Genzyme Receives Positive CHMP Opinion in the European Union for Once-daily, Oral AUBAGIO® to Treat Relapsing-Remitting

PR Newswire/Les Echos/ 
PRESS RELEASE 
 Genzyme Receives Positive CHMP Opinion in the European Union for Once-daily, 


        Oral AUBAGIO(r) to Treat Relapsing-Remitting Multiple Sclerosis
     - Genzyme Planning to Request Re-examination of New Active Substance
                                 Designation -

Paris, France - March 22, 2013 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its
subsidiary Genzyme announced today that the Committee for Medicinal Products for
Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive
opinion regarding the approval of once-daily, oral AUBAGIO(r) (teriflunomide)
for the treatment of adult patients with relapsing-remitting multiple sclerosis
(MS).

"The fact that AUBAGIO has demonstrated a positive effect on disability
progression in two, phase III clinical studies underscores its importance as a
new treatment option for relapsing-remitting MS patients," said Professor Ludwig
Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland.

There are approximately 630,000 people affected by MS in Europe. AUBAGIO is
approved to treat relapsing MS in the United States and Australia.

"This positive CHMP opinion and broad recommended indication reflect the strong
data from AUBAGIO's clinical development program. As we've seen from the uptake
of AUBAGIO in the United States, many patients are looking for an alternative to
current injectable therapies," said Genzyme CEO and President David Meeker, MD.

The CHMP did not recommend that AUBAGIO receive a new active substance (NAS)
designation.

"We are very disappointed about the CHMP opinion regarding new active substance
designation. We believe based on the product's characteristics and current data
that AUBAGIO is a new active substance," added Meeker. "AUBAGIO has been studied
over 10 years in one of the largest and broadest clinical development programs
of any MS therapy. This decision could have a detrimental impact on future
scientific innovation in MS and other diseases. We are considering all options
and planning to request a re-examination of the new active substance
designation."

Additional marketing applications for AUBAGIO are under review by regulatory
authorities around the world.

About AUBAGIO(r)
AUBAGIO is an immunomodulator with anti-inflammatory properties. Although the
exact mechanism of action for AUBAGIO is not fully understood, it may involve a
reduction in the number of activated lymphocytes in the central nervous system
(CNS).

Indications and Usage
AUBAGIO (teriflunomide) is a once-daily, oral treatment indicated for patients
with relapsing forms of multiple sclerosis (MS). AUBAGIO 14 mg has shown
significant efficacy across key measures of MS disease activity, including
reducing relapses, slowing the progression of physical disability, and reducing
the number of brain lesions as detected by MRI.

Important Safety Information About AUBAGIO
The AUBAGIO U.S. label includes a boxed warning citing the risk of
hepatotoxicity and, teratogenicity (based on animal data).

In MS clinical studies with AUBAGIO, the incidence of serious adverse events
were similar among AUBAGIO and placebo-treated patients. The most common adverse
events associated with AUBAGIO in MS patients included increased ALT levels,
alopecia, diarrhea, influenza, nausea and paresthesia. Teriflunomide is the
principal active metabolite of leflunomide, which is indicated in the U.S. and
Europe for the treatment of rheumatoid arthritis. Severe liver injury including
fatal liver failure has been reported in patients treated with leflunomide.

Leflunomide has an estimated 2.1 million patient years of exposure in rheumatoid
arthritis globally since its launch.

AUBAGIO is contraindicated in pregnant women and women of childbearing potential
who are not using reliable contraception.

AUBAGIO is supported by a robust clinical program with more than 5,000 trial
participants in 36 countries and is amongst the largest of any MS therapy. Some
patients in extension trials have been treated for up to 10 years. The EU
AUBAGIO submission includes efficacy data from the TOWER (Teriflunomide Oral in
people With relapsing remitting multiplE scleRosis) and TEMSO (TEriflunomide
Multiple Sclerosis Oral) trials.

For full prescribing information and more information about AUBAGIO, please
visit www.genzyme.com.

About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies
for patients affected by rare and debilitating diseases for over 30 years. We
accomplish our goals through world-class research and with the compassion and
commitment of our employees. With a focus on rare diseases and multiple
sclerosis, we are dedicated to making a positive impact on the lives of the
patients and families we serve. That goal guides and inspires us every day.
Genzyme's portfolio of transformative therapies, which are marketed in countries
around the world, represents groundbreaking and life-saving advances in
medicine. As a Sanofi company, Genzyme benefits from the reach and resources of
one of the world's largest pharmaceutical companies, with a shared commitment to
improving the lives of patients. Learn more at www.genzyme.com.

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, consumer healthcare, emerging
markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT:
SAN) and in New York (NYSE: SNY).

Sanofi 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
projections and estimates and their underlying assumptions, statements regarding
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results, events, operations, services, product development and potential, and
statements regarding future performance. Forward-looking statements are
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"intends", "estimates", "plans" and similar expressions. Although Sanofi's
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,
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 EMA, 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 product candidates, the absence of
guarantee that the product candidates if approved will be commercially
successful, the future approval and commercial success of therapeutic
alternatives, the Group's ability to benefit from external growth opportunities,
trends in exchange rates and prevailing interest rates, the impact of cost
containment policies and subsequent changes thereto, the average number of
shares outstanding as well as those discussed or identified in the public
filings with the SEC and the AMF made by Sanofi, including those listed under
"Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements"
in Sanofi's annual report on Form 20-F for the year ended December 31, 2012.
Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements.

Contacts:
Sanofi Media Relations                        Sanofi Investor Relations
Marisol Péron                                 Sébastien Martel
Tel: +33 (0) 1 53 77 46 46                    Tel: +33 (0) 1 53 77 45 45
E-mail: mr@sanofi.com                         E-mail: ir@sanofi.com 

Genzyme Media Relations                       Sanofi Investor Relations
Erin Walsh                                    Kristen Galfetti
Tel: 617-768-6881                             Tel: +1 908 981 5560
E-mail: Erin.Walsh@genzyme.com                E-mail: ir@sanofi.com


                  
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-0- Mar/22/2013 12:47 GMT
 
 
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