Sanofi and DNDi Partnership on Malaria

Develop a new medicine against malaria that is affordable, meets the requirements of the WHO and is adapted to the needs of patients, in particular children.

Sanofi and DNDi Partnership on Malaria

In April 2005, Sanofi and DNDi formed a public-private partnership with the goal of developing a non-patented fixed-dose combination of artesunate-amodiaquine to better meet the patients’ needs, specifically those of children. DNDi developed the formulation combining two active ingredients in a single tablet and carried out the initial pharmaceutical and clinical development. Sanofi developed the product, carried out additional clinical studies, prepared the dossier for regulatory authorities and applied for WHO prequalification. The new treatment is simpler (1 or 2 tablets once a day) than the existing ones and dissolves in water, which makes it suitable for children.

The medicine is sold at a preferential prices, including “no profit no loss” prices, to governments of endemic countries, NGOs, and major sponsors such as UNITAID and the Global Fund. It is now registered in 33 countries and at the end of 2013, more than 277 million treatments were distributed.

In addition, an innovative Risk Management Plan (RMP) was designed by the partners to provide high-quality information on the safety and efficacy on this drug. This RMP comprises 23 clinical studies in 19 countries, primarily set-up in Africa, each of which documenting different aspects of ASAQ Winthrop safety and efficacy. It is expected that over 20,000 patients will be included in this RMP, which is the first such program to be submitted to the WHO. It is expected that this initiative will help build capacity in pharmacovigilance in sub-Saharan Africa, using narrowly-tailored methods of data collection on the safety and efficacy of medicines when they are used in “real life” situations.

Partners

  • Sanofi

    Goods Supplier
    Canada | Staff size: Unknown

    Sanofi S.A. is a French multinational pharmaceutical company headquartered in Paris, France, the world's fourth-largest by prescription sales. Sanofi engages in the research and development,...

  • Ministry of Health and the Fight against HIV/AIDS

    Government
    Cote d Ivoire | Staff size: Unknown

    The main goal of the Ministry of Health is to provide and continually improve the health services of Cote d'Ivoire through the provision of preventive, curative and rehabilitative health care...

  • Drugs for Neglected Diseases Initiative (DNDi)

    Association
    United States | Staff size: 251-500

    Drugs for Neglected Diseases initiative (DNDi) is a collaborative, patients’ needs-driven, non-profit drug research and development (R&D) organization that is...

  • Medicines for Malaria Venture (MMV)

    Foundation
    Staff size: 101-250

    MMV is a not-for-profit public-private partnership established as a foundation in Switzerland in 1999. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering,...

  • National Malaria Control Programme (NMCP)

    Government
    Nigeria | Staff size: Unknown

    Globally, millions of deaths attributable to malaria are still being recorded. The disease constitutes a huge epidemiologic burden in Africa and continues to cripple the economic development in...

More Resources

Key Information

LocationEast Asia and Pacific, Zambia, Uganda, Tanzania, Senegal, Nigeria, Mozambique, Mali, Malawi, Kenya, Indonesia, India, Ghana, Gabon, Cote d Ivoire, Congo, The Republic of, Congo, The Democratic Republic of, Colombia, Chad, Cameroon, Cambodia, Burkina Faso, Brazil, Benin, South Asia, Latin America and Caribbean, Eastern Africa
StatusActive
  • Start Date 2008
Sectors