FDA Accepts Sanofi Pasteur File Submission for Novel Influenza Vaccine Delivered by Intradermal Microinjection

SWIFTWATER, Pa., Sept. 13 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN andNYSE: SNY), announced today that it has filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Fluzone® Intradermal (Influenza Virus Vaccine).  The file has been accepted by the FDA and an action date is anticipated in the first half of 2011.

"Upon FDA licensure, this new formulation of Sanofi Pasteur's Fluzone vaccine will be the first vaccine available in the U.S. using a novel microinjection system for intradermal delivery of vaccine," said Wayne Pisano, President and Chief Executive Officer, Sanofi Pasteur.  "We believe that Fluzone Intradermal Vaccine could be an important tool in increasing adult immunization rates due to its ease of use for health-care providers and the high-level of interest expressed by patients for this immunization option."

Typically, adult vaccines are administered into the muscle (referred to as intramuscular or IM injection) utilizing a needle 1 inch to 1.5 inches in length (approximately 25 mm to 40 mm) depending on body mass.  Vaccination via the intradermal (ID) route involves introduction of the vaccine into the dermal layer of the skin with an ultra-thin needle of only 1.5 mm in length, or less than one-tenth the length of the standard needles used for the traditional IM route of administration.  The injection volume is only 0.1 mL, or one-fifth the amount injected when vaccine is administered using standard IM administration.

In addition to providing a less invasive option that may be preferred by patients, ID vaccination is believed to stimulate an antibody response by having direct access to the immune system due to the high concentration of specialized immune cells in the dermal layer of the skin.  The microinjection system was designed to consistently deposit vaccine antigens in the dermal layer of the skin of adults irrespective of a person's gender, age, ethnicity or body mass.

Sanofi Pasteur's novel ID influenza vaccine candidate could overcome the technical difficulties that have historically limited the use of this route of administration and provides reliable intradermal influenza immunization.  This innovation in influenza immunization has been made possible with the development of a new, easy-to-use, pre-filled microinjection system developed in collaboration with BD (Becton, Dickinson and Company).

"In February, the Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention expanded the recommendation for annual influenza immunization to everyone 6 months of age and older by adding all healthy adults over the age of 18 years to those previously recommended," said Pisano. "The use of innovative technologies to develop new vaccines offering health-care providers and the public options for complying with immunization recommendations fulfills our mission of supporting public health in increasing immunization rates by providing vaccine solutions tailored to the specific needs of all segments of the population."

Sanofi Pasteur is seeking licensure of Fluzone Intradermal Vaccine in the U.S. for adults 18 years through 64 years of age.  Clinical trials, involving more than 5,800 adults in the U.S., were conducted to evaluate the vaccine dose, vaccine safety and the ability of the vaccine to induce an immune response.  The Phase III clinical trial compared the ID vaccine, containing 9 mcg of hemagglutinin of each of three seasonal influenza strains, to the standard-dose IM vaccine, containing 15 mcg of hemagglutinin of each of the three influenza strains.  Sanofi Pasteur already has licensed a microinjection system influenza vaccine, marketed as Intanza® / IDflu®, in Europe, Australia, New Zealand and other countries.

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, provided more than 1.6 billion doses of vaccine in 2009, 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-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, 2009.  Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE Sanofi Pasteur

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