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ASMQ – Fixed-Dose Artesunate/Mefloquine (Malaria)

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Target disease: malaria
Major Partners: Industrial partners: Farmanguinhos, Brazil; Cipla, India. Other partners: Shoklo Malaria Research Unit, Thailand; Universiti Sains Malaysia; University of Oxford, UK; TDR; Indian Council of Medical Research (ICMR), India; Epicentre, France; National Institute of Medical Research, Tanzania; Centre Hospitalier Universitaire Vaudois (CHUV), Switzerland
DNDi project manager and coordinator: Jean-René Kiechel, Gwenaëlle Carn
Project start: January 2002
Funding: Social and Institutional Development Department, Social Policy Division, Ministry of Foreign Affairs (DGIS), The Netherlands; French Development Agency (AFD), France; European Union - Specific International Scientific Cooperation Activities (INCO); Médecins Sans Frontières/Doctors without Borders, International; Spanish Agency for International Development Cooperation (AECID), Spain; Department for International Development (DFID), UK; individual donors


                                                       

Status: ASMQ, the new co-formulation of artesunate (AS) and mefloquine (MQ), offers a simple regimen for children and adults that is as easy as 1-2-3: a single daily dose of one or two tablets over three days. This co-formulation was one of two malaria projects undertaken in 2002 by a number of public and private partners coordinated by TDR and MSF (who turned over the project to DNDi upon its foundation) as part of the FACT (Fixed-dose, Artesunate-Containing Therapy) Project.
Farmanguinhos/Fiocruz successfully registered ASMQ in Brazil in March 2008. The co-formulation was used by Brazilian authorities and the Malaria Programme for a large intervention study, which included over 25,000 patients, with remarkable positive results. April 2009 marked an important milestone for ASMQ as the first public order of treatments was completed by Brazilian government.

In 2010, registration for ASMQ in 2 or 3 other countries in Latin America is being investigated. Farmanguinhos/Fiocruz, with support from DNDi, committed to a technology transfer to the Indian manufacturer, Cipla, in order to facilitate its future availability in Southeast Asia. This transfer was successfully achieved and the registration lots  manufactured by Cipla at the end of 2009 / beginning of 2010. A CTD format registration file for the ASMQ FDC was submitted in March 2010 for pre-qualification and will be used in 2010 for registration in Asia.
Further clinical research with partners will examine the potential therapeutic utility of ASMQ in pregnancy and in Africa region. A successful clinical study in India has recently been completed, and a report is now available.

A comparison of ACT’s has been performed in Myanmar by MSF. This important study, with very favorable results for the FDC, is in line with published data in Asia using the free combination of AS and MQ. Submission to prequalification first half of 2010 as well as to an ASEAN (Association of Southeast Asian Nations) registration second half of 2010 are planned.

ASMQ is the only fixed-dose ACT available with a 3-year shelf life. It has been optimised for regions and for rural and remote settings. An innovative weight- and age-based dosing regimen, based on comparisons between regional databases of >180,000 individuals, has been developed. This work, as well as preliminary results from the Brazilian intervention study, was presented during the 57th American Society of Tropical Medicine & Hygiene in December 2008. Additional information on the ASMQ FDC was provided during a session at the ASTMH in 2009



Last update: March 2010



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