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ASAQ: Contribution of sanofi-aventis
In the partnership with DNDi on ASAQ development, sanofi-aventis contributed resources and expertise in 5 main fields:
- Industrial pharmaceutical development: development of processes required to reach production on an industrial scale at the Maphar – sanofi-aventis plant in Casablanca, Morocco,
- Scientific: pre-clinical pharmaco-toxicology studies were designed to further document the safety profile of AS+AQ in animals, as per the latest international requirements,
- Regulatory: preparation of registration files for Morocco, sub-Saharan malaria endemic countries and WHO pre-qualification process,
- Marketing: preparation of ASAQ launch and marketing in endemic countries, through private and public distribution channels,
- Medical: preparation and implementation of follow-up clinical studies.
Sanofi-aventis’ Impact Malaria Program Effective malaria treatments are often not accessible to those who need it, because of their price, inappropriate distribution channels or lack of information. sanofi- aventis has developed a comprehensive program, called Impact Malaria, that aims at mobilizing the expertise and resources of a major pharmaceutical firm against malaria.
4 strategic axes of Impact Malaria:
1. Research and development of new antimalarial drugs, to anticipate resistance to existing compounds, is carried out by the sanofi-aventis R&D department. Sanofi-aventis R&D currently has several malaria drugs and vaccines projects. The most advanced one is ferroquine, a compound that is active against chloroquine-resistant falciparum, developed with the Université des Sciences et Technologies of Lille (France) (Pr J. Brocard).
2. Improvement of existing drugs to meet the needs and requirements of patients and health care providers. The ASAQ fixed-dose combination developed by the DNDi and Impact Malaria is an example of how existing drugs can be further developed for the benefit of patients. This new formulation will greatly reduce the number of tablets taken by patients, and will decrease the likelihood of development of resistances.
3. Development of Information Education and Communication tools to ensure that drugs are appropriately used, along with other effective interventions. Tools are developed to help healthcare providers, at all levels of the “healthcare pyramid”, to appropriately use antimalarial drugs. Tools are also developed for patients to understand how they can prevent malaria through simple measures such as using insecticide-impregnated bednets. Communication and training tools are developed with local malaria programs and tailored to the target populations, taking into account their local structures, conditions, specificities, literacy rates, etc.
4. Pricing policies that give access to high quality drugs to all population segments. Production costs have been optimized to offer the lowest possible prices without compromising quality. Drugs are made available through both the public and the private distribution channels to reach all population segments. For patients who cannot afford brand name antimalarial drugs, the “CAP Program” gives them access to drugs at a “no profit-no loss” price through local pharmacies. The same “no profit-no loss” approach is used for sales to the public sector, NGOs, etc.
Safe and effective drugs are indispensable in the fight against malaria. However, drugs alone will not suffice to reduce morbidity and mortality. Our involvement goes beyond the provision of affordable, high quality drugs, by supporting projects that will demonstrate what efforts are required for an effective and sustainable control of malaria in a variety of settings.
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