Sanofi and DNDi Partnership on Malaria

Partnership objective

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.

More than 277 million treatments of ASAQ Winthrop have been distributed in Africa since the medication became available in 2007. More than 277 million treatments of ASAQ Winthrop have been distributed in Africa since the medication became available in 2007. Copyright Sanofi Pasteur

What are the health needs and challenges?

According to the World Health Organization, 627,000 malaria deaths were reported in 2012, 90% of which in Africa. Malaria is the third leading cause of mortality among African children and has a heavy impact on the economy of families and the affected countries, hindering the ability of adults to work and children to go to school. In 2001, the WHO recommended the use of artesunate-based combination therapy (ACT) to treat uncomplicated malaria to fight growing resistance to existing treatments.

Description of partnership activities and how they address needs and challenges

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.

Lessons learned

The medicine is available in most of the African malaria endemic countries, affordable for the patients most in-need, including children.

Improved public health is a complex challenge and the combination of expertise from various partners is essential to build sustainable solutions for patients most in-need.

Summary of impact and forward looking information

More than 277 million treatments of ASAQ Winthrop have been distributed in Africa since the medication became available in 2007. To participate in the fight against development of resistance to treatment, Sanofi decided in 2012 to share all the data collected during its clinical trials with the Worldwide Antimalarial Resistance Network (WWARN).

Sanofi and DNDi, received the 2014 Corporate Social Responsibility Alliance Excellence Award from the Association of Strategic Alliance Professionals (ASAP), in recognition of the “profound, measurable, and positive social impact” that this decade-long public-private partnership has had in the fight against malaria.

Videos

Sanofi-DNDi: A Longstanding R&D Partnership Interview with Robert Sebbag

ASAQ, an innovation in malaria treatment in Côte d'Ivoire

Sanofi - The production of ASAQ Winthrop® in Morocco

Partnership information

Company(ies) Sanofi

Partner(s) Drugs for Neglected Diseases initiative (DNDi), WorldWide Antimalarial Resistance Network (WWARN)

Type of Partner(s) NGOs, PDPs

Therapeutic Focus Infectious Diseases

Disease(s) Malaria

Program Type(s) Availability of Treatment - Differential Pricing, Research & Development - Development of Treatments, Research & Development - Pediatric R&D

Targeted Population(s) Children, Elderly, Marginalised / Indigenous People, Men, Mothers, People with low income, Women, Youth

Region(s) Latin America & Caribbean, Middle East & North Africa, South Asia, Sub-Saharan Africa

Number of Countries 26

Country(ies) Benin, Burkina Faso, Burundi, Cameroon, Central African Republic, Colombia, Côte d'Ivoire, Democratic Republic of the Congo, Gabon, Ghana, Guinea, India, Kenya, Liberia, Madagascar, Mali, Mauritania, Morocco, Mozambique, Niger, Nigeria, Senegal, Sierra Leone, Tanzania, Togo, Zambia

Start Date 2005

More information Sanofi Access to Medicines

Anticipated completion date Ongoing

« Above all, this project demonstrates what can be achieved by working together... towards the common goal of developing an effective malaria drug to meet the needs of the world’s poorest populations. »

Dr. Bernard Pécoul, Executive Director of DNDi