Aubagio® Significantly Reduced Risk of New Clinical Relapse or MRI Lesion in Multiple Sclerosis Study

PR Newswire/Les Echos/ 
PRESS RELEASE 
 Aubagio(r) Significantly Reduced Risk of New Clinical Relapse or MRI Lesion in 


                            Multiple Sclerosis Study
    - Data Presented at ECTRIMS Highlight Potential of Early Intervention with
     Aubagio To Delay Second Clinical Attack and Reduce MRI Lesion Burden -

Paris, France - October 3, 2013 - Sanofi (EURONEXT: SAN and NYSE: SNY) and its
subsidiary Genzyme announced today positive new data from the TOPIC study of 
its once-daily, oral Aubagio(r) (teriflunomide). These new data, presented 
today at the 29th Congress of the European Committee for Research and Treatment
in Multiple Sclerosis (ECTRIMS), include the following:

  * Aubagio 14 mg significantly reduced the risk of a new clinical relapse or
    MRI lesion over the twoyear study period. There was a 35 percent reduction 
    among patients who received Aubagio 14 mg compared to placebo (p=0.0003).

  * As measured by MRI over the two-year study period, there was a 5 percent
    increase in total lesion volume among patients treated with Aubagio 14 mg
    compared to a 28 percent increase among patients treated with placebo
    (p=0.0374). In addition, there was a 59 percent reduction in
    gadolinium-enhancing T1 lesions among patients treated with Aubagio 14 mg
    compared to placebo (p=0.0008).

Similar results were observed for the 7 mg dose, though the effects did not
achieve statistical significance on some end points.

The TOPIC trial was designed to assess whether early initiation of Aubagio in
patients who experienced their first neurological symptoms suggestive of MS
could prevent or delay a second clinical attack, i.e., conversion to clinically
definite multiple sclerosis (CDMS).

As previously announced, patients receiving Aubagio 14 mg and 7 mg in the TOPIC
trial were significantly less likely than placebo to develop CDMS, the primary
endpoint. Compared to placebo, Aubagio 14 mg reduced the risk of conversion to
CDMS by 43 percent.

"The findings presented today are encouraging, as they are in line with the 
body of evidence supporting the value in treating MS early," said Dr. Aaron 
E. Miller, Medical Director, The Corinne Goldsmith Dickinson Center for 
Multiple Sclerosis, Mount Sinai Medical Center. "These results demonstrate 
Aubagio's consistent efficacy and safety across a spectrum of MS patients."

The average duration of Aubagio exposure in TOPIC was approximately 16 months.
Adverse events observed in the trial were consistent with previous clinical
trials with Aubagio in MS. The most common types of adverse events reported 
more frequently in the Aubagio arms were ALT (Alanine aminotransferase) 
elevations, headache, hair thinning, diarrhea, paresthesia and upper 
respiratory tract infection. There were no deaths reported in either Aubagio 
group over the course of the study. There was one death due to suicide in the 
placebo arm. The rate of treatment discontinuation due to adverse events was 
similar across treatment arms (9.9 percent in placebo arm, compared to 12.1 
percent in 7 mg Aubagio arm and 8.3 percent in 14 mg Aubagio arm).

"We are proud to share these results, which underscore Aubagio's potential for
treating patients in the earlier stages of MS," said Genzyme President and CEO,
David Meeker, M.D. "This study, in addition to the studies that support
Aubagio's indication in relapsing remitting MS, reflects our commitment to
advancing our understanding of this complex disease."

The trial compared treatment with either 14 mg or 7 mg once-daily, oral Aubagio
against placebo. This double-blind, multi-center trial enrolled 618 patients 
who had experienced a first acute or sub-acute, welldefined neurological event
consistent with demyelination, as well as onset of MS symptoms within 90 days 
of randomization, and MRI scan showing two or more T2 lesions characteristic 
of MS.

Aubagio is approved in the U.S., EU, Australia, Argentina, Chile, South Korea,
and Mexico for the treatment of relapsing forms of MS. Marketing applications
for Aubagio are also under review by additional regulatory authorities
globally.

About Aubagio(r) (teriflunomide) 
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). Aubagio is supported by one of the largest clinical programs of any MS
therapy, with more than 5,000 trial participants in 36 countries. Some patients
in extension trials have been treated for up to 10 years.

EU Indication and Usage
Aubagio (teriflunomide) 14 mg is a once-daily, oral therapy indicated in the
European Union for the treatment of adult patients with relapsing remitting
multiple sclerosis.

U.S. Indication and Usage
Aubagio (teriflunomide) is a once-daily, oral therapy indicated in the U.S. for
the treatment of adult patients with relapsing forms of multiple sclerosis. The
recommended dose of Aubagio is 7 mg or 14 mg orally once daily.

Important Safety Information About Aubagio
The Aubagio label includes the risk of hepatotoxicity and, teratogenicity 
(based on animal data). In the U.S., this information can be found in the boxed
warning.

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 2.5 million patient years of exposure in 
rheumatoid arthritis globally since its launch.

Aubagio is contraindicated in patients with severe hepatic impairment, pregnant
women and women of childbearing potential who are not using reliable
contraception, breast feeding women, patients with immunodeficiency states,
patients with significantly impaired bone marrow function or significant
anaemia, leucopenia, neutropenia or thrombocytopenia, patients with severe
active infection until resolution, patients with severe renal impairment
undergoing dialysis and patients with hypoproteinaemia.

For full prescribing information and more information about Aubagio for EU 
patients, please visit: 
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/
002514/human_med_001645.jsp&mid=WC0b01ac058001d124 


For full prescribing information and more information about Aubagio for U.S.
patients, please visit: http://products.sanofi.us/aubagio/aubagio.pdf

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.

Genzyme(r) and Aubagio(r) are registered trademarks of Genzyme Corporation, a
Sanofi company.

About Sanofi
Sanofi, an integrated global 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 
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Sanofi's management believes that the expectations reflected in such 
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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 
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commercial potential of such product candidates, the absence of guarantee that 
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approval and commercial success of therapeutic alternatives, the Group's 
ability to benefit from external growth opportunities, trends in exchange 
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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
Jack Cox                           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: +1 617 768 6881               Tel: +1 908 981 5560
E-mail: Erin.Walsh@genzyme.com     E-mail: ir@sanofi.com


                  
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-0- Oct/03/2013 09:34 GMT