Swiftwater, Pa – July 27, 2009 - Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that it has shipped the first doses of the 2009-2010 formulation of Fluzone®, Influenza Virus Vaccine. Fluzone vaccine is indicated for active immunization in people 6 months of age and older against influenza disease caused by influenza virus subtypes A and type B contained in the seasonal influenza vaccine. Fluzone vaccine is the only vaccine licensed in the United States for children as young as 6 months of age through adults.
Sanofi Pasteur, the only U.S. manufacturer of inactivated influenza vaccine, is committed to supporting the U.S. Centers for Disease Control and Prevention’s (CDC) recommendation for annual immunization against seasonal influenza. The company has begun shipment of its Fluzone vaccine to health-care providers to assist them in their early seasonal influenza immunization efforts. In total, Sanofi Pasteur expects to supply over 50 million doses of Fluzone vaccine to the U.S. for the 2009- 2010 season.
Vaccination Timing
The CDC recommends that health-care providers begin their immunization efforts for seasonal influenza as soon as vaccine is available and continue their immunization efforts throughout the entire influenza season. Immunization for seasonal influenza remains a public health priority. On average each year, one out of five Americans suffers from seasonal influenza, approximately 226,000 are hospitalized and 36,000 die from influenza-related complications.
Although seasonal influenza cases typically peak in February, seasonal influenza can occur at any time from early fall to late spring. The influenza vaccine offers protection for the full season, so there is no need to delay immunization once vaccine is available. However, those who missed an immunization opportunity early in the season are urged to seek immunization throughout the influenza season because immunization is beneficial in disease prevention as long as influenza is circulating in the community.
The vaccine formulation for the 2009-2010 season contains three strains of the influenza virus: the A/Brisbane/59/2007 (H1N1)-like virus; the A/Brisbane/10/2007 (H3N2)-like virus; and the B/Brisbane/60/2008-like virus. The three strains for the new influenza vaccine formulation were confirmed by the Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee in February 2009 and correspond with recommendations made by the World Health Organization (WHO) also in February. Influenza vaccine is formulated each year to match the strains predicted to circulate during the upcoming season. This formulation for the 2009-2010
influenza season introduces a new B strain. The two A strains are unchanged from the 2008-2009 season formulation.
The seasonal influenza vaccine does not incorporate the A/California/7/2009(H1N1) virus strain of the novel A(H1N1) influenza and is not expected to offer protection against this new type of influenza. Sanofi Pasteur is working with the WHO and the CDC on the development of a separate vaccine for the novel A(H1N1) influenza, commonly referred to as the new “swine” influenza.
Influenza Vaccine Recommendations
Approximately 260 million people, or four out five residents of the U.S. are recommended to receive the influenza vaccine annually. The CDC recommends an annual influenza immunization for all children 6 months through 18 years of age; adults over 50 years of age; pregnant women; anyone with chronic health conditions, such as asthma, chronic obstructive pulmonary disease (COPD), heart disease, and diabetes; as well as caregivers and household contacts of these high-risk groups, such as relatives and health-care providers. The CDC also recommends annual immunization for anyone who wishes to reduce their risk of contracting influenza.
About Fluzone Vaccine
Fluzone vaccine is produced by the world’s leading manufacturer of influenza vaccines, Sanofi Pasteur. Sanofi Pasteur produces approximately 40 percent of the influenza vaccines distributed worldwide, and in the U.S. Fluzone vaccine accounts for more than 45 percent of the influenza vaccines distributed each year. Fluzone vaccine has been produced for nearly four decades and Sanofi Pasteur has provided an unmatched record of reliability and service to health-care providers.
Sanofi Pasteur is committed to raising immunization rates and improving global access to vaccines. As part of this commitment, the company has expanded its influenza vaccine production capacity in the U.S. A new U.S. influenza vaccine production facility was licensed by the FDA earlier this year and contributed to the production of Fluzone vaccine for the 2009-2010 season. In addition, Sanofi Pasteur has new formulation and filling capacity in the U.S that enables the company to increase the amount of no preservative influenza vaccine it supplies. A Fluzone vaccine formulation (trade name: Fluzone®, Influenza Virus Vaccine, No Preservative) that does not contain a preservative at any stage in the manufacturing process was introduced in 2004-2005. It is the first FDA-licensed injectable influenza vaccine to be manufactured in this way. Fluzone vaccine also is the only influenza vaccine licensed for children as young as 6 months of age with a 0.25 mL pediatric dose for children 6 months through 35 months of age.
Sanofi Pasteur has a robust research and development program for both seasonal and pandemic influenza vaccines and the company is actively conducting research into the development of several new technologies and formulations to meet public health needs in immunization patients of all ages. Sanofi Pasteur has developed a high-dose formulation of Fluzone vaccine, Fluzone High-Dose that is intended for immunization of adults 65 years of age and older. A biological license application supplement for Fluzone High-Dose vaccine has been filed with the FDA and is under review.
Important Information
Fluzone vaccine is given for active immunization in persons 6 months of age and older against influenza virus types A and B contained in the vaccine.
Side effects to Fluzone vaccine are soreness at the injection site that can last up to 2 days, pain, and swelling; fever, fatigue, and muscular pain. Other side effects may occur. Fluzone vaccine should not be administered to anyone with a history of serious allergic reaction to any vaccine component, including eggs, egg products, or thimerosal (the only Fluzone vaccine product containing thimerosal is the multi-dose vial), or to persons who have been previously diagnosed with Guillain-Barré syndrome (GBS). If you notice any other problems or symptoms following vaccination, please contact your health-care professional immediately.
Vaccination with Fluzone vaccine may not protect all individuals.
For more information about Fluzone vaccine, talk to your health-care professional. The full Prescribing Information for Fluzone vaccine is available at http://www.Fluzone.com.
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).
Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than 1.6 billion doses of vaccine in 2008, 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
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