Sanofi Pasteur Announces FDA Approval of Fluzone® Intradermal Quadrivalent (Influenza Vaccine) for Adults

SWIFTWATER, Pa., Dec. 12, 2014 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN andNYSE: SNY), today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application (sBLA) for Fluzone Intradermal Quadrivalent vaccine. Fluzone Intradermal vaccine, which has been available in trivalent formulation for three years, is now available in a quadrivalent formulation to help protect against four strains of influenza virus. Fluzone Intradermal Quadrivalent vaccine is indicated for adults 18 through 64 years of age for active immunization for the prevention of influenza ("the flu") caused by influenza A subtype viruses and type B viruses contained in the vaccine.

"Influenza B is a common cause of influenza-related morbidity and mortality across all age groups," said David P. Greenberg, M.D., Vice President, Scientific & Medical Affairs, and Chief Medical Officer, Sanofi Pasteur US. "Fluzone Intradermal Quadrivalent vaccine will offer another influenza vaccination option for health care providers and their adult patients with broad coverage against influenza viruses that may be predominant, coupled with the efficiency of using the intradermal microinjection system."

Traditional three-strain—or trivalent—influenza vaccines contain two strains of influenza A and one strain of influenza B. Influenza B represents 20 to 25 percent of circulating influenza strains and is associated with substantial morbidity and mortality.ⁱ Two distinct families (lineages) of influenza B (Victoria and Yamagata) have been co-circulating worldwide for over a decade, making it difficult to predict which will predominate during a given season.^ii,iii In fact, the Centers for Disease Control and Prevention (CDC) has noted that in six (approximately 50 percent) of the past 13 influenza seasons (2001-2013), the B strain included in the vaccine did not match the predominant B strain in circulation.^{ii,iii,iv,v,vi} Accurately predicting which influenza strains will predominate during the upcoming season is critical as the degree of match between circulating and vaccine strains can significantly impact the effectiveness of seasonal influenza vaccines.^vii

"An intradermal vaccine provides a similar level of protection to the traditional flu shot," said John Shiver, Senior Vice President, Research and Development, Sanofi Pasteur. "Fluzone Intradermal Quadrivalent vaccine offers four-strain protection in a microinjection system that is convenient, efficient and easy to use, allowing for streamlined administration by health care providers."

Fluzone Intradermal Quadrivalent vaccine was developed to help address frequent B-strain mismatches and broaden coverage against influenza by incorporating a B strain from each lineage. The vaccine is administered directly into the skin through a small, 1.5 mm micro-needle, which is 90 percent smaller than typical needles used for intramuscular injection of influenza vaccines.^viii,ix,x,xi Because the skin has a high concentration of immune cells, an intradermal vaccine is able to use the skin's natural defenses.^xii In addition, the microinjection system is ideal for those immunizing since it has a pre-affixed needle and a needle shield.

Fluzone Intradermal Quadrivalent Vaccine Immunogenicity and Safety
The FDA approval of Fluzone Intradermal Quadrivalent vaccine was based on results from a phase III clinical study of 3,355 adults that compared this vaccine, which included B strains from both lineages, to two trivalent intradermal controls: licensed trivalent Fluzone Intradermal vaccine that contained a B strain of one lineage and an investigational intradermal vaccine that contained a B strain from the opposite lineage. In the study, antibody responses to all four strains in Fluzone Intradermal Quadrivalent vaccine were found to be non-inferior to those following the trivalent vaccine controls with respect to the strains contained in each, demonstrating that Fluzone Intradermal Quadrivalent vaccine could improve vaccine effectiveness by generating robust immune responses to influenza strains from both B lineages simultaneously.

Additionally, the study showed that Fluzone Intradermal Quadrivalent vaccine had a systemic safety profile that was comparable to that observed with Fluzone Intradermal vaccine and the investigational intradermal vaccine. The most commonly reported solicited reactions were pain, pruritus (itching), erythema (redness), swelling, and induration (hardness) at the injection site; myalgia (muscle ache), headache, and malaise. Most of these reactions were mild or moderate in intensity and occurred within three days of vaccination.

The development of Fluzone Intradermal Quadrivalent vaccine builds on the experience of Fluzone Intradermal vaccine and entails the addition of a second B strain to cover both B lineages. The vaccine will be made available in the United States during the 2015-2016 influenza season.  

About Fluzone Intradermal Quadrivalent (Influenza Vaccine) 
Indication
Fluzone Intradermal Quadrivalent vaccine is indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.

Fluzone Intradermal Quadrivalent vaccine is approved for use in persons 18 through 64 years of age.

Safety Information
The most common local reactions to Fluzone Intradermal Quadrivalent vaccine include pruritus, erythema, swelling, and induration at the injection site. Such reactions occurred more frequently with trivalent Fluzone Intradermal vaccine than with trivalent Fluzone vaccine.  Other adverse reactions to Fluzone Intradermal Quadrivalent vaccine include pain at the injection site; myalgia, headache, and malaise. Other adverse reactions may occur.

Fluzone Intradermal Quadrivalent vaccine should not be administered to anyone with a known hypersensitivity (eg, anaphylaxis) to any vaccine component, including egg protein, or to a previous dose of any influenza vaccine. 

If Guillain-Barre syndrome has occurred within 6 weeks following previous influenza vaccination, the decision to give Fluzone Intradermal Quadrivalent vaccine should be based on careful consideration of the potential benefits and risks. Vaccination with Fluzone Intradermal Quadrivalent vaccine may not protect all individuals.

Before administering Fluzone Intradermal Quadrivalent vaccine, please see accompanying full Prescribing Information.

About Sanofi
Sanofi, an integrated global 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 a broad 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, 2013. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

ⁱ Glezen WP, et al. The burden of influenza B: a structured literature review. Am J Public Health. 2013;103(3):e43-e51.
ⁱⁱ CDC. Update: influenza activity—United States, 2011-12 season and composition of the 2012-2013 influenza vaccine. MMWR. 2012;61(22):414-420.
ⁱⁱⁱ Reed C, Meltzer MI, Finelli L, Fiore A. Public health impact of including two lineages of influenza B in a quadrivalent seasonal influenza vaccine. Vaccine. 2012;30(11):1993–1998.
^iv CDC. Update—influenza activity—United States, 2009-10 season. MMWR. 2010;59(29):901-908.
^v CDC. Update: influenza activity—United States, 2010-11 season and composition of the 2011-12 influenza vaccine.  MMWR. 2011;60(21):705-712.
^vi CDC. Update: influenza activity – United States, 2012-13 season and composition of the 2013-2014 influenza vaccine. MMWR. 2013;62(23):473-479.
^vii CDC. Seasonal influenza (flu) - selecting the viruses in the influenza (flu) vaccine. http://www.cdc.gov/flu/professionals/vaccination/virusqa.htm. Accessed August 1, 2014. 
^viii Fluzone Intradermal vaccine [Prescribing Information]. Swiftwater, PA: Sanofi Pasteur Inc.; 2014. Accessed November 25, 2014. Available at: https://www.vaccineshoppe.com/image.cfm?pi=fluID&image_type=product_pdf.
^ix Laurent PE, Bonnet S, Alchas P, et al. Evaluation of the clinical performance of a new intradermal vaccine administration technique and associated delivery system. Vaccine. 2007;25:8833-8842.
^x Immunization Action Coalition. Administering vaccines: dose, route, site, and needle size. http://www.immunize.org/catg.d/p3085.pdf. Accessed November 25, 2014.
^xi Lambert PH, Laurent PE. Intradermal vaccine delivery: will new delivery systems transform vaccine administration? Vaccine. 2008;26:3197-3208.
^xii Kenney RT, Frech SA, Muenz LR, et al. Dose sparing with intradermal injection of influenza vaccine. N Engl J Med. 2004;351(22):2295-2301.

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