Malaria Implementation

 

  • Target disease: Malaria
  • Partners (since project start): Farmanguinhos, Brazil; Cipla Ltd., India; Shoklo Malaria Research Unit, Thailand; Universiti Sains, Malaysia; Oxford University, UK; WHO-TDR; Indian Council of Medical Research (ICMR), India; Epicentre, France; Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland; National Institute of Medical Research (NIMR), Tanzania; Kenya Medical Research Institute (KEMRI), Kenya; Centre National de Recherche et de Formation sur le Paludisme (CNRFP), Burkina Faso; Medicines for Malaria Venture (MMV), Switzerland; Ifakara Health Institute, Tanzania; Worldwide Antimalarial Resistance Network (WWARN)
  • Project start: January 2002
  • Funding (since project start): Department for International Development (DFID), UK; Dutch Ministry of Foreign Affairs (DGIS), the Netherlands; European and Developing Countries Clinical Trials Partnership (EDCTP), Europe; European Union – Specific International Scientific Cooperation Activities (INCO); French Development Agency (AFD), France; Médecins Sans Frontières/Doctors without Borders, International; Spanish Agency for International Development Cooperation (AECID), Spain; Swiss Agency for Development and Cooperation (SDC), Switzerland; Fondation ARPE, Switzerland; Other private foundations and individuals.

 

Overall Objective:

  • Develop and make available worldwide an affordable fixed-dose combination of AS and MQ which would be easy to administer, particularly to infants and children, targeted initially for use in Asia and Latin America

 

 

 

The ASMQ fixed-dose combination treatment (ASMQ FDC) was developed by the FACT consortium created by DNDi and TDR in 2002. Within FACT, the Brazilian government-owned pharmaceutical company, Farmanguinhos/Fiocruz, was the first manufacturer of ASMQ FDC. Through a South-South technology transfer, ASMQ FDC production was transferred to the Indian pharmaceutical company Cipla in 2010 to ensure availability in India and Asia at affordable, pre-agreed prices. Both Farmanguinhos and principally Cipla supplied treatments in response to a large request from Venezuela in 2013 (over 382,000 treatments). ASMQ FDC is now registered in Brazil (2008), India (2011), Malaysia and Myanmar (2012), Tanzania (2013), Vietnam, Niger and Burkina Faso (2014), Thailand and Cambodia (2015). The Cipla ASMQ FDC product was prequalified by the WHO in 2012 and was included in the WHO Essential Medicines Lists for adults and children in April 2013, in line with current treatment guidelines. Farmanguinhos/ Fiocruz was admitted into the PAHO Strategic Fund in April 2013, allowing procurement by South American national control programmes. In 2014 Farmanguinhos was requested to obtain WHO prequalification in order to remain in the Fund. The prequalification file is being generated and submission is planned for 2015.

Additional clinical studies are ongoing that will provide information of ASMQ FDC use in children, adults, and pregnant women in Africa. According to WHO recommendations, AS+MQ could be considered for use in some countries in Africa. DNDi sponsored a key multicentre Phase IIIB study in Tanzania, Burkina Faso, and Kenya to assess the efficacy, safety, and pharmacokinetics of ASMQ FDC compared to artemether-lumefantrine in children below the age of five with uncomplicated P. falciparum malaria. The study found ASMQ FDC to be as safe and efficacious as Artemether-Lumefantrine (AL) FDC – Africa’s most widely adopted treatment – results which were presented at ASTMH in November 2014. The pharmacokinetic data collected confirmed there was no need to change the dosing in children. The report has been finalized and a publication is in preparation.

By the end of 2014, 832,000 ASMQ treatments were distributed.

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

Last update: October 2015