Sanofi Pasteur's Fluzone High-Dose Vaccine Significantly More Effective Than Standard Dose Fluzone Vaccine in Preventing

 Sanofi Pasteur's Fluzone High-Dose Vaccine Significantly More Effective Than
 Standard Dose Fluzone Vaccine in Preventing Influenza in Adults 65 Years of
                                Age and Older

- Efficacy trial in more than 30,000 older adults meets primary endpoint for
superior efficacy -

PR Newswire

LYON, France, Aug. 26, 2013

LYON, France, Aug. 26, 2013 /PRNewswire/ --Sanofi Pasteur, the vaccines
division of Sanofi (EURONEXT: SAN and NYSE: SNY), today announced topline
results of a large-scale, multi-center efficacy trial in people 65 years of
age and older showing a superior clinical benefit of Fluzone^® High-Dose
(Influenza Virus Vaccine) relative to the standard dose of Fluzone vaccine in
preventing influenza.

Today's announcement reflects the positive findings related to the primary
endpoint for the study population. Further data analyses of secondary
endpoints are ongoing, including an evaluation of the relative efficacy based
on the match of the vaccine strains to circulating influenza virus strains.
Sanofi Pasteur anticipates submitting the full clinical study report to the
FDA for review by early 2014 and will seek a modification to the label for
Fluzone High-Dose vaccine reflecting the superior efficacy data in adults 65
years of age and older.

"We are pleased that this study demonstrates the superior relative efficacy of
Fluzone High-Dose vaccine compared to Fluzone vaccine in preventing influenza
in older adults," said David P. Greenberg, M.D., Vice President, U.S.
Scientific and Medical Affairs, Sanofi Pasteur. "This efficacy trial
complements the previous evidence of superior immune responses for Fluzone
High-Dose vaccine compared to Fluzone vaccine and reaffirms the Phase III
safety data in this population that were the basis for FDA licensure of
Fluzone High-Dose vaccine in 2009."

In the study, Fluzone High-Dose vaccine was 24.2 percent more effective in
preventing influenza in adults 65 years of age and older than Fluzone vaccine.
The results met the pre-specified primary objective of the study,
demonstrating statistically superior efficacy for Fluzone High-Dose vaccine.
Additionally, the study results suggested consistent clinical benefit across
the study years, influenza virus types, clinical illness definitions, and
laboratory methods of influenza confirmation. This large, multi-year trial
also reaffirmed the safety of Fluzone High-Dose vaccine as demonstrated in
previous studies.

"Influenza vaccines have been shown to offer public health benefits in
preventing influenza and its complications in all age groups; however, older
adults still have the highest rates of influenza-related hospitalization and
death despite having high immunization rates," said John Shiver, Senior Vice
President, Research and Development, Sanofi Pasteur. "This led Sanofi Pasteur
to develop Fluzone High-Dose vaccine, which this trial has confirmed provides
better protection against influenza compared to Fluzone vaccine in people 65
years of age and older."

Fluzone High-Dose vaccine was licensed in the United States by the Food and
Drug Administration (FDA) in December 2009 based on the vaccine's safety
profile and superior immunogenicity compared to Fluzone vaccine.
Immunogenicity (the ability of a vaccine to trigger the body to produce
antibodies against an infectious agent) is commonly used to evaluate vaccines
in clinical trials. Fluzone High-Dose vaccine contains 60 mcg of hemagglutinin
antigen per strain of influenza virus in the vaccine as compared to 15 mcg of
influenza virus hemagglutinin antigen per strain of influenza virus in
standard dose Fluzone vaccine. Fluzone High-Dose vaccine was licensed by the
FDA under an accelerated approval process to address the medical need in older
adults. As a requirement of the accelerated approval pathway, Sanofi Pasteur
embarked on this large-scale, two-season, confirmatory efficacy trial,
involving more than 30,000 participants 65 years of age and older, to evaluate
the clinical benefit of Fluzone High-Dose vaccine compared to Fluzone vaccine
in the prevention of influenza disease. 

About Influenza Disease in People 65+ ^ Years of Age

Research has shown that the immune system weakens as people age. Older adults
are not only more susceptible to infections, but also less responsive to
vaccination. When infected with the influenza virus, they are less able to
mount an effective immune response to neutralize the attack. Compared to
younger adults, people 65 years of age and older suffer disproportionately
from seasonal influenza disease and its complications, including severe
illness leading to hospitalization and death. Although this group comprises
only 15 percent of the U.S. population, on average it accounts for 65 percent
of the estimated 226,000 hospitalizations and 90 percent of the 3,000 to
49,000 deaths attributed to seasonal influenza and its complications each
year. The first baby boomers began to turn 65 in 2011 and, by the year 2030,
the number of adults 65 years of age and older is anticipated to double and
surpass 70 million people, comprising 20 percent of the U.S. population. Thus,
better prevention of influenza in older adults can have a significant impact
on public health, quality of life, and healthcare costs.

About Fluzone High-Dose Vaccine

Indication
Fluzone High-Dose vaccine is an inactivated influenza virus vaccine given for
active immunization in persons 65 years of age and older against influenza
disease caused by influenza virus subtypes A and type B contained in the
vaccine. Approval of Fluzone High-Dose vaccine is based on superior immune
response relative to Fluzone vaccine. Data demonstrating a decrease in
influenza disease after vaccination with Fluzone High-Dose vaccine relative to
Fluzone vaccine have not yet been reviewed by FDA.

Safety Information

The most common side effects to Fluzone High-Dose vaccine include pain,
swelling, and redness at the injection site; fever, headache, fatigue, and
muscle aches. Other side effects may occur. Fluzone High-Dose vaccine should
not be given to anyone with a severe allergic reaction to any vaccine
component, including eggs or egg products, or to a previous dose of any
influenza vaccine.

The decision to give Fluzone or Fluzone High-Dose vaccine should be based on
the potential benefits and risks if Guillain-Barre syndrome has occurred
within six weeks of receipt of a prior influenza vaccine. Vaccination with
Fluzone or Fluzone High-Dose vaccine may not protect all individuals.

Before administering Fluzone High-Dose vaccine or Fluzone vaccine, please see
full Prescribing Information available at www.sanofipasteur.usor
www.vaccineshoppe.com.

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 health care 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 Pasteur, the vaccines division of Sanofi, provides more than 1 billion
doses of vaccine each year, making it possible to immunize more than 500
million people across the globe. A world leader in the vaccine industry,
Sanofi Pasteur offers the broadest range of vaccines protecting against 20
infectious diseases. The company's heritage, to create vaccines that protect
life, dates back more than a century. Sanofi Pasteur is the largest company
entirely dedicated to vaccines. Every day, the company invests more than EUR 1
million in research and development. For more information, please visit:
www.sanofipasteur.com or www.sanofipasteur.us.

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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.

SOURCE Sanofi Pasteur

Website: http://www.sanofipasteur.us
Website: http://www.sanofipasteur.com
Contact: U.S. Media Relations: Donna Cary, +1-570-957-0717,
donna.cary@sanofipasteur.com, www.sanofipasteur.us; Global Media Relations,
Alain Bernal, +33-4-37-37-50-38, alain.bernal@sanofipasteur.com,
www.sanofipasteur.com; Investor Relations, Sebastien Martel,
+33-1-53-77-45-45, ir@sanofi.com, www.sanofi.com
 
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