R&D status September 2014: DNDi Malaria programme

[September 2014]

Malaria is transmitted by mosquitoes. It kills one child every 30 seconds in sub-Saharan Africa and is the leading parasitic cause of morbidity and mortality worldwide. 3.2 billion people are at risk. DNDi with its partners have delivered two fixed-dose combination (FDC) of the five artemisinin-based drugs (ACTs), FDC’s that were recommended by WHO for the treatment of uncomplicated falciparum malaria.

These inexpensive, efficacious, field-adapted ACT-FDC treatments are key to the global treatment arsenal and strategies to combat malaria worldwide.
Implementation
Implementation

 

Two projects in implementation

  • ASAQ Winthrop is a fixed-dose combination (FDC) therapy of artesunate (AS) and amodiaquine (AQ) that was developed in partnership with Sanofi and made available in 2007. ASAQ was pre-qualified by WHO in 2008 and is today registered in 35 countries (31 African countries, India, Bangladesh, Equator, and Colombia). Over 320 million treatments were distributed since 2007. A technology transfer with a manufacturer in Tanzania is ongoing.
  • ASMQ is a FDC of artesunate (AS) and mefloquine (MQ) that was developed in partnership with Farmanguinhos/Fiocruz and registered in Brazil in 2008. ASMQ FDC production technology was transferred to the Indian pharmaceutical company Cipla in 2010 to ensure availability in India and Asia at an affordable, pre-agreed price. ASMQ FDC manufactured by Cipla was prequalified by WHO in 2012. ASMQ FDC is now registered in Brazil, India, Malaysia, Myanmar, Uganda, Tanzania, and in Vietnam . Over 1’200’000 ASMQ FDC treatments were distributed since 2008.


DNDi is also  performing a clinical study with ASMQ FDC in Africa

  • A phase IIIb study on ASMQ investigated activity and tolerability of the FDC in comparison to artemether-lumefantrine in children under five in Africa, the population most affected by malaria in Africa. The Pharmacokinetics of the FDC in African children were also investigated in the same study. The project has recruited 940 patients in four sites in Burkina Faso, Tanzania and Kenya. The final report of the study is expected end of 2014.

 

  • By 2015, DNDi aims to have completed its malaria portfolio and will transfer its malaria projects by collaboration with the Medicines for Malaria Venture (MMV).


For more information on the partners and donors involved in DNDi Malaria programme, please click on each hyperlink that will refer you to each project.