SWIFTWATER, Pa., Oct. 18, 2012 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that it has filed a Supplemental Biologics License Application (sBLA) with the U.S. Food and Drug Administration (FDA) for a quadrivalent formulation of its Fluzone® (Influenza Virus Vaccine). The sBLA file has been accepted by the FDA for full review, and an action date is anticipated in the second quarter of 2013.
"The addition of a fourth influenza virus strain to the seasonal influenza vaccine formulation has the potential to make a substantial impact in reducing influenza disease and influenza-related complications, hospitalizations and deaths among those who contract the disease," said David Greenberg, M.D., Senior Director, U.S. Scientific and Medical Affairs, Sanofi Pasteur. "Two influenza B-lineage strains typically co-circulate in the U.S each year, so it makes sense to include both in the vaccine rather than attempting to predict which of the two will be the dominant strain. In fact, in six of the past 12 influenza seasons, the B strain selected by health authorities for inclusion in the vaccine was not the predominant B-lineage strain that circulated during the next influenza season."
The strains for each season's influenza vaccine are selected by the FDA, in consultation with global health authorities, from the strains anticipated to circulate in the approaching influenza season. Seasonal influenza vaccines contained only two strains (one strain of type A influenza and one strain of type B influenza) until 1978, when the decision was made to incorporate a second type A influenza strain in order to provide protection against the two different A strains that were co-circulating. From then until now, influenza vaccines have been trivalent to help protect against three stains of influenza virus (two of type A and one of type B). However, since the influenza B Victoria lineage re-emerged worldwide in 2001-2002, two influenza B strains (one each from the Victoria and Yamagata lineages) have co-circulated with varying prevalence, making it difficult to predict the next season's dominant B strain. Even in years where the correct B virus strain was selected for the vaccine, some influenza disease was caused by the B strain omitted from the vaccine. These factors raised the hypothesis that the addition of a second B-lineage strain to expand the licensed trivalent influenza vaccine to a quadrivalent vaccine could help reduce influenza disease and the frequent complications that occur, often resulting in preventable hospitalizations or even deaths.
Sanofi Pasteur is seeking FDA licensure of Fluzone Quadrivalent Influenza Virus Vaccine for active immunization of children and adults 6 months of age and older for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. This is the same age indication for Sanofi Pasteur's currently licensed trivalent influenza virus vaccine, Fluzone vaccine. Fluzone vaccine is used in the U.S. to help protect more than 50 million people each year against influenza and is the only influenza vaccine licensed in the U.S. for children as young as 6 months of age. While influenza B can affect people of any age, it is responsible for a substantial burden of disease and influenza-associated complications and hospitalizations in children.
If approved by the FDA, Fluzone Quadrivalent vaccine would be the first quadrivalent influenza vaccine for Sanofi Pasteur. Sanofi Pasteur also has development efforts underway for quadrivalent formulations of the company's other influenza vaccines including Fluzone High-Dose and Fluzone Intradermal vaccines, which are marketed in the U.S., and Vaxigrip® vaccine, which is marketed outside the U.S.
Important Safety Information about Fluzone Vaccine
Fluzone vaccine is an inactivated influenza virus vaccine indicated for active immunization of persons 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
The most common local and systemic adverse reactions to Fluzone vaccine include pain, erythema and swelling at the vaccination site; fever, malaise and myalgia. Other adverse reactions may occur. Fluzone vaccine should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein or thimerosal (the multi-dose vial of Fluzone vaccine is the only presentation that contains thimerosal), or to a previous dose of any influenza vaccine.
The decision to give Fluzone vaccine should be based on the potential benefits and risks, especially if Guillain-Barre syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine. Vaccination with Fluzone vaccine may not protect all individuals.
Before administering Fluzone vaccine, please see the full Prescribing Information available at www.sanofipasteur.us or www.vaccineshoppe.com.
(1) Reed C, et al. Public health impact of including two lineages of influenza B in a quadrivalent seasonal influenza vaccine. Vaccine 30 (2012) 1993-1998.
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.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'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.
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