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FACT: An international network to develop two new anti-malarial fixed-dose combinations AS/AQ and AS/MQ by 2006
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Two new malaria treatments - DNDi's FACT (Fixed Dose Artesunate Combination Therapy) project aims to develop two new artesunate-based formulations to treat chloroquine-resistant falciparum malaria. These drug combinations should be registered in 2006 for distributed and use in developing countries at an affordable price. These combinations are WHO recommended artesunate amodiaquine (AS/AQ) and artesunate mefloquine (AS/MQ).
Funding - Drug development is an expensive business. A key element of the project is that FACT products are intended for the poorest of the poor and to become public goods. Partners in the FACT project therefore contribute both in kind (expertise, facilities etc) and through direct financing and try to find the most efficient and cost effective ways of moving forward, while maintaining quality or work and end products.
Thanks to this innovative collaborative model, DNDi estimates that it will cost 4 million Euros to develop to develop adult and paediatric formulations for AS/AQ and AS/MQ. One million of this budget is still needed.
The FACT antimalaria project received financial support under the European Union's 5th Framework Programme for Research and Technological Development, from Médecins Sans Frontières, and from WHO/Tropical Diseases Research. , an encouraging example of different global stakeholders successfully working to meet global health needs.
FACT Funding Partners
The Drugs for Neglected Diseases Initiative (DNDi) estimates that the total budget of the FACT Project from start to finish (2002 - 2006) will be 4,0 million EUROs (ME). So far, the project has been supported by the following:
EU funding - 1,2 ME
In 2002, the European Union committed €1.2m over three years to the development of the two FACT drugs. The EU (EC) Directorate General for Research funds projects through its International Cooperation Programme (INCO), a part of the EU Framework Programme for Research and Technological Development., a 5- year plan outlining the EC s priorities and budget for research activities. The FACT project was approved under the FP5 (1997-2001) under the INCO DEV programme set up to encourage international cooperation in research with developing countries.
Tropical Disease Research-WHO (TDR) funding: 0,45 ME
In addition to its financial contribution, the UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases (TDR) has shared its extensive experience with this project either directly or through consultants, and contributed to the scientific coordination with DNDi.
Far Manguinhos funding: 0,40 ME
Far Manguinhos contributed to the pharmaceutical development and scale up of one of the FDC's and provided funding for drug substance. Management of some pre-clinical activities was also done by them.
Médecins Sans Frontières (MSF) funding: 0,15 ME
MSF provided initial management of this project before the creation of DNDi in 2003. MSF has also provided financial management and support.
DNDi funding: 0,8 ME
DNDi provides overall project management, scientific coordination and financial support.
Still to be fundraised: 1 ME is needed over 2005-6 to complete the FACT projects which means getting the two new products registered and to patients during the course of 2006.
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