Sanofi-aventis And DNDi Welcome Clinton Foundation Announcement On ACTs And Commit To Providing Fixed-dose Combination "ASAQ" At Equally Low Price

Main Category: HIV / AIDS
Also Included In: Tropical Diseases
Article Date: 22 Jul 2008 - 3:00 PDT

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Sanofi-aventis and the non-profit Drugs for Neglected Diseases initiative (DNDi) welcome the agreement announced by Clinton Foundation HIV/AIDS Initiative (CHAI) to reduce the volatility and the price levels of Artemisinin-based Combination Therapies (ACT). The CHAI's initiative is consistent with sanofi-aventis and DNDi's long-standing efforts to make ACTs more affordable and accessible to all malaria patients.

In late 2004 sanofi-aventis and DNDi announced a partnership to jointly develop a non-patented fixed-dose combination of artesunate and amodiaquine available to the public sector at a price of less than $1 for adults and less than $0.50 for children. This was achieved in 2007 with the launch of ASAQ Winthrop® ("ASAQ"), which played a decisive role in encouraging all ACT manufacturers to aim for a similar price level.

Sanofi-aventis commits to providing "ASAQ" at equivalent prices to those of other manufacturers, notably given the quantities anticipated by CHAI. In comparison, however, "ASAQ" provides several benefits over the medicines included in CHAI's agreement:

-- In line with the World Health Organization's (WHO) recommendations, "ASAQ" is a fixed-dose combination which ensures better patient compliance than co-blister presentations

-- ASAQ requires fewer tablets per day than co-blister presentations: 1 tablet a day for 3 days for infants, children and adolescents, 2 tablets once a day for 3 days for adults (instead of up to 4 tablets a day for children and 8 tablets a day for adults)

-- ASAQ tablets are water-soluble and are therefore adapted to children's needs.

"ASAQ" was submitted to the WHO for prequalification in February 2007 and is currently in the final stages of review.

In addition to providing affordable medicines, sanofi-aventis' Access to Medicines' program and DNDI work with additional partners to:

-- put together a pharmacovigilance plan to provide a comprehensive picture of ASAQ safety in addition to efficacy studies;

-- provide complementary information and educational tools to its medicines to facilitate the appropriate prescription of medicines and raise awareness about malaria among the general public.

Sanofi-aventis has one of the most ambitious pipelines in the industry for antimalarials and together with DNDi and other partners remain actively committed to the global fight against malaria.

About the partners - to arrange interviews or to speak with someone, please review the attached press releases.

About DNDi

The Drugs for Neglected Diseases initiative (DNDi) is an independent, not-for-profit product development partnership working to research and develop new and improved treatments for neglected diseases such as malaria, leishmaniasis, human African trypanosomiasis, and Chagas disease. With the objective to address unmet patient needs for these diseases, DNDi was established in 2003 by Institut Pasteur and Médecins Sans Frontières along with four publicly-funded research organizations in neglected disease-endemic countries. Working in partnership with industry and academia, DNDi has the largest ever R&D portfolio for the kinetoplastid diseases and currently has 2 post-registration, 5 clinical, and 4 preclinical projects, along with a variety of concerted discovery efforts. In 2007, DNDi delivered its first product, a fixed-dose antimalarial "ASAQ", in partnership with sanofi-aventis in 2007. In April 2008, DNDi delivered its second product, fixed-dose "ASMQ", with Farmanguinhos as first-line treatment for children and adults suffering from uncomplicated P. falciparum malaria cases in Latin America and Asia.

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: http://www.sanofi-aventis.com.