Progress in Africa on medical R&D – from patient needs to new treatments

[Nairobi, KenyaJune 23, 2009]
Over 250 African and international health researchers, policymakers and three Ministers of Health (Kenya, Sudan, and Uganda) from 28 countries are meeting today in Nairobi at the 2nd international Drugs for Neglected Diseases initiative (DNDi) stakeholder conference organised to stimulate greater regional research partnership to fight the most neglected diseases such as sleeping sickness, kala azar, malaria, and Chagas disease.

At this international conference on R&D for neglected diseases, two projects are being highlighted as showing tangible proof of how global and South-South collaboration are strengthening Africa’s capacity to conduct clinical trials and to develop new treatments for diseases: LEAP, an East African research partnership tackling kala azar, and NECT (Nifurtimox-Eflornithine Combination Therapy), an improved treatment for sleeping sickness.

“A new treatment for a most neglected disease and this encouraging clinical research partnership show how much can be achieved in Africa when researchers and clinicians get the support they need and work together to find innovative solutions for neglected diseases,” remarked Hon. Beth Mugo, Minister for Public Health and Sanitation, Government of Kenya.

Better treatments are still desperately needed by millions of the world’s poorest people as current therapies are often toxic, prohibitively expensive, or difficult to administer, particularly in resource-poor settings. However, little progress was made in the past thirty years: only 1.3% (21 out of 1,556) of new drugs developed from 1975 to 2004 were for neglected tropical diseases and tuberculosis, even though these diseases account for 12% of the global disease burden.

Because R&D was market driven, there was little incentive for companies to create medicines for neglected diseases affecting the poorest of the poor.Today, thanks to public and private investments and innovative models like Drugs for Neglected Diseases initiative, global and South-South collaboration, R&D for new medicines is making tangible progress in Africa. Multinationals are also taking a renewed interest in partnering with the public sector and in making their drug libraries and know-how available to develop new treatments.

“Developing countries have the ability to provide new solutions for neglected diseases, but every day we face an uphill battle to find home-grown capacity for research and development into diseases that affect our poor,” said Monique Wasunna, Assistant Director of the Kenya Medical Research Institute (KEMRI) and the head of DNDi Africa. “By working together in regional, needs-driven research platforms, we have been able to do more in the past five years than had been done in the previous twenty years.”

In addition to new treatments, clinical research platforms for kala azar and sleeping sickness are helping African scientists overcome regional differences and address on-the-ground difficulties. Nine clinical studies with DNDi partners are ongoing or completed for new treatments for these diseases as well as malaria.

“We work closely with clinicians in rural hospitals to make sure that our medicines meet the real needs of patients and health workers in Africa. We help our partners by strengthening lab capacity and training on good clinical trial practice, but the real expertise of the diseases is already here on the ground, in the endemic countries,” remarked Dr. Bernard Pecoul, DNDi Executive Director. “Without our partners in Africa, true innovation to find the most adapted treatments for the most neglected patients would not be possible” he added.

R&D progress in Africa on neglected tropical diseases:

Sleeping Sickness – NECT (Nifurtimox-Eflornithine Combination Therapy) – the first new treatment option since 19 years against sleeping sickness, a fatal disease which threatens 60 million people across sub-Saharan Africa – has been added to the Essential Medicines List (EML) of the World Health Organization WHO. NECT,and is ready to be used after some of the most robust clinical evidence in the field of sleeping sickness was provided in a clinical study involving the national control programmes of the Republic of Congo and the Democratic Republic of Congo, Epicentre, Médecins Sans Frontières, the Swiss Tropical Institute and WHO. NECT was voted DNDi project of the year in 2008.

Leishmaniasis East Africa Platform (LEAP): LEAP is a regional clinical research network that brings together experts from leishmaniasis-endemic East African countries including Ethiopia, Kenya, Sudan, and Uganda to develop combination therapies in Africa and enrolled over 1,000 patients since 2003. LEAP strengthens clinical research capacity, in some of the most remote and rural regions of Africa. This includes building and renovation hospital wards, clinics, and health posts; re-equipping clinical laboratories; and training health service personnel with particular emphasis on building expertise in clinical trial methodology. Good Clinical Practice and Ethics, patient evaluation, treatment and safety, accurate diagnosis, and follow-up by parasitology.

Malaria – ASAQ – fixed-dose combination (FDC) of artesunate and amodiaquine for use in sub- Saharan Africa; launched in March 2007; registered in 24 disease-endemic countries; in landmark partnership with sanofi-aventis; obtained WHO prequalification in October 2008; 5 million treatment courses delivered in 2008 in Africa  and more than 20 million forecast for 2009.

ASMQ – FDC of artesunate and mefloquine for treatment in Latin America and Asia; registered in Brazil in March 2008 in partnership with Farmanguinhos/Fiocruz; South-South technology transfer underway to Cipla for availability in Asia and Africa; in use by Brazilian national authorities. The new WHO prequalified medicine has now reached millions of patients in 24 sub-Saharan African countries.

For further information, please call:

Samantha Bolton on +254 (0)716 1979 19; sbolton@dndi.org

Ann-Marie Sevcsik on +41 (0)79 814 9147; amsevcsik@dndi.org

A video news release and photos are also available

Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit drug development initiative established in 2003 working to research and develop new and improved treatments for neglected diseases such as leishmaniasis, human African trypanosomiasis (HAT), Chagas disease, and malaria. DNDi was founded in 2003 by five publicly funded research institutions in Brazil, France, India, Kenya, and Malaysia, along with the humanitarian Organisation, Médecins Sans Frontières (MSF).

With the objective to address unmet patient needs for these diseases, DNDi has developed the largest ever R&D portfolio for the kinetoplastid diseases and has already made available two new antimalarial treatments: “ASAQ” in 2007 with sanofi-aventis, and “ASMQ” in 2008 with Farmanguinhos in Brazil. In December 2008, DNDi, Epicentre, and MSF released promising Phase III clinical study results of NECT (nifurtimox-eflornithine combination therapy), which show NECT is a safe, effective treatment for the advanced stage of HAT. To date, DNDi has secured funding from a number of public and private donors, including MSF and the Bill & Melinda Gates Foundation. Significant funding has come from public donors including: the European Union, France, Germany, the Netherlands, Spain, Switzerland, the United Kingdom, and the United States of America. For further information, please consult www.dndi.org.

Kenya Medical Research Institute (KEMRI) is a leading health research Institution in Africa with a firm scientific foundation, physical infrastructure, resources and a global network. The vision of the Institute is to continue to be a leading centre of excellence in health research nationally, regionally, and internationally. KEMRI is one of the founding partners of DNDi, Established in 1979, KEMRI conducts health sciences research and is one of the leading health research institutions in Africa. With a focus on infectious and parasitic diseases, and on public health and biotechnology research, KEMRI has been making a significant contribution to regional research capacity for many years. For further information, please consult www.kemri.org.