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SCIENCE,
PEOPLE,
AFFORDABLE
MEDICINES
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
SYNTHON.COM
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SYNTHON IS A COMPANY
COMMITTED TO DELIVERING
QUALITY MEDICINES
AT SUSTAINABLE PRICING
THROUGH INNOVATIVE SCIENCE
SCIENCE-DRIVEN
INNOVATION
Good health is something we all desire and deserve.
We believe everyone on the planet is entitled to access to
quality medicines at sustainable pricing. We will put our
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
cutting-edge science, ability to innovate and talented people
into action to provide solutions for health care challenges
today and tomorrow.
Innovation and continuous improvement are the heart beat of
our company. We work to develop therapies that address the
needs of people worldwide and help improve their health and
well-being. With our portfolio of innovative products we will
provide treatment options for patients in selected therapeutic
areas with high unmet medical need. Through the provision of
high-quality generic medicines we make treatments more
affordable and increase access to important remedies. To make
this happen, we hold ourselves to the highest standards of
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scientific and operational excellence in everything we do – from
the discovery phase in R&D through production and to
delivery of our products to our customers - across every
technological platform.
A GROWING,
GLOBAL OPERATION
Our products are currently approved by regulatory agencies
in over 90 countries. We have globally-oriented API or drug
product manufacturing facilities in the Czech Republic,
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
Argentina and Spain. In Chile, our ultramodern multi-purpose
drug product site is compliant with local and European GMP
standards and contains highly advanced facilities varying
from development to large-scale production of tablets,
capsules and pre-filled syringes. Furthermore, our facilities in
Mexico and Chile manufacture and package products for the
local markets. With our state-of-the-art biopharmaceutical
laboratories and GMP facilities for the manufacture of
monoclonal antibodies and the production of antibody-drug
conjugates (ADCs) - up to Phase III clinical trials and early
launches - in our main campus in the Netherlands, our
worldwide infrastructure is fully rigged up, positioning us to
SYNTHON.COM
deliver on our ambitions.
We continue to invest and expand globally and are continually
looking to find partners for our products in all major markets.
Synthon’s strategy from its inception included development of
a vertically integrated organization. Today, we control every
facet of the development chain beginning with the production
of raw materials through to the manufacture and sale of our
products. This is, and has always been, one of our greatest
strengths in enabling us to deliver high-quality medicines to
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the people most in need of them.
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SYNTHON.COM
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
OUR
STRATEGY
Synthon’s ambition is to become a recognized
leader in specialty pharmaceuticals.
The vertically-integrated model we developed
for small molecule generics is expanding as
we continuously strive to improve our R&D
capabilities, global regulatory and IP expertise,
and world-class manufacturing and supply
chain operations. And we have extended this
model to our new biological and new chemical
entity technological platforms. Our innovative
R&D and proven ability to manufacture and
distribute high-quality pharmaceuticals
positions us well for our future in specialty
pharmaceuticals.
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SYNTHON.COM
GROWING
R&D CAPABILITIES
Research and development remain vital to the
overall value chain and are essential to our
company. We therefore invest heavily in
basic and applied research. In addition to
chemical and (bio)pharmaceutical R&D,
we carry out analytical and clinical research
worldwide. We have our own fully-functional
clinical drug development unit which is
well-equipped to take our development phase
compounds into clinical trials - up to and
including Phase III.
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SYNTHON.COM
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Small molecule generics continue to form the
backbone of our product portfolio. Our generic
pipeline is rich with research projects and
pending regulatory applications. Recent product
launches in our major markets include linezolid
in Croatia and Slovakia for the treatment of
serious infections caused by Gram-positive
bacteria that are resistant to several antibiotics,
and, following a fast approval process,
aripiprazole - a product used predominantly
for the treatment of schizophrenia - in Germany.
In addition, we launched celecoxib - indicated
for the relief of the signs and symptoms of
osteoarthritis, rheumatoid arthritis, ankylosing
spondylitis, and for the management of acute
pain in adults - all over Europe on expiration
of the compound patent. Further we brought
sevelamer carbonate tablets to the European
DISTINCTIVE IN
GENERICS
market - for the control of serum phosphorus
in patients with chronic kidney disease.
In Western Europe we launched eplerenone used in the management of chronic heart
failure - and zoledronic acid solution for
infusion - for the treatment of men and
post-menopausal women with osteoporosis
or osteoporosis caused by treatment with
steroids, and patients with Paget’s disease of
the bone. In selected markets we launched
bortezomib lyophilized powder for injections for the treatment of progressive multiple
myeloma in patients who have received at
least one prior therapy and who have already
undergone or are unsuitable for bone marrow
transplantation, as well as pemetrexed - used
in the treatment of pleural mesothelioma and
non-small cell lung cancer.
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SYNTHON.COM
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
PROMISING
BIOPHARMACEUTICAL
PIPELINE
Synthon started its biopharmaceutical
franchise (the development of biopharmaceutical medicines based on therapeutic
proteins) in 2007. The franchise focuses on
new molecular entity development. This
highly-innovative business covers a wide
spectrum of technologies, including complex
medicinal chemistry, cell line development,
bioanalytical chemistry and protein production,
conjugation, purification and formulation.
Our principal technology platforms include
antibody-drug conjugate (ADC) technology,
comprising a unique linker-drug platform to
generate next generation ADC candidates.
In 2014, we brought our most advanced ADC
candidate SYD985 to the clinic for a two-part
first-in-human Phase I study. Our portfolio of
new molecular entities is well-positioned to
encompass multiple clinical-stage programs
in the coming years and reflects our focus
and commitment to bring medicines for
treating medically-complex and serious
conditions to patients with a high unmet
medical need, notably in oncology and
autoimmune diseases.
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SYNTHON.COM
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
We believe in a collaborative model based
upon strong partnerships with leading
scientists, research institutions and marketing
partners. Our strategy of developing robust
business-to-business partnerships enables
us to share knowledge with and draw upon
the specialist skills of partner companies to
manage costs, deliver short product development cycle times and bring much-needed
products to market. Such has been the
success of our efforts that in the past decade,
the number of marketing partners has jumped
from around 60 to almost 200 today.
In terms of partnering our clinical innovative
programs, we are in a position to choose the
optimum commercial path for each program.
We look to partner a technology or product
candidate at an appropriate pre-market stage
or value inflection point.
STRENGTH THROUGH
COLLABORATIVE
PARTNERSHIPS
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
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INTELLECTUAL
PROPERTY
Intellectual property rights will remain a
crucial factor in the pharmaceutical industry.
We actively promote and defend our
interests worldwide, particularly with regard
to patent and regulatory issues. To this end,
we have access to high quality legal
representation and patent attorneys.
By having the right legal expertise at hand,
we can proactively ensure that our interests
are fully protected and a seamless and
effective business operation is maintained.
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SYNTHON.COM
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
REGULATORY
AFFAIRS
We provide our customers with a complete
product, including all components necessary
for trouble-free registration, wherever in the
world. In practical terms, this means that our
experts are familiar – down to the smallest
detail – with increasingly stringent and
ever-changing regulatory regimes in more
than 90 countries. We compile registration
files, compliant with the chemical,
pharmaceutical and clinical requirements of
regulatory authorities, such as the EMA,
FDA and TGA. In cases where we out-license
a biopharmaceutical before regulatory
submission, our counterparts can count on
detailed documentation and support that
can eventually be used to build a dossier for
submission.
OUR PRODUCTS
Our products are all high-quality, efficacious and
affordable medicines, often supported by our own
strong patents, guaranteeing a long product lifespan.
Our global commercial generic portfolio includes*
Allergy
Levocetirizine Montelukast Oncology
Urticaria / allergic rhinitis Asthma / allergy tab 5 mg
chewable 4/5 mg; tab 10 mg
Anti-infective
inf bag 2 mg/ml 300 ml
Anti-infective
Linezolid Cardiovascular
Bisoprolol Bisoprolol HCT Dobutamine Doxazosin Eplerenone
Simvastatin Hypertension Hypertension Heart Failure Hypertension / BPH Heart failure /
left ventricular dysfunction
Hypercholesterolemia tab 5/10 mg
tab 5+12.5/10+25 mg
inj 12.5 mg/ml - 20 ml
tab 2/4/8 mg
tab 25/50 mg
tab 5/10/20/40/80 mg
Anastrozole Bicalutamide Bortezomib
Exemestane Ibandronate Imatinib
Letrozole Zoledronic acid
20
vial 4mg/5ml
Osteoporosis Osteoporosis
Osteoporosis
tab 150 mg, pfs 3mg/3ml
tab 60 mg
sol 5mg/100ml
Arthritis
cap 100/200 mg
Hypertension / BPH Chronic kidney failure BPH tab 2/4/8 mg
tab 800 mg
mr cap 0.4 mg, mr tab 0.4 mg
tab 50 mg, vial 2mg/2ml, 6mg/6ml
tab 100/400 mg
tab 2.5 mg
Skeletal
Ibandronate Raloxifene Zoledronic acid
Celecoxib
Schizophrenia
Schizophrenia Alzheimer Depression Sedation Depression Epilepsy
Alzheimer
Anesthetic / Insomnia Schizophrenia Depression Parkinson / RLS Anesthetic / Sedation Insomnia Insomnia tab 1 mg
tab 50/150 mg
lyo 1 mg/vial; lyo 3.5 mg/vial
tab 25 mg
Pain
Central Nervous System
Aripiprazole
Clozapine Donepezil Escitalopram Flumazenil Fluvoxamine Levetiracetam Memantine Midazolam Olanzapine Paroxetine Pramipexole Propofol Zolpidem Zopiclone Breast cancer Prostate cancer Multiple myeloma
Breast cancer Skeletal events related
to bone metastases
Chronic myeloid leukemia
Breast cancer Skeletal events related
to bone metastases
tab 5/10/15/20/30 mg
tab 25/100 mg
tab 5/10 mg
tab 10/15/20 mg
inj 0.1 mg/ml - 5/10 ml
tab 50/100 mg
tab 250/500/750/1000 mg; sol 100mg/ml 150 ml, 300 ml
tab 5/10/15/20 mg
inj 1 mg/ml - 5ml; inj 5 mg/ml - 1/3/10ml
tab 2.5/5/7.5/10 mg
tab 20 mg; drops 20mg/20 drops – 20ml flask
tab 0.125/0.25/0.5/1.0/1.5 mg
inj 1%: 20/50/100 ml, 2%: 50ml
tab 5/10 mg
tab 3.75/5/7.5 mg
Urology
Doxazosin Sevelamer
Tamsulosin * Please note that the reference date for this product list is September, 2015. Our portfolio of approved products differs from country to country. In addition to the above mentioned commercial products, Synthon owns a rich pipeline of research projects and pending regulatory applications for multiple products.
1991
_
1993
_
1997
_
2014
_
Founded in The Netherlands
Launched first product:
generic dobutamine
Opened office in
North Carolina, USA
New monoclonal antibody
production facility
established in the
Netherlands
_
SYNTHON.COM
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
New plant dedicated to the
manufacture of API to support
our MS product line opens in
Argentina
1998
_
2000
_
2001
_
Acquired drug product
manufacturing facility in Spain
Acquired API production
facility in Blansko,
the Czech Republic
Acquired API production
facility in Argentina
2003
_
2006
_
2007
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Introduced simvastatin
Introduced tamsulosin
Acquired Laboratorios Rider
in Chile
Launched biopharma­ceuticals
business
2009
_
2010
_
2011
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Opened new R&D and
production unit in the
Czech Republic
Acquired Laboratorios Nafar in
Mexico
Opening new biopharma­ceutical
lab in Nijmegen,
The Netherlands
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Opened office in Moscow,
Russia
2012
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Multi-purpose GMP drug
product manufacturing facility
in Chile in business
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Inauguration of R&D pilot
plant in Argentina
22
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Opened office in South Korea
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Licensed biosimilar
trastuzumab to
Amgen/Watson
(now Amgen/Actavis)
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Acquired Syntarga in
The Netherlands
2013
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New antibody-drug
conjugation (ADC) facility
with high-potent clean room
suite and cutting edge
QC laboratories operational
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New facility for linker-drug
production opens in
Blansko, Czech Republic
LEADERSHIP BY
EXAMPLE
Synthon was founded in 1991, and within
two years its creative vision and passion for
making healthcare more affordable led to the
development of dobutamine, a sympathomimetic drug used in the treatment of heart
failure and cardiogenic shock. The success
of this first product out of the blocks led to
rapid international growth. Synthon grew
over the course of its first decade from a
small Nijmegen-based outfit employing less
than a hundred people into a fully-fledged
specialty pharma company with laboratories,
offices and production plants all around the
world.
A headcount of more than 1,500 highly
educated people around the world, strong
profits and a sound financial foundation are
the core ingredients to successfully delivering
what we do best: affordable medicines to
those in need. This would not have been
possible without the right combination of
technical expertise, business discipline and
entrepreneurial capability at every level of
management.
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SYNTHON.COM
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
A CORE OF
TALENTED PEOPLE
Our success stands or falls with the quality
of our people. Our company is our people.
We aren´t just content to bring together a
group of talented scientists. We openly seek
people who share the same values and are
both entrepreneurial in attitude and able to
work selflessly as part of a team for the good
of our company and our ambitious goals.
People with the drive to contribute to the
creation of new and effective medicines.
We keep the pride and satisfaction of our
highly committed group of colleagues at the
center while building our company. Together
we will continue our work to unlock our
opportunities and bring important medicines
– irrespective of whether they are complex
generics or new molecular entities – to our
ultimate focal point: the patient.
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
GLOBAL PRESENCE
Nijmegen, The Netherlands
Synthon Headquarters
Barcelona, Spain
Synthon Hispania
Blansko, Czech Republic
Synthon s.r.o.
Durham, NC, United States of America
Synthon Pharmaceuticals, Inc.
San Lorenzo, Argentina
Synthon Argentina S.A.
Santiago, Chile
Laboratorios Rider Ltda
Guadalajara, Mexico
Laboratorios Nafar
Moscow, Russia
Synthon LLC
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SYNTHON.COM
Seoul, South Korea
Synthon Korea Co. Ltd.
CONTACT
Would you like to learn more about Synthon?
Please visit www.synthon.com
If you are interested in our product portfolio,
please feel free to contact us.
SCIENCE, PEOPLE, AFFORDABLE MEDICINES
Business Development Generics
[email protected]
(+31) 24 37 27 700
Business Development Biopharmaceuticals
[email protected]
(+31) 24 37 27 700
If you would like to know more about job
opportunities, please visit www.synthon.com
and click on Careers.
Editorial coordination
Synthon Holding BV
Corporate Communications
Nijmegen, The Netherlands
SYNTHON.COM
Design
Zuiderlicht
Maastricht, The Netherlands
Printing
Drukkerij Tesink
Zutphen, The Netherlands
September 2015
© Synthon Holding BV
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www.synthon.com
Disclaimer
Copyright © 2015 Synthon Holding BV.
All rights reserved. Reproduction of the
content in other publications is permitted.
However, credit to Synthon would be
appreciated.
This brochure contains information on
pharmaceutical products and has been
composed for healthcare professionals.
It has been composed with the greatest
possible care. It may however contain
inconsistencies and for that reason it
cannot be relied upon. Synthon is not
liable for any consequences as a result of
the reliance on any information contained
in this brochure.