Sanofi Pasteur Announces FDA Approval of Menactra Meningococcal Conjugate Vaccine Indication for Infants

SWIFTWATER, Pa., April 22, 2011 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN andNYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has granted licensure to expand the indication for its 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 children 9 months through 23 months of age. This is the first U.S. approval of a meningococcal vaccine for this age group.

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"Licensure of Menactra vaccine for infants as young as 9 months of age gives the opportunity to help protect infants against this potentially deadly disease when the likelihood of exposure supports a need for early protection," said Stephen I. Pelton, MD, Professor of Pediatrics and Epidemiology, Boston University Schools of Medicine and Public Health and Chief, section of Pediatric Infectious Diseases, Boston Medical Center.

Meningococcal disease is a rare but deadly disease caused by the bacterium Neisseria meningitidis.  The disease can progress quickly and take the life of a child within 24 hours. Menactra vaccine was the first quadrivalent conjugate vaccine licensed in the United States for active immunization against meningococcal disease caused by the serogroups contained in the vaccine (A, C, Y and W-135).  More than 36 million doses of Menactra vaccine have been distributed in the United States since its licensure in 2005.

The FDA approval of Menactra vaccine for infants was based on results of one Phase II and three Phase III modified single-blind, controlled, multicenter trials in which more than 3,300 infants from the United States received Menactra vaccine using a two-dose schedule, starting as young as 9 months of age. Results from these studies showed that 2 doses of Menactra vaccine given 3 months apart elicit a robust immune response against the serogroups included in the vaccine. The studies also showed that measles-mumps-rubella-varicella vaccine (MMRV) and pneumococcal conjugate vaccine (PCV7) can be administered concomitantly with Menactra vaccine in children. Vaccine related reactions included swelling, tenderness at injection site, and irritability.

"The approval of Menactra vaccine for infants is a significant advancement toward potentially eliminating the threat of this serious disease in this vulnerable population for included serogroups," said Michael Decker, MD, MPH, vice president, scientific and medical affairs at Sanofi Pasteur. "With this approval, it is now possible to help protect persons from 9 months through 55 years of age."

About Menactra Vaccine

Menactra (Meningococcal  [Groups A, C, Y and W-135] Polysaccharide Diphtheria Toxoid Conjugate Vaccine) is the only U.S. licensed conjugate vaccine for persons age 9 months through 55 years of age for active immunization against invasive meningococcal disease caused by N. meningitidis serogroups A, C, Y and W-135.  

Sanofi Pasteur is a vaccine industry leader with a strong heritage of meningococcal vaccine development.  Meningococcal vaccines designed to help protect against serogroups A and C were introduced in the mid-1970s.  In 1981, Menomune® - A/C/Y/W-135 (Meningococcal Polysaccharide Vaccine, Groups A, C, Y and W-135 Combined) became the first meningococcal vaccine available to help protect against meningococcal disease caused by four of the five most common serogroups (A, C, Y and W-135).  In 2005, Menactra vaccine became the first quadrivalent meningococcal conjugate vaccine available in the United States for people ages 11 through 55 years of age.  Menactra vaccine was approved for use in children ages 2 through 10 years of age in 2007; and approved for use in infants as young as 9 months of age in 2011.

Side effects following administration of Menactra vaccine include: pain, redness and swelling at the injection site, as well as headache or irritability and fatigue.  Other side effects may occur. Vaccination should be avoided by persons with known hypersensitivity (severe allergic reaction) to any ingredient of the vaccine, including latex (which is used in the vial stopper), or by any persons previously diagnosed with Guillain-Barre syndrome.  Vaccination with Menactra vaccine may not protect all individuals.

For Menactra vaccine prescribing information, please contact Sanofi Pasteur US.

About Meningococcal Disease

Meningococcal disease, which includes meningitis, is a serious bacterial infection that strikes between 1,000 and 2,600 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 more common viral illnesses.  Unlike more common illnesses, the disease can progress quickly and may cause death or disability in just a single day.  

About sanofi-aventis

Sanofi-aventis, a leading global pharmaceutical company, discovers, develops and distributes therapeutic solutions to improve the lives of everyone. Sanofi-aventis is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: www.sanofi-aventis.com

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provides more than one 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 one 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-aventis' 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-aventis, 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 products candidates, the absence of guarantee that the products 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 as well as those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2010. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

Contacts

U.S. Media Relations
Amy Ba
T. +1-570-957-0717
[email protected]
www.sanofipasteur.us

COM10327

SOURCE Sanofi Pasteur