Following Positive Phase II Data, Sanofi Pasteur to Conduct Phase III Trials of Quadrivalent Influenza Virus Vaccine

SWIFTWATER, Pa., Oct. 25 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of the sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today the results of a clinical trial of its investigational Fluzone® Quadrivalent (Influenza Virus Vaccine) compared to the currently licensed Fluzone (Influenza Virus Vaccine).  Data from the Phase II trial assessing the immunogenicity and safety of the investigational quadrivalent vaccine were presented at the 48th Annual Meeting of the Infectious Diseases Society of America in Vancouver, British Columbia.  

In this study, sponsored by Sanofi Pasteur, quadrivalent inactivated influenza vaccine (QIV) containing two strains of type A (H1N1 and H3N2) and two strains of type B (one each from the Yamagata and Victoria lineages) was evaluated in comparison to two trivalent seasonal influenza vaccines (TIV) each containing the two strains of type A plus one of the two type B strains.  The data indicated that the QIV vaccine was immunologically non-inferior to TIV for all strains and the safety profiles of QIV and TIV did not materially differ. Moreover, QIV induced responses to both B lineage strains simultaneously.  

"Based on the data from this trial, Sanofi Pasteur plans to proceed with Phase III clinical trials of Fluzone Quadrivalent vaccine this fall," said Wayne Pisano, President and Chief Executive Officer, Sanofi Pasteur.  "We believe that Fluzone Quadrivalent vaccine could be an important vaccine for public health that may help reduce overall morbidity and mortality caused by influenza."

Since influenza B Victoria lineage re-emerged worldwide in 2001-2002, both Victoria and Yamagata lineages have circulated with varying prevalence, making it difficult to predict the next season's dominant lineage.  Even in years where there was a good match, some influenza disease was caused by the B lineage omitted from the vaccine.  This raised the hypothesis that the addition of a second B lineage strain to expand the licensed trivalent influenza vaccine to a quadrivalent vaccine could reduce influenza morbidity and mortality.

Study Design and Results

The immunogenicity and safety of the quadrivalent influenza vaccine was assessed in adults 18 years of age and older in comparison to the Fluzone vaccines licensed for use during the 2008-2009 and the 2009-2010 seasons.  This study design took advantage of the fact that the 2008-2009 and 2009-2010 TIVs contained identical A strains, but B strains of opposite lineages.  Adult study participants (n = 570) were randomized to receive one of three study vaccines: 2008-2009 TIV (n = 190), 2009-2010 TIV (n = 190) or QIV (n = 190); and were stratified into two age groups: 18 to 61 years of age, and 61 years of age and older.  Blood specimens were collected pre-vaccination and 21 to 28 days post-vaccination and standardized hemagglutination inhibition (HAI) antibody assays were performed by persons blinded to vaccine assignment to determine immunogenicity.  

The immunogenicity endpoints of the study were: geometric mean HAI antibody titers (GMTs), the percent of study participants with a 4-fold rise of HAI titers pre- to post-vaccination and the percent of participants with post-vaccination HAI titers greater than or equal to 1:40.  Safety was an observational objective with immediate reactions monitored in the clinic for 20 minutes post vaccination, solicited systemic and injection-site reactions recorded by participants on diary cards for three days post-vaccination and unsolicited adverse events (AEs) and serious adverse events (SAEs) reported by participants from vaccination to second visit (21 to 28 days post-vaccination).

The safety profiles of QIV and TIV did not materially differ as assessed by rates of solicited injection-site and systemic reactions, unsolicited AEs and SAEs.  For all groups, the most frequently reported solicited injection-site reaction was pain and the most frequently reported solicited systemic reactions were myalgia, headache and malaise.  In the evaluation of immunogenicity, HAI antibody responses to QIV were comparable to both licensed TIVs as assessed by GMTs, 4-fold rise rates and the percent of participants with titers greater than or equal to 1:40.  QIV induced statistically non-inferior GMT responses to each A strain (H1N1 and H3N2) and each B lineage strain (Victoria and Yamagata) compared with the control TIVs containing the respective strains.  

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