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Framework
to push malaria research
 Medicines
for Malaria Venture (MMV), constituted in November 1999, by the
World Health Organization, brings under one umbrella public, private
and philanthropic partners to fund and manage the discovery, development
and commercialization of new drugs for treatment and prevention
of malaria in disease endemic countries. Dr P V Venugopal,
director, International Operations, MMV, in a discussion with Jayashree
Padmini points out that he is keenly looking for good projects
in India
MMV
has been established by WHO to direct all efforts towards intensifying
R&D in malaria research. What is the approach taken by MMV in
developing drugs for malaria?
Even if a medicine more effective than Artemisinin is developed,
it will not become a blockbuster for an MNC as the financial prospects
of anti-malarial market poses restrictions.
It
is in view of the lack of initiative in new drug development in
malaria that WHO has created MMV. Our approach is to scout for projects
in malarial research and create an atmosphere conducive to research
in this area. Our strategy is to frame innovative methodologies
to bring down the cost of R&D, create an incentive framework
to push research in malaria, pace up research speed & boost
motivation at academic level and rope in industry partners in order
to commercialize research results faster.
MMV’s
long term goal is to develop a new class of anti-malarial molecules
that will be effective with a three-day course of treatment and
would be safe for use in infants. In the short term, we are looking
at developing innovative combinations of Artemisinin that would
comprehensively address the issue of drug resistance. We expect
to build upon insights from the integrated analysis of plasmodium,
human and anopheles genomics to develop interventions to effectively
tackle malaria.
What
is the methodology adopted by MMV to spearhead its objective?
We
proactively search for projects across the globe through different
media such as advertising in Nature, through the Net, and of course
word of mouth. Our Advisory Committee screen through the collected
projects and selected ones are funded, that is the first step to
say. The key strategy is to link academic groups with industry groups
to optimize access both to the technologies associated with drug
R&D and also the mindset and thinking that is required to generate
a product.
MMV
project managers together with an expert scientific committee will
closely monitor the projects. Our scientific team holds interactive
sessions with the project participants every three months and the
progress is reviewed by the Advisory Committee that meets twice
a year. Continued funding is dependent on success and progress toward
the goal of discovering and developing an appropriate drug.
The
process employed by MMV is one of ‘virtual’ drug discovery
and ‘virtual’ drug development, with all processes being
outsourced,but appropriately managed by a central unit.
Where
do the funds come from and what is the annual availability?
MMV
is a virtual R&D organization. We get funds from different agencies
apart from WHO. These include the World Bank, Swiss government,
Department for International Development, UK, Rockefeller Foundation,
Bill & Melinda Gates Foundation, Exon Mobil Corporation, etc.
At the peak, we will have an annual budget of about $30 million
and at the moment the quantum is $15 mn in order to build and sustain
the pipeline. But an additional valuable contribution is in kind
from participating institutions/ industry in terms of the entire
gamut of R&D activity.
What
kind of projects does MMV take up and what are the criteria?
MMV
take up projects in different categories such as discovery project
- lead optimization, development project - innovative combinations
and exploratory project - identification of totally new targets.
However, we would prefer to take up projects at a stage where at
least toxicology studies have been completed. Our objective is to
work towards and to develop totally new molecules. We have invited
the third round of proposals in three categories, viz., discovery
projects, development projects and natural products. We are determined
on this despite all restrictions.
What
are the restrictions you are talking about?
Rather
than restrictions, I would like to put it as lack of incentives.
The smaller market, that too dominantly in the developing countries,
itself is the hurdle. In the US, there is the Orphan Drug Law, which
gives protection to a particular drug and its manufacturer. Countries
like Japan, UK and some other European countries also have similar
laws.
Do
you suggest such laws for malarial drugs in India or say tropical
countries?
Incorporating
such provisions to the country’s law is in the hands of the
national governments. But MMV is created to ensure that research
efforts are directed to malaria and to change the image that malaria
is a neglected disease.
Does
that mean only institutional research is directed towards malaria
while industry’s interests are entirely different.
Not
really, because we have been successful in roping in major pharmaceutical
companies to work for malaria drug development. Two projects are
going on in collaboration with GlaxoSmithKline (GSK). On the anti-malarial
activities of cysteine protease inhibitors, University of California
and GSK Philadelphia are jointly working at and the consortium of
Bristol University, UK, London School of Hygiene and Tropical Medicine
and GSK, Madrid aims to target the glycolytic pathway of Plasmodium
falciparum in the design and discovery of novel anti-malarials,
and an innovative combination. Further, MMV’s interest does
not limit to only the allopathic remedies and we are open to explore
possibilities in alternative systems of medicines. But, we need
to instill considerable amount of science and technology into the
Indian systems of medicine.Which of the ongoing projects are expected
to yield results at the earliest?
Earliest
will be in 3 years. Either the combination therapy, chloproguanil-dasone-artesunate,
a project of GSK or the pyronaridine-artesunate combination, of
the South Korean company Shin Poong.
What
are the challenges in vaccine development and what are MMV’s
efforts?
Across
the globe, lot of work is going on in the area of vaccine development
and NIH and Bill Gates Foundation are the major forces actively
involved in developing malarial vaccine. However, knowing the actual
scenario of research worldwide in malaria and the technological
complexity of the parasites- plasmodium falciparum and plasmodium
vivax, involved I can say that it will take a longer period to realize
an effective vaccine.
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