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Sanofi Pasteur’s New Quadrivalent Influenza Vaccine Accepted for Review for European Approval

PR Newswire/Les Echos/ 
PRESS RELEASE 
Sanofi Pasteur's New Quadrivalent Influenza Vaccine Accepted for Review for 
                           European Approval 
- The addition of a fourth influenza virus strain to the seasonal trivalent 
     vaccine aims to increase protection against influenza - 
Lyon, France - April 11, 2013 - Sanofi Pasteur, the vaccines division of Sanofi
(EURONEXT: SAN and NYSE: SNY), announced today that a decentralized marketing
authorization application has been accepted for review in the European Union
countries for a quadrivalent (four-strain) formulation of Vaxigrip(r) Sanofi
Pasteur's seasonal inactivated split-virion influenza vaccine produced at its
facility in Val de Reuil, France. The file has been accepted for review by
France's Agence nationale de sécurité du medicament et des produits de santé
(ANSM) as the regulatory agency for the "Reference Member State", and by
national regulatory agencies from the EU countries. 
"The inclusion in the seasonal influenza vaccine of the four influenza viruses
anticipated to circulate in the forthcoming season has the potential to reduce
the risk of influenza disease and influenzarelated complications, specifically
hospitalizations and deaths among those, at risk, who contract the disease,"
said Olivier Charmeil, President and CEO of Sanofi Pasteur. 
Annual influenza vaccination is considered to date as the most effective method
for preventing seasonal flu and its complications. Vaccination is especially
important for people at higher risk of serious influenza complications and for
people who live with or care for high risk individuals. 
Currently licensed trivalent seasonal influenza vaccines are formulated every
year, based on the seasonal recommendations made by the World Health
Organization (WHO) and national authorities, and contain inactivated strains
that confer protection against three different influenza viruses: two influenza
A virus subtypes (H3N2 and H1 N1) and one influenza B virus. 
Influenza viruses are capable of evading the body's immune system by undergoing
continuous genetic variation and may change from season to season. Individuals
are susceptible to new strains despite previous infection by other influenza
viruses. Additionally, for over a decade, two distinct influenza B families
(lineages) have co-circulated with varying prevalence, making it difficult to
predict which B-lineage strain will predominate in a country or in a region in
seasons to come. 
Sanofi Pasteur's new quadrivalent influenza vaccine includes two A strains and
two B strains corresponding to both of the B lineages.
The marketing authorization application for the quadrivalent version of
Vaxigrip(r) is intended to be presented in all countries of the world where
Vaxigrip(r) (licensed trivalent vaccine) is currently commercialized. Once
approved, the new quadrivalent vaccine will be commercialized in Western
European countries* by Sanofi Pasteur MSD (the joint venture between MSD and
Sanofi Pasteur), and in other countries (including Eastern Europe) by Sanofi
Pasteur. 
The current application is for the active immunization of children and adults
from 9 years of age for the prevention of influenza disease caused by influenza
virus subtypes A and B contained in the vaccine. It is based on a clinical
development program that involved more than 3,000 adults aged 18 to 60, seniors
aged 60 and over and children/teenagers 9 to 17 years old. Clinical trials
evaluated the safety of Sanofi Pasteur's new quadrivalent influenza vaccine and
its ability to generate an immune response compared to trivalent vaccines. In
parallel, development efforts are underway for a pediatric indication of this
new quadrivalent influenza vaccine, for children from 6 months to 9 years of
age. 
Additionally, Sanofi Pasteur filed, in October 2012, a Supplemental Biologics
License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for
a quadrivalent formulation of its Fluzone(r) (Influenza Virus Vaccine) produced
at the Sanofi Pasteur facility in Swiftwater, Pa. (USA). The sBLA file has been
accepted by the FDA for full review and an action date is anticipated in the
second quarter of 2013. 
As a world leader in the research, development and manufacturing of influenza
vaccines, Sanofi Pasteur is dedicated to saving lives through the development of
innovative new influenza vaccines. With the production of more than 200 million
doses of seasonal influenza vaccine in 2012, Sanofi Pasteur confirmed its
leadership by supplying an estimated 40 percent of the world influenza vaccine
market. 
* Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Ireland,
Italy, Liechtenstein, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden,
Switzerland, UK. 
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 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  
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
plans, objectives, intentions and expectations with respect to future financial
results, events, operations, services, product development and potential, and
statements regarding future performance. Forward-looking statements are
generally identified by the words "expects", "anticipates", "believes",
"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 : 
Media Relations                         Investor Relations
Pascal Barollier                        Sébastien Martel
T. + (33) 4 37 37 50 38                 Tél.: + (33) 1 53 77 45 45
pascal.barollier@sanofipasteur.com      ir@sanofi.com 
                  
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-0- Apr/11/2013 07:27 GMT
 
 
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