Press releases and press packs are intended to journalists, investors and shareholders.
Paris, France and Geneva, Switzerland - October 16, 2008
Coarsucam™ (artesunate/amodiaquine) first fixed-dose antimalarial combination to receive WHO Prequalification
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).
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.
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.
