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Paris, France - October 23, 2008
Sanofi-aventis is complying with the EMEA’s recommendation to temporarily suspend the marketing authorisation of Acomplia® in obese and overweight patients
- Sanofi-aventis will comply with the European Authorities request to temporarily
suspend the marketing authorisation of Acomplia® in obese and overweight patients
and will make every effort to actively support patients and Health Care Professionals
in this process.
- Sanofi-aventis is committed to provide additional evidence for the re-evaluation of
the benefit / risk profile of Acomplia® in patients with diabetes and cardiovascular
diseases through the ongoing clinical studies.
- Sanofi-aventis remains committed to Acomplia® to bring an important therapeutic
approach to obese and overweight patients.
Sanofi-aventis announced today that the European Medicines Agency
(EMEA) has recommended to the European Commission (EC) the temporary suspension of the
marketing authorisation of Acomplia® (rimonabant) for the approved indication of overweight and
obese patients.
Acomplia® has been marketed in 18 EU countries since 2006 and has provided significant clinical
benefits to patients suffering from obesity and overweight with associated co-morbidities.
Since the start of the commercialisation of Acomplia®, sanofi-aventis has been closely
collaborating with both the regulatory authorities and healthcare providers to monitor on an
ongoing basis the real life use of the product and to ensure its use in the right patient population.
More than 700,000 patients have been treated with Acomplia® world-wide to date. In the
postmarketing surveillance of Acomplia the safety profile of the product is aligned to the one
described in the current European SmPC for the product and is consistent with the one observed
during the clinical development.
“This first in its class medication continues to demonstrate great promise to reduce
cardiometabolic risk and the pattern of side effects remains consistent across the randomized
clinical trials conducted to date. As with any new drug category, more will be learned about
optimizing benefit and minimizing risk through continuing controlled use of the medication in
different patient populations. While the pendulum has swung in the direction of extreme caution
with today’s regulatory decision, at the end of the day, the medical community will allow the
scientific process to unfold before rendering any final decisions about this medication’s ultimate
therapeutic potential” declared Robert Anthenelli, M.D. Professor of Psychiatry, Psychology and
Neuroscience University of Cincinnati College of Medicine and Cincinnati Veterans Affairs Medical
Center.
Sanofi-aventis believes that Acomplia® will remain an important therapeutic answer to a highly
prevalent and increasing unmet medical need. As discussed with the EMEA, sanofi-aventis will
continue the ongoing clinical trial program except phase IV and is committed to provide additional
evidence for the positive re-evaluation of the benefit / risk profile of Acomplia®, including through
studies in diabetes and in patients at risk of cardiovascular disease.
Inline with its commitment to the EMEA, sanofi-aventis and its subsidiaries will inform Health Care
Professionals as of today of the temporary marketing authorisation suspension. Patients who are
currently taking Acomplia® should consult their doctor or pharmacist at a convenient time to
discuss their treatment.
Sanofi-aventis will enter immediately in discussion with health care authorities in non European
Union countries where Acomplia is available to determine how to implement an equivalent EMEA
decision.
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 sanofiaventis’
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.