Oral Therapy Teriflunomide (Aubagio?(*)) Significantly Reduces Relapses Leading to Hospitalization of Patients with Multiple Sclerosis

Paris (ots/PRNewswire) -

- New findings from the pivotal TEMSO Phase III study presented
today at the joint ECTRIMS / ACTRIMS Congress -

- U.S. FDA Accepts New Drug Application for Teriflunomide for
relapsing forms of MS -

Sanofi and its subsidiary Genzyme announced today new data from
the pivotal TEriflunomide Multiple Sclerosis Oral (TEMSO) Phase III
trial showing that once-daily oral teriflunomide significantly
reduced annualized rates of relapses leading to hospitalization. New
data also confirmed the safety profile and efficacy of teriflunomide
over a six-year period after the initial randomization. A total of
fifteen presentations on teriflunomide are on the program for the
fifth joint triennial congress of the European and American Committee
for Treatment and Research in Multiple Sclerosis (ECTRIMS / ACTRIMS)
in Amsterdam, Netherlands.

The companies also announced today that the U.S. Food and Drug
Administration has accepted for review Sanofi's new drug application
(NDA) for oral teriflunomide as a potential therapy for people with
relapsing forms of multiple sclerosis (MS). Sanofi expects to file an
application for regulatory approval with the European Medicines
Agency (EMA) in the first quarter of 2012.

"The new results of the TEMSO study show that both 7mg and 14mg
doses of teriflunomide could reduce the severity of relapses measured
through annual rates of relapses leading to hospitalization as well
as deliver encouraging long-term results on safety and efficacy,"
said Professor Paul O'Connor, Director of the MS Clinic at St.
Michael's Hospital, Toronto, Canada, and principal investigator of
the TEMSO study.

New post-hoc analyses showed that teriflunomide-treated patients'
annualized rate of relapses leading to hospitalization was
significantly reduced by 36% (p=0.015) with 7 mg and by 59%
(p<0.0001) with 14 mg compared with placebo. The risk of
hospitalization per relapse was also significantly reduced by 43%
(p<0.001) for the 14 mg dose and numerically reduced by 6% (p=NS) for
the 7 mg dose. These analyses also showed teriflunomide significantly
reduced the annualized rate of emergency medical facility visits (a
visit to a medical facility/hospital for emergency care not resulting
in an admission) by 42% (p=0.004) for the 14 mg dose and numerically
reduced by 31% (p=NS) for the 7 mg dose vs placebo.

"The additional data presented at ECTRIMS further supports the
potential of teriflunomide as a new once a day oral therapy that can
significantly decrease the number of relapses requiring
hospitalizations for patients suffering from this complex and
unpredictable disease and who need safer and more effective
therapeutic options," said Dr. Elias Zerhouni, President, Global
Research & Development, Sanofi.

Long-term data on safety and efficacy of teriflunomide were also
presented at this congress. The results from the extension of the
TEMSO study showed that both doses of teriflunomide were well
tolerated six years after the initial randomization, with a
consistent safety profile to the core two- year study. The beneficial
effects of teriflunomide on clinical and MRI endpoints reported in
TEMSO also continue to be sustained over five years after the initial
randomization.

In addition to the TEMSO extension, the follow up to the Phase II
long-term efficacy and safety study was presented. These new findings
showed that teriflunomide was well tolerated up to nine years of
continuous exposure, with a safety profile consistent with that
reported during the 36 weeks of initial double-blind treatment. The
reductions in disease activity observed with teriflunomide in the
initial study were maintained for up to eight years of treatment.

About TEMSO study

TEMSO was a two-year randomized, double-blind, placebo-controlled
multinational study that included 1,088 people with relapsing forms
of MS from 126 centers in 21 countries. Trial participants were 18-55
years of age, with an Expanded Disability Status Scale (EDSS) of 5.5
or less, and had at least one relapse in the previous year or at
least two relapses in the preceding two years. Trial participants
were randomized to placebo or teriflunomide, 7mg or 14mg, once daily
and followed for 108 weeks. The primary endpoint was annualized
relapse rate, defined as the number of confirmed relapses per trial
participant year; a relapse is a new or worsening of a previous
clinical sign or symptom. The key secondary endpoint was the time to
sustained disability progression, measured by the EDSS. Disability
progression was defined as an increase from baseline of at least 1.0
point on the EDSS persisting for at least 12 weeks. Change from
baseline in total lesion volume was also a key prespecified MRI
endpoint in the study. Safety and tolerability evaluations were based
on adverse events, physical examinations, vital signs and laboratory
investigations. A long-term extension of TEMSO is ongoing.

About Teriflunomide

Teriflunomide is an immunomodulatory, disease-modifying oral drug
with anti-inflammatory properties, and is under investigation for the
treatment of relapsing forms of MS. Teriflunomide blocks the
proliferation and functioning of activated T and B lymphocytes -
which are thought to be especially damaging in MS - by selectively
and reversibly inhibiting a critical mitochondrial enzyme. With nine
years of continuous use in a Phase II extension, teriflunomide has
the longest clinical experience of any investigational oral MS
therapy. In addition to the TEMSO trial, two other Phase III trials,
TOWER and TENERE, are ongoing in people with RMS. A Phase III study,
TOPIC, is also underway in early MS or CIS (clinically isolated
syndrome). Teriflunomide is also being evaluated as an adjunct
therapy to interferon-beta in the Phase III TERACLES trial.

(*) Aubagio(TM) is the proprietary name submitted to health
authorities for the investigational agent teriflunomide.

About Multiple Sclerosis

Today more than 2,000,000 people around the world suffer from MS,
a chronic autoimmune disease that affects the central nervous system
- the brain, spinal cord and optic nerves. In MS, immune cells called
lymphocytes mistakenly attack myelin, the fatty "insulation" that
surrounds and protects nerves, resulting in abnormal nerve
transmission and MS symptoms such as fatigue, weakness, walking and
balance problems, vision problems, pain, spasticity and cognitive
difficulties. MS is the most common disabling neurological disease in
young adults after accidents, and is two to three times more common
in women than in men. MS is usually characterized by relapses
followed by periods of complete or incomplete recovery. There is no
typical individual with MS, as the disease is a very variable
condition and the symptoms depend on which areas of the central
nervous system are affected. MS symptoms can vary from time to time
and can change in severity and duration, even in the same person.The
vast majority of people with MS - approximately 90 percent - are
initially diagnosed with a relapsing form of MS.

Magnetic resonance imaging (MRI) is a common and important tool
used to help establish a diagnosis of MS and monitor the course of
the disease and effects of treatment. Providing a highly sensitive,
non-invasive way to image the brain, spinal cord or, other areas of
the body, MRI has made it possible to visualize and understand a
great deal about the underlying pathology of MS.

About Genzyme, a Sanofi Company

One of the world's leading biotechnology companies, Genzyme is
dedicated to making a major positive impact on the lives of people
with serious diseases. Since its founding in 1981, the company has
introduced breakthrough treatments that have provided new hope for
patients. The company's areas of focus are rare genetic diseases,
multiple sclerosis, cardiovascular disease, and endocrinology.
Genzyme is a Sanofi company. Genzyme's press releases and other
company information are available at http://www.genzyme.com .

Genzyme's Multiple Sclerosis business unit is responsible for the
development of teriflunomide, along with the investigational MS
therapy alemtuzumab.

About Sanofi

Sanofi, a global and diversified healthcare leader, discovers,
develops and distributes therapeutic solutions focused on patients'
needs. Sanofi has core strengths in the field of healthcare with
seven growth platforms: diabetes solutions, human vaccines,
innovative drugs, rare diseases, consumer healthcare, emerging
markets and animal health. Sanofi is listed in Paris and in New York
.

Forward Looking Statements

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in the Private Securities Litigation Reform Act of 1995, as amended.
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approval and commercial success of therapeutic alternatives, the
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as those discussed or identified in the public filings with the SEC
and the AMF made by Sanofi, including those listed under "Risk
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ots Originaltext: sanofi-aventis Group
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Contact:
Contacts:Sanofi Media Relations: Marisol Péron, Tel:
+33(0)1-53-77-45-02, E-mail: mr@sanofi.com . Sanofi Investor
Relations :
Sébastien Martel, Tel: +33(0)1-53-77-45-45, E-mail: ir@sanofi.com .
Genzyme Media Relations : Bo Piela, Tel: +1-617-768-6579, Mobile :
+1-508-308-9783, E-mail: bo.piela@genzyme.com .