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Sanofi Pasteur Launches IMOJEV® First Single-dose Vaccine Against Japanese Encephalitis in Australia

MELBOURNE, Australia, December 9, 2012 /PRNewswire/ --

- About 3 billion people living in Asia Pacific and travellers to the region are at risk of Japanese encephalitis -

Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that IMOJEV® vaccine against Japanese encephalitis (JE) is now available in Australia. IMOJEV® is the first single dose vaccine against JE for adults in Australia. For children, one dose of IMOJEV is recommended for primary immunization; the addition of a booster dose to extend the duration of protection is being assessed by Australian Health Authorities. IMOJEV® vaccine is licensed in Australia for people from 12 months of age and older.

About 3 billion people in the Asia Pacific Region are at risk of JE[1] for which there is no specific treatment[2]. In 1995 the first outbreak in Australia was identified in the islands of the Torres Strait[3]. More recently outbreaks have also occurred in Northern Queensland. JE is the leading cause of childhood viral neurological infection and disability in Asia. JE is also a potential risk for travellers to endemic areas. Over 1.5 million Australians travel to JE endemic countries of the Asia Pacific region[4].

"IMOJEV® has shown to provide seroprotection to over 90% adults just 2 weeks after vaccination with one dose which provides strong motive to be vaccinated before traveling[5]," said Joseph Torresi MD, Head of Travel Medicine at the Austin Hospital. "There is no specific treatment for JE and vaccination is the most effective way to be protected."

The Australian health authorities granted marketing authorization to IMOJEV® vaccine based on the review of clinical studies involving over 4,000 children and adults which demonstrated the safety of IMOJEV® vaccine and its ability to generate a protective immune response with one dose.

"IMOJEV® is an innovative vaccine that confers high-level protection against Japanese encephalitis with just one dose," said Russell Jacobson, General Manager of Sanofi Pasteur in Australia. "IMOJEV® makes scheduling a trip in the Asia Pacific region, or other endemic areas, more convenient for business travellers, tourists and the military alike."

About IMOJEV® vaccine

IMOJEV® vaccine is a live-attenuated JE vaccine indicated for active immunization of people 12 months and older. The clinical data supporting the use of IMOJEV® in children and in adults have been generated in multi-center studies conducted in the United States, Australia, Thailand, and the Philippines with more than 2,400 adults and 2,200 children receiving IMOJEV®. The safety and immunogenicity of IMOJEV® were compared to a licensed JE vaccine (JE-VAX®) and placebo in adults and to a control vaccine in children. A pivotal Phase III study in adults showed that a single dose of IMOJEV® is as immunogenic as three doses of JE-VAX®. A single administration of IMOJEV® elicited a protective level of neutralizing antibodies in approximately 93% and 99% of adults 14 days and 28 days after vaccine administration, respectively[5]. Over 84% of adults were still seroprotected 5 years after vaccination [6]. A Phase III study in children showed that approximately 95% of JE virus naive subjects were seroprotected 28 days after a single dose of IMOJEV®[7]. The vaccine was well tolerated and there was no indication during the clinical development program of any safety concerns. The frequency of local and systemic reactions was comparable to those reported after administration of a placebo or a control vaccine.

About Japanese encephalitis

JE is caused by a virus transmitted by mosquitoes. The disease is neuro invasive with inflammation of the brain and its membranes (meninges). Most JE virus infections are mild (fever and headache) or without apparent symptoms, but up to 1 to 200 infections results in severe disease characterized by rapid onset of high fever, headache, neck stiffness, disorientation, coma, seizures, spastic paralysis and death. The case fatality rate is 30-35% among those with disease symptoms with over 15,000 deaths per year[8]; 50% of those who survive suffer from lasting damage to the central nervous system. In areas where the JE virus is common, encephalitis occurs mainly in young children[9].

About Sanofi

Sanofi, a global and diversified 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 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: http://www.sanofipasteur.com or http://www.sanofipasteur.us

1. Erlanger TE, Weiss S, Keiser J, et al. Past, present, and future of Japanese encephalitis. Emerg Infect Dis. 2009; 15:1-7.

2. Japanese encephalitis. WHO Initiative for Vaccine Research http://www.who.int/vaccine_research/diseases/vector/en/index1.html

3. Hanna JN, Ritchie SA, Phillips DA, et al. Japanese encephalitis in north Queensland, Australia, 1998. Medical Journal of Australia 1999; 170:533-6.

4. Australian Social Trends September 2010 Australian bureau of statistics catalogue no. 4102.0

5. Torresi J, McCarthy K, Feroldi E, et al. Immunogenicity, safety and tolerability in adults of a new single-dose, live-attenuated vaccine against Japanese encephalitis: Randomised controlled phase 3 trials. Vaccine 2010; 28:7993-8000.

6. Nasveld PE, Ebringer A, Elmes N, et al. Long term immunity to live attenuated Japanese encephalitis chimeric virus vaccine: Randomized, double-blind, 5-year phase II study in healthy adults. Hum Vaccin 2010; 6:1038-46.

7. Feroldi E, Pancharoen C, Kosalaraksa P, et al. Single-dose, live-attenuated Japanese encephalitis vaccine in children aged 12-18 months: Randomized, controlled phase 3 immunogenicity and safety trial. Human Vaccines & Immunotherapeutics 2012; 8:929-37.

8. Campbell GL, Hills SL, Fischer M, et al. Estimated global incidence of Japanese encephalitis: a systematic review. Bull World Health Organ. 2011; 89:766-74E

9. United Nations. The United Nations urbanization prospects: the 2005 revision. POP/DB/WUP/Rev.2005/1/F1. New York: United Nations; 2005.

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, 2011. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Contacts:

Global Media Relations
Pascal Barollier
T. +33-4-37-37-50-38
[email protected]
http://www.sanofipasteur.com

Australia Media Relations
Alan Brindell
T. +61-2-8666-2362
[email protected]
http://www.sanofipasteur.com.au

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