety
ture initiative Zero by Choice. Under this initiative,
and environmental protection, beyond the ordinary
both management and staff take on key roles and are
legal requirements and on a voluntary basis. Our com-
encouraged to take proactive responsibility for their
mercial activities can only be truly successful if we pay
own safety and that of their colleagues. With its objec-
proper attention to social and ecological concerns.
tive of reducing the accident rate further, Zero by
Choice will raise the bar for occupational safety in our
In 2010, certification of our production sites by exter-
company even higher. With an accident rate of 2.6 ac-
nal organisations remained a key element of our envi-
cidents per one million hours worked in 2010, we are
ronmental and safety management processes. Our
on the right track to achieving our end goal of reducing
commitment was rewarded, amongst other things, by
the rate of 3.1 in 2009 to below one in 2014.
receipt of an ISO 14001 certificate for environmental
management at our chemical plant in Petersburg,
28
Boehringer Ingelheim annual report 2010
Employee reporting
rapidly evolving and competitive business environ-
In 2010, as in previous years, the average number of
ment. Boehringer Ingelheim’s goal, past and future, is
employees increased once more. The average number
to recruit the right employees both internally and ex-
of employees at Boehringer Ingelheim for the year
ternally, to develop them within the company and to
was 42,224, representing a year-on-year increase of
bind them to Boehringer Ingelheim in the long term.
almost 2 %.
We believe that we are in a strong competitive position
Average capacity of employees by region
2010
2009
with our remuneration system. In addition to the basic
Americas
13,491
13,519
salary that is usual for the market, we have established
Europe
21,016
21,314
variable salary components which are dependent on
7,717
6,701
42,224
41,534
Asia, Australasia, Africa (AAA)
the success of the company and the employee’s achievement of individual targets. Manager and employee
meet at the beginning of the year to agree on the em-
Supporting young people and giving them the best
ployee’s individual targets for the year. Achievement of
possible start in their professional life has traditionally
these targets during the course of the year then has a
been one of our particular concerns at Boehringer In-
direct effect on the employee’s variable salary compo-
gelheim. Last year, we maintained a consistently high
nent. Apart from these purely pecuniary incentives,
number of young employees in our locations through-
comprehensive employee benefits such as our company
out Germany, spread over 30 different occupations re-
pension scheme and voluntary preventive health checks
quiring training (685 apprentices in 2010). Boehringer
also make our overall remuneration system more at-
Ingelheim sees the training of young people as an in-
tractive.
vestment in the future. We always do our utmost to help
people with disabilities to integrate into professional
For the last few years, Boehringer Ingelheim has addi-
life. It is important to us that our young employees re-
tionally offered for top executives a remuneration
ceive integrated training. This means that the promo-
component, which is tied to the long-term success of
tion of social skills and the development of personality
the company. This salary component is clearly linked
are important components in training, in addition to
to the achievement of long-term company targets and
the acquisition of technical skills and knowledge.
as such is distinct from more short-term targets.
Talent management is a particularly important element
Boehringer Ingelheim builds on the involvement, in-
of our corporate strategy. Ensuring the employability
novation and energy of its employees. We believe that a
of our people and exploiting opportunities for their
good balance between work and private life is an im-
professional development feature among Boehringer
portant key to our company’s success as well as satis-
Ingelheim’s core objectives. Our talent management
faction in the workplace. To this end, we support our
approach, now firmly anchored in our company’s or-
employees so that they can find the perfect balance be-
ganisation, is all about ensuring that the company has
tween their careers and private lives. Key initiatives here
the right people in the right position at the right time.
include our “BI-Fit” health programme, healthcare
Under our talent management concept, the perform-
services, comprehensive counselling services, and sup-
ance and conduct of each individual employee is eval-
port for families such as child-minding, part-time work
uated and differentiated in terms of both remuneration
models and flexitime. These measures are country-de-
and professional development opportunities. Develop-
pendent and tailored to the local requirements
ing our employees in this differentiated way gives
of individual countries. As a family company itself,
Boehringer Ingelheim a strategic competitive edge in a
Boehringer Ingelheim has always had a sustainable
Business and operating environment
29
group management report
family-friendly policy close to its heart. We will re-
tries. To make it easier for people to access medication,
main loyal to this philosophy in the future and contin-
Boehringer Ingelheim has chosen not to enforce its pat-
ue to promote a family-friendly management culture.
ent in developing countries. The only condition is that
generic manufacturers meet WHO production stand-
In its 125th year, Boehringer Ingelheim is still blazing
ards, so that patients are guaranteed a high-quality
a successful trail in the research, development and
product. In this way, Boehringer Ingelheim is crystal-
marketing of innovative drugs for humans and ani-
lising its long-term commitment to combating the
mals. The world’s largest family-owned pharmaceuti-
AIDS epidemic.
cal company, Boehringer Ingelheim has remained true
to the values of its founder, Albert Boehringer, and to
In addition to the above, Boehringer Ingelheim’s com-
the corporate mission statement – “Value through In-
mitment to society encompasses numerous initiatives
novation”. In September of last year, the occasion of
through which the company supports the provision of
the 125th anniversary was marked in the three Ger-
medical supplies in many countries and regions, wheth-
man locations, Ingelheim, Biberach and Dortmund,
er through donations of medication or other types of
with family celebrations for both current and former
donations. In Italy, for example, a cooperation agree-
employees and their relatives.
ment has been in place for many years between our
local organisation and Banco Farmaceutico. As part
Corporate citizenship
of the agreement, people in need are provided with
The ethical principles to which Boehringer Ingelheim
medication free of charge, particularly during the win-
has been committed for 125 years have helped to create
ter months. As another example, Boehringer Ingelheim
a culture of corporate and social responsibility. For
has collaborated with Direct Relief International (DRI)
Boehringer Ingelheim, commitment to society has many
to stock clinics set up to treat victims of the severe
facets and is firmly anchored in our corporate philoso-
storms that batter the Gulf Coast of the USA.
phy. This commitment is at the heart of a long tradition at Boehringer Ingelheim, and we will continue to
As an integral part of our corporate culture, Boehringer
place particular value on the realisation of this pledge
Ingelheim actively promotes voluntary work among
in the future. We have been taking our responsibility to
our employees. During the past year in the USA alone,
society extremely seriously for many years. This in-
our employees have given more than 13,000 hours of
cludes involvement in a wide range of projects world-
their free time to help those in need.
wide aimed at those most in need of help in many different countries and regions.
Every year, the Federal Minister of the Interior confers
the “Helping Hand” award for ideas and concepts that
Boehringer Ingelheim has set itself the goal of improv-
encourage people to take up voluntary work in the area
ing access to medication in the less developed coun-
of civil defence. Last year, Boehringer Ingelheim was
tries in the world. In 2010, our viramune® Donation
awarded second place in the “Exemplary Employer
Programme remained a key focus of our social com-
Conduct” category, not least because our plant fire bri-
mitments. By making viramune® available free of
gade makes an important contribution to civil defence.
charge in a large number of developing countries,
Boehringer Ingelheim is working to prevent the trans-
As a good corporate citizen, Boehringer Ingelheim
mission of the HI virus from mother to child during
has been an active supporter of research, science and
birth. More than two million mother-child pairs have
culture for many years. Last year, for example, the
been treated with viramune® since the year 2000, in
Boehringer Ingelheim Foundation launched a remark-
171 individual support programmes spanning 71 coun-
able initiative with the aim of strengthening cutting-
30
Boehringer Ingelheim annual report 2010
edge research at Johannes Gutenberg University in
the associated favourable exchange rate effects had a
Mainz. Over a period of ten years, the Boehringer In-
positive effect here (+4.9 % and approximately +EUR
gelheim Foundation will invest a total of EUR 100 mil-
668 million impact on sales). The significant decline in
lion in the establishment and operations of the Insti-
sales due to the loss of exclusivity for key sales drivers
tute for Molecular Biology (IMB) at the University of
on the US pharmaceuticals market (around EUR 1.4
Mainz. The new institute will be committed to out-
billion after adjustment for currency effects) was al-
standing research, meeting international standards of
most compensated for by corresponding growth of the
excellence for researchers and equipment and further
rest of the portfolio.
strengthening the existing areas of research in Mainz.
Currently under construction, the institute is to begin
Boehringer Ingelheim’s business is divided into the
scientific operations at the beginning of 2011.
two fields of Human Pharmaceuticals and Animal
Health. The Human Pharmaceuticals business is in
turn subdivided into Prescription Medicines, Consumer
Results from operations,
financial position and net
assets
Health Care and Industrial Customers, and generated
Results from operations
Prescription Medicines
The achievement of sustainable long-term success of
Prescription Medicines are at the centre of our business
the company, accompanied by stable profits and solid
activities and form the core of our Human Pharmaceu-
financing is the foundation for securing the independ-
ticals business, accounting for 83 % of the total sales in
ence of the group of companies and is at the centre of
this business field. With net sales of EUR 9,702 mil-
Boehringer Ingelheim’s strategic orientation. As in pre-
lion, sales were down 3.5 % on the previous year (8.5 %
vious years, we based our actions on these principles
after adjustment for exchange rate effects).
total sales of EUR 11,665 in the last financial year.
This represents a year-on-year decrease of approximately 3.7 % and accounts for just under 93 % of group
sales.
in the last financial year. As expected, due to loss of
sales as a result of patent expiries, 2010 was a year of
The loss of exclusivity for flomax® and mirapex® in
transition for the group that marked the end of a ten-
the USA and the termination of the contract for Du-
year period of long-term growth. However, it was also
loxetine (cymbalta®/xeristar®) had a negative impact
a year in which the foundation for the subsequent sus-
on sales in business with prescription medicines. How-
tained growth phase was successfully laid. In particu-
ever, after adjustment for these non-recurring effects,
lar, the positive results from research and development
business performance was positive. The growth rates
give us cause to be optimistic about the future.
of our established products spiriva®, micardis® and
combivent® are particularly worthy of mention. Posi-
With a market share of 1,9 %, Boehringer Ingelheim is
tive effects also resulted from the new product launch-
ranked 15 among the world’s biggest pharmaceutical
es of pradaxa® and twynsta®.
companies according to the provisional figures of the
Net sales (in millions of EUR)
2010
2009
Change
spiriva®
2,863
2,404
19.1%
At EUR 12,586 million, consolidated sales for 2010
micardis®
1,555
1,393
11.6%
were close to the level of the previous year. The devel-
combivent®
727
654
11.2%
opment of foreign exchange rates on the markets and
sifrol®/mirapex®
668
801
— 16.6%
market researchers.
Business and operating environment
31
group management report
As in previous years, our highest-selling and most important product was spiriva®, which is used to treat
Net sales by region
(in millions of EUR)
2010
2009
Change
chronic obstructive pulmonary disease (COPD). In the
Americas
4,587
5,235
— 12.4%
reporting period, it generated sales of EUR 2,863 million,
Europe
2,801
2,700
+ 3.7%
which equates to growth of 19.1 % compared to 2009.
Asia, Australasia, Africa (AAA)
2,097
1,821
+ 15.2%
In the largest sales market, the USA, sales increased
from EUR 1,089 million to EUR 1,331 million.
Consumer Health Care
Consumer Health Care is our business with non-pre-
Our second-biggest product is micardis®, a drug for
scription drugs. Despite a declining market in Japan
the treatment of high blood pressure. With sales in-
and a weak cold and flu season at the start of the year,
creasing by 11.6 %, taking total sales to EUR 1,555 mil-
we posted sales of EUR 1,318 million in the last finan-
lion, there was also a very positive trend here.
cial year. After sales of EUR 1,261 million in the previous year, this equates to an increase of 4.5 %.
In regional terms, business development for Prescription Medicines was very mixed. Growth in the Europe
Our highest-selling non-prescription products are dul-
and Asia, Australasia and Africa regions contrasted
colax®, mucosolvan®, buscopan® and pharmaton®.
with a decline in sales in the Americas region, caused
Compared with the previous year, all of them grew and
by the patent expiries of flomax® and mirapex® re-
each generated sales of more than EUR 100 million.
stricted to the USA.
While dulcolax® was again the highest-selling drug
at EUR 159 million, buscopan® posted the strongest
At EUR 2,801 million, total sales for Prescription Med-
growth rate of the aforementioned products at 20.7 %.
icines in the Europe region were up 3.7 % on 2009. The
This performance for our Consumer Health Care busi-
AAA region achieved a sales increase of 15.2 % to EUR
ness is extremely pleasing in the context of a difficult
2,097 million. In the important Japanese market, we
business environment.
attained growth of just under 12 % (sales of EUR 1,318
million in 2010) and strengthened our business in Chi-
Net sales (in millions of EUR)
na by 51 % with sales of EUR 145 million.
dulcolax®
2010
2009
Change
159
146
8.9%
mucosolvan®
148
133
11.3%
Countries in the Americas region generated total sales
buscopan®
134
111
20.7%
of EUR 4,587 million in 2010, a decrease of 12.4 %
pharmaton®
130
121
7.4%
compared with the previous year. However, this decrease
was limited to the country with the highest sales, the
Sales of EUR 502 million were achieved in the Europe
USA (-17.4 %), while the other countries in the region
region, which is our most important region in the Con-
achieved a double-digit growth rate of just under 20 %.
sumer Health Care segment. This equates to an increase
of just under 6 % compared with 2009. Sales in our
most important market, Germany, were at roughly the
same level as the previous year at EUR 131 million.
Components of growth in net sales (as %)
2010
2009
Price/quantity/new introductions
— 6.2
6.6
9.7
7.9
12.1
Acquisitions and sale of business
0.2
0.1
— 0.2
0.9
— 0.3
Currency effect
4.9
3.0
— 3.6
— 5.2
— 0.9
32
Boehringer Ingelheim annual report 2010
2008
2007
2006
The AAA region attained sales of EUR 441 million
achieved EUR 67 million in sales and growth of just
(+1.3 %) in the reporting period. In particular, sales
under 12 % compared to last year.
figures were negatively impacted by the development
on the Japanese market (- 6 %), which accounted for
Net sales (in millions of EUR)
2010
2009
Change
67 % of sales. The highest growth was posted in the
ingelvac circoflex®
239
157
52.2%
Americas region, at just over 7 %. Total sales were EUR
metacam®*
95
85
11.8%
374 million here.
ingelvac® prrs
44
34
29.4%
ingelvac® m. hyo
43
30
43.3%
Industrial Customer
The Industrial Customer business comprises the third-
The ground-breaking ceremony for the new European an-
party business areas of Biopharmaceuticals and Phar-
imal research centre in Hanover marked a major step in
maceutical Production and our commission business
the long-term expansion of our Animal Health business.
for Pharma Chemicals. Following the clearly perceptible effects of the economic crisis in the previous year,
Overall, we strengthened and extended our position as
the Industrial Customer business declined further in
one of the top companies in the animal health sector
the reporting period. Net sales fell to EUR 638 million
last year. With a market share of 5,9 %, Boehringer In-
(-18.7 % compared with 2009). This was primarily due
gelheim is ranked 6 among companies in this market
to the lower sales for biopharmaceuticals, which make
segment, according to the provisional figures of the
up around two-thirds of Industrial Customer sales.
market researchers
However, sales were also down 7.3 % in Pharma Chemicals and Pharmaceutical Production owing to a diffi-
This is also borne out by an assessment of the sales de-
cult market environment.
velopment in the regions and individual countries.
Impressive growth of 76 % was achieved in our region
Animal Health
with the strongest sales, the Americas, mainly driven by
The Animal Health business of Boehringer Ingelheim
the USA and Canada. A high double-digit growth rate of
again recorded extraordinary success. Net sales broke
just under 57 % in the AAA region and equally pleasing
the USD 1 billion barrier for the first time in 2010.
22 % growth in Europe underline the innovative strength
Sales growth amounted to 51 %, and was, amongst
and future potential of the Animal Health business.
other factors, attributable to the additional sales from
the parts of the Fort Dodge Animal Health business
Expenditure and income
acquired in 2009. The integration of this business is
In the 2010 financial year, Boehringer Ingelheim’s
going well and is laying the foundation for further
operating expenses rose to EUR 12,184 million, a
growth. However, organic growth was also a signifi-
change of + 6.7 % year-on-year. At EUR 1,803 million,
cant factor in the positive development of the Animal
material expenses were 5.8 % below the previous year
Health business. In particular, porcine vaccines en-
(EUR 1,913 million). Consequently, the ratio of ma-
sured sound progress in the strategic core segments. In
terial costs to total sales was 14.3 %. Personnel costs
this fiercely contested market, our highest-selling
amounted to EUR 3,358 million (+ 4.3 %). The person-
product ingelvac circoflex® generated sales of EUR
nel expenses ratio was thus 26.7 % (2009: 25.3 %).
239 million, an increase of more than 50 % compared
with 2009. As well as the success with livestock, our
Depreciation increased by 7.8 % year-on-year to EUR
two highest-selling products in the pet segment also
598 million. An increase of EUR 692 million (+12 %) to
performed pleasingly. metacam small animals®
EUR 6,425 million was posted for other operating expenses. Among other things, this cost block includes
Results from operations, financial position and net assets
33
group management report
commission and licence payments, which are depend-
of capital. Our financial activities are therefore geared
ent on sales. As expected, at EUR 1,896 million, oper-
towards supporting the business strategy.
ating income was down on the previous year (EUR
2,239 million) as was the return on net sales of 15.1 %
As we are a company that operates internationally, the
(2009: 17.6 %).
developments on the foreign exchange markets have a
considerable influence on the measurement of our suc-
The extraordinary income item section (EUR – 594
cess. The US dollar in particular represents the greatest
million) solely comprises the effects of converting the
individual risk owing to the importance of our US
consolidated financial statements according the German
business and the associated supply relationships. Cur-
Accounting Law Modernisation Act (BilMoG).
rency risks arising from the global orientation of our
business activities are therefore calculated within the
In the reporting period, the financial result totalled
framework of our group-wide financial reporting and
EUR – 154 million, down EUR 55 million on the previ-
hedged using derivative financial instruments. The
ous year. This was largely due to the rise in the interest
type and scope of measures are regularly discussed and
portion of additions to provisions for pensions and
decided upon by the relevant committee in a standard-
similar obligations and, on the other hand, reduced in-
ised process.
terest gains due to the low interest level.
Investments are of great strategic importance to
Income before taxes developed in line with the result
Boehringer Ingelheim and secure the long-term suc-
from operating activities. It fell to EUR 1,114 million
cess and development of our business activities. Con-
(– 48.2 % compared with 2009).
tinuous investment forms the basis for future profitable growth. In total, EUR 576 million was invested in
Tax expenses amounted to EUR 226 million. Here, it
tangible and intangible assets in the year under review.
must be taken into consideration that personal taxes
Whereas our new oral thrombin inhibitor pradaxa®
on group activities levied on the shareholders are not
was the focal point of our activities regarding the ex-
to be shown as tax expenses according to the account-
pansion and preservation of our modern production
ing rules. These are presented as part of withdrawals
network in 2009, production operations for the manu-
from accumulated group equity. Taking this extraordi-
facture of active ingredient pellets in Ingelheim were
nary effect into consideration, the actual tax ratio is
significantly expanded again last year. Boehringer In-
markedly higher than the figure shown in the profit
gelheim’s microParts site in Dortmund also saw expan-
and loss statement.
sion investment, which has already been completed,
resulting in a doubling of production capacity for our
Negatively impacted by the aforementioned develop-
respimat® inhalation devices. Both projects are geared
ment of operating and extraordinary income, net in-
towards ensuring coverage of future global demand. In
come for the 2010 financial year fell by 49.5 % to EUR
the field of veterinary medicine, the foundation stone
888 million compared with the previous year’s figure
of our European research centre for animal vaccines,
of EUR 1,759 million.
the Boehringer Ingelheim Veterinary Research Centre,
was laid in 2010. In addition to our German sites, ex-
Financial position
pansion of our business in China was a second focal
Boehringer Ingelheim’s financial management is
point of investment activities. For instance, the Centre
focused on safeguarding liquidity, minimising or limit-
of Competence specialising in quality control was built
ing financial and economic risks and an appropriate
last year in Shanghai.
capital structure that ensures optimisation of the cost
34
Boehringer Ingelheim annual report 2010
Cash flow stood at EUR 2,234 million in 2010. This
Group equity increased by 6.5 % to EUR 6,474 million,
constitutes a decrease of 7.2 % compared with the pre-
which is chiefly attributable to the withheld net in-
vious year. Due to the lower income for the period un-
come for the year. Consolidated long-term disposable
der review compared to 2009, cash flow from operating
capital (equity, pension provisions and long-term lia-
activities fell by EUR 335 million to EUR 2,056 mil-
bilities) increased by EUR 1,017 to EUR 10,408 million
lion. Despite this decrease, as in previous years, invest-
in 2010, accounting for 64.1 % of total assets. Conse-
ments were financed entirely through funds generated
quently, this item covers all intangible and tangible as-
by the company itself. A total of EUR 519 million was
sets, inventories and trade accounts receivable.
invested in tangible assets and EUR 57 million in intangible assets. Cash flow from financing activities was
Other provisions totalled EUR 2,845 million and were
reflecting an outflow of funds totalled EUR 806 mil-
thus on the same level as in 2009, as were liabilities
lion, mainly as a result of payments to the shareholders
(EUR 3,127 million).
of the Boehringer Ingelheim group.
The balance sheet and the respective balance sheet raOverall, this development of cash flow led to an increase
tios round off the positive picture already shown in the
in the group’s financial assets of EUR 806 million to
financial position and results of operations. The com-
EUR 6,113 million (+13.5 %) in the year under review.
bined evaluation of the net assets, financial position
and results of operations shows that Boehringer Ingel-
In summary, it can be emphasised that with the exist-
heim is a soundly financed and profitable company. In
ing liquidity, the solid financial structure and the high
2010, we created a solid basis for our further business
cash flow from operating activities, all the prerequi-
development.
sites for the continuation of our business activities and
the successful implementation of our strategy remain
fulfilled.
Net assets
Total assets amounted to EUR 16,233 million in the
Report on post balance sheet
date events
last financial year. They thus increased by EUR 1,229
million (+ 8.2 %) year-on-year. Tangible and intangible
On 11 January 2011, Boehringer Ingelheim and Eli
assets totalled EUR 4,050 million and were fully cov-
Lilly & Company announced a global agreement on the
ered by the group equity.
joint development and marketing of diabetes active ingredients that are currently in the middle and late
At the end of the financial year, financial assets
stages of clinical development. The agreement covers
reached a figure of EUR 3,168 million and were thus
Boehringer Ingelheim’s two oral antidiabetic ingredi-
EUR 1,469 higher than in 2009.
ents, linagliptin and BI 10773, Lilly’s two basal insulin analogues, LY 2605541 and LY 2963016, and the
With stocks of EUR 1,850 million, the balance sheet
option for joint development and marketing of Lilly’s
inventories item was almost on the previous year’s level.
monoclonal TGF-beta antibody.
For trade accounts receivable, an increase of EUR 130
million to EUR 2,156 million was posted in 2010.
This alliance enables the scientific expertise and joint
corporate resources of two leading pharmaceutical
Liquid funds, including non-fixed securities, totalled
research companies to be used in a targeted manner in
EUR 3,118 million.
Results from operations, financial position and net assets / Report on post balance sheet date events
35
group management report
order to address patients’ needs arising from the increasing incidence of type-2 diabetes.
Risk report
Under the terms of the contract, Lilly is to make an
Boehringer Ingelheim uses an established risk manage-
initial one-off payment of EUR 300 million to
ment system that has proved itself over the last few
Boehringer Ingelheim. Boehringer Ingelheim is also
years and was not modified in the 2010 financial year.
entitled to payments totalling EUR 625 million if specific approval-related milestones for Linagliptin and
The aim of risk management is to identify business-
BI 10773 are reached. Lilly is entitled to payments to-
specific risks and, in particular, risks that jeopardise
talling EUR 650 million if specific approval-related
the continued existence of the company as early as
milestones for its two basal insulin analogues are
possible, to assess them and to reduce them to a rea-
reached. Should Boehringer Ingelheim decide to par-
sonable level by means of suitable measures. When
ticipate in the phase-III development and potential
assessing the risks, in the context of holistic risk man-
marketing of the monoclonal TGF-beta antibody, Lilly
agement, we also endeavour to take into account the
would be entitled to options and bonus payments of up
resulting opportunities and incorporate them in the
to USD 525 million if specific approval-related mile-
analysis, as particularly in our innovation driven busi-
stones are reached. Each company will bear half of the
ness environment risks and opportunities are often ly-
ongoing development costs. After the products result-
ing close together..
ing from this alliance have been successfully approved
by the authorities, the companies will also share the
Those responsible for the key business areas and func-
product marketing costs and gross profits equally.
tions are included in the process of calculating and
assessing risks. With the group-wide risk and informa-
On 18 January 2011, Boehringer Ingelheim and Amgen
tion system, we ensure that all identified risks are ana-
Inc. signed an agreement on the purchase of Amgen’s
lysed and assessed carefully. Following appropriate
biopharmaceutical development and production site in
classification, adequate countermeasures are com-
Fremont, USA by Boehringer Ingelheim. The site,
menced and their implementation is consistently mon-
which currently has a workforce of 360, consists of a
itored.
modern production facility with a surface area of
around 9,000 square metres as well as development
In the year under review, Internal Auditing performed
facilities and laboratories for process development.
targeted routine audits as well as extraordinary audits
Our global contract manufacturing business in bio-
worldwide. In addition to adherence to legal require-
pharmaceuticals will be further strengthened and ex-
ments and group-internal guidelines, the main focal
panded as a result of the transaction, which is sched-
points here were the functionality of systems, the ef-
uled for completion in March 2011.
fectiveness of internal controls for the prevention of loss
of assets, and the efficiency of structures and process-
Since the end of the 2010 financial year, we have not
es. An audit plan approved by the Board of Managing
become aware of any other events that are of material
Directors was consistently followed.
significance to the group of companies or that could
lead to a reappraisal of its asset, financial or earnings
Currency risks resulting from the global orientation of
position.
our business activities are monitored at regular intervals and limited by means of corresponding hedging
strategies with appropriate financial instruments such
as forward exchange contracts. From the portfolio of
36
Boehringer Ingelheim annual report 2010
trade accounts receivable and trade accounts payable,
the loss of exclusivity of products established on the
we did not identify any extraordinary risks beyond the
market and risks associated with the development and
usual level in the sector for the group. The same ap-
registration of new products, these risks increasingly
plies to possible default risks for receivables, which are
include changing and restrictive requirements relating
largely hedged against economic risks.
to pricing and reimbursement on many sales markets.
Frequently, the prices of pharmaceutical products are
In the management of our financial assets, we pursue a
not only subject to state monitoring and regulation,
conservative investment strategy that is reflected by the
but also to price pressure from cheaper generic drugs
defensive orientation of the portfolio. Our investments
caused by the state reimbursement systems.
are focused on EMU government bonds with top credit
ratings and short-term investments at selected banks.
There are currently no indications of any risks going
A large proportion of the cash and cash equivalents has
beyond this which could jeopardise the continued ex-
a short-term investment horizon.
istence of the Boehringer Ingelheim group.
Boehringer Ingelheim is exposed to risks arising from
legal disputes and proceedings as well as official investigations. As the legal or administrative decisions in
ongoing or future proceedings cannot be predicted, we
Report on expected
developments
have made appropriate provisions for resultant risks.
After 10 years of growth outstripping that of the
Protection of innovations through trademark and pat-
worldwide pharmaceutical market, the 2010 financial
ent rights is of particular importance to Boehringer
year was a year of transition for Boehringer Ingelheim.
Ingelheim as a research company. These rights are in-
The expiry of the exclusivity protection for our block-
creasingly the target of attacks and breaches. We have
buster products flomax® and mirapex® in the USA,
taken the necessary precautions so that we can detect
which we have known about for a long time and have
threats at an early stage and, by commencing appropri-
made allowances for, as well as the high level of in-
ate countermeasures, defend our legal position using
vestment in R&D and marketing associated with the
all legal means available to us, if applicable.
planned new product launches had a tangible negative
impact on our growth and operating income in this fi-
Risks in the area of environmental health and safety
nancial year. We regard attainment of the sales level of
are minimised preventively by adherence to our own
the previous year as a good starting point for the tran-
very high safety standards. Appropriate emergency
sition to a new growth phase in the coming years.
plans have been drawn up for possible incidents of any
kind and are practised and subjected to comprehensive
In addition to our stable product range, led by our
quality testing at regular intervals. To provide protec-
blockbusters spiriva® and micardis®, pradaxa® has
tion against the financial impact of potential damage
significant sales potential. We received approval for
or loss events and liability risks, Boehringer Ingelheim
the launch of pradaxa® in the indication stroke pre-
has appropriate insurance coverage for the company’s
vention in arterial fibrillation (SPAF) in the USA and
risk profile. Its scope and amount are monitored on an
Canada in the last quarter of 2010. In other key mar-
ongoing basis.
kets, we expect approval in the first few months of
2011. In addition, our development products in the
Boehringer Ingelheim is also exposed to business risks
treatment areas of diabetes and oncology have also
specific to the pharmaceutical industry. In addition to
shown excellent results in trials so far. Consequently,
Risk report / Report on expected developments
37
group management report
we also expect them to deliver significant sales poten-
in healthcare systems, which are increasingly less
tial, as well as significant progress in treatment.
willing to reward the high investment expenditure
appropriately.
We worked in our realigned organisational structure
for the first time in 2010. In addition to closer linking
We are confident that we can successfully overcome
of the strategic units with the operating national sub-
these challenges and achieve our ambitious goals with
sidiaries as well as increased productivity and flexibil-
a high level of innovation on the basis of a well-filled
ity with a greater focus on the emerging markets, we
pipeline. For Boehringer Ingelheim, it remains a stated
intend to strengthen our position, particularly in the
aim to continue to develop the company competitively
emerging markets of China, India and Russia, thus
and successfully as an independent family-owned en-
creating a sound starting point for further growth.
terprise. For us, long-term and sustainable organic
growth still takes precedence over short-term profit
After laying the foundations for a further growth period
targets. As in the past, Boehringer Ingelheim will strive
in the year of our 125th anniversary, we expect sales to
to offer its employees a state-of-the-art and attractive
significantly exceed those of the year under review in
working environment in future. With our well-trained
2011. We are confident that, assisted by the launch of
employees, who are a key factor in the success of our
our new products, we can significantly increase our
company, we will stand by our mission statement of
growth in the next few years and achieve growth in the
“Value through Innovation” and research and develop
mid single-digit range in 2011. This trend will be in-
innovations offering medical benefits, bringing them
tensified through further product launches, leading us
to market readiness to provide patients with the best
to expect even stronger growth for 2012. In particular
therapies possible.
through our collaboration with Eli Lilly, in which we
intend to jointly develop and market four promising
substances in the diabetes treatment area, we will be
able to strengthen and expand our position in the global pharmaceuticals market on a long-term basis. As a
result of our well-filled product pipeline and with
promising results for our development products in trials as well as significant sales potential, we believe that
our high level of R&D investment is justified and that
we are well-positioned for the future.
We will also maintain our strategic orientation of driving growth and product supply mainly through our
own research and development in future. This was reflected by a further increase in R&D budgets in 2010.
Boehringer Ingelheim will face the challenges inherent
in the pharmaceutical research industry over the next
few years. In addition to patent expiries and patent
challenges, rising investment in R&D, tougher hurdles
and higher expenditure for product approvals, another
major factor here is the intensifying cost pressure
38
Boehringer Ingelheim annual report 2010
2010
Consolidated Financial Statements
Overview of the major consolidated companies
40
Consolidated balance sheet
42
Consolidated profit and loss statement
43
Cash flow statement
44
Statement of changes in group equity
45
Notes to the consolidated financial statements 2010
46
Auditor’s report
64
Consolidated Financial Statements 2010
39
consolidated financial statements
Overview of the major consolidated companies
C. H. Boehringer Sohn AG & Co. KG*
Boehringer Ingelheim GmbH
germany
D P
Boehringer Ingelheim
Pharma GmbH & Co. KG,
Ingelheim
Boehringer Ingelheim
Vetmedica GmbH, Ingelheim
Boehringer Ingelheim
microParts GmbH, Dortmund
R
Boehringer Ingelheim
Boehringer Ingelheim
Europe GmbH
International GmbH
austria
D P
R
Boehringer Ingelheim RCV
GmbH & Co. KG, Vienna
belgium
D
Boehringer Ingelheim s.r.o.,
Prague
finland
D
D
Boehringer Ingelheim
Norway KS, Asker
poland
Boehringer Ingelheim Sp.zo.o.,
Warsaw
D P
Boehringer Ingelheim
International Trading (Shanghai)
Co. Ltd., Shanghai
Boehringer Ingelheim Shanghai
Pharmaceuticals Co. Ltd.,
Shanghai
philippines
D
D
SCS Boehringer Ingelheim
Comm. V., Brussels
china
Boehringer Ingelheim
Finland Ky, Espoo
norway
R
Forschungsinstitut für Molekulare
Pathologie Gesellschaft mbH,
Vienna
Boehringer Ingelheim
Pharma Ges.m.b.H., Vienna
czech republic
austria
D
Boehringer Ingelheim
(Phil.), Inc., Manila
south korea
D
Boehringer Ingelheim
Korea Ltd., Seoul
Boehringer Ingelheim Vetmedica
Korea Ltd., Seoul
D Distribution
P Production
R Research and Development
* sole general partner:
Boehringer AG
40
Boehringer Ingelheim annual report 2010
C. H. Boehringer Sohn Grundstücksverwaltung GmbH & Co. KG
Boehringer Ingelheim
Auslandsbeteiligungs GmbH
argentina
D R
Boehringer Ingelheim S.A.,
Buenos Aires
D
Boehringer Ingelheim Pty. Ltd.,
North Ryde
D P
japan
D P
Labso Chimie Fine S.A.R.L.,
Blanquefort
R
D
D P
Boehringer Ingelheim
España S.A., Barcelona
sweden
D P
R
the netherlands
R
Boehringer Ingelheim Corp.,
Ridgefield, Connecticut
Boehringer Ingelheim
Pharmaceuticals, Inc.,
Ridgefield, Connecticut
Boehringer Ingelheim
USA Corporation,
Ridgefield, Connecticut
Boehringer Ingelheim
Vetmedica, Inc.,
St. Joseph, Missouri
Boehringer Ingelheim
Roxane, Inc., Columbus, Ohio
D
Boehringer Ingelheim
(Schweiz) GmbH, Basel
Boehringer Ingelheim
Chemicals, Inc.,
Petersburg, Virginia
venezuela
Pharmaton S.A., Lugano
taiwan
D P
Roxane Laboratories, Inc.,
Columbus, Ohio
D
switzerland
D P
Ben Venue Laboratories, Inc.,
Bedford, Ohio
Boehringer Ingelheim AB,
Stockholm
Boehringer Ingelheim Vetmedica,
S.A. de C.V., Guadalajara
D
D
Boehringer Ingelheim C.A.,
Caracas
Boehringer Ingelheim
Taiwan Ltd., Taipei
thailand
D
D
Boehringer Ingelheim
(Thai) Ltd., Bangkok
Boehringer Ingelheim B.V.,
Alkmaar
Boehringer Ingelheim
(N.Z.) Ltd., Auckland
D P
Laboratorios Fher S.A., Barcelona
Boehringer Ingelheim
Seiyaku Co. Ltd., Yamagata
new zealand
Boehringer Ingelheim (Pty.) Ltd.,
Randburg
Europharma S.A., Barcelona
Boehringer Ingelheim
Vetmedica Japan Co. Ltd.,
Tokyo
mexico
usa
D
Boehringer Ingelheim S.A.,
Barcelona
Boehringer Ingelheim
Promeco S.A. de C.V.,
Mexico City
Boehringer Ingelheim del Ecuador
Cia. Ltda., Quito
france
D P
Boehringer Ingelheim
Japan, Inc., Tokyo
D P
Unilfarma Lda., Lisbon
spain
united kingdom
Boehringer Ingelheim Ltd.,
Bracknell
Ingelheim Pharmaceuticals (Pty.)
Ltd., Randburg
SSP Co. Ltd., Tokyo
D
Boehringer Ingelheim
Danmark A/S, Copenhagen
Boehringer Ingelheim
France S.A.S., Paris
R
Nippon Boehringer Ingelheim
Co. Ltd., Tokyo
Boehringer Ingelheim S.A.,
Bogotá
ecuador
D P
D R
Boehringer Ingelheim Ltda.,
Santiago de Chile
denmark
italy
D
south africa
Bidachem S.p.A.,
Fornovo S. Giovanni
Boehringer Ingelheim
(Canada) Ltd., Burlington
columbia
D P
Boehringer Ingelheim
Italia S.p.A., Reggello
Solana Agro Pecuaria Ltda.,
Arapongas
chile
indonesia
portugal
Boehringer Ingelheim Lda.,
Lisbon
PT Boehringer Ingelheim
Indonesia, Jakarta
Boehringer Ingelheim do Brasil
Quimica e Farmaceutica Ltda.,
São Paulo
canada
D P
Boehringer Ingelheim Ellas AE,
Athens
australia
brazil
greece
turkey
D
D
Boehringer Ingelheim Ilac
Ticaret A.S., Istanbul
Overview of the major consolidated companies
41
consolidated financial statements
C. H. Boehringer Sohn AG & Co. KG, Ingelheim
Consolidated balance sheet
Notes 1)
31.12.2010
31.12.2009
(3.1)
736
745
Tangible assets
(3.2)
3,314
3,219
Financial assets
(3.3)
3,168
1,699
Assets (in millions of EUR)
Intangible assets
Fixed assets
7,218
5,663
Inventories
(3.4)
1,850
1,801
Accounts receivable and other assets
(3.5)
2,712
2,538
Securities
1,095
899
Cash and cash equivalents
2,023
2,978
Current assets
7,680
8,216
54
65
Deferred charges and prepaid expenses
Deferred taxes
Total assets
Liabilities and equity (in millions of EUR)
Notes 1)
Shareholders’ capital
Group reserves
Balance sheet currency conversion difference
Net income
Equity
Minority interests
Group equity
1,281
1,060
16,233
15,004
31.12.2010
31.12.2009
178
178
5,413
4,208
—5
— 244
888
1,759
6,474
5,901
0
179
6,474
6,080
Provisions
(3.6)
6,411
5,548
Accounts payable
(3.7)
3,127
3,146
9,538
8,694
34
47
Liabilities
Deferred charges
Deferred taxes
Total liabilities and equity
1)
For explanation, see relevant section in the Notes to the consolidated financial statements.
42
Boehringer Ingelheim annual report 2010
187
183
16,233
15,004
C. H. Boehringer Sohn AG & Co. KG, Ingelheim
Consolidated profit and loss statement
Notes 1)
2010
2009
(4.1)
12,586
12,721
Changes in inventories
7
253
Other internal work performed and capitalised
5
5
(in millions of EUR)
Net sales
Other operating income
(4.2)
Total revenues
1,482
682
14,080
13,661
Material costs
(4.3)
— 1,803
— 1,913
Personnel costs
(4.4)
— 3,358
— 3,221
Amortisation of intangible and depreciation of tangible assets
(4.5)
— 598
— 555
Other operating expenses
(4.6)
— 6,425
— 5,733
1,896
2,239
Operating income
Financial income
(4.7)
— 154
— 99
Holding income
(4.8)
— 34
11
Income before taxes
Extraordinary result
Taxes
2)
1,708
2,151
(4.9)
— 594
0
(4.10)
— 226
— 387
888
1,764
0
—5
888
1,759
Income after taxes
Third-party share
Net income
1)
2)
(4.11)
For explanation, see relevant section in the Notes to the consolidated financial statements.
Due to legal requirements the disclosure of the shareholders’ personal taxes arising from consolidated business activities as tax expenses is not
allowed. These taxes are shown as withdrawals from the accrued group capital.
Consolidated balance sheet / Consolidated profit and loss statement
43
consolidated financial statements
C. H. Boehringer Sohn AG & Co. KG, Ingelheim
Cash flow statement
(in millions of EUR)
2010
2009
Income after taxes
888
1,764
Write-downs/write-ups on fixed assets 1)
631
551
Change in provisions for pensions
715
94
2,234
2,409
— 46
539
Cash flow
Change in other provisions
Other non-cash income and expenses
1
29
Loss/gain on disposals of fixed assets
72
—2
Change in inventories
Change in accounts receivable and other assets not related to investing or financing activities
Change in trade accounts payable and other liabilities not related to investing or financing
activities
Cash flow from operating activities
Investments in intangible assets
25
— 246
— 141
— 386
— 89
48
2,056
2,391
— 57
— 313
Investments in property, plant and equipment
— 519
— 630
Investments in non-current financial assets 1)
— 14
— 59
0
2
21
74
Proceeds from disposals of intangible assets
Proceeds from disposals of tangible assets
Proceeds from disposals of non-current financial assets
1)
4
6
Cash flow from investing activities
— 565
— 920
Cash receipts from/cash payment to owners and minority shareholders
— 837
— 229
Cash proceeds from borrowings/repayments of loans
Cash flow from financing activities
Change in liquid funds from cash relevant transactions
Changes in liquid funds due to changes in scope of consolidation
Changes in liquid funds due to exchange rate movements
Financial funds 2) as of 1.1.
2)
Financial funds as of 31.12.
1)
Excl. fixed-asset securities
Liquid funds, securities within fixed and current assets
(+) = source of funds, ( - ) = use of funds
2)
44
Boehringer Ingelheim annual report 2010
31
1,224
— 806
995
685
2,466
0
0
44
— 14
5,384
2,932
6,113
5,384
C. H. Boehringer Sohn AG & Co. KG, Ingelheim
Statement of changes in group equity
Accrued
group
capital
thereof
currency
effects
Equity
Minority
interests
thereof
currency
effects
Group
equity
178
4,525
— 225
4,703
190
—9
4,893
0
0
0
0
0
0
0
(in millions of EUR)
Balance as of 31.12.2008
Contributions
Withdrawals
0
— 542
0
— 542
0
0
— 542
Net income
0
1,759
0
1,759
5
0
1,764
Change of scope of consolidation
0
0
0
0
0
0
0
Other changes
0
— 19
— 19
— 19
— 16
— 11
— 35
178
5,723
— 244
5,901
179
— 20
6,080
0
0
0
0
0
0
0
Balance as of 31.12.2009
Contributions
Withdrawals
0
— 456
0
— 456
0
0
— 456
Net income
0
888
0
888
0
0
888
Change of scope of consolidation
0
0
0
0
0
0
0
0
141
239
141
— 179
20
— 38
178
6,296
—5
6,474
0
0
6,474
Other changes
Balance as of 31.12.2010
1)
The shareholders’ capital consists of the equity of C. H. Boehringer Sohn AG & Co. KG and C. H. Boehringer Sohn Grundstücksverwaltung GmbH & Co. KG. As of
31.12.2010, the capital consists only of the limited partners. The shareholders’ personal taxes arising from consolidated business activities are shown as withdrawals
from the accrued group capital.
Cash flow statement / Statement of changes in group equity
45
consolidated financial statements
C. H. Boehringer Sohn AG & Co. KG, Ingelheim
Notes to the consolidated financial statements 2010
1 Principles and methods
1.1 General principles
The consolidated financial statements of Boehringer Ingelheim for the 2010 financial year were prepared
in accordance with section 264a of the Handelsgesetzbuch (HGB – German Commercial Code) in line
with the requirements of group accounting of sections 290 et seq. HGB.
In accordance with section 297 paragraph 1 HGB, the consolidated financial statements consist of the
consolidated balance sheet, the consolidated profit and loss statement, the notes to the consolidated financial statements, the cash flow statement and the statement of changes in group equity.
The consolidated financial statements were prepared in euro in accordance with section 298 paragraph 1
in conjunction with section 244 HGB.
To improve the clarity of the consolidated financial statements, individual items of the consolidated balance sheet and the consolidated profit and loss statement have been combined. These items are presented
and explained separately in the notes. The additional disclosures required for the individual items can
also be found in the notes.
Where the Bilanzrechtsmodernisierungsgesetz (BilMoG – German Accounting Law Modernisation Act)
that entered into force on 29 May 2009 has resulted in changes to the recognition and measurement of
items of the balance sheet and profit and loss statement, the prior-year amounts have not been restated in
line with the new policies in accordance with section 67 paragraph 8 of the Einführungsgesetz zum
Handelsgesetzbuch (EGHGB – Introductory Act to the HGB). Thus, figures can only be compared with
those for the previous year to a limited extent.
1.2 Information on companies included in consolidation
The parent company of the Boehringer Ingelheim Group is C. H. Boehringer Sohn AG & Co. KG, Ingelheim.
Boehringer AG, Ingelheim is the sole, personally liable, managing shareholder of this company.
Besides C. H. Boehringer Sohn AG & Co. KG there is C. H. Boehringer Sohn Grundstücksverwaltung
GmbH & Co. KG, the general partner which is controlled by C. H. Boehringer Sohn AG & Co. KG.
The Boehringer Ingelheim Group consists of a total of 145 affiliated companies in Germany and abroad.
In addition to C. H. Boehringer Sohn AG & Co. KG and C. H. Boehringer Sohn Grundstücksverwaltung
GmbH & Co. KG, a further 109 companies in which C. H. Boehringer Sohn AG & Co. KG directly or indirectly holds the majority of voting rights have been fully consolidated in the consolidated financial statements.
46
Boehringer Ingelheim annual report 2010
34 companies were not included in consolidation in accordance with 296 paragraph 2 HGB in the reporting year as they are individually and collectively insignificant to the net assets, financial position and results of operations of the Group. The total amount of the sales, equity and net income of the companies
not included in consolidation account for less than 1% of the aggregated group financial statements totals.
These companies were also not classified as associates in accordance with section 311 paragraph 2 HGB
on account of immateriality. There are ongoing restrictions on disposal at two other companies on account of their articles of association. These were not included in consolidation in accordance with section
296 paragraph 1 sentence 1 HGB.
Compared with the previous year, the total number of affiliated companies increased by three:
• one company was liquidated,
• four companies were founded.
The following subsidiaries were exempted from the reporting and disclosure obligations of section 264
paragraph 3 HGB:
• Boehringer Ingelheim GmbH, Ingelheim
• Boehringer Ingelheim Europe GmbH, Ingelheim
• Boehringer Ingelheim Vetmedica GmbH, Ingelheim
• Boehringer Ingelheim Secura Versicherungsvermittlungs GmbH, Ingelheim
• Boehringer Ingelheim Grundstücksgesellschaft mbH, Ingelheim
• Boehringer Ingelheim Finanzierungs GmbH, Ingelheim
• Boehringer Ingelheim R&D Beteiligungs GmbH, Ingelheim
• Boehringer Ingelheim Venture Fund GmbH, Ingelheim
Exempted from the duty to prepare and disclose annual financial statements in accordance with HGB
provisions for corporations under section 264b HGB are:
• C. H. Boehringer Sohn AG & Co. KG, Ingelheim
• C. H. Boehringer Sohn Grundstücksverwaltung GmbH & Co. KG, Ingelheim
• Boehringer Ingelheim Pharma GmbH & Co. KG, Ingelheim
• Boehringer Ingelheim Veterinary Research Center GmbH & Co. KG, Hanover.
1.3 Consolidation methods
For inventories, accounts receivable and payable and income and expense items, business transactions
among the consolidated companies were eliminated as part of debt consolidation in accordance with section 303 HGB, the elimination of intercompany profits in accordance with section 304 HGB and the consolidation of income and expenses in accordance with section 305 HGB.
Within the capital consolidation the revaluation method of section 301 HGB was applied for the firsttime consolidation of subsidiaries. First-time consolidation occurs at the date at which the company becomes a subsidiary.
Notes to the consolidated financial statements 2010
47
consolidated financial statements
The carrying amount of the shares held by the parent company is offset against the corresponding equity
of the subsidiary. The equity is stated at the fair market value amount of the assets, liabilities and deferred
items at the time of consolidation. Any remaining balance after the offsetting is disclosed as goodwill.
This type of consolidation method and the date of first-time consolidation were already applied to subsidiaries or successive share purchases consolidated for the first time before 1 January 2010.
1.4 Currency translation
Assets and liabilities resulting from foreign currency transactions were translated using the middle spot
exchange rate as at the balance sheet date. The realisation principle (section 298 paragraph 1 in conjunction with section 252 paragraph 1 no. 4, 2nd half-sentence HGB) and the historical cost convention (section 298(1) in conjunction with section 253 paragraph 1 sentence 1 HGB) were complied with for remaining terms of more than one year.
In these consolidated financial statements, the financial statements of foreign subsidiaries domiciled in a
state outside the euro zone and denominated in foreign currency have been converted into euro in accordance with section 308a HGB, using the modified closing rate method.
Using the modified closing rate method, the asset, equity and liability items of the annual financial statements prepared in foreign currency were translated into euro using the average annual rate as at the closing date, with the exception of equity, which was translated using the historical rate. The items of the
profit and loss statement were translated into euro using the average rate. The resulting translation difference was reported within consolidated equity after the reserves under “Difference in equity from currency
translation”. The most important currencies for the Group developed were as follows in the reporting year
(basis: EUR 1):
Year-end rate
31.12.2010
US dollar
Average annual rate
31.12.2009
2010
2009
1.34
1.44
1.33
1.39
108.65
133.16
116.46
130.23
Pound sterling
0.86
0.89
0.86
0.89
Canadian dollar
1.33
1.51
1.37
1.59
Japanese yen
48
Boehringer Ingelheim annual report 2010
2 Accounting and evaluation methods
2.1 Fixed assets
Acquired intangible assets and tangible assets are carried at cost less straight-line amortisation and depreciation
respectively in line with technical and economic circumstances. This is based on the following useful lives:
Intangible assets
2 to 15 years
Buildings
20 years
Technical equipment and machinery
10 years
Other equipment, operating and office equipment
3 to 10 years
Only straight-line depreciation and amortisation is used in the consolidated financial statements. Anticipated permanent impairments are shown by unscheduled write-offs. Direct costs of materials and labour
costs, appropriate portions of materials and labour overheads and the depreciation of fixed assets (if caused
by production) were taken into account in determining production costs.
All capitalised, intangible assets have a limited useful life.
Goodwill from the first-time consolidation of shares is usually being amortized over a period of five
years.
A useful life of ten years was applied to the goodwill for Boehringer Ingelheim Korea Ltd., acquired in
2007, as past experience of products, sales markets and the business conditions of Boehringer Ingelheim
Korea Ltd. has shown that this presents a true and fair view.
Under long-term financial assets, shareholder rights, securities and loans have been carried at the lower
of cost and fair market value.
2.2 Current assets
Inventories are carried at the lower of cost and fair value.
Raw materials, consumables and supplies are capitalised at the lower of average acquisition prices or fair
market value on the balance sheet date.
Finished goods inventories and work in progress are measured at cost on the basis of individual calculations, taking into account the directly attributable costs of materials, direct labour costs, special direct
costs, appropriate shares of production and materials overheads and depreciation.
Measurement is at fair market value in all cases, i.e. discounts were recognised on the expected sales prices for costs yet to be incurred.
Goods for resale are valued at the lower of either purchase cost or fair market value.
Notes to the consolidated financial statements 2010
49
consolidated financial statements
All identifiable risks in inventory assets arising from above-average storage periods, diminished marketability and lower replacement costs are taken into account by appropriate valuation adjustments.
Receivables and other assets are recognised at cost less allowances for specific risks and general credit
risk. Low-interest or non-interest bearing receivables with a term of more than one year were discounted.
Securities classified as current assets include other securities and were recognised at the lower of cost or
quoted/market prices on the reporting date. Cash and cash equivalents are recognised at the lower of cost
or fair market value.
Prepaid expenses in accordance with section 250 paragraph 1 HGB include expenses paid in advance for
a certain period after the balance sheet date.
2.3 Group reserves
Group reserves include the retained earnings of the consolidated subsidiaries from prior years and consolidation entries that affect earnings related to prior years.
2.4 Provisions
Tax provisions and other provisions include all uncertain liabilities and expected losses from executory
contracts. They are carried at the amount required to settle the obligation based on reasonable business
judgement in accordance with the prudence principle (i.e. including future cost and price increases). Provisions with a residual term of more than one year are discounted with the seven-year average interest rate
related to the duration of the provision (in accordance with the Rückstellungsabzinsungsverordnung –
German Regulation on the Discounting of Provisions).
In accordance with the respective option under section 67 paragraph 1 sentence 2 EGHGB, provisions
with a remaining term of more than one year that already existed as at 31 December 2009 were not reversed because further additions would be required in subsequent years.
2.5 Liabilities
Liabilities are recognised at settlement amount.
2.6 Deferred taxes
To calculate deferred taxes on temporary or quasi-permanent differences between the accounting carrying
amounts of assets, liabilities, prepaid expenses and deferred income and their tax carrying amounts or on
tax loss carryforwards, the amounts of the resulting tax benefits and expenses at the time of reversal were
measured using tax rates specific to the respective consolidated company (10% – 40%) and not discounted.
Differences due to consolidation measures in accordance with sections 300 to 305 HGB were also measured
using company-specific tax rates at the time of the expected reversal of the difference. Deferred tax assets
on loss carryforwards were taken into account if it is likely that they will be used within the next five years.
Deferred tax assets and liabilities are reported without being netted.
50
Boehringer Ingelheim annual report 2010
3 Notes to the consolidated balance sheet
3.1 Intangible assets
(in millions of EUR)
Concessions/
similar rights
Goodwill
Advance
payments
Total
1,020
— 21
569
21
1,610
—1
—1
— 23
Procurement/manufacturing costs
Balance as of 1.1.2009
Currency conversion difference
Additions due to first consolidation
0
0
0
0
Additions
302
4
7
313
Disposals
— 28
0
0
— 28
20
0
— 14
6
1,293
572
13
1,878
67
0
2
69
0
0
0
0
Additions
42
0
15
57
Disposals
— 78
0
0
— 78
Reclassifications
Balance as of 31.12.2009
Currency conversion difference
Additions due to first consolidation
Reclassifications
Balance as of 31.12.2010
10
0
—3
7
1,334
572
27
1,933
539
532
0
1,071
—2
—1
0
—3
Accumulated depreciation
Balance as of 1.1.2009
Currency conversion difference
Additions due to first consolidation
0
0
0
0
Additions
80
5
0
85
Write-ups
—1
0
0
—1
Disposals
— 19
0
0
— 19
0
0
0
0
597
536
0
1,133
20
0
0
20
Reclassifications
Balance as of 31.12.2009
Currency conversion difference
Additions due to first consolidation
0
0
0
0
95
5
0
100
Write-ups
0
0
0
0
Disposals
— 56
0
0
— 56
Additions
Reclassifications
0
0
0
0
Balance as of 31.12.2010
656
541
0
1,197
Book value as of 31.12.2009
696
36
13
745
Book value as of 31.12.2010
678
31
27
736
Notes to the consolidated financial statements 2010
51
consolidated financial statements
3.2 Tangible assets
Land and
buildings
Technical
facilities
and machines
Other
facilities/
operating
equipment
Advance
payments/
construction
in progress
Total
2,357
2,436
1,773
559
7,125
— 28
—9
—5
—8
— 50
(in millions of EUR)
Procurement/manufacturing costs
Balance as of 1.1.2009
Currency conversion difference
Additions due to first consolidation
0
0
0
0
0
Additions
82
121
139
288
630
Disposals
— 81
— 112
— 102
— 14
— 309
Reclassifications
180
175
62
— 423
—6
2,510
2,611
1,867
402
7,390
163
102
71
20
356
0
0
0
0
0
Balance as of 31.12.2009
Currency conversion difference
Additions due to first consolidation
Additions
31
82
123
283
519
Disposals
— 82
— 109
— 150
—8
— 349
Reclassifications
Balance as of 31.12.2010
33
96
52
— 188
—7
2,655
2,782
1,963
509
7,909
1,226
1,481
1,241
0
3,948
— 14
—1
—5
0
— 20
Accumulated depreciation
Balance as of 1.1.2009
Currency conversion difference
Additions due to first consolidation
0
0
0
0
0
Additions
96
191
183
0
470
Write-ups
—3
0
0
0
—3
Disposals
— 43
— 90
— 91
0
— 224
0
0
0
0
0
1,262
1,581
1,328
0
4,171
89
70
51
0
210
Reclassifications
Balance as of 31.12.2009
Currency conversion difference
Additions due to first consolidation
Additions
0
0
0
0
0
106
202
190
0
498
Write-ups
0
0
0
0
0
Disposals
— 55
— 96
— 133
0
— 284
Reclassifications
0
0
0
0
0
Balance as of 31.12.2010
1,402
1,757
1,436
0
4,595
Book value as of 31.12.2009
1,248
1,030
539
402
3,219
Book value as of 31.12.2010
1,253
1,025
527
509
3,314
52
Boehringer Ingelheim annual report 2010
3.3 Financial assets
(in millions of EUR)
Investments
in affiliated
companies
Loans Investments
to affiliated
in related
companies
companies
Loans
to related
companies
Investment
securities
Other loans
Total
Procurement/manufacturing costs
Balance as of 1.1.2009
Currency conversion difference
Additions due to first consolidation
36
8
67
3
1,663
19
1,796
0
—1
1
0
—3
1
—2
0
0
0
0
0
0
0
Additions
29
0
47
0
109
6
191
Disposals
0
0
0
—3
— 259
—6
— 268
Reclassifications
0
0
— 11
0
11
0
0
Balance as of 31.12.2009
65
7
104
0
1,521
20
1,717
Currency conversion difference
11
0
—1
0
8
0
18
0
0
0
0
0
0
0
Additions due to first consolidation
Additions
7
0
2
0
1,542
5
1,556
Disposals
—4
0
0
0
— 64
—6
— 74
Reclassifications
0
0
0
0
0
0
0
79
7
105
0
3,007
19
3,217
Balance as of 1.1.2009
0
0
12
0
43
2
57
Currency conversion difference
0
0
0
0
0
1
1
Balance as of 31.12.2010
Accumulated amortization
Additions due to first consolidation
0
0
0
0
0
0
0
Additions
0
0
0
0
3
0
3
Write-ups
0
0
—5
0
—4
0
—9
Disposals
0
0
0
0
— 34
0
— 34
Reclassifications
0
0
—6
0
6
0
0
Balance as of 31.12.2009
0
0
1
0
14
3
18
Currency conversion difference
0
0
0
0
1
0
1
Additions due to first consolidation
0
0
0
0
0
0
0
Additions
0
0
33
0
1
0
34
Write-ups
0
0
0
0
0
0
0
Disposals
0
0
0
0
—4
0
—4
Reclassifications
0
0
0
0
0
0
0
Balance as of 31.12.2010
0
0
34
0
12
3
49
Book value as of 31.12.2009
65
7
103
0
1,507
17
1,699
Book value as of 31.12.2010
79
7
71
0
2,995
16
3,168
As in the previous year, the “Other loans” item does not include any loans to shareholders.
Notes to the consolidated financial statements 2010
53
consolidated financial statements
3.4 Inventories
(in millions of EUR)
31.12.2010
31.12.2009
Raw materials and supplies
381
314
Unfinished products
817
784
Finished products and goods for resale
649
698
3
5
1,850
1,801
Residual term
over 1 year
31.12.2009
Residual term
over 1 year
2,156
4
2,026
3
7
0
5
0
Advance payments to suppliers
3.5 Accounts receivable
(in millions of EUR)
Trade accounts receivable
Receivables from affiliated companies
Receivables from related companies
Other assets
31.12.2010
17
0
10
0
532
12
497
21
2,712
16
2,538
24
The “Other assets” item includes receivables from shareholders of EUR 28 million (previous year: EUR 0
million).
3.6 Provisions
(in millions of EUR)
31.12.2010
31.12.2009
Pension provisions
3,007
2,256
559
479
Tax provisions
Other provisions
2,845
2,813
6,411
5,548
Provisions for pensions and similar obligations
The provisions for pensions and similar obligations were determined on the basis of actuarial calculations using the projected unit credit method taking into account future adjustments in salaries and pensions.
In addition to local biometric data (e.g. Prof Heubeck’s 2005 G mortality tables in Germany), pension obligations in the significant countries were calculated on the basis of the following actuarial parameters:
(in % as of 31 December 2010)
Germany
USA
Japan
5.17
5.62
2.08
Salary increase
4.0
5.0
2.8
Pension increase
2.0
3.0
0.0
Discount rate
54
Boehringer Ingelheim annual report 2010
Provisions for pensions and similar obligations were discounted, using the average interest rate related to
a residual term of 15 years in accordance with the German Regulation on the Discounting of Provisions
of 18 November 2009. The interest rates used to discount significant, foreign pension obligations (US, Japan) were determined in line with the German Regulation on the Discounting of Provisions of 18 November 2009.
The one-time transition amount as of 1 January 2010 was calculated on the basis of the method mentioned above. The following interest rates were used for discounting:
USA:
5.67 %
Japan:
2.12 %
Germany:
5.25 %
In total EUR 574 million were additionally recognised as a result of the remeasurement of pension obligations with regard to first-time adoption of BilMoG as of 1 January 2010. In accordance with section
67paragraph 7 EGHGB, this amount was completely recognised in the income statement in the financial
year under the position “extraordinary result”.
The plan assets intended solely to cover pension obligations that are unavailable to all other creditors (i.e.
assets within the meaning of section 246 paragraph 2 sentence 2 HGB) were measured at fair market value,
which is essentially derived from stock market prices and offset against pension obligations.
The assets intended solely to cover the unit-linked pension obligation from the credit balance that are unavailable to all other creditors (cover assets within the meaning of section 246 paragraph 2 sentence 2
HGB) were measured at fair market value and offset against the associated obligations. The costs of assets
as of 31 December 2010 were EUR 7 million. The fair market value (market value on the balance sheet
date) was EUR 8 million. The assets are offset by the settlement amount of the corresponding liabilities in
the same amount. The current income from cover assets and the total write-up to market value of EUR 1
million is equal to the expenses from the increase in obligations.
Other provisions
In line with the principle of individual measurement, the amount of provisions was reduced as a result of
the remeasurement. Nevertheless the prior year amount was retained in accordance with section 67 paragraph 1 sentence 2 EGHGB, as the amount of overstatement would have to be added again by 31 December 2024 at the latest. The overstatement amounts to EUR 11 million.
Notes to the consolidated financial statements 2010
55
consolidated financial statements
3.7 Accounts payable
(in millions of EUR)
Residual term
less than
1 year
1-5
years
over
5 years
31.12.
2010
31.12.
2009
Residual term
less than
1 year
237
662
841
1,740
1,516
175
1,261
39
87
1,387
1,630
1,343
Bank loans
Other accounts payable
of which:
- Trade accounts payable
802
1
0
803
821
818
- Advance payments
23
18
0
41
51
27
- Accounts payable
to affiliated companies
29
0
0
29
20
20
1
0
0
1
2
2
406
20
87
513
736
476
1,498
701
928
3,127
3,146
1,518
- from taxes (in millions of EUR)
76
75
- social security liabilities (in millions of EUR)
14
16
- Accounts payable
to related companies
- Other liabilities*
* Of which:
As in the previous year, there were no liabilities secured by mortgages or similar collateral rights on the
balance sheet date.
At the end of the year, there were liabilities to shareholders of EUR 0 million (previous year: EUR 133
million).
56
Boehringer Ingelheim annual report 2010
4 Notes to the consolidated profit and loss statement
The structure of the consolidated profit and loss statement was based on the total cost format.
4.1 Net sales
by business and business segment (in millions of EUR)
2010
2009
11,665
12,111
Prescription Medicines
9,702
10,058
Consumer Health Care
1,318
1,261
638
786
Human Pharmaceuticals
of which:
Industrial Customers
Other Sales
Animal Health
7
6
921
610
12,586
12,721
by geographic region (in millions of EUR)
2010
2009
Europe
4,089
3,980
of which: Germany
Americas
of which: USA
977
1,051
5,724
6,257
4,511
5,260
2,773
2,484
1,695
1,599
12,586
12,721
(in millions of EUR)
2010
2009
Costs of raw material, supplies and goods for resale
1,375
1,491
428
422
1,803
1,913
Asia / Australasia / Africa
of which: Japan
4.2 Other operating income
Other operating income includes income from currency translation of EUR 715 million.
4.3 Material costs
Expenditure on services
4.4 Personnel costs
(in millions of EUR)
2010
2009
Salaries and wages
2,713
2,577
645
644
177
223
3,358
3,221
Social benefits and retirement benefits
of which: retirement benefits
Notes to the consolidated financial statements 2010
57
consolidated financial statements
The interest component of the addition to provisions for pensions and similar obligations was not reported in personnel expenses and therefore the operating result; instead it was reported as a separate item
within the financial result.
Average headcount
Production
2010
2009
12,647
12,404
5,242
5,291
16,543
16,189
7,093
6,934
Administration
Marketing and sales
Research and development
Apprentices
699
716
42,224
41,534
4.5 Amortisation and intangible fixed assets and depreciation of tangible fixed assets
Amortisation of intangible fixed assets and depreciation of tangible fixed assets include write-offs of
EUR 23 million (previous year: EUR 15 million).
4.6 Other operating expenses
Other operating expenses include expenses from currency translation of EUR 796 million.
Other operating expenses also include third-party services in the areas of research, development, medicine and marketing plus administrative expenses, fees and contributions, commission, rent, freight, expenses for third-party repairs, non-income-related taxes and restructuring expenses.
4.7 Financial income
(in millions of EUR)
2010
2009
Interest expense relating to pensions and similar obligations and other provisions
— 222
— 137
Other interest expense and similar expenditure
— 115
— 79
Interest expense and similar expenditure
— 337
— 216
Amortization of and loss on disposal on financial assets and short-term investments
—4
—3
Income from plan assets
75
0
Income from other investment securities and from long-term loans
80
75
Other interest income and similar proceeds
32
45
— 154
— 99
2010
2009
0
6
4.8 Holding income
(in millions of EUR)
Gains from the sale of investments
Write-ups on financial assets
— 33
5
Expense from loss allocation
—1
11
of which from affiliated companies
58
Boehringer Ingelheim annual report 2010
—1
0
— 34
11
4.9 Extraordinary result
The adoption of section 66 and section 67 paragraph 1 to paragraph 5 EGHGB (transitional BilMoG regulations) resulted in extraordinary expenses of EUR 587 million from the addition to provisions for pensions and similar obligations and EUR 20 million from the addition to other long-term provisions. The
adoption of section 66 and section 67 paragraph 1 to paragraph 5 EGHGB resulted in extraordinary income of EUR 13 million from the reversal of provisions for pensions and similar obligations also included
in this item.
4.10 Taxes
(in millions of EUR)
Income taxes
Deferred taxes
2010
2009
369
679
— 143
— 292
226
387
As a result of the conclusion of profit transfer agreements, significant German corporations have been included in the trade and corporation tax group of the parent company C. H. Boehringer Sohn AG & Co. KG
since 1 January 2004. As the income taxes of the shareholders of C. H. Boehringer Sohn AG & Co. KG incurred on operating income cannot be reported in the consolidated profit and loss statement, only the
trade income tax of the companies concerned and other fully consolidated German partnerships is shown
as tax expenses.
Total deferred tax assets amounted to EUR 1,281 million as at the balance sheet date. Deferred tax assets
essentially relate to the different carrying amounts of inventories and provisions. Deferred tax assets were
recognised in the amount of EUR 187 million. They mainly relate to the differences in the carrying
amounts of tangible assets and provisions.
4.11 Net income
The net income for 2010 was positively influenced by prior-period operating income (essentially from the
reversal of other provisions) of EUR 99 million (previous year: EUR 217 million) and negatively influenced by prior-period operating expenses of EUR 37 million (previous year: EUR 37 million).
Notes to the consolidated financial statements 2010
59
consolidated financial statements
5 Notes to the cash flow statement
The cash flow statement shows how the cash and cash equivalents (cash and long-term securities and investments classified as current assets that can be sold at any time) of the Boehringer Ingelheim Group
changed as a result of cash inflows and outflows in the reporting year. In accordance with German Accounting Standard 2 on the cash flow statement (GAS 2), this has been broken down according to cash
flows from operating activities and cash flows from investing and financing activities.
The changes in the balance sheet items of the affiliated companies included were translated using average
rates for the year. As in the balance sheet, cash and cash equivalents are carried at the closing rate. The
effect of exchange rate changes on cash and cash equivalents has been shown separately.
In the financial year, EUR 89 million (previous year: EUR 26 million) were paid for interest and EUR 347
million (previous year: EUR 712 million) for taxes.
6 Other disclosures
6.1 Contingent liabilities
(in millions of EUR)
31.12.2010
31.12.2009
21
16
Liabilities from guarantees, bills and
cheque guarantees, warranties and
the granting of security for third-party liabilities
The risk of utilisation of the individual contingent liabilities is estimated as follows:
The risk of utilisation of guarantees for the liabilities of affiliated companies to banks is rated as low on
account of the solid results from operations, financial position and net assets.
6.2 Other financial commitments
(in millions of EUR)
31.12.2010
31.12.2009
Rental and leasing obligations
249
199
Purchase commitment
563
804
812
1,003
There are obligations from rental and lease agreements of EUR 249 million (previous year: EUR 199 million), EUR 39 million of which (previous year: EUR 64 million) are related to long-term rental agreements
with subsidiaries not included in consolidation.
60
Boehringer Ingelheim annual report 2010
The purpose of the lease agreements is the lower capital commitment compared to buying property and
the absence of the resale risk. Risks could arise from the term of the lease if it were no longer possible to
fully utilise the properties, for which there are no indications at this time.
Other financial commitments include future expenses from follow-up investments, investments already
initiated and future major repairs. As at the balance sheet date, commitments include future cash investments of EUR 449 million (previous year: EUR 677 million) in other off-balance sheet transactions.
6.3 Derivative financial instruments and hedges
Owing to its extensive international structure, the Boehringer Ingelheim Group is highly dependent on
developments in the world’s currencies and interest rates. In order to hedge against the risks, particularly
those inherent in supplies, services and financial funding, use is generally made of foreign exchange forward contracts and foreign exchange options in the case of currency risks. Regarding interest rate risks,
use is made of interest rate swaps and interest rate options.
The use of derivative financial instruments and the organisational processes are set out in internal guidelines. There is a strict separation of trading, processing, documentation and control.
Risk positions are regularly tracked, analysed and measured in a special consolidated financial report.
The positions entered into are periodically re-evaluated and monitored. The fair market values of the derivative financial instruments are calculated using standard market measurement methods (foreign exchange forward contracts and interest swaps using the net present value method, foreign exchange and
interest options using recognised option pricing models) on the basis of the market data available on the
balance sheet date.
Foreign exchange and interest options are recorded at the lower of fair market value or paid or received
option premium. They are derecognised on maturity.
Provisions of EUR 46 million were recognised for foreign exchange forward contracts not included in
hedge accounting for which there was a negative fair market value within a currency as at the balance
sheet date. In line with the imparity principle, positive fair market values within a currency are not recognised.
If the requirements for hedge accounting of foreign exchange forward contracts with highly probable
forecasted transactions in accordance with section 254 HGB are met, the foreign exchange forward contracts are not recognised in the balance sheet in line with the net hedge presentation method.
Notes to the consolidated financial statements 2010
61
consolidated financial statements
The following accounting policies apply in the recognition of hedge accounting in accordance with section
254 HGB:
Nominal value
(in millions of EUR)
Market value
31.12.2010
31.12.2009
31.12.2010
31.12.2009
1,892
2,660
—1
44
Foreign exchange options
0
629
0
26
Interest options
1
2
0
0
Foreign exchange forward contracts
For economic hedges use is made of hedge accounting. Hedge accounting is recognised per foreign currency from the net amount of highly probable forecasted transactions and foreign exchange forward contracts
that match the forecasted net cash flow in terms of maturity, nominal value and foreign currency (macro
hedge). The highly probable forecasted transactions (cash inflows and cash outflows for planned sales and
purchases) are derived from company planning.
As the critical terms (maturity, nominal value, foreign currency) match, the opposing changes in value of
the hedged item and the hedging instrument are fully offset. An effective hedge can therefore be assumed
both prospectively and retrospectively. The critical term match method is exclusively used to measure
prospective and retrospective hedge effectiveness.
As at 31 December 2010, hedge accounting for highly probable forecasted net cash flows was recognised
as follows:
January to December 2011:
Net cash flow (in millions of EUR)
FX forward contracts (in millions of EUR)
Nominal value
Nominal value
USD
818 USD
683 USD
JPY
416 JPY
441 JPY
Market value
16
— 50
January to December 2012:
Net cash flow (in millions of EUR)
FX forward contracts (in millions of EUR)
Nominal value
Nominal value
USD
148 USD
111 USD
JPY
465 JPY
425 JPY
Market value
7
— 19
January to December 2013:
Net cash flow (in millions of EUR)
FX forward contracts (in millions of EUR)
Nominal value
JPY
62
87 JPY
Boehringer Ingelheim annual report 2010
Nominal value
78 JPY
Market value
—2
The amount of the hedged foreign currency risk correlates to the relative change in the exchange rate between the planning date and the realisation date of the forecasted transactions. If all currencies were to
appreciate or depreciate against the euro by 10.0%, there would be a foreign currency risk of plus or minus EUR 193 million without hedging.
As at the balance sheet date, two floating-rate loans exist in the amount of EUR 516 million. Interest rate
swaps with matching amounts and matching maturities were concluded to hedge against the interest rate
risk. As this only involves transforming the floating-rate loan portions into a fixed interest rate, use is
made of hedge accounting (micro hedges). The opposing changes in value of the hedged item and the
hedging instrument are fully offset until 2014 and 2016 respectively. As at the balance sheet date, the interest rate swaps including accrued interest had a fair market value of EUR – 18 million. The carrying
amount (equal to deferred accrued interest) was EUR 4 million and is reported within liabilities to banks.
The net hedge presentation method was used.
6.4 Research and development expenses
(in millions of EUR)
2010
2009
Research and development expenses
2.453
2.215
The research and development expenses not capitalised include costs for phase IV clinical studies.
6.5 Total auditor fees
The total fee charged by the auditor for the financial year was EUR 1.3 million. EUR 0.8 million of this
relates to audits of financial statements, EUR 0.1 million to other confirmation services and EUR 0.4 million to other services.
Notes to the consolidated financial statements 2010
63
consolidated
auditor’s
report
financial statements
Auditor’s report
We have audited the consolidated financial state-
We conducted our audit of the consolidated fi-
ments prepared by C. H. Boehringer Sohn AG &
nancial statements in accordance with § (Article)
Co. KG, Ingelheim – comprising the balance
317 HGB (German Commercial Code) and Ger-
sheet, the income statement, statement of chang-
man generally accepted standards for the audit of
es in equity, cash flow statement and the notes to
financial statements promulgated by the Institut
the consolidated financial statements, together
der Wirtschaftsprüfer (Institute of Public Audi-
with the group management report for the busi-
tors in Germany) (IDW). Those standards require
ness year from 1 January to 31 December 2010.
that we plan and perform the audit such that
The preparation of the consolidated financial
misstatements materially affecting the presenta-
statements and the group management report in
tion of the net assets, financial position and re-
accordance with German commercial law is the
sults of operations in the consolidated financial
responsibility of the Managing Directors of the
statements in accordance with (German) princi-
managing corporate general partner. Our respon-
ples of proper accounting and in the group man-
sibility is to express an opinion on the consoli-
agement report are detected with reason-able as-
dated financial statements and the group man-
surance. Knowledge of the business activities
agement report based on our audit.
and the economic and legal environment of the
Group and expectations as to possible misstatements are taken into account in the de-termination of audit procedures. The effectiveness of the
accounting-related internal control sys-tem and
the evidence supporting the disclosures in the
consolidated financial statements and the group
management report are examined primarily on a
test basis within the framework of the audit. The
audit includes assessing the annual financial
statements of the companies included in consolidation, the determination of the companies to be
included in consolidation, the accounting and
consolidation principles used and significant estimates made by the Managing Directors of the
managing corporate general partner, as well as
evaluating the overall presentation of the consolidated financial statements and the group management report. We believe that our audit provides a reasonable basis for our opinion.
64
Boehringer Ingelheim annual report 2010
With the exception of the following qualification, our audit has not led to any reservations:
Contrary to § (Article) 314 (1) Nos.6 (a) and (b)
HGB the total remuneration granted to the members and the former members of the board of
managing directors as well as the pension provisions recognized and not recognized for the
former members of the board of managing directors are not disclosed in the notes to the consolidated financial statements.
In our opinion based on the findings of our audit, with the qualification mentioned above, the
consolidated financial statements comply with
the legal requirements. The consolidated financial statements give a true and fair view of the
net assets, financial position and results of operations of the Group in accordance with (German)
principles of proper accounting. The group management report is consistent with consolidated
financial statements that comply with the legal
requirements and as a whole provides a suitable
view of the Group’s position and suitably
presents the opportunities and risks of future development.
Frankfurt am Main, 24 February 2011
PricewaterhouseCoopers
Aktiengesellschaft
Wirtschaftsprüfungsgesellschaft
Philip Marshall
Georg Wolfgang Wegener
Wirtschaftsprüfer
Wirtschaftsprüfer
(German Certified
(German Certified
Public Accountant)
Public Accountant)
Auditor’s report
65
product portfolio
66
Boehringer Ingelheim annual report 2010
2010
Product Portfolio
A selection
Branded Prescription Medicines
68
Consumer Health Care
78
Animal Health
86
Product Portfolio 2010
67
product portfolio
Branded Prescription Medicines
Respiratory diseases
Chronic obstructive pulmonary disease (COPD) and
Asthma
asthma are among the most prevalent chronic diseases
Asthma is a chronic disease involving airway inflamma-
affecting the lungs, and cause significant morbidity and
tion in response to exposure to asthma triggers, such as
premature deaths worldwide.
allergens. Airway inflammation causes airways to narrow, mucus to increase and breathing to be more diffi-
COPD
cult. In the early stages of the disease, this airflow limi-
COPD is a disease of the lung in which the airways be-
tation is fully reversible and patients can be free of
come narrowed. This leads to a limitation of air-flow
symptoms between attacks.
causing shortness of breath and other respiratory symptoms. The airflow limitation is only partially reversible
and usually worsens gradually over time.
COPD is caused by noxious stimuli, such as cigarette
smoke or air pollution. COPD can manifest itself as
chronic obstructive bronchitis with cough and sputum,
or as emphysema caused by destruction of the lung tissue. The course of COPD is characterised by occasional
sudden worsening of symptoms called acute exacerbations.
68
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• Chronic obstructive
pulmonary disease (COPD)
spiriva®
tiotropium bromide
Maintenance treatment of patients with
COPD (chronic obstructive pulmonary
disease, including chronic bronchitis
and emphysema), the maintenance
treatment of associated dyspnoea and
for prevention of exacerbations.
• Bronchospasms associated
with reversible obstructive
airway diseases
combivent®
ipratropium bromide,
salbutamol
Management of reversible bronchospasms associated with obstructive
airway diseases in patients requiring
more than one bronchodilator.
• Chronic obstructive
pulmonary disease (COPD)
• Chronic bronchitis
• Asthma
atrovent®
ipratropium bromide
Bronchodilator for maintenance treatment of bronchospasm associated with
chronic obstructive pulmonary disease,
including chronic bronchitis, emphysema and asthma.
• Bronchial asthma
• Chronic bronchitis
berodual®
bronchodual®
duovent®
fenoterol,
ipratropium
bromide
For prevention and treatment of symptoms in chronic obstructive airway disorders with reversible air flow limitations, such as bronchial asthma, and
especially chronic bronchitis, with or
without emphysema.
• Bronchial asthma
berotec®
dosberotec®
fenoterol
Symptomatic treatment of acute asthma
attacks and other conditions with reversible airway narrowing, e.g. chronic
obstructive bronchitis, prophylaxis of
exercise-induced asthma.
• Bronchial asthma
inflammide®
budesonide
Chronic control of symptoms of bronchial asthma.
• Bronchial asthma
• Allergic rhinitis
alesion®
flurinol®
epinastine
Prophylactic treatment of bronchial
asthma. Prophylaxis and symptomatic
treatment of allergic rhinitis.
Respiratory diseases
69
product portfolio
Branded Prescription Medicines
Diseases of the central nervous system
Mental and neurological diseases, such as depression
Restless legs syndrome (RLS)
and Parkinson’s disease, significantly impact patients
Restless legs syndrome (RLS) is a common neurological
and their families, and are a substantial burden to
disorder characterised by an uncontrollable urge to
society.
move the legs, primarily occuring in the evening and
night hours, usually accompanied by unpleasant and
Parkinson’s disease
sometimes painful sensations in the legs as well as dis-
Parkinson’s disease (PD) is a degenerative disorder of
turbed sleep resulting in daytime tiredness or sleepiness.
the central nervous system. Patients usually notice mo-
The sensations are felt deep within the legs and are de-
tor symptoms, like hand tremor (shaking), as their first
scribed as creeping, crawling or aching.
sign of the disease, which progresses eventually to include shaking of the arms, legs or head. Other motor
symptoms that may develop over time include stiffness
that often results in loss of facial expression and a gradual slowing or loss of motion or “freezing”. About 30–
40 % of patients also suffer from non-motor symptoms
associated with PD, such as dementia, depression and
sleep disorders. The primary symptoms are the result of
a lack of the neurotransmitter dopamine in distinct areas of the human brain.
70
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• Parkinson’s disease (PD)
• Restless legs syndrome (RLS)
sifrol®
sifrol® er
mirapex®
mirapex® er
mirapex er®
mirapexin®
mirapexin® er
pexola®
pramipexole
Symptomatic treatment of idiopathic
Parkinson’s disease. It may be used as
monotherapy or in combination with
levodopa. Symptomatic treatment of
idiopathic moderate to severe restless
legs syndrome.
• Sleep disorders
lendormin®
lendorm®
lindormin®
sintonal®
brotizolam
Short-term treatment of disorders of
initiating and maintaining sleep.
Diseases of the central nervous system
71
product portfolio
Branded Prescription Medicines
Cardiovascular diseases
Cardiovascular diseases are the leading causes of death
Acute myocardial infarction
in many countries, and are still increasing in preva-
An acute myocardial infarction, or heart attack, is an
lence.
acute event that occurs when a thrombus or clot suddenly prevents blood flow to an area of the heart mus-
Stroke
cle. Unless the blood flow is restored quickly, the affect-
Stroke is the rapidly developing loss of brain functions
ed section of heart muscle becomes permanently
due to a blockage of the blood flow to the affected brain
damaged. Heart attack is a leading cause of death in all
tissue. This can be due to ischaemia (lack of blood sup-
developed countries.
ply) caused by thrombosis or embolism, or due to a
bleeding. As a result, the affected area of the brain is
unable to function and the damage quickly becomes
permanent, if untreated. Stroke is an acute event needing emergency diagnosis and intervention. Stroke is one
of the leading causes of death and long-term disability
in the developed world. Symptoms of a transient ischaemic attack (TIA) are similar to stroke, but lasting for
only a few minutes or hours. As a TIA may precede a
stroke, emergency medical care and subsequent preventive treatment is necessary.
72
Boehringer Ingelheim annual report 2010
Indications
• Essential hypertension
• Cardiovascular prevention
Brand names
Active ingredients
micardis®
micardisplus®
micardis® plus
micardis® hct
co-micardis®
telmisartan;
telmisartan, hydrochlorothiazide
Treatment of essential hypertension.
For the reduction of the risk of myocardial infarction (heart attack), stroke or
death from cardiovascular (CV) causes in
patients 55 years of age or older at high
risk of developing major CV events who
are unable to take ACE inhibitors (USA).
For the reduction of cardiovascular morbidity in patients with manifest atherothrombotic cardiovascular disease (history of coronary heart disease, stroke or
peripheral arterial disease), or type 2
diabetes mellitus with documented target organ damage (EU).
• Hypertension
twynsta®
micamlo®
telmisartan, amlodipine
Treatment of hypertension alone or with
other antihypertensive agents. As initial
therapy in patients likely to need multiple antihypertensive agents to achieve
their blood pressure goals (USA).
Add on therapy in adult patients with not
adequately controlled blood pressure on
amlodipine and replacement therapy in
adult patients receiving telmisartan and
amlodipine from separate tablets (EU).
• Secondary prevention of
stroke or transient ischaemic
attacks (TIA)
aggrenox®
asasantin®
asasantin® retard
dipyridamole,
acetylsalicylic acid
Prevention of stroke following a first
stroke or transient ischaemic attacks.
• Hypertension
catapresan®
catapres®
catapressan®
atensina®
clonidine
All forms of high blood pressure, unless
caused by phaeochromocytoma.
• Acute myocardial infarction,
acute massive pulmonary
embolism
• Acute ischaemic stroke
• Catheter clearance due to
thrombotic occlusion
actilyse®
alteplase
Fibrinolytic treatment of acute myocardial infarction, acute massive pulmonary
embolism, acute ischaemic stroke and
for catheter clearance due to thrombotic
occlusion.
Cardiovascular diseases
73
product portfolio
Branded Prescription Medicines
Cardiovascular diseases (continued)
Hypertension and cardiovascular disease
Venous thrombo-embolism
Hypertension, also referred to as high blood pressure, is
Patients undergoing orthopaedic surgery are at consid-
a chronic disease in which the blood pressure is chroni-
erable risk of developing deep vein thrombosis in the
cally elevated. Hypertension is one of the major risk fac-
legs or a potentially fatal pulmonary embolism. Both
tors for strokes, heart attacks, heart failure and chronic
are also known as venous thrombo-embolism (VTE). In
renal failure.
the longer term, thrombo-embolic events may recur and
chronic venous insufficiency and/or pulmonary hyper-
About one billion people worldwide are affected by hy-
tension may occur. To prevent VTE events and its conse-
pertension. The prevalence of essential hypertension in-
quences, patients should receive some kind of thrombo-
creases steadily with age. As the world population ages
prophylaxis.
and preventive strategies in terms of lifestyle changes
are so far failing, the prevalence of hypertension is set
Atrial fibrillation
to increase even further.
Patients with atrial fibrillation (AF) are at higher risk of
developing blood clots, which can cause a disabling
Hypertension is a major risk factor for cardiovascular
stroke if the clots travel to the brain. AF is the most
morbidity and mortality. The organs at risk are primari-
common type of arrhythmia. It is associated with a hy-
ly the heart, the main blood vessels, the brain and the
percoagulable state which predisposes to stroke and sys-
kidneys. The primary goal of any antihypertensive treat-
temic embolism, which can be prevented by effective
ment is to prevent cardiovascular events, such as heart
chronic anticoagulation.
attacks or strokes, and finally to reduce cardiovascular
mortality. Cardiovascular disease (CVD) is responsible
for nearly one in three deaths worldwide and is the
number one cause of death.
Proper control of treatable risk factors and disease are
vital for the prevention of cardiovascular events.
74
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• Acute myocardial infarction
metalyse®
tenecteplase
Fibrinolytic treatment of acute myocardial infarction.
• Ventricular tachycardia
mexitil®
mexiletine
Serious symptomatic ventricular tachycardic heart rhythm disturbances.
• Hypertension
motens®
caldine®
tens®
midotens®
lacidipine
Treatment of essential hypertension.
• Primary prevention of venous
thrombo-embolic events
after orthopaedic surgery
pradaxa®
pradax®
pradaxar®
dabigatran
etexilate
Primary prevention of venous thromboembolic events (VTE) in adults after
elective total hip or knee replacement
surgery.
• Stroke prevention in atrial
fibrillation
pradaxa®
pradax®
prazaxatm
dabigatran
etexilate
Prevention of stroke and blood clots in
patients with abnormal heart rhythm
(atrial fibrillation).
Cardiovascular diseases
75
product portfolio
Branded Prescription Medicines
Infectious diseases
HIV infection/acquired immune deficiency
syndrome (AIDS)
Acquired immune deficiency syndrome (AIDS) is a set of
symptoms and infections resulting from the damage to
the human immune system caused by the human immunodeficiency virus (HIV). If untreated, this condition
progressively reduces the effectiveness of the immune
system and leaves individuals susceptible to opportunistic infections and tumours. Babies of infected mothers
are at risk of getting the virus during pregnancy, childbirth or breastfeeding.
Urological diseases
Benign prostate hyperplasia
Benign prostate hyperplasia (BPH) refers to an enlargement of the prostate in middle-aged and elderly men,
which can lead to problems with urination and consequent infections of the urinary tract.
76
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• HIV/AIDS
viramune®
nevirapine
Available as tablets and suspension for
adults and children – for the combination therapy of HIV-1 infection and for
the prevention of mother-to-child transmission of HIV-1 in pregnant women
who are not taking antiretroviral therapy
at time of labour.
• HIV/AIDS
aptivus®
tipranavir
Capsule and oral solution – co-administered with 200 mg of ritonavir, is indicated for combination antiretroviral
treatment of HIV-1-infected patients
with evidence of viral replication, who
are treatment-experienced and infected
with HIV-1 strains resistant to more than
one protease inhibitor.
Brand names
Active ingredients
• Benign prostate hyperplasia
(BPH)
flomax®
alna®
josir®
pradif®
secotex®
urolosin®
tamsulosin
Lower urinary tract symptoms (LUTS)
associated with benign prostate hyperplasia (BPH).
• Benign prostate hyperplasia
(BPH)
flomax® cr
alna® ocas®
pradif® t
pradif® ocas®
secotex® adv
secotex® ocas®
tocas®
urolosin® ocas®
tamsulosin
Lower urinary tract symptoms (LUTS)
associated with benign prostate hyperplasia (BPH).
Indications
Infectious diseases / Urological diseases
77
product portfolio
Consumer Health Care
Cough and cold
mucosolvan® (ambroxol) and bisolvon® (bromhexine)
respiratory tract, which play an important role in the
are both indicated for secretolytic therapy in broncho-
body’s natural defence mechanisms. Ambroxol also
pulmonary diseases associated with abnormal mucus
stimulates synthesis and release of surfactant by type II
secretion and impaired mucus transport.
pneumocytes.
Cough is the most common symptom of clinical impor-
bisolvon® (bromhexine), available for all age groups,
tance and the most frequent reason to consult a doctor.
has been on the market since 1963. Bromhexine is con-
The clinical symptoms of cough and expectoration have
tained in various formulations of bisolvon®. There are
led to the development of drugs that affect respiratory
high and low strength syrups 8 mg/5 ml, 4 mg/5ml, tab-
mucus, i. e. the mucoactive agents.
lets and soluble tablets (both with 8 mg bromhexine)
and solution for oral use (10 mg/5 ml), adapted to the
mucosolvan® (ambroxol), which promotes mucus clear-
need of the patients. Bromhexine is a synthetic deriva-
ance, facilitates expectoration and eases productive
tive of the herbal active ingredient vasicine. It has been
cough, allowing patients to breathe freely and deeply, is
shown to increase the proportion of serious bronchial
the world’s leading cough brand. It is available in many
secretion, making it more easily expectorated. Bromhex-
different formulations.
ine also enhances mucus transport by reducing mucus
viscosity and by activating the ciliated epithelium.
Ambroxol is a mucoactive drug with several properties,
including secretolytic and secretomotoric actions that
restore the physiological clearance mechanisms of the
Sore throat
mucoangin® is the best documented product in its cat-
In addition to its secretolytic activity, ambroxol is a very
egory of pain relief in acute sore throat and is well toler-
potent inhibitor of the neuronal sodium channels.
ated.
Therefore mucoangin® (ambroxol) has a strong local
anaesthetic effect, described first in the late 1970s, but
Pain in sore throat is the hallmark of acute pharyngitis,
usually caused by a viral infection. The infection is as a
rule self-limited and the patient recovers normally in a
couple of days. What is most bothersome for the patient
is the continuous pain in the throat maximised when
swallowing. The main goal of the treatment is thus to
reduce pain.
78
Boehringer Ingelheim annual report 2010
explained and confirmed in more recent work.
Indications
Brand names
Active ingredients
• Acute and chronic bronchopulmonary diseases
mucosolvan®
mucosan®
surbronc®
lasolvan®
mucopect®
ambroxol
Secretolytic therapy in acute and chronic
bronchopulmonary diseases associated
with abnormal mucus secretion and impaired mucus transport.
• Acute and chronic bronchopulmonary diseases
bisolvon®
bromhexine
Secretolytic therapy in acute and chronic
bronchopulmonary diseases associated
with abnormal mucus secretion and impaired mucus transport.
• Irritable cough
silomat® dmp
bisoltussin®
bisolvon® Dry
bisolsek TM
bisolvon® antitusivo
dextrometorphan
Symptomatic treatment of irritable,
non-productive cough.
Brand names
Active ingredients
mucoangin®
lysopadol®
lysopain® dol
ambroxol
Indications
• Sore throat
Pain relief in acute sore throat.
Cough and cold / Sore throat
79
product portfolio
Consumer Health Care
Gastrointestinal diseases
In our gastrointestinal portfolio, we offer several
Abdominal cramping, pain and discomfort are common
brands, such as dulcolax®, dulcolax® balance, dul-
ailments. Approximately one in four persons worldwide
cofibre®, laxoberal®, buscopan®, buscogast® for
suffers on a regular basis.
heartburn relief as well as the heartburn brand zantac®
and buscopan® antiacido.
buscopan® is an antispasmodic product with the active
ingredient hyoscine butylbromide. The product is
Constipation is a common problem. dulcolax® the
basically a natural substance extracted from Duboisia
worldwide No. 1 selling laxative remedy for constipa-
plant species as scopolamine (hyoscine) and chemically
tion relief.
modified to the quaternary ammonium compound
hyoscine butylbromide. As an antispasmodic product,
Within the dulcolax® franchise, Boehringer Ingelheim
buscopan® acts directly on the site of abdominal pain by
markets a range of products for the treatment, regula-
relaxing the muscles of the gastrointestinal tract.
tion and prevention of intestinal irregularity and disruption. The primary ailment within this area is consti-
This means buscopan® relieves abdominal pain by di-
pation, for which dulcolax® tablets are today the main
rectly treating its main cause – abdominal cramp or
method of treatment.
spasm.
dulcolax® tablets have a special enteric “comfort coat-
Several buscopan® line extensions are available today –
ing” which ensure that the active ingredient in dulcolax®
the mono-variant and in different combinations with
tablets, bisacodyl, is taken to where it needs to act – the
analgesics (paracetamol, ibuprofen and metamizol/
colon. Here, in the colon, the colonic juices activate the
dipyrone) – and different formulations (tablets, drops,
key ingredient which then relieve the constipation. Here
suppositories, syrup and solutions for intravenous injec-
it stimulates the natural movement of the bowels to pro-
tion).
vide gentle, predictable relief within 6 –12 hours. One to
two tablets taken before going to bed will still provide
The umbrella brand buscopan® now also offers bus-
relief the next morning.
cogast® and buscopan® antiacido for heartburn re-
dulcolax® is specifically formulated to provide effec-
with just one capsule per day – giving the stomach time
tive, predictable relief of constipation. dulcolax® offers
to recover. The new buscopan® antiacido effervescent
a reliable range of products.
tablets is giving quickly powerful soothing relief for
lief. buscogast® stops heartburn for up to 24 hours
even tough heartburn that lasts for a full 12 hours.
Other products within the dulcolax® franchise include
dulcoease® (stool softener), dulcoenema® and dulcofibre®.
80
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• Constipation
dulcolax®
bisacodyl,
sodium
picosulphate
Laxative for use in patients suffering
from constipation. In preparation for
diagnostic procedures, in pre- and postoperative treatment, and in conditions
which require defecation to be facilitated.
• Constipation
dulcolax® balance
dulcolax® m balance
macrogol
Symptomatic treatment of constipation
for adults and children from eight years
onwards.
• Intestinal irregularity
dulcofibre®
dulcofiber®
glucomannan
Food supplement, helps intestinal regularity, supports regulation of bowel
movement.
• Constipation
laxoberal®
laxoberon®
guttalax®
dulcolax® np
sodium picosulphate
Laxative for use in cases of constipation
and in conditions which require defecation to be facilitated.
• Abdominal cramping
buscopan®
buscapina®
hyoscine butylbromide
Treatment for the relief of abdominal
cramping, pain and discomfort.
• Heartburn
zantac® (*)
buscopan® antiacido
ranitidine
Relieves heartburn associated with acid
indigestion and sour stomach. Prevents
heartburn associated with acid indigestion and sour stomach brought on by
certain foods and beverages.
omeprazole
Symptomatic treatment of heartburn
or acidic reflux in adults due to hyperacidity.
* only available in the USA
• Heartburn
buscogast®
buscasan® 24
Gastrointestinal diseases
81
product portfolio
Consumer Health Care
Vitamins and supplements
pharmaton® is a multivitamin and mineral supple-
pharmaton® matruelle® is a pre-natal multivitamin
ments brand developed to enhance people’s physical
for active planning, pregnant and lactating women, con-
and mental well-being. A full range of products adapted
taining all important micronutrients for mother and
to the needs of different target audiences has been de-
baby, such as vitamins, minerals and omega-3 fatty acids,
veloped that work in harmony with the body.
to cover the increased needs for these substances in
those particular periods. Moreover, it helps to protect
pharmaton®, a range of products for adults, contains a
against embryonal neural tube diseases of the foetus
synergic and unique blend of vitamins, minerals and
and against iron and folic acid anaemia during preg-
trace elements and standardised Ginseng G115 extract.
nancy.
The main target indications are: exhaustion, tiredness,
decreasing concentration and mental alertness. Numer-
pharmaton® cardioactive, a product designed for
ous clinical studies have shown that a regular intake of
adults over 40 years, contains a blend of vitamins and
pharmaton® has a positive effect on mental and physi-
minerals combined with omega-3 fatty acids to help
cal performance and well-being.
maintain cardiovascular health.
pharmaton® kiddi®, a range of products designed for
children, contains selected vitamins, minerals and key
nutrients that are very important for growth. It is especially recommended in the preventive treatment of vitamin deficiencies.
Urological diseases
Benign prostate hyperplasia (BPH) refers to an enlargement of the prostate in middle-aged and elderly men,
which can lead to lower urinary tract symptoms (LUTS),
such as frequent nighttime urination, urge to urinate
every few hours, weak flow and feeling of unfinished
urinating.
82
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• Tiredness, decreasing
concentration, increased
demand for vitamins
pharmaton®
standardised ginseng
extract, vitamins,
minerals, trace
elements
For states of exhaustion ( e. g. caused by
stress), tiredness, feeling of weakness,
decreasing concentration as well as
decreasing mental alertness.
• Increased demand for
vitamins in childhood
pharmaton® kiddi®
vitamins, minerals,
amino acids
Increasing demand for vitamins, minerals and amino acids, especially during
the period of growth. Preventive treatment in case of vitamin deficiencies, e. g.
restricted diets, convalescence, loss of
appetite, following illness, infection or
surgery.
• Prophylaxis of iron and folic
acid deficiency during
pregnancy
pharmaton®
matruelle®
vitamins, minerals,
trace elements,
omega-3 fatty acids
[docosahexaenoic
acid (DHA)]
For women of child-bearing age intending to become pregnant, already pregnant and lactating, to cover the increased needs for vitamins, minerals,
trace elements and DHA. To provide protection against embryonal neural tube
diseases of the foetus, and prophylaxis
of iron and folic acid anaemia during
pregnancy.
• Maintenance of cardiovascular health
pharmaton®
cardioactive
vitamins, minerals, trace elements
and fish oil (omega-3 fatty acids rich
in EPA and DHA)
Helps to maintain cardiovascular health.
Covers the daily needs for vitamins,
minerals, trace elements and fish oil
(omega-3 fatty acids rich in EPA and
DHA), by acting complementary to daily
nutrition.
Brand names
Active ingredients
flomax relief® (*)
tamsulosin
Indications
• Benign prostate hyperplasia
(BPH)
Treatment of lower urinary tract symptoms (LUTS) of a common condition
called benign prostate hyperplasia
(BPH).
* only available in UK
Vitamins and supplements / Urological diseases
83
product portfolio
Consumer Health Care
Leg vein health
Under the brand name antistax®, Boehringer
Red vine leaf extract, the active ingredient in antistax®
Ingelheim markets a range of products developed for
products, works on the endothelium inside the veins by
the prevention and treatment of symptoms attributable
sealing them from the inside, thereby reducing the
to known venous insufficiency. The most common
swelling and the sensation of pain and heaviness.
symptoms of venous insufficiency observable for consumers are varicose veins, oedema of the lower leg,
Products available in the antistax® range include
heavy or tired legs, sensation of tension, tingling and
antistax® tablets, antistax® capsules and antistax®
pain. antistax® capsules and tablets are scientifically
creme.
proven to help maintain healthy leg vein circulation.
Both cosmetic products antistax® leg chilling gel
Heavy, aching and tired legs often occur after long peri-
and antistax® leg cooling spray complete the range.
ods of standing or sitting, and increase at the end of the
day or during the summer when outdoor temperatures
rise. antistax® tablets and antistax® capsules offer effective treatment of the described symptoms. antistax®
helps to keep the fluid that flows out of the capillaries
into the surrounding tissue, at normal levels, even when
standing or sitting for a long time.
Pain
The brand thomapyrin® comprises products for the
For this reason, the triple combination is recommended
treatment of acute pain of mild to intermediate intensity.
by many national and international medical societies as
first choice acute treatment for tension type headache
thomapyrin® classic is the core product, which is com-
and migraine. thomapyrin® is positioned as the expert
posed of a triple combination of acetylsalicylic acid, pa-
treatment of headache. Several line extensions are
racetamol and caffeine. The three components suppress
available: thomapyrin® classic for normal headache,
pain synergistically via interaction with several pain-
thomapyrin® intensiv for stronger headache, thomapyrin®
related molecular mechanisms. As a result thomapyrin®
medium for milder headache, and thomapyrin® effer-
classic disposes of a fast and superior efficacy compared
vescent as a galenic alternative.
with its single components which is, amongst others,
well proven by state-of-the-art clinical studies.
84
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• Chronic venous insufficiency
antistax®
red vine leaf extract
Prevention and treatment of symptoms
of chronic venous insufficiency; varicose
veins, leg oedema, painful swollen legs,
tingling legs, tired and heavy legs.
• Heavy, tired legs
antistax®
leg chilling gel
antistax®
leg cooling spray
cooling, caring
substances,
red vine leaf
extract
Symptomatic treatment of heavy, tired
legs.
Brand names
Active ingredients
thomapyrin® classic
thomapyrin®
intensiv (*)
acetylsalicylic acid,
paracetamol, caffeine
Indications
• Pain
For adults and adolescents older than
twelve years for acute treatment of mild
to moderate headache, migraine attacks,
with and without aura, and for the treatment of tension-type headache.
* only available in Germany
Leg vein health / Pain
85
product portfolio
Animal Health
Food producing animals – swine
Infectious respiratory diseases
Pain and inflammatory diseases
ingelvac circoflex® is the first one-dose piglet vaccine
metacam® as a member of the class of non-steroidal
for the reduction of the early and late form of porcine
anti-inflammatory drugs (NSAID) marries the need for
circovirus disease (PCVD). This vaccine provides signifi-
maintained profitability and the concern for animal
cant reduction of mortality in the acute phase of PCVD
welfare in animal production.
as well as improved growth rates in the chronic phase of
the disease. ingelvac circoflex® protects with minimal
Due to its long-acting feature and its outstanding effi-
systemic adverse reactions or injection site swellings.
cacy in controlling inflammatory symptoms, it helps
Recently, the European Commission approved the mix-
minimising losses from inflammation and maintaining
ing of ingelvac circoflex® with ingelvac mycoflex®.
profitability in disease situations. At the same time,
ingelvac® prrs mlv is licensed for the active immunisa-
metacam® effectively controls pain and supports the
tion against the respiratory and reproductive form of
restoration of the well-being in farm animals. The use
porcine reproductive and respiratory syndrome (PRRS).
of metacam® is convenient and inflicts no stress on animals due to its low-volume, one-shot feature.
ingelvac® m. hyo and ingelvac mycoflex® are licensed
for the active immunisation of pigs against enzootic
metacam® is licensed for the use in swine suffering from
pneumonia (EP) in a one-dose regimen. Through their
non-infectious locomotor disorders. In addition, it is
advanced depot-adjuvant systems they provide a long-
used in the treatment of puerperal septicaemia and tox-
lasting and effective protection until slaughter, proven
aemia (mastitis-metritis-agalactia syndrome) as well as
even in high-challenge situations.
for the relief of post operative pain associated with minor soft tissue surgery such as castration.
Infectious enteric diseases
enterisol® ileitis is the first and only vaccine against
ileitis caused by Lawsonia intracellularis. It is licensed
to improve weight gain and to reduce growth variability
associated with the disease. enterisol® ileitis helps to
reduce the total antimicrobial use in pork production.
86
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• Infectious respiratory
diseases
ingelvac circoflex®
recombinant vaccine
(porcine circovirus
type 2, PCV 2)
For the active immunisation of pigs over
the age of two weeks against porcine
circovirus type 2 to reduce mortality,
clinical signs – including weight loss –
and lesions in lymphoid tissues associated with porcine circovirus diseases
(PCVD).
In addition, vaccination has been shown
to reduce PCV 2 nasal shedding, viral
load in blood and lymphoid tissues, and
duration of viraemia.
• Infectious respiratory
diseases
ingelvac® m.hyo
inactivated vaccine
(Mycoplasma
hyopneumoniae)
For active immunisation of pigs from
three weeks of age to reduce lung
lesions following infections with Mycoplasma hyopneumoniae.
• Infectious respiratory
diseases
ingelvac® prrs mlv
attenuated live vaccine
(PRRS virus)
For the active immunisation of swine
from three weeks of age against the
respiratory and reproductive form of
PRRS virus infection (porcine reproductive and respiratory syndrome).
• Infectious respiratory
diseases
ingelvac mycoflex®
inactivated vaccine
(Mycoplasma
hyopneumoniae)
For active immunisation of pigs from
three weeks of age to reduce lung
lesions following infections with Mycoplasma hyopneumoniae.
• Infectious enteric diseases
enterisol® ileitis
attenuated live
vaccine (Lawsonia
intracellularis)
For active immunisation of pigs from
three weeks of age and older to reduce
intestinal lesions caused by Lawsonia
intracellularis infection and to reduce
growth variability and loss of weight
gain associated with the disease.
• Pain and inflammatory
diseases
metacam®
Meloxicam
Alleviation of inflammation and pain in
muscolo-skeletal disorders (dog, cat,
pigs, horse) after surgery (dog, cat, pigs)
and during colic (horse).
As adjunctive treatment of diarrhoea,
respiratory disease and acute mastitis
(cattle) as well as mastitis-metritis-agalactia syndrome and treatment of castration (pigs).
Food producing animals – swine
87
product portfolio
Animal Health
Food producing animals – cattle
Mastitis
Pain and inflammatory diseases
mamyzin® Injection contains penethamate hydroiodide,
metacam® as a member of the class of non-steroidal
a prodrug of penicillin G which offers a unique pharma-
anti-inflammatory drugs (NSAIDs) combines the need
cokinetic profile.
for maintained profitability and the concern for animal
welfare in animal production.
Achieving very high absorption and accumulation rates
of its active principle in the udder, mamyzin® is an
Due to its long-acting feature and its outstanding effica-
excellent first line treatment of (penase negative)
cy in controlling inflammatory symptoms, it helps mini-
Staphylococcus aureus and Streptococcus spp. Highly
mising losses from inflammation and maintaining prof-
suitable for combination therapy, mamyzin® is addition-
itability in animals suffering from disease. At the same
ally an ideal tool in whole herd sanitation programmes
time metacam® effectively controls pain and supports
where it is used to control subclinical mastitis during
the restoration of well-being in farm animals. The use
lactation, as initial dry-off treatment in problem herds,
of metacam® is convenient and inflicts no stress on ani-
and for metaphylaxis in heifers.
mals due to its low-volume, one-shot feature.
benestermycin® is a broad spectrum and long-acting
metacam® is licensed for use in cattle suffering from
antibiotic preparation designed to effectively treat exist-
respiratory disease. Also, it is indicated in calves affected
ing infections at dry-off and to prevent new infections
by diarrhoea and as adjunctive therapy in the treatment
during the dry period in dairy cattle.
of mastitis in lactating cattle.
ubrolexin® delivers enhanced bactericidal activity
through a specifically designed combination of two
complementary targeted antibiotics working in synergy.
ubrolexin® marks a new quality of broad spectrum
mastitis treatment because it achieves uncompromised
efficacy on both ends of the pathogen spectrum. This
makes ubrolexin® a simple-to-use, “no compromise”
product for the routine treatment of clinical mastitis.
88
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• Mastitis
mamyzin®
penethamate hydroiodide
For the treatment of mastitis in dairy
cows caused by Gram-positive pathogens.
• Mastitis
benestermycin®
penethamate hydriodide
benethamine penicillin
framycetin sulphate
Treatment of subclinical infections
present at drying off and assistance in
preventing new infections as well as
acute clinical mastitis during the dry
period.
• Mastitis
ubrolexin®
cefalexin (as monohydrate),
kanamycin (as monosulphate)
Treatment of clinical mastitis in lactating
dairy cows for bacteria susceptible to
the combination of cefalexin and kanamycin such as Staphylococcus aureus,
Streptococcus dysgalactiae, Streptococcus uberis and Escherichia coli.
• Infectious respiratory
diseases
express® (*)
attenuated live and inactivated
vaccines (IBRV, BVDV, PI3V, BRSV,
C. fetus and
Lepto spp.)
For prevention of reproductive and respiratory diseases in cattle.
Meloxicam
Alleviation of inflammation and pain in
muscolo-skeletal disorders (dog, cat,
pigs, horse) after surgery (dog, cat, pigs)
and during colic (horse).
As adjunctive treatment of diarrhoea,
respiratory disease and acute mastitis
(cattle) as well as mastitis-metritis-agalactia syndrome (pigs).
* only available in Canada
and USA
• Pain and inflammatory
diseases
metacam®
Food producing animals – cattle
89
product portfolio
Animal Health
Companion animals – small animals
The main small animals products of Boehringer Ingel-
metacam® is a non-steroidal anti-inflammatory drug
heim Animal Health address major chronic diseases:
(NSAID). It is available as oral suspension, tablets and
heart failure and osteoarthritis.
injectable solution for dogs and as oral suspension and
injectable solution for cats. In dogs, the indications in-
As the first of a new class of heart treatments termed in-
clude the alleviation of inflammation and pain in both
odilators, vetmedin® has been shown to significantly
acute and chronic musculo-skeletal disorders as well as
improve the clinical signs and extend the life expectan-
the reduction of post-operative pain following surgery.
cy in dogs with congestive heart failure. vetmedin®
In cats, the indications include the alleviation of inflam-
works through two complementary modes of action; it
mation and pain in chronic musculo-skeletal disorders
opens up the blood vessels taking blood to and away
as well as the recently approved alleviation of mild to
from the heart, thereby lowering the pressure on the
moderate post-operative pain following surgical proce-
heart and reducing the work the heart has to do to
dures. The variety of formulations offers veterinarians
pump blood around the dog’s body. At the same time,
and owners the flexibility to use the formulations they
vetmedin® has a direct effect on the heart muscle, help-
prefer to manage the various levels of inflammation and
ing it to beat stronger and pump blood more efficiently.
pain associated with the licensed indications.
prozinc® is an aqueous protamine zinc (PZI) suspension of recombinant human insulin that is used to reduce hyperglycaemia in cats with diabetes mellitus.
Companion animals – horse
The main horse products of Boehringer Ingelheim
metacam® is indicated for the alleviation of inflamma-
Animal Health focus on the therapeutic areas respiratory
tion and relief of pain in both acute and chronic mus-
disease, lameness and colic.
culo-skeletal disorders in horses. It is available as oral
suspension and as solution for injection. The solution
ventipulmin® is a treatment of acute and chronic respi-
for injection is also indicated for the relief of pain asso-
ratory disease where airway obstruction due to bron-
ciated with equine colic, complementing buscopan®
chospasm and/or mucus accumulation is a contributing
compositum.
factor and improved mucociliary clearance is desirable.
ventipulmin® can be used alone or as adjunctive thera-
In North America there is also a comprehensive range of
py in chronic obstructive pulmonary disease (COPD)
equine vaccines available.
and in acute, sub-acute and chronic respiratory allergic
conditions.
90
Boehringer Ingelheim annual report 2010
Indications
Brand names
Active ingredients
• Congestive heart failure
vetmedin®
Pimobendan
Treatment of congestive heart failure
in dog, caused by dilatative cardiomyophathy or by cardiac valve insufficiency (mitral valve and/or tricuspidal
valve regurgitation associated with typical clinical signs, e.g. coughing, laboured
breathing, reduced tolerance to exercise
or ascites.
• Pain and inflammatory
diseases
metacam®
Meloxicam
In dogs, the indications include the alleviation of inflammation and pain in both
acute and chronic musculo-skeletal disorders as well as the reduction of postoperative pain following surgery.
In cats, the indications include the alleviation of inflammation and pain in
chronic musculo-skeletal disorders as
well as the recently approved alleviation
of mild to moderate post-operative pain
following surgical procedures.
For the reduction of hyperglycaemia and
hyperglycaemia associated clinical signs
in cats with diabetes mellitus.
prozinc®
protamine zinc
recombinant
human insulin
Brand names
Active ingredients
• Acute and chronic
obstructive respiratory
diseases
ventipulmin®
Clenbuterol
Respiratory diseases attended by bronchial spasms, like subacute and chronic
bronchiolitis, chronic-obstructive pulmonary disease (COPD), auxillary with
acute bronchitis and pneumonia of
bronchia.
• Pain and inflammatory
diseases
metacam®
Meloxicam
Alleviation of inflammation and pain in
muscolo-skeletal disorders (dog, cat,
pigs, horse) after surgery (dog, cat, pigs)
and during colic (horse).
As adjunctive treatment of diarrhoea,
respiratory disease and acute mastitis
(cattle) as well as mastitis-metritis-agalactia syndrome (pigs).
• Feline diabetes mellitus
Indications
Companion animals – small animals / horse
91
impressum
If you have any queries or comments,
please contact us.
Boehringer Ingelheim GmbH
Binger Strasse 173
55216 Ingelheim
Germany
Telephone + 49 6132 77-0
Fax + 49 6132 72-3000
Contact
Corporate Communications
Dr Bernd Mann
Telephone + 49 6132 77-92300
Fax + 49 6132 72-92300
E-mail [email protected]
Internet www.boehringer-ingelheim.com
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Copyright
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Boehringer Ingelheim GmbH, 2011
All rights reserved. No part of this Annual Report 2010 may be reproduced or transmitted
in any form or by any means, electronic or photocopy, without permission in writing from
Boehringer Ingelheim GmbH. Figures from third parties used in the annual report are based
on data available at the time the financial statement was drawn up.
92
Boehringer Ingelheim annual report 2010
C. H. Boehringer Sohn AG & Co. KG, Ingelheim
Comparison of Balance sheet / financial data 2001 –
(in millions of EUR)
Assets (as of December 31)
2001
2002
2003
322
302
242
Tangible assets
2,467
2,840
2,767
Financial assets
1,008
1,689
2,462
Fixed assets
3,797
4,831
5,471
Inventories
1,014
971
1,000
Accounts receivable (incl. deferred charges and deferred taxes)
2,314
2,360
2,537
Liquid funds
1,002
1,055
1,134
Current assets
4,330
4,386
4,671
Total assets
8,127
9,217
10,142
Liabilities and equity (as of December 31)
2001
2002
2003
200
178
178
2,753
2,818
3,139
Intangible assets
Shareholders’ capital
Reserves (incl. currency conversion difference)
Net income
401
537
529
Total equity
3,354
3,533
3,846
1
203
188
Group equity
3,355
3,736
4,034
Provisions (incl. deferred taxes)
3,150
3,568
3,963
Liabilities (incl. deferred charges)
1,622
1,913
2,145
Total liabilities
4,772
5,481
6,108
Total liabilities and equity
8,127
9,217
10,142
Minority interests
Summary of selected financial data
2001
2002
2003
Net sales
6,694
7,580
7,382
Operating income
980
1,082
901
Operating income as % of net sales
14.6
14.3
12.2
Income after taxes
401
551
537
Income after taxes as % of net sales
6.0
7.3
7.3
Return on shareholders’ equity (in %)
13.6
16.0
15.0
Equity ratio (in %)
41.3
38.3
37.9
Cash flow
1,117
1,049
1,059
Financial funds
1,645
2,645
3,516
Personnel costs
1,916
2,175
2,252
28.6
28.7
30.5
27,980
31,843
34,221
Personnel costs as % of net sales
Average number of employees
Research and development costs
Comparison of balance sheets /
financial data 2001 – 2010
1,019
1,304
1,176
R & D as % of net sales
15.2
17.2
15.9
Investments in tangible assets
548
634
516
Depreciation of tangible assets
305
340
354
– 2010
2004
2005
2006
2007
2008
2009
2010
267
233
554
547
539
745
736
3,314
2,712
2,900
2,886
2,972
3,177
3,219
2,756
3,396
3,043
1,638
1,739
1,699
3,168
5,735
6,529
6,483
5,157
5,455
5,663
7,218
1,085
1,229
1,280
1,387
1,561
1,801
1,850
2,477
3,013
3,137
2,912
3,496
3,663
4,047
1,333
1,247
945
1,015
1,312
3,877
3,118
4,895
5,489
5,362
5,314
6,369
9,341
9,015
10,630
12,018
11,845
10,471
11,824
15,004
16,233
2004
2005
2006
2007
2008
2009
2010
178
178
178
178
178
178
178
3,297
2,940
3,275
1,385
3,101
3,964
5,408
888
1,491
1,722
1,809
1,424
1,759
888
4,363
4,609
5,175
3,372
4,703
5,901
6,474
193
216
188
167
190
179
0
4,556
4,825
5,363
3,539
4,893
6,080
6,474
4,172
4,958
4,641
4,726
5,120
5,731
6,598
1,902
2,235
1,841
2,206
1,811
3,193
3,161
6,074
7,193
6,482
6,932
6,931
8,924
9,759
10,630
12,018
11,845
10,471
11,824
15,004
16,233
2004
2005
2006
2007
2008
2009
2010
8,157
9,535
10,574
10,952
11,595
12,721
12,586
1,372
1,923
2,140
2,100
1,980
2,239
1,896
16.8
20.2
20.2
19.2
17.1
17.6
15.1
908
1,514
1,729
1,812
1,428
1,764
888
11.1
15.9
16.4
16.5
12.3
13.9
7.1
23.1
34.2
37.4
35.0
42.2
37.4
15.0
41.0
38.4
43.7
32.2
39.8
39.3
39.9
1,430
2,069
2,317
2,392
1,997
2,409
2,234
4,015
4,585
3,934
2,581
2,932
5,384
6,113
2,443
2,671
2,836
2,886
3,004
3,221
3,358
29.9
28.0
26.8
26.4
25.9
25.3
26.7
35,529
37,406
38,428
39,800
41,300
41,534
42,224
1,232
1,360
1,574
1,900
2,109
2,215
2,453
15.1
14.3
14.9
17.3
18.2
17.4
19.5
427
532
596
654
665
630
519
377
439
419
432
453
470
498
www.boehringer-ingelheim.com