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Press release from PR Newswire

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

Thursday, November 08, 2012

Sanofi Pasteur Announces Publication of Pivotal Safety and Immunogenicity Data of Menactra® Vaccine for Infants and Toddlers09:50 EST Thursday, November 08, 2012- Two-Dose Series Given at Regularly Scheduled Pediatric Visits Demonstrates Strong Immune Responses -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 PublicationThe 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 VaccineMenactra 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.usForward Looking StatementsThis 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 Barollier                                          Sean ClementsT. +33-4-37-37-50-38                                      T. +570-957-1362       pascal.barollier@sanofipasteur.com                    sean.clements@sanofipasteur.comwww.sanofipasteur.com                               www.sanofipasteur.us SOURCE Sanofi Pasteur