Sanofi Pasteur Presents Phase III Data on Intradermal Microinjection of Influenza Vaccine

SWIFTWATER, Pa., Oct. 25 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN andNYSE: SNY), announced today the results of the Phase III clinical trial of its investigational Fluzone® Intradermal (Influenza Virus Vaccine) candidate compared to Fluzone (Influenza Virus Vaccine) administered via the traditional intramuscular method (IM).  Data from the clinical trial assessing the immunogenicity and safety of the investigational intradermal vaccine were presented by Dr. Geoffrey J. Gorse at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia.  

Earlier this year, Sanofi Pasteur announced that it had filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for Fluzone Intradermal vaccine.  The file has been accepted for review by the FDA and an action date is anticipated in the first half of 2011.  

"The results from this large Phase III study in adults show that administration of influenza vaccine with an intradermal microinjection system may reduce the amount of antigen required for an immune response similar to that seen with Fluzone vaccine," said Geoffrey J. Gorse, M.D., Professor of Internal Medicine, Division of Infectious Diseases and Immunology, St. Louis University.  "The reduced amount of antigen, smaller volume of vaccine administered and shorter needle associated with intradermal microinjection compared with traditional intramuscular injection are attractive attributes for health-care providers and their patients that are likely to lead to increased acceptance of influenza vaccination and increase population coverage."  

Phase III Study Design and Results

The immunogenicity and safety of the Fluzone Intradermal vaccine candidate was assessed in comparison to the licensed Fluzone influenza virus vaccine administered intramuscularly.  Compared to licensed Fluzone vaccine, Fluzone Intradermal vaccine has a lower antigen content (9mcg HA vs. 15mcg HA per strain) and injection volume (0.1 mL vs. 0.5 mL).  The multicenter, active-controlled, modified double-blind Phase III trial was conducted in the United States during the 2008-2009 influenza season among 4,292 adults, 18 through 64 years of age.  Study participants were randomized 2:1 to receive either the investigational Fluzone Intradermal vaccine containing 9mcg  hemagglutinin (HA) per each of the three vaccine strains or the licensed Fluzone vaccine administered intramuscularly containing 15mcg HA antigen per each of the three strains in the vaccine.  Influenza strains in both vaccines were: A/Brisbane/59/07 (H1N1), A/Uruguay/716/2007 (H3N2) and B/Florida/04/2006.

In the study, antibody titers to HA using a hemagglutination inhibition (HAI) assay were assessed in blood specimens obtained on the day of vaccination (Day 0) and 28 to 35 days later.  Geometric mean titers (GMTs), rates of 4-fold rise in titers and seroprotection rates were calculated for each study group and each vaccine strain.  Fluzone Intradermal vaccine was found to induce comparable immunologic responses to the licensed Fluzone vaccine.

Systemic reactogenicity of Fluzone Intradermal was comparable to that of Fluzone IM in the study.  Injection-site reactions were reported more frequently in participants given Fluzone Intradermal compared with those given Fluzone IM, as was expected given that the vaccine antigens were administered into the dermal space.  Most of the reported injection-site and systemic reactions were of Grade 1 or Grade 2 in intensity and resolved in three to seven days without sequelae.

About Intradermal Microinjection

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).  Vaccination via the intradermal route involves introduction of the vaccine into the dermal layer of the skin, a procedure that can be technically challenging, particularly for providers who do not routinely perform this procedure.  Sanofi Pasteur's novel intradermal influenza vaccine candidate is designed to overcome the technical difficulties that have historically limited the use of this route of administration by incorporating a new, easy-to-use, pre-filled microinjection system developed in collaboration with Becton, Dickinson and Company (BD).  The microinjection system uses 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.  

In addition to offering patients an option they may find preferable to the traditional intramuscular injection, intradermal vaccination differs from intramuscular injection by depositing the antigen in the dermal layer of the skin, a site that contains a high concentration of specialized immune cells.

Sanofi Pasteur is seeking licensure of Fluzone Intradermal vaccine in the U.S. for adults 18 years through 64 years of age.  Sanofi Pasteur already has licensed a microinjection system influenza vaccine, marketed as Intanza® / IDflu®, in Europe, Australia, New Zealand, Argentina, Canada 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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