Japan Chooses Sanofi Pasteur for First Enhanced Inactivated Polio Vaccine

Japan Chooses Sanofi Pasteur for First Enhanced Inactivated Polio Vaccine
April 27, 2012
- Approval of IMOVAX® POLIO by Japanese health authorities, a major milestone towards a polio-free world -

Lyon, France and Tokyo, Japan – April 27, 2012 – Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today that the Japanese Ministry of Health, Labor and Welfare (MHLW) has approved the company's standalone Inactivated Poliovirus Vaccine (IPV) against acute flaccid poliomyelitis (IMOVAX® POLIO). IMOVAX® POLIO will be added to the country's public immunization program on September 1st.

Since 1988, start of the Global Polio Eradication Initiative led by the World Health Organization (WHO) and its partners, the number of polio cases has been reduced by 99% worldwide. (1) The approval of IMOVAX® POLIO by Japanese health authorities is a major milestone towards a polio-free world. IMOVAX® POLIO is an inactivated poliovirus vaccine made from poliovirus types 1, 2, and 3. Since its launch in France in 1982, IMOVAX®POLIO has been approved in 86 countries. Sanofi Pasteur has supplied more than 800 million doses of standalone IPV and IPV-containing combination vaccines worldwide to date.

"Inactivated poliovirus vaccine is the standard of care for polio vaccination in polio-free countries. Sanofi Pasteur is committed to doing its utmost to contribute to protecting as many infants as possible in Japan from polio." said Olivier Charmeil, president and CEO of Sanofi Pasteur.

Poliomyelitis, known as "infantile paralysis" in Japan, is an infectious disease caused by the poliovirus. The virus enters the body through the mouth and multiplies in the intestine, causing severe paralysis in some cases. One in 200 infections leads to irreversible paralysis (usually the legs). Among those paralyzed, 5% to 10% die when their breathing muscles become immobilized.
As many of those infected are under the age of 5, national routine immunization is applied in many countries in the world. (1)

In Japan, immunization with Oral Poliovirus Vaccine (OPV) has been conducted throughout the country since 1961. As a result, Japan was certified polio-free by the WHO in 2000. Yet, as poliomyelitis has not been completely eradicated from the surface of the earth, vaccination against polio remains an important part of the Japanese public immunization program due to the risk of virus importation.

Over 60 polio-free countries use IPV
Japan and the Western Pacific Region were declared polio-free in 2000 by the WHO. IPV is the standard of care for polio vaccination in over 60 polio-free countries including the US and Europe, where the vaccine is included in the national polio immunization program.

Sanofi Pasteur: a major public health partner in Japan
Sanofi Pasteur was the first international vaccine company to enter Japan with the launch, in 2008, of ActHIB®, a pediatric vaccine against Haemophilus influenzae type b (Hib) disease. The vaccine has been integrated in Japan's public immunization program since 2011.

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

Reference
1. WHO Fact sheet N°114 Poliomyelitis http://www.who.int/mediacentre/factsheets/fs114/en/

Contacts:

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

Japan  Media Relations
Yumiko Kurahashi
T. + 81 3 6301 3073
[email protected]
www.sanofipasteur.jp

 

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