Sanofi Pasteur Begins Shipping Seasonal Influenza Vaccine for Upcoming 2014-2015 Season in United States

SWIFTWATER, Pa., July 22, 2014 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN andNYSE: SNY), announced today that the first lots of Fluzone^® (Influenza Vaccine) for the 2014-2015 influenza ("the flu") season have been released by the U.S. Food and Drug Administration (FDA) for distribution. The lots were shipped on July 21, 2014, representing the first of at least 65 million doses of seasonal influenza vaccine manufactured by Sanofi Pasteur that will be delivered to U.S. health care providers and pharmacies in August.

The U.S. Centers for Disease Control and Prevention (CDC) recommends annual influenza vaccination for everyone six months of age and older, with rare exception[i],[ii] — this means people should be vaccinated again even if they were vaccinated last season as immunity may wane. Furthermore, while influenza disease activity typically peaks in February, public health officials recommend that people seek influenza vaccine as soon as it becomes available in their community to ensure season-long protection.

"The flu impacts people in the U.S. every year, and the single best way to help prevent getting or spreading the influenza virus is timely vaccination," said David P. Greenberg, M.D., Vice President, Scientific & Medical Affairs, and Chief Medical Officer, Sanofi Pasteur U.S. "Sanofi Pasteur is committed to helping people fight the flu by offering a broad range of flu vaccine options to meet the needs of patients across multiple age groups."

This season, Sanofi Pasteur will provide the following influenza vaccine options in its Fluzone vaccine family to help address the unique immunization needs of all age groups, from children as young as six months through adults 65 years of age and older:

• Fluzone vaccine is approved for use in people six months of age and older. Fluzone vaccine will be available in two presentations: a 0.5 mL prefilled syringe and a 5 mL multi-dose vial. Children six months through 35 months of age should receive a 0.25 mL dose; children 36 months of age and older, adolescents, and adults should receive a 0.5 mL dose. Fluzone vaccine is the only trivalent influenza vaccine licensed by the FDA for children as young as six months of age.
• Fluzone Quadrivalent vaccine, which helps protect against four influenza strains (two A strains and two B strains), was first licensed by the FDA in 2013. The influenza B strain is associated with high hospitalization and mortality rates, especially in children and young adults. In fact, on average, over multiple recent seasons, 34 percent of influenza-related deaths in children up to 18 years of age were due to influenza B. 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, is available for adults 65 years of age and older. Adults age 65 and older are at greater risk for influenza and its complications because the immune system weakens with age. Fluzone High-Dose vaccine contains four times the amount of antigen than is contained in standard-dose Fluzone vaccine and induces higher antibody responses against the flu to address the age-related decline of their immune system. In a large-scale clinical trial, Fluzone High-Dose vaccine demonstrated higher efficacy in preventing influenza in adults 65 years of age and older compared to standard-dose Fluzone vaccine.
• Fluzone Intradermal vaccine, which was introduced in 2011, will also be available for the upcoming influenza season. Fluzone Intradermal vaccine features a 90 percent smaller, affixed microneedle, and offers an efficient way to vaccinate patients by eliminating steps in the vaccination process.

"The CDC continues to stress that the single best way to prevent the flu is to receive an annual flu vaccination," said Dr. Greenberg. "Patients should work with their health care providers to find the best vaccine option for them this season."

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.

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 United States, up to 20 percent of the population gets the flu and, on average, more than 200,000 people are hospitalized from influenza-related complications.[iii] 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.[iii] Combined with pneumonia, influenza is the nation's seventh leading cause of death.[iv] Vaccination is safe and effective and the best way to help prevent influenza and its complications.

Children six months through eight years of age who have not previously received two doses of influenza vaccine may require two doses of vaccine for the 2014-2015 influenza season and should consult with their health care provider about the number of doses of influenza vaccine required based on their immunization history. Individuals who are not immunized early in the season still have time to do so prior to the peak of influenza activity, which typically occurs in February.

Influenza vaccination is beneficial throughout the season, and 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 indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in each vaccine.

Fluzone and Fluzone Quadrivalent vaccines are approved for use in persons 6 months of age and older.

Fluzone Intradermal vaccine is approved for use in persons 18 through 64 years of age. Fluzone High-Dose vaccine is approved for use in persons 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 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), erythema, and swelling at the injection site; myalgia, malaise, headache, and fever (also irritability, abnormal crying, drowsiness, appetite loss, and vomiting in young children receiving Fluzone or Fluzone Quadrivalent vaccine). Erythema, induration, swelling, and pruritus at the injection 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 known hypersensitivity (eg, anaphylaxis) to any vaccine component, including egg protein or thimerosal (the multidose vial is the only presentation containing thimerosal), 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, Fluzone Quadrivalent, Fluzone Intradermal, or Fluzone High-Dose vaccine should be based on careful consideration of the potential benefits and risks. 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 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] Centers for Disease Control and Prevention (CDC). Preventing the Flu: Good Health Habits Can Help Stop Germs. http://www.cdc.gov/flu/protect/habits.htm. Accessed May 19, 2014.
[ii] Centers for Disease Control and Prevention (CDC). Who Should Get Vaccinated Against Influenza? http://www.cdc.gov/flu/protect/whoshouldvax.htm. Accessed on March 28, 2014.
[iii] Centers for Disease Control and Prevention (CDC). Seasonal Influenza: Flu Basics. http://www.cdc.gov/flu/about/disease/index.htm. Accessed May 15, 2014.
[iv] Melonie Heron, Ph.D. National Vital Statistics Reports. Deaths: Leading Causes for 2010. 2013; 62(6): 1-97.

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SOURCE Sanofi Pasteur