Drugs for Neglected Diseases Initiative

Médecins Sans Frontières (MSF), the global medical aid charity, has committed $25 million over 5 years for an initiative to develop drugs for diseases of the developing world—like sleeping sickness, leishmaniasis, and Chagas disease. Resources for research into these diseases have been severely limited.The Drugs for Neglected Diseases Initiative (DNDi), established as a legal entity in Geneva last week, will be run like a virtual pharmaceutical company, using every facility and material resource made available to it—including the pharmaceutical industry itself. But, perhaps above all, it will depend on the skills and experience of large networks of researchers in the developing, and developed, world.Yves Champey, who is interim director of DNDi, a doctor, and past research director of Rhône-Poulenc Rohrer, was driven to develop DNDi after working with poor communities in West Africa. Champey told The Scientist that DNDi would use the existing research capacity on the target diseases of the Indian Council of Medical Research (ICMR), the Kenya Medical Research Institute (KEMRI), the Oswaldo Cruz Foundation (Fiocruz) of Brazil, and other "major research institutions from the South." DNDi would also depend on the public health systems in these countries for access to patients and to organize high-quality clinical trials, he said.The director of KEMRI, Davy Koech, told The Scientist that KEMRI was selected as the principal partner of DNDi in Africa because of its strategic location and because of the quality and scale of its research. "We've created a critical mass of researchers and medics—more than 200—as well as the right facilities for research and clinical trials," said Koech.Rashid Juma, principal research officer at the Clinical Research Centre at KEMRI, told The Scientist that KEMRI was also creating an African network for DNDi. "We've assembled research institutes in 18 African countries to meet in Khartoum in August to prioritize our work." Countries including Ethiopia, Eritrea, Ghana, South Africa, and Sudan will be represented. They will discuss a handful of orphan drug candidates that show laboratory activity against one or more of the neglected pathogens.In Malaysia, Visweswaran Navaratnam of the Universiti Sains Malaysia, a member of the original DNDi planning team, told The Scientist, "We are creating collaborative platforms for DNDi [in Asia], whereby different groups in each country can contribute to a different segment of the development process." Groups would share lead compounds across nations, he said.An example of such collaboration, said Navaratnam, is the ongoing development of fixed artemisinin combination therapy for chloroquine-resistant malaria, involving Malaysia, Brazil, Africa, and France. The project is funded by the European Union and managed jointly by the Special Programme for Research and Training in Tropical Diseases (TDR) and DNDi. "This was established [in 2002] to test out the idea of a South–South collaborative development," said Navaratnam."And it works," said Champey. "After a year we have two combinations we're ready to put into toxicology, which is a major step."After a call for proposals earlier this year, DNDi has already received 71 research and development proposals, five of which have been chosen for submission to DNDi's Scientific Advisory Committee by the end of September. According to Champey, they include a miltefosine combination therapy for leishmaniasis and research on new targets for leishmaniasis and sleeping sickness.DNDi has budgeted for $255 million in its first 12 years, most of which will be raised from a variety of outside sources, including individuals. But by 2015, DNDi aims to have six or seven drugs registered and a "balanced portfolio" of eight in the pipeline. Compared with the usual pharmaceutical company estimates of $500 million per drug, this is more than an order of magnitude cheaper.Is this realistic? "One of the visions is that there will be a lot of in-kind contributions from collaborators and governments," said Navaratnam, "so you would expect unit costs to be lower. Whether the budget is adequate we really have to wait and see." DNDi also expects the resulting drugs ultimately to be manufactured at low cost by companies in the South. "To be honest, there are a lot of assumptions," Navaratnam said. "We are very conscious of all the difficulties we are going to face," said Champey. "But somebody had to start to do something for these patients. And if we fail, others coming after us will take advantage of analyzing our failure. That's the pessimistic view. But the optimistic view is that the small team we have is so highly motivated that it will work." Moreover, Champey believes the pharmaceutical industry will help. "They know the situation is unacceptable, and we are giving them an easy way to show they are not as bad as some think." All DNDi needs from them is some access to expertise and a few pharmacological tools, Champey said. "It would be a drop in the ocean for them. And any good CEO can understand this in a few seconds."DNDi's founding partners are MSF, TDR, Fiocruz, the ICMR, the Ministry of Health (Malaysia), KEMRI, and the Institut Pasteur (France).Editor's note: The original version of this story stated, incorrectly, that MSF had pledged $100 million to the DNDi. In fact, MSF has promised to cover fixed costs incurred by DNDi to the extent of not more than $5 million a year for 5 years. The first paragraph has been corrected accordingly. The Scientist wishes to apologize for this error.

Drugs for Neglected Diseases Initiative

South" research network for neglected diseases

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