Sanofi-aventis is Complying With the EMEA's Recommendation to Temporarily Suspend the Marketing Authorisation of Acomplia(R) in Obese and Overweight Patients

Paris (ots/PRNewswire) -

- Sanofi-aventis Will Comply With the European Authorities
Request to Temporarily Suspend the Marketing Authorisation of
Acomplia(R) 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(R) in
patients with diabetes and Cardiovascular Diseases Through the
ongoing Clinical studies.

- Sanofi-aventis Remains Committed to Acomplia(R) 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(R) (rimonabant)
for the approved indication of overweight and obese patients.

Acomplia(R) 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(R),
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(R)
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(R) 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(R), 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(R) 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:
http://www.sanofi-aventis.com.

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