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Malaria - Actions
Research and development of new antimalarial drugs
Sanofi-aventis anticipates the development of resistance to currently-used drugs and is also conducting research on a malaria vaccine.
The Group has set up a Research and Development program on infectious diseases, including malaria. This aim of this program is to conduct research and develop partnerships with outside organizations (including academic institutions and universities) working in the field of malaria treatment and prevention. The most advanced projects are subsequently developed in our own research centers and wholly financed by the Group. Project and Progress| Project | Progress |
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| Collaborative research with the University of Montpellier II, begun in 2003 on a series of products called "bicationic compounds" that interfere with phospholipid biosynthesis in the parasite. This led to the selection of a candidate for development: SAR97276 | About to begin Phase II of clinical development | | Collaboration with Palumed in Toulouse was started in 2002 and focused on "trioxaquins", compounds potentially associating two action mechanisms against the parasite | Pre-clinical phase of development | | Ferroquine, or SAR97193, a new 4-aminoquinoline derivative, is the result of cooperation with USTL (Lille, France) begun in 2002. Ferroquine is very effective against strains of Plasmodium falciparum, whether they are sensitive or resistant to chloroquine | Phase II of clinical development | | Through sanofi pasteur, the Group is involved in a collaborative project with the Pasteur Institute in Paris for research to develop a malaria vaccine. | Pre-clinical phase of development | Through these projects, sanofi-aventis hopes to anticipate the malaria-causing parasite's ability to rapidly develop resistance to all treatments, in support of the Group's goal to curb malaria and other major diseases, and to reverse the current trend by 2015.
New presentations of current malaria drugs
Respond better to the needs of prescribing physicians and patients: a fundamental goal for the Access to Medicines Division
The Group's current activities are focused primarily on two projects: - Offering a fixed-dose combination of two antimalarial drugs to be taken orally that is adapted to the needs of patients (children in particular).
- Suggesting a solution to provide immediate care for children with malaria who cannot receive treatments that are administered orally.
Faced with the worrying emergence of resistant parasites, since 2004, the World Health Organization (WHO) has recommended first-line treatment based on a combination of two antimalarial compounds, one of which must be an artemisinin derivative (ACT: artemisinin-based combination therapy). Sanofi-aventis, which had oral administration forms of amodiaquine and artesunate, developed treatments composed of the two modified antimalarial compounds in the same thermally molded pack: the co-blister format. Produced in one of the Group's industrial sites in Morocco and registered in this country, the co-blister was brought to market in more than 20 African countries. To further improve patient treatment compliance, a fixed-dose combination consisting of two antimalarial drugs in a single tablet has been developed; it is known as ASAQ. This development was undertaken in partnership, since 2004, with the Drugs for Neglected Diseases initiative (DNDi). Sanofi-aventis has given up its right to any patent on this drug. For a treatment cost of less than US$ 0.50 for children under age five and a cost of less than US$ 1 for older children and adults, ASAQ is available at a "no profit – no loss" price to public organizations in endemic countries, international institutions, NGOs, and programs promoting access to drugs in pharmacies.
Implementation plan
- In February 2007, ASAQ received marketing authorization in Morocco, where it is manufactured. It is to be registered in most sub-Saharan countries in 2007-2008. The Group has submitted an application to WHO as part of the pre-qualification procedure for drugs.
Education and communication: the example of Impact Malaria
Improve care provided by healthcare professionals to treat malaria and improve local populations' ability to protect themselves against the risk of contracting malaria
Drugs alone are not enough; it is also necessary to ensure they are used correctly. The Impact Malaria program includes Information, Education and Communication (I.E.C) initiatives for all those involved in the fight against malaria. I - Initiatives designed for medical personnelThese initiatives are intended to disseminate information with the most up-to-date recommendations concerning malaria diagnosis and treatment. Designed to be adapted to suit each country, they are carried out in partnership with national malaria programs. Sanofi-aventis makes available to health ministries specific ACT (artemisinin-based combination therapy) training tools designed for healthcare personnel. To ensure the widest possible dissemination of current knowledge, Impact Malaria has also published a manual for prescribing physicians in endemic zones, entitled "PaluTrop", which was written by leading African and French specialists in the treatment of malaria. This 40-page educational manual is intended for prescribing physicians and nurses who must work far from the hospitals in their countries. Since 2002, in partnership with the Army Medical Corps Institute of Tropical Medicine in Marseille (IMTSSA), Impact Malaria has provided certificate courses in malaria treatment for more than 60 African physicians. II – Initiatives for local populations and communitiesImpact Malaria develops and supports Information and Education initiatives for local populations to promote malaria prevention and the correct use of malaria treatments. - A Pilot Project to combat malaria in the Lagdo region (Cameroon), a region with a high prevalence of malaria, is carried out in cooperation with CARE Cameroon. As part of the project, surveys were conducted to see how malaria is viewed by local communities. These surveys meant that appropriate malaria prevention communication tools could be designed and adapted for used by the community as well as in health centers and schools in the area. The aim is to raise awareness among the community and the families of children under five who are particularly at risk of malaria-related complications. An entomological study has allowed a better understanding of the behavior of the Anopheles mosquito in the Lagdo region, facilitating the fight against the vectors of the malaria. Lastly, sanofi-aventis will provide ACT (artemisinin-based combination therapy) for the treatment of confirmed cases of malaria.
- In Benin, a project conducted with PlanetFinance, run in partnership with N.G.Os that are established in the field, aims to train the educators among healthcare personnel, in order to raise awareness of malaria risks in families and communities. Malaria prevention and disease symptom information kits, using pictograms that can be understood by everyone, including the illiterate, have been developed thanks to this partnership.
- Finally, alongside Total and C.F.A.O (leader in specialized distribution in Africa and French Overseas Departments and Territories), sanofi-aventis has supported the development of a Practical Guidebook for the Fight against Malaria. This guidebook is made up of thematic sheets and is designed to be used as a reference tool for firms wishing to organize malaria care for employees and their families and, beyond that, for the communities where the companies are located. (Source: Sanisphere)
Implementation plan
- Another project launched in mid-2007 concerns the Makoua region in Congo Brazzaville, in partnership with the N.G.O "Actions de Solidarité Internationales" and the Agency for Preventive Medicine. Thanks to these projects, it will be possible to determine, for various regions with varying malaria transmission profiles, the scope of resources that need to be mobilized in order to make a significant and lasting impact on the disease.
Differential pricing policy
Sanofi-aventis has established a differential pricing policy in public and private markets to ensure all patients will have access to antimalarial medicines
Private-sector pharmacies:Sanofi-aventis sells the same antimalarial drug at two different prices according to the patient's financial resources: - the brand name (sanofi-aventis) product is sold at the normal price for the country in question;
- the same drug is sold under the Impact Malaria brand name at a lower price to poorer patients through the CAP (Antimalarial Drug Access Card) Program. The CAP card is provided by the pharmacist to families whose income is below the country's poverty line. The card enables the family to buy the drug at a very affordable price. This has been made possible thanks to the commitment of the wholesale distributors and pharmacists who, like sanofi-aventis, give up their profit margin.
Public-sector systems:In malaria-endemic countries, supplies of antimalarial drugs are purchased through calls to tender organized by central purchasing structures, NGOs, United Nations organizations, etc. Within the scope of these calls to tender, sanofi-aventis offers the lowest possible price for ACT (artemisinin-based combination therapy).
The drugs are then distributed by the health care system to hospitals, dispensaries, health clinics, etc.
Implementation plan
- The Group's roll-out plan is based on two priorities:
- optimizing production costs;
- initiatives that make it possible to offer the lowest prices for most underprivileged patients.
- The "no profit – no loss" approach is fundamental to ensure the viability of production in the long term. Sanofi-aventis actively pursues a cost reduction policy for antimalarial drugs based on competition among raw material manufacturers, without compromising the quality of our products.
Progress
- Since 2005, sanofi-aventis has distributed more than 12 million ACT treatments at preferential prices in 16 endemic countries.
- Sanofi-aventis is prepared to satisfy increasing demand for ACT. The Group's plant in Casablanca, Morocco, can manufacture up to 12 million ASAQ treatments (Coarsucam®, Artesunate Amodiaquine Winthrop®).
- The CAP (Antimalarial Drug Access Card) Program is operational in nearly 400 pharmacies throughout 6 countries (Cameroon, Gabon, Madagascar, Kenya, Mali, Congo Brazzaville). In two years, via 400 pharmacies, more than 26,000 families have used the Impact Malaria card and nearly 47,000 patients have received antimalarial drugs at a preferential price.
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