Malaria Implementation

 

  • Target disease: Malaria
  • Partners (since project start): Sanofi, France; MMV, Switzerland; AEDES, Belgium; Zenufa, Tanzania; National Centre for Research and Training on Malaria, Burkina Faso; Universiti Sains Malaysia; Oxford University, UK; Institute of Research for Development (IRD), Senegal; Université de Bordeaux Faculté de Pharmacie, France; Mahidol University, Thailand; Bertin Pharma, France; Médecins Sans Frontières; Epicentre, France; WHO-TDR; Kenya Medical Research Institute (KEMRI), Kenya; Indian Council of Medical Research (ICMR), India; National Malaria Control Programme, Ministry of Health, Burundi; Ministry of Health, Sierra Leone; Ministry of Health, Ghana; Komfo Anokye Teaching Hospital (KATH), Ghana
  • Project start: January 2002
  • Funding (since project start): Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; European Union – Specific International, Scientific Cooperation Activities (INCO); French Development Agency (AFD), France; Global Fund – AmFM, Switzerland; Médecins Sans Frontières/Doctors without Borders, International; Médecins Sans Frontières, Italy; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Other private foundations and individuals.

 

Overall Objective:

  • Develop and make available an affordable, field-adapted FDC of AS and AQ, which is easy to administer to all age/weight categories, particularly to infants and children.

 

 

ASAQ Winthrop, the fixed-dose combination (FDC) of artesunate (AS) and amodiaquine (AQ), was the first treatment made available by DNDi in 2007 through an innovative partnership with Sanofi. ASAQ Winthrop was pre-qualified by WHO in October 2008 and included on the WHO Essential Medicines List (EML) in 2011. First registered in Morocco, where it is manufactured, ASAQ is now registered in 31 African countries, as well as in India, Bangladesh, Colombia, and Ecuador.

There were significant challenges to overcome: the development of a stable bilayer formulation of the two drugs, together with the dual-aluminium blister packaging designed to withstand the rigors of a tropical environment; as a result it is the only ACT FDC with a three-year shelf-life currently available. ASAQ Winthrop obtained WHO authorization in 2010, for a three-year shelf life, giving the product the longest shelf life of any pre-qualified FDC artemisinin-based treatment available for malaria. Registration, manufacture and distribution of this stable formulation was undertaken with Sanofi, the industrial partner, who were already providing co-blistered CoarsucamTM to Africa at the time, and who committed to making the generic ASAQ Winthrop® available at less than one US dollar per adult treatment for the public market. Its low price and prequalified status, allowing purchases by procurement agencies, led to price decreases not only of ASAQ but also other ACTs, and having an affordable drug on the market led to increased patient access to high quality treatments.

In partnership with Sanofi, MMV and National Malaria Control Programmes, high-quality data on ASAQ effectiveness and safety in ‘real-life’ conditions is being collected, as part of a Risk Management Plan (RMP). The largest study, undertaken by Sanofi and MMV with support from DNDi, has been ongoing in 15,000 patients in Côte d’Ivoire, and results are expected in 2015.

DNDi and partners are also working on the transfer of technology to a second manufacturer in Africa, Zenufa, based in Tanzania. By the end of 2015, 500 million treatments had been distributed, by Sanofi and generic companies.

The Medicines for Malaria Venture Access and Product Management team has taken over managing this treatment to help maximize patient access.

Last update: August 2015