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Sanofi Pasteur Announces Publication of Pivotal Safety and Immunogenicity Data of Menactra® Vaccine for Infants and Toddlers



Sanofi Pasteur Announces Publication of Pivotal Safety and Immunogenicity Data
                of Menactra® Vaccine for Infants and Toddlers

- Two-Dose Series Given at Regularly Scheduled Pediatric Visits Demonstrates
Strong Immune Responses -

PR Newswire

SWIFTWATER, Pa., Nov. 8, 2012

SWIFTWATER, Pa., Nov. 8, 2012 /PRNewswire/ -- Sanofi Pasteur, the vaccines
division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the
Pediatric Infectious Disease Journal (PIDJ)  has published the pivotal
clinical trial data used by the U.S. Food and Drug Administration (FDA) to
support the license expansion for Sanofi Pasteur's meningococcal conjugate
vaccine, Menactra^® (Meningococcal [Groups A, C, Y and W-135] Polysaccharide
Diphtheria Toxoid Conjugate Vaccine), to include a two-dose schedule for
infants and toddlers 9 months through 23 months of age.  

"The trial data demonstrate the ability of Menactra vaccine to provide
protection against four clinically important meningococcal strains using a
two-dose series that can be given during regularly scheduled pediatric
visits," said Miriam Pina, M.D., lead author of the PIDJ manuscript and
clinical director at Sanofi Pasteur. "At a programmatic level, this two-dose
series offers flexibility over the classic four-dose schedule and avoids
introducing another vaccine into the already crowded 2,4,6 month infant
vaccine schedule."   

Meningococcal disease is a rare, but sometimes deadly disease caused by the
bacterium Neisseria meningitidis.  The disease can progress quickly and take
the life of a child within 24 hours. Disease incidence peaks first in infancy,
with a second peak occurring between 15 and 18 years of age in the U.S. and
Europe.  The Centers for Disease Control and Prevention (CDC) recommends
meningococcal vaccination in a two-dose series for infants and children 9
through 23 months of age who are at high risk for meningococcal disease,
including those travelling to countries where meningococcal infection is
hyperendemic or  endemic, those with persistent complement component
deficiency, or functional or anatomic asplenia, and children who are in a
defined risk group during a community or institutional meningococcal disease
outbreak.

Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the
U.S. for active immunization against meningococcal disease caused by the
serogroups contained in the vaccine (A, C, Y and W-135).  Approximately 45
million doses of Menactra vaccine have been distributed in the U.S. since its
licensure in 2005.

About the PIDJ Publication
The FDA approval of Menactra vaccine for infants 9 months through 23 months of
age was based on the results of three Phase III controlled, multicenter trials
in which more than 3300 healthy infants received Menactra vaccine using a
two-dose schedule. 

The data from these studies (including a previous Phase II study) show that
Menactra vaccine is both safe and immunogenic when two doses are administered
three months apart to children 9 months of age through 23 months of age.

Thirty days post-vaccination, protective antibody titers were achieved by 86
to 100 percent of children receiving two doses of Menactra vaccine. When
Menactra vaccine was concomitantly administered with measles, mumps, rubella,
varicella vaccine (MMRV) or pneumococcal conjugate vaccine (PCV7), 81 to 98
percent of participants achieved protective meningococcal responses.

Menactra vaccine did not interfere with measles, mumps, rubella, or varicella
vaccine responses, but demonstrated some interference with responses to three
of the seven pneumococcal strains covered by PCV7; however, the clinical
significance of this interference is unknown. Adverse events were generally
mild and similar across groups. Serious adverse events were uncommon.

In summary, Menactra vaccine was demonstrated to be safe and immunogenic when
given in two doses to infants and toddlers and can be administered with other
common childhood immunizations.

Important Safety Information about Menactra Vaccine
Menactra vaccine is indicated for active immunization to prevent invasive
meningococcal disease caused by N. meningitidis serogroups A, C, Y, and W-135.
Menactra vaccine is approved for use in individuals 9 months through 55 years
of age. Menactra vaccine does not prevent N. meningitidis serogroup B disease.

The most common local and systemic adverse reactions to Menactra vaccine
include injection site pain, redness, and induration (all age groups);
irritability, crying, drowsiness, loss of appetite, and diarrhea (infants and
children); headache, fatigue, and malaise (adolescents and adults). Other
adverse reactions may occur.

Menactra vaccine is contraindicated in persons with known hypersensitivity to
any component of the vaccine. Persons previously diagnosed with Guillain-Barré
syndrome (GBS) may be at increased risk of GBS following receipt of Menactra
vaccine. The decision to give Menactra vaccine should take into account the
potential benefits and risks. GBS has been reported in temporal relationship
following administration of Menactra vaccine. Vaccination with Menactra
vaccine may not protect all individuals.

About Meningococcal Disease
Meningococcal disease, which includes meningitis, is a serious bacterial
infection that strikes between 800 and 1,200 Americans each year. 
Approximately 10 percent of individuals who contract meningococcal disease
will die. Of those who survive, up to one in five suffer permanent
disabilities such as hearing loss, neurological damage and limb amputations. 
Meningococcal disease can be hard to recognize, especially in its early
stages, because symptoms are similar to those of viral illnesses that are more
common.  Unlike more common illnesses, the disease can progress quickly and
may cause death or disability in just a single day. 

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, 2011. Other than as
required by applicable law, Sanofi does not undertake any obligation to update
or revise any forward-looking information or statements.

Contacts:
Global Media Relations                                  U.S. Media Relations          
Pascal                                                  Sean Clements
Barollier                                          
T.                                                      T. +570-957-1362      
+33-4-37-37-50-38                                      
pascal.barollier@sanofipasteur.com                      sean.clements@sanofipasteur.com
www.sanofipasteur.com                                   www.sanofipasteur.us

 

SOURCE Sanofi Pasteur

Website: http://www.sanofipasteur.com
Website: http://www.sanofipasteur.us
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