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For use : 00.01, Thursday, September 8th, 2005.
Image of blood-laden mosquito available from Wellcome Trust Media
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Attention for Neglected Diseases.
A dramatic sea-change in research into ten so-called ‘neglected diseases’,
including malaria, tuberculosis (TB), leprosy and sleeping sickness, could
result in at least eight new drugs being developed by 2010, an influential
report claims today (Sept 8th).
After a barren period when very few therapies were introduced for these
diseases, which kill around 3m people a year and cause the loss of the
equivalent of 92m years’ of healthy life, there are now over 60 drug
research projects underway.
Around three-quarters of these projects are conducted under the umbrella
of drug development Public-Private Partnerships, with 13 of them having
already reached clinical trial stage and two* awaiting regulatory approval.
These PPP-driven projects should result in six or seven new drug
registrations in the next five years.
The 100-page report, financed by the Wellcome Trust and carried out by
a team from the London School of Economics and Political Science led
by Dr Mary Moran, demonstrates that PPPs have been a critical driver of
this considerable increase in activity, and recommends policy-makers
should support them when it comes to neglected disease research and
development.
In the four years to 2004 Public-Private Partnerships spent £62m ($112m)
on a combined portfolio of 46 drug projects. In contrast, a company will
have to invest around £220 ($400m) out of pocket costs to bring just one
commercial drug to market, according to the report, “The New Landscape
of Neglected Disease Drug Development.”
The report, on the basis of a vast amount of empirical data, also finds that
the PPP approach brings together the best skills of both public and private
partners. This model consequently performs better than either sector
working alone when it comes to delivering safe, effective, affordable
drugs for neglected diseases.
Despite this, relatively little public money is given to PPPs, with just
£23m ($43m) coming from only four members of the Organisation for
Economic Co-Operation and Development over the past five years. Over
the same period philanthropic organisations have contributed over £111m
($200m.)
The report points out the surprising lack of policy incentives to support
PPPs, which have become a cornerstone of both large and small
pharmaceutical company involvement in neglected disease R&D. And, it
adds, some of those that are on offer could well be counter-productive.
The report warns: “Continued lack of public support is likely to lead to
the collapse of PPPs, leaving governments with little recourse but to fund
expensive in-house industry activity from start to finish or to build
alternative drug-making capacity.”
There are currently five PPPs** concentrating on drugs for neglected
diseases. All, apart from one, which is operated by the World Health
Organisation, were set-up in the last six years, therefore they have not had
time to establish a track record in bringing drugs to the market.
However the report points ou : “PPPs now conduct the majority of
neglected disease drug projects, have the majority of drugs in clinical
trials and are likely to have registered several products within the next
few years. This is an excellent outcome for a very modest annual
investment of philanthropic and public funds.”
Dr Moran and her colleagues also describe how multi-national
pharmaceutical companies, which had moved away from neglected
disease research, have now returned to this area on a “no-profit-no-loss”
basis. Eight are involved in this type of research, with four having
dedicated institutes employing over 200 scientists.
“These companies are not motivated by commercial returns in neglected
disease markets but rather by longer term business concerns, including
managing reputational risk, addressing ethical issues and positioning
themselves strategically in growing developing country commercial
markets,” the report explains.
Between 1975 and 1997 only 13 new drugs were developed for neglected
diseases. But that was when the WHO and multi-national companies were
alone in working on this problem. Now they are involved in more than
half the 63 projects which are underway, sixteen of which are joint
ventures with PPPs.
Dr Moran’s team recommends the creation of a public fund to pay for
research and development of neglected disease drugs within PPPs, which
they estimate would cost up to £1bn ($1.9bn) over ten years.
They also urge a package of incentives to encourage research by small or
medium sized companies, who are increasingly becoming players in the
neglected disease field.
Dr Moran, Programme Director of the Pharmaceutical Research and
Development Policy Group at the LSE, said:“ For many years, it was the
sad truth that virtually nothing was happening in neglected disease R&D.
But we are now seeing some really promising developments that simply
did not exist 10 years ago. In reality, the current problem is not that
nothing is happening – it is that policy-makers and government donors
are still working off this old R&D script. As a result, policies have tended
to focus on how to get R&D started but have largely failed to support
neglected disease initiatives that are already working on- and in some
cases already delivering – new drugs.
“We hope our report goes some way towards bringing this “R&D script”
up to date. With the right information and tools, we are confident that
policy-makers can give a highly-effective boost to neglected disease drug
development for the millions of patients who are waiting on these
products”
Dr Ted Bianco, Director of Technology Transfer at the Wellcome Trust
said: “This report gives us confidence that Public-Private Partnerships are
stimulating an unprecedented level of research into badly needed, new
drugs for neglected diseases.
“It is evident that this model has attractions for small and large companies
alike and most importantly looks set to deliver much needed medicines to
some of the most under-privileged people of the world.
“There is a political consensus within the G8 that it is a global
responsibility to check the misery caused by infectious diseases in
developing countries. Dr Moran’s proposals on how governments may
more fully engage with the PPPs is timely particularly as the
philanthropic organisations cannot be expected to shoulder the financial
burden of this type of research forever.”
Dr Chris Hentschel, Chief Executive Officer of the Geneva-based
Medicines for Malaria Venture said : "In public policy, just as in drug
research, we need to rigorously follow the evidence of what works and
what does not. Few who know this area will be surprised at the
conclusion of this report which is supported by data meticulously
compiled and analysed. Public policy initiatives supportive of the
burgeoning PPP pipelines need to be implemented quickly otherwise the
enormous value already created in them may be lost."
An article outlining the report is published today by the Public Library of
Science. The full report is also available on-line at www.wellcome.ac.uk
Ends.
Notes to Editors.
* Rectal artesunate for malaria and paromomycin for visceral
leishmaniasis.
* PPPs :
Medicines for Malaria Venture, founded 1999.
TB Alliance, founded 2000.
Institute for OneWorld Health, founded 2000
Drugs for Neglected Diseases Initiative, founded 2003.
WHO/ Special Programme for Research and Training in Tropical
Diseases, founded 1975.
….
The Wellcome Trust is an independent research-funding charity
established in 1936 under the will of tropical medicine pioneer Sir Henry
Wellcome. The Trust’s mission is to promote research with the aim of
improving human and animal health and it currently spends more than
£400m p.a. The Technology Transfer Division manages the charity's
intellectual property portfolio and related matters and provides translation
funding for early-stage healthcare technology development. Over 70
research and license agreements have been transacted and the division has
an interest in around 20 life science Small, Medium Enterprises located in
the UK or US.
The London School of Economics and Political Science is the world's
leading social sciences institution for teaching and research. Based in the
heart of London, its 7,500 undergraduate and postgraduate students come
from more than 150 countries worldwide to study in one of the 19
departments or more than 30 research centres. A total of 13 Nobel prize
winners have either studied or taught at LSE and many world leaders
have also studied at the School. In the most recent national research
assessment in the UK, LSE came second after Cambridge for the quality
of its research - and top if only the social sciences are taken into account.
For additional information on LSE, visit www.lse.ac.uk
Media Contact : Mark Anderson, Wellcome Trust.
0207 611 8612.
Neglected Diseases as listed by the World Health Organisation:
Human African Trypanosomiasis ( HAT or sleeping sickness): Around
60m people in 36 sub-Sahara African countries at risk. Reduces many
victims to zombie-like state. Fatal if not treated. Most drugs are old,
difficult to administer and one – Melarsoprol – contains arsenic and can
kill up to one in twenty patients.
Chagas disease : Prevalent in South and Central America as well as
Mexico, affecting 16-18 million people in 21 countries with 120m at risk.
Is often symptomless for years but can eventually cause heart damage and
kill. Two drugs available for treatment but these can have serious and
frequent side-effects.
Dengue: More than one-third of the world’s population – 2500 million
people –are under threat from this mosquito-borne disease which is
nicknamed “breakbone fever” because of the crushing intensity of the flulike symptoms it brings. Affects 100 countries in Africa, the Americas,
SE Asia and western Pacific. No specific treatment.
Leishmaniasis: Has spread significantly in the last decade and now
affects 88 countries with 350m people at risk. In worst cases it causes
severe scarring and eats away the mouth, palate and nose tissue, leading
to victims being ostracised by their communities. Transmitted by
sandflies. Drugs are either toxic or unaffordable.
Leprosy: Earliest reported cases in 600 BC. Over past 20 years more than
12m patients have been cured and the disease has been wiped-out in 108
of the 122 countries where it was a threat. However in 2002 there were
still 650,000 cases reported in India, Brazil, Madagascar, Mozambique,
Myanmar and Nepal. Effective drugs have been available since the 1940s
but an extended course is needed.
Lymphatic filariasis (Elephantiasis): This mosquito-spread disease
causes massive swelling of the limbs and genital area. Of the 120m
people who have it around one-third are seriously incapacitated or
disfigured. Two-thirds of cases occur in India and Africa with the rest in
S. Asia, the Pacific and Americas. It is a continuing problem but drugs
can be effective if given early enough. Some have been donated by major
pharmaceutical companies (GlaxoSmithKline and Merck).
Malaria: There are more than half a billion episodes a year resulting in
at least one million deaths. Most victims are young children. The majority
of cases occur in Africa with nearly 25% in SE Asia and the western
Pacific. Malaria is estimated to cost Africa alone $12bn in lost GDP each
year. Extensive resistance to some drugs has now prompted the WHO to
recommend combination therapies, preferably those containing
derivatives of artemisinin – taken from the Chinese herb qinghao - but
these can be expensive.
Onchocerciasis (River Blindness): One of the world’s leading causes of
infectious blindness, caused by a parasitic worm which lives in the body
for up to 14 years. Some 18m people in tropical Africa are infected. Of
these 800,000 have vision impairment and another 270,000 are blind. A
single dose of ivermectin, taken annually, is effective but does not
completely clear the infection. This drug is being donated free by Merck.
Schistosomiasis ( Bilharzia): Affects 200m people living in 74
developing countries. Parasite picked-up from snails living in freshwater
causes damage to the bladder and kidneys. Kills relatively few – around
15,000 – but children are especially vulnerable. Two effective drugs are
available – praziquantel and oxamniquine.
Tuberculosis: Kills around 1.6m people a year with someone becoming
infected every second. They, in turn, will infect between 10 and 15
people. The WHO declared TB a global health emergency in 1993. Most
cases occur in Africa, SE Asia and the western Pacific. Various vaccines
are in development and the disease can be effectively treated with a
cocktail of drugs, but only after several months of intensive therapy.