E-DRUG: more money and interest for neglected diseases?
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[The "in Focus" message shows that funders are getting more interested in
neglected diseases. The WHO assembly (see
http://www.who.int/gb/ebwha/e/e_wha57.html) is also disussing neglected
diseases next week: Trypanosomiasis and Buruli Ulcer.
See for example A57/5, Surveillance and control of Mycobacterium ulcerans
disease (Buruli ulcer), and A57/6 Control of human African trypanosomiasis.
WB]
In focus
29 April 2004
New generation of non-profit initiatives tackles world's "neglected"
diseases
A new generation of non-profit drug companies and public-private
partnerships are taking on the challenge of developing drugs and vaccines
against diseases plaguing developing countries and traditionally ignored by
the pharmaceutical industry because they lack profit potential.
Buying up the rights to develop and market drugs for "neglected" diseases
from the drug companies who own them but have yet to develop them are a
growing number of initiatives such as One World Health, a US-based
non-profit drug company and another US-based non-profit organization, the
Areas Global TB Vaccine Foundation.
The Bill and Melinda Gates Foundation announced on 12 February 2004 a US$
82.9 million grant to the Aereas Global TB Vaccine Foundation to support
the development of new vaccines to prevent tuberculosis which causes nearly
two million deaths every year, the majority of which occur in developing
countries. The grant, the largest ever for TB vaccine development, will
allow Aeras to fund human trials of promising TB vaccines and early
research on the next generation of vaccines.
Similarly, One World Health, received US$ 10 million from the Bill and
Melinda Gates Foundation to test a promising new treatment for
leishmaniasis (kala azar). It is estimated that around 350 million people
in 88 countries are at risk of contracting this often-lethal disease but 90
% of cases are concentrated in India, Bangladesh, Brazil, Nepal and Sudan,
according to the World Health Organization. Some 1.5 to 2 million new cases
occur annually.
The pharmaceutical industry has responded with its own initiatives. The
development of drugs against malaria, a disease which kills almost a
million people every year ? mostly in Africa, has benefited from a recent
agreement between Chongqing Holley Holding, a Chinese pharmaceutical
company, Sigma-Tau, an Italian pharmaceutical company, Medicines for
Malaria Venture, a non-profit organization and the University of Oxford. On
19 March, they signed an agreement for the international development of the
anti-malarial drug, Dihydroartemisinin-piperaquine (Artekin). Unlike the
conventional chloroquine and sulfadoxine-pyrimethamine treatments,
artemisinin, from which the drug is derived, has not yet produced any known
cases of resistance.
"Not only should this antimalarial be effective," said Dr Christopher
Hentschel, CEO of Medicines for Malaria Venture, "our goal is also to be
able to make it available at a cost that's affordable for people living on
less than a dollar a day."
The US-based firm, Johnson & Johnson, announced on 30 March 2004 that it
has granted royalty-free rights to the International Partnership for
Microbicides for a vaginal medication to prevent HIV infection in women
originally developed by the firm's subsidiary, Tibotec Pharmaceuticals. The
partnership, also based in the US, will conduct the remaining trials of the
drug, known as TMC-120, in order to gain regulatory approval. If the trials
are successful the product could be on the market by 2010. Research into
microbicides has previously been held up by a lack of resources and the
absence of interest in the pharmaceutical industry. (See related news
article, Microbicides preventing HIV infection could be available by 2010,
in this issue of the Bulletin, (2004;82:393).
These examples are indicative of a growing trend in which non-profit
entities, governments, international organizations and
pharmaceutical/biotech firms are partnering to develop drugs or vaccines
and make them accessible to needy countries.
"Public-private partnerships are not new ? they started in the 1970s and
built strength through the 1990s. But a few things have happened in the
past few years. They've become consolidated and accepted, and they've
scaled up considerably," said Robert Ridley, Ad Interim Director of the
UNICEF/UNDP/World Bank/WHO Special Program for Research and Training in
Tropical Diseases (TDR) in Geneva.
There are nearly one hundred such partnerships, according to the Initiative
on Public-Private-Partnerships for Health at the Global Forum for Health
Research, a non-profit group based in Geneva whose mission is to track such
arrangements and help them perform more effectively. "Each of them has a
unique structure, but the majority are involved in product development,"
said Roy Widdus, Project Manager.
The recent initiatives offer a window on how the new breed of
public-private partnership functions. One World Health, for example, is
using its Gates grant for clinical trials in Bihar, India, to assess the
efficacy of paromomycin for the treatment of leishmaniasis.
In the 1990s the World Health Organization received a donation of
paromomycin from Farmitalia ? the Italian pharmaceutical firm holding the
license. Farmitalia was not interested in developing the drug on its own
because of paromomycin's lack of potential to become profitable, given the
expense of conducting clinical trials and the poor economic status of
people most in need of it.
"We began with Phase I and II trials on the drug, but unfortunately, we ran
out of funds and had to stop," said Philippe Desjeux, Medical Officer in
charge of leishmaniasis control programmes in WHO's department of
Communicable Diseases. "Then One World [Health] came to see us, looking for
a project. I suggested they take over the trials and continue to Phase III,
which they did. It's a nice example of the complimentarity of efforts
between a non-profit organization, industry, a foundation, and an
international organization."
Another public-private partnership is seeking new preventive strategies
against leishmaniasis. The non-profit US-based Infectious Diseases Research
Institute and biotech company Corixa are working on the project with the
Special Program for Research and Training in Tropical Diseases (TDR). Phase
I trials on a new vaccine were recently completed in the US.
According to Dr Farrokh Modabber, manager of the TDR-Infectious Disease
Research Institute Collaborative Project, a public-private collaboration
was the only practical route for developing a leishmaniasis vaccine. "It's
a risky, expensive and time-consuming business developing vaccines," he
said. "It is unlikely at this time that any private company would undertake
single-handedly a project for a vaccine against a disease affecting mostly
poor countries."
Similarly, the only serious efforts to develop an effective vaccine against
tuberculosis are taking place through the Aeras Global TB Vaccine
Foundation.
Aeras announced in February that it would begin Phase II trials of two new
vaccines against tuberculosis. The project has enlisted partnerships with
scientists, academic institutions, governments, and companies in Europe,
South Africa and other developing countries and the US. A clinical research
site is already in operation in Cape Town, South Africa, where more than
9000 volunteers are enrolled in a clinical trial. Other sites are being
considered in Peru and India. Aeras is also partnering with The Biovac
Institute in Cape Town to manufacture vaccines for future Phase I and II
clinical trials.
Other ambitious non-profit-generated drug development projects are in the
pipeline. In July 2003, M�d�cins sans Fronti�res, the Pasteur Institute,
the Special Program for Research and Training in Tropical Diseases (TDR),
the Oswaldo Cruz Foundation, the Indian Council for Medical Research and
the Malaysian Ministry of Health together established in Geneva a
not-for-profit entity, the Drugs for Neglected Diseases Initiative. The new
group's objective is to develop treatments for African trypanosomiasis,
Chagas disease ? a parasitic illness affecting nearly a quarter of Latin
America's poor ? and leishmaniasis.
The push toward public-private partnerships is not without critics.
According to Bernard P�coul, Executive Director, the goals of the most
widely publicized partnerships are not portrayed accurately. "Many of the
most ambitious current projects will benefit rich countries as well as poor
ones ? the tuberculosis vaccine, for example. And although a vaccine and
better treatment for kala azar [leishmaniasis] will help people in
developing countries, they also have strategic interest for Western
countries, the US in particular, because its military personnel is at
risk," he said. The cutaneous version of the disease, dubbed "Baghdad
Boil," has infected 150 US soldiers serving in Iraq, according to newspaper
reports.
"You don't see so much energy committed to a disease like trypanosomiasis,
which affects as many as half a million people," continued P�coul,
"?[because] almost all of them are very poor and live in isolated areas of
sub-Saharan Africa where tourists rarely venture."
At present only 10 % of money spent on drug development is devoted to
conquering 90 % of the world's health problems. P�coul remains sceptical of
the contribution these new initiatives can make towards addressing this gap
without a change in public policy.
"We will never find a solution to the 10/90 gap until we see a radical
change in public policy ? and there are not strong signs this is happening.
It's great to have a money injection, as we've had lately, but we need
sustainable solutions," said Bernard P�coul.
Judith Mandelbaum-Schmid, Zurich
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