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

PR Newswire/Les Echos/ 
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
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
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
* 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: or  
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-0- Apr/11/2013 07:27 GMT
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