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Swiftwater, PA – July 25, 2013 – Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the first lots of Fluzone® (Influenza Virus Vaccine) for the 2013-2014 season have been released by the U.S. Food and Drug Administration (FDA) for U.S. distribution and were shipped July 24. This shipment represents the first of more than 60 million doses of seasonal influenza vaccine the company plans to deliver to U.S. health care providers this fall. Influenza vaccine is anticipated to be available to the public from local health care providers and pharmacies in August.
“Although influenza disease typically peaks in the U.S. during the winter, the virus can circulate at any time of year, and in fact, last year, reports of increased levels of influenza disease began in the fall,” said David P. Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs. “Annual immunization of more than 130 million people in a few months is a huge undertaking for health care providers each year, and that is why as the largest producer of influenza vaccine in the U.S., our goal is to deliver a reliable supply of influenza vaccine to support health care providers in planning their fall clinics.”
New for 2013-2014
For the 2013-2014 season, two new influenza virus strains have been included in the trivalent seasonal influenza vaccine. There is a new A(H3N2) antigen and a new influenza B antigen. The A(H1N1) component of the vaccine is unchanged since the 2009 pandemic. Last season, influenza A(H3N2) disease predominated in the U.S., and it was particularly severe in older adults.
The 2013-2014 influenza season will be the first in which quadrivalent influenza vaccines will be available in the U.S. Until this year, seasonal influenza vaccines included only one B strain. Fluzone Quadrivalent vaccine includes two A strains and two B strains to help protect against influenza disease. Epidemics of influenza B occur every two to four years in all age groups. Influenza B is a common cause of influenza-related morbidity and mortality in children and has been associated with pneumonia and other respiratory illnesses, nervous system disease, muscle pain and inflammation, and other complications. In recent years, up to 44 percent of influenza-associated deaths in children and adolescents 18 years of age and younger were due to influenza B.
In addition to the strain changes in the 2013-2014 vaccine and the availability of quadrivalent vaccines, Sanofi Pasteur is pleased to announce that no presentations of Fluzone vaccine contain natural rubber latex.
This season, Sanofi Pasteur will provide the following influenza vaccine options in its Fluzone vaccine family to help address the unique immunization needs of children, adolescents, and younger and older adults:
- Fluzone vaccine, upon which health care providers have relied for more than 40 years, is approved for use in people six months of age and older. Fluzone vaccine will be provided in a 0.25mL pediatric dose for children six months through 35 months of age and a 0.5mL dose for children 35 months of age and older and adults. Fluzone vaccine also will be available in a 5 mL multi-dose vial for immunization of people six months of age and older, adolescents, and adults. Fluzone vaccine is the only influenza vaccine licensed by the FDA for children as young as 6 months of age.
- Fluzone Quadrivalent vaccine, which helps protect against four influenza strains, is the newest addition to Sanofi Pasteur’s Fluzone family of influenza vaccines, having been licensed by the FDA in June 2013. Like Sanofi Pasteur’s Fluzone vaccine, Fluzone Quadrivalent vaccine is licensed for use in children six months of age and older, adolescents, and adults.
- Fluzone High-Dose vaccine, which was introduced in 2010 for adults 65 years of age and older, will be widely available this season. Adults 65 years of age and older are at greater risk for influenza and its complications because the immune system weakens with age. Older adults often do not produce as much antibody following immunization as do younger people. Fluzone High-Dose vaccine is specifically formulated to elicit stronger influenza antibody responses in adults 65 years of age and older.
- Fluzone Intradermal vaccine, which was introduced in 2011, also will be widely available for the 2013-2014 season. Fluzone Intradermal vaccine features an ultra-fine needle that is 90 percent shorter than the typical needle used for intramuscular injection of influenza vaccine. Fluzone Intradermal vaccine is anticipated to be an attractive immunization option for adults 18 through 64 years of age, an age group that has among the lowest rates of immunization.
“With these influenza vaccine options, our goal is to help improve the immunization experience for patients and their health care providers, thus helping to improve immunization rates,” said Dr. Greenberg. “We are pleased to offer many different influenza vaccines to meet the specific needs of every patient six months of age and older.”
Due to extended shipping time and earlier incidence of disease, the first doses of Fluzone vaccine were shipped to Alaska and Hawaii and to the Centers for Disease Control and Prevention (CDC) for use in the Vaccines for Children program. Direct shipments to health care providers and distributors will be ongoing through October, with health care providers who have placed reservations with Sanofi Pasteur receiving initial shipments by the end of August to support fall immunization campaigns.
Sanofi Pasteur is still accepting orders for most presentations of Fluzone vaccines. Health care providers wishing to reserve vaccine can do so by visiting www.vaccineshoppe.com or by calling 1-800-VACCINE (1-800-822-2463). Members of the public seeking a specific vaccine option, such as Fluzone High-Dose vaccine, Fluzone Intradermal vaccine, or Fluzone Quadrivalent vaccine, can search for local providers at www.Fluzone.com.
About Influenza
Influenza is a serious respiratory illness that is easily spread and can lead to severe complications, even death. Each year in the U.S., 5 to 20 percent of the population gets the flu, and an estimated 226,000 people are hospitalized from influenza-related complications. Influenza seasons are unpredictable and can be severe. Depending on virus severity during the influenza season, annual deaths can range from a low of 3,000 to a high of about 49,000 people. Combined with pneumonia, influenza is the nation’s ninth leading cause of death. Vaccination is safe and effective and the best way to help prevent influenza and its complications.
The CDC recommends influenza vaccination for everyone six months of age and older. Children six months through 8 years of age who have not previously received two doses of influenza vaccine may require two doses of vaccine for the 2013-2014 influenza season and should consult their health care provider about the number of doses of influenza vaccine required based on their prior immunization history. Health care providers are recommended to begin offering influenza vaccine as soon as the vaccine becomes available and continue vaccination efforts throughout the entire influenza season. Influenza disease activity typically peaks in February, so individuals who are not immunized early in the season still have time to do so prior to the peak of influenza activity. Influenza vaccination is beneficial in December and January, or even into the spring, as long as influenza viruses are still in circulation.
About Fluzone Vaccines
Indication
Fluzone, Fluzone Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose vaccines are inactivated influenza virus vaccines indicated for active immunization for the prevention of influenza disease caused by influenza subtype A and type B viruses contained in the vaccines.
Fluzone and Fluzone Quadrivalent vaccines are approved for use in people six months of age and older. Fluzone Intradermal vaccine is approved for use in people 18 through 64 years of age. Fluzone High-Dose vaccine is approved for use in people 65 years of age and older.
Approval of Fluzone High-Dose vaccine is based on superior immune response relative to Fluzone vaccine. Data demonstrating a decrease in influenza disease after vaccination with Fluzone High-Dose vaccine relative to Fluzone vaccine are not yet available.
Safety Information
The most common local and systemic adverse reactions to Fluzone, Fluzone Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose vaccines include pain (tenderness in young children receiving Fluzone or Fluzone Quadrivalent vaccine), redness (erythema), and swelling at the vaccination site; and muscle aches (myalgia), fatigue (malaise), headache, and fever (also irritability, abnormal crying, drowsiness, appetite loss, and vomiting in young children receiving Fluzone or Fluzone Quadrivalent vaccine). Redness, firmness (induration), swelling, and itching (pruritus) at the vaccination site occur more frequently with Fluzone Intradermal vaccine than with Fluzone vaccine. Other adverse reactions may occur.
Fluzone, Fluzone Quadrivalent, Fluzone Intradermal, and Fluzone High-Dose vaccines should not be administered to anyone with a severe allergic reaction (e.g., anaphylaxis) to any vaccine component, including egg protein, egg products, or thimerosal (the only Fluzone vaccine product containing thimerosal is the multi-dose vial of Fluzone vaccine), or to a previous dose of any influenza vaccine. The decision to give Fluzone, Fluzone Quadrivalent, Fluzone Intradermal, or Fluzone High-Dose vaccine should be based on the potential benefits and risks, especially if Guillain-Barré syndrome (severe muscle weakness) has occurred within six weeks of receipt of a prior influenza vaccine. Vaccination with Fluzone, Fluzone Quadrivalent, Fluzone Intradermal, or Fluzone High-Dose vaccine may not protect all individuals.
Before administering Fluzone, Fluzone Quadrivalent, Fluzone Intradermal, or Fluzone High-Dose vaccine, please see the full Prescribing Information available at www.sanofipasteur.us or www.vaccineshoppe.com.
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 health care 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, 2012. 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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