Significant Step towards Expanded Global Access to Malaria Treatment
Sanofi-aventis and the non-profit Drugs for Neglected Diseases initiative (DNDi) welcome the approval, by the World Health Organization (WHO) Prequalification of Medicines Program, of Coarsucam™ / Artesunate Amodiaquine Winthrop® (“ASAQ”), the first fixed-dose combination of the two antimalarial compounds, artesunate (AS) and amodiaquine (AQ).
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ASAQ is the first antimalarial, fixed-dose combination with a soluble formulation, specifically designed for children, to be granted a “prequalified” status.
The WHO Prequalification Program aims to make quality priority medicines available, primarily in the fields of HIV/AIDS, malaria and tuberculosis. Products found to live up to the WHO quality standards are included in a “prequalified list” of products. This list, initially intended for procurement of medicines by United Nations agencies, has now become a vital tool for many agencies and organizations involved in bulk purchasing of medicines.
“We are very pleased to see that the quality of the documentation generated on “ASAQ” has been recognized by the WHO Prequalification Program. The “prequalified” status makes ASAQ eligible for procurement by more countries and international agencies than before,” said Dr Robert Sebbag, Vice-President of Access to Medicines at sanofi-aventis.
“Over 200 million patients suffer from malaria, and more than one million patients, mainly children, die from this disease every year. This new status means that ASAQ will be made available to many more patients: this is a major milestone. We believe that with its very simple dosing regimen and soluble tablets specifically designed for children, ASAQ will make a difference in the field,” said Dr Bernard Pécoul, Executive Director, DNDi.
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About the WHO Prequalification of Medicines Program
The WHO Prequalification of Medicines Program focuses on medicines used in the treatment of HIV/AIDS, tuberculosis and malaria and interested manufacturers of these medicines apply voluntarily to benefit from the Program. Once the products are found living up to the WHO quality standards, after inspection of manufacturing facilities that must comply with the “Good Manufacturing Practices”, and review of submitted data, they are included in list of “prequalified” products. This list was initially intended for procurement of these medicines by United Nations agencies such as UNAIDS and UNICEF. It has over the past few years become a vital tool for many agencies and organizations involved in bulk purchasing of medicines, such as The Global Fund to fight HIV/AIDS, tuberculosis and malaria, UNITAID, the President’s Malaria Initiative, etc. A “prequalified” status makes ASAQ eligible to tenders that receive funding from these agencies.
About ASAQ
Coarsucam™/Artesunate Amodiaquine Winthrop® (“ASAQ”) is the result of a partnership started in late 2004 between sanofi-aventis and DNDi to jointly develop a new fixed-dose combination of artesunate and amodiaquine. ASAQ is available under the name Artesunate-Amodiaquine Winthrop® (ASAQ) for public markets, and under the brand name Coarsucam® in private markets. ASAQ was first registered in February 2007 in Morocco, where it is manufactured, and soon thereafter in 20 sub-Saharan African countries. It was submitted to the WHO Prequalification of Medicines Program in February 2007.
ASAQ is available in 4 presentations for 4 age ranges (infants, small children, children, adolescents and adults), and each presentation is easily identified with a specific color code and pictograms to ensure appropriate usage in the field. These 4 presentations make possible a simple dosing regimen: 1 tablet per day for 3 days for infants and children, and 2 tablets once a day for 3 days for adolescents and adults. Importantly, ASAQ tablets are soluble and can be easily administered to small children, the first victims of malaria.
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 6 clinical and 4 preclinical projects. 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 Far-manguinhos 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: www.sanofi-aventis.com.
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include product development, product potential projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects,” “anticipates,” “believes,” “intends,” “estimates,” “plans” and similar expressions.
Although sanofi-aventis’ management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of sanofi-aventis, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMEA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such products candidates, the absence of guarantee that the products candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in sanofi-aventis’ annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
Contacts
Sanofi-aventis
Robert Sebbag, MD
Tel: +33 1 41 24 57 78
Mobile: +33 6 08 17 21 83
E-mail : robert.sebbag@sanofi-aventis.com
François Bompart, MD
Tel: +33 1 41 24 53 45
Mobile: +33 6 08 25 61 67
E-mail : francois.bompart@sanofi-aventis.com
DNDi
Bernard Pécoul, MD
Tel: +41 (0) 22 906 92 30 or 32
Mobile: +41 79 219 65 60
E-mail: bpecoul@dndi.org
Jean Francois Alesandrini
Tel: +41 (0) 22 906 92 30 or 43
Mobile. +41 79 596 50 66
Email : jfalesandrini@dndi.org
Read more : ASAQ Update, October 2008
