Sanofi Pasteur Announces FDA Has Expanded Age Indication of Adacel® Tdap Vaccine to Include Persons 10 Years of Age

SWIFTWATER, Pa., April 1, 2014 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN andNYSE: SNY), announced today that the U.S. Food and Drug Administration (FDA) has expanded the approved age indication of Adacel^® (Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed; Tdap) for active booster immunization for the prevention of tetanus, diphtheria, and pertussis as a single dose in persons 10 through 64 years of age.

"We are pleased the FDA has expanded the age indication for Adacel vaccine, especially in a time when we have seen increases in reports of pertussis, commonly referred to as whooping cough," said David P. Greenberg, M.D., Vice President, U.S. Scientific and Medical Affairs, Sanofi Pasteur. "This approval not only reinforces the safety profile of Adacel, but importantly provides an additional opportunity to vaccinate a younger age group to help prevent this highly contagious disease."

The FDA approval was based on data from a Phase IV, open label, multi-center trial to evaluate the safety and immunogenicity of a single dose of Adacel vaccine in persons 10 years of age compared with those in persons 11 years of age. Antibody responses to all of the vaccine antigens (tetanus, diphtheria, and pertussis) and rates of adverse reactions were similar in the two age groups.

To reduce pertussis morbidity in adolescents and adults and maintain the standard of care for tetanus, diphtheria, and pertussis protection, the U.S. Centers for Disease Control and Prevention recommends that persons in these age groups receive a single dose of a Tdap vaccine because immunity from early childhood vaccination wanes over time.¹

Adacel vaccine was licensed in the United States by the FDA in June 2005 to address pertussis protection for people 11 through 64 years of age. Adacel vaccine provides demonstrated immunogenicity against tetanus, diphtheria, and pertussis, and has a safety profile similar to that of tetanus-diphtheria (Td) vaccine.

About Pertussis
Pertussis, also known as whooping cough, is a highly contagious and often serious disease, especially in young children.^2,3 In adolescents and adults, it often presents as a severe and episodic cough that may last for weeks and even months.⁴ Pertussis is caused by bacteria called Bordetella pertussis, found in the nose and throat of persons with the disease; it is spread through contact with respiratory droplets generated by coughing or sneezing.^1,2

Pertussis is often undiagnosed or misdiagnosed in adults, leading to vast underreporting of the disease.⁵ Estimates indicate that there may be as many as 800,000 to 3.3 million adult and adolescent cases of pertussis in the U.S. in any given year.⁵ Pertussis disease can be treated with antibiotics.⁶ If caught early enough, antibiotic treatment may help lessen disease severity.⁶ Antibiotic therapy also helps reduce transmission and is important for disease control.⁶

About Adacel Vaccine

Indication
Adacel vaccine is given as a single dose to people 10 through 64 years of age to help prevent tetanus (lockjaw), diphtheria, and pertussis (whooping cough).

Safety Information
Side effects to Adacel vaccine include pain, redness, and swelling at the injection site; headache, body ache or muscle weakness, and tiredness. Other side effects may occur. Tell your doctor if you have ever experienced a severe brain disorder, such as encephalopathy (altered consciousness), Guillain-Barre syndrome (severe muscle weakness), brachial neuritis (inflammation of nerves in the arms), or an Arthus-type reaction (severe, exaggerated swelling involving an injection site) after a previous dose of a tetanus toxoid- or pertussis-containing vaccine.

There is a small risk of allergic reactions (eg, anaphylaxis). Some signs of allergic reactions are hives, swelling of the throat, low blood pressure, shock, and difficulty breathing. If you begin to experience any of these signs seek treatment right away. These reactions are rare and usually occur before leaving the doctor's office. If you notice any other problems or symptoms following vaccination, please contact your health care professional promptly. Fainting can happen after getting Adacel vaccine. The tip caps of the prefilled syringes may contain natural rubber latex that may cause allergic reactions in latex-sensitive individuals. Vaccination with Adacel vaccine may not protect all people receiving the vaccine.

For more information about Adacel 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 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.

References:

1. Kretsinger K, Broder KR, Cortese MM et al. Preventing tetanus, diphtheria, and pertussis among adults: use of tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine recommendations of the Advisory Committee on Immunization Practices (ACIP) and recommendation of ACIP, supported by the Healthcare Infection Control Practices Advisory Committee (HICPAC), for use of Tdap among health-care personnel. Morb Mortal Wkly Rep 2006; 55(RR-17):1-37. http://www.cdc.gov/MMWR/preview/mmwrhtml/rr5517a1.htm.  March 4, 2014.
2. Centers for Disease Control and Prevention (CDC). Disease Information: Pertussis: Causes & Transmission. http://www.cdc.gov/pertussis/about/causes-transmission.html. March 4, 2014.
3. Centers for Disease Control and Prevention (CDC). Disease Information: Pertussis: Complications. http://www.cdc.gov/pertussis/about/complications.html. Accessed March 4, 2014.
4. Centers for Disease Control and Prevention (CDC). Disease Information: Pertussis: Signs & Symptoms. http://www.cdc.gov/pertussis/about/signs-symptoms.html. Accessed March 4, 2014.
5. Cherry JD. The epidemiology of pertussis: a comparison of the epidemiology of the disease pertussis with the epidemiology of Bordetella pertussis infection. Pediatrics. 2005;115(5):1422-7. http://pediatrics.aappublications.org/cgi/reprint/115/5/1422. Accessed March 4, 2014.
6. Centers for Disease Control and Prevention (CDC). Disease Information: Pertussis: Treatment. http://www.cdc.gov/pertussis/clinical/treatment.html. Accessed March 4, 2014.

SOURCE Sanofi Pasteur