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Sanofi Pasteur (SASY.PA) to Donate 60 Million Doses of H5N1 Vaccine to World Health Organization Over 3 Years for its Influenza Vaccine Global Stockpile


6/16/2008 7:44:56 AM

LYON, France and SWIFTWATER, Pa., June 16 /PRNewswire/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today its commitment to donate 60 million doses of H5N1 vaccine to the World Health Organization (WHO) over 3 years for the establishment of an H5N1 vaccine global stockpile.

"The H5N1 virus is currently circulating in some of the poorest regions of the world and an outbreak of pandemic influenza would most likely hit populations living in areas with limited access to vaccines. This donation of H5N1 vaccine aims to address the needs of those most vulnerable populations," said Wayne Pisano, President and Chief Executive Officer of sanofi pasteur. "In addition to supporting the efforts of governments, it is essential that industry collaborates with international organizations such as WHO, the Bill and Melinda Gates Foundation and other global health players. This is the best way to build a stockpile of vaccines for developing nations, ready to be deployed on the ground in the event of a pandemic flu outbreak," added Pisano.

Sanofi Pasteur's leadership position in developing and producing influenza vaccines places the company at the forefront of readiness against the threat of pandemic influenza. The company is committed to addressing current and future public health needs by investing in a robust research and development program and in an ambitious seasonal and pandemic influenza vaccine production plan.

Each year since 2004, sanofi pasteur produced millions of doses of H5N1 avian influenza vaccine, both in France and in the United States. In April 2007, the U.S. Food and Drug Administration (FDA) licensed sanofi pasteur's H5N1 vaccine, the first avian influenza vaccine for humans in the U.S.

Sanofi Pasteur recently conducted clinical trials with a novel, proprietary adjuvant aimed at dramatically reducing the amount of antigen needed to elicit a protective immune response to the H5N1 strain currently identified by global health authorities and experts as a potential source for the next pandemic. These data show the ability of this new investigational H5N1 pandemic influenza vaccine to generate a high immune response with a very low dose of H5N1 antigen.

Sanofi Pasteur is committed to producing as many doses as possible of its most advanced vaccine in the shortest possible timeframe should a pandemic be declared by WHO. Under such circumstances, sanofi pasteur's seasonal influenza vaccine facilities would globally be able to switch to pandemic vaccine manufacturing.

Sanofi Pasteur recently completed the construction of a new influenza vaccine manufacturing facility in the United States, incorporating the latest technology in vaccine production. This new facility is planned to go online in 2009. Sanofi Pasteur is also on track to build a facility to manufacture seasonal influenza vaccine in China for the local market. This vaccine manufacturing facility is due to be operational by 2012. A new formulation and filling facility located in France is also planned to become operational in 2009. This new state-of-the-industry facility will boost sanofi pasteur's filling capabilities.

With the production of 180-million doses of seasonal influenza vaccine last year, sanofi pasteur confirmed its leadership by supplying an estimated 40 percent of the world influenza vaccine market(1).

Reference: 1. Data based on internal estimates

Pandemic Influenza Overview

Influenza is a disease caused by a highly infectious virus that spreads easily from person to person, primarily when an infected individual coughs or sneezes. An influenza pandemic is a global epidemic of an especially virulent virus, newly infectious for humans, and for which there is no preexisting immunity. This is why pandemic strains have such potential to cause severe morbidity and mortality. The H5N1 viral strain has been identified by global health authorities as being a potential cause of a pandemic. In an attempt to minimize the impact of a pandemic, many countries are developing national and transnational plans against a possible influenza pandemic situation. According to the World Health Organization (WHO), there have been 383 cases of avian influenza transmitted to humans since 2003, with 241 resulting in death.

Sanofi Pasteur and Pandemic Preparedness

Sanofi Pasteur is committed to global pandemic preparedness. As the world leader in research, development and manufacturing of influenza vaccines, sanofi pasteur is involved in pandemic preparedness projects worldwide, with the goal of developing a vaccine to protect against a pandemic influenza virus. Sanofi Pasteur is also investing in major expansions of its seasonal influenza vaccine production facilities in the U.S. and France, which could be used to produce pandemic influenza vaccine if the need arises. For more information please visit http://pandemic.influenza.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 and in New York .

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided more than a 1.6 billion doses of vaccine in 2007, 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 EUR1 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 financial projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future events, operations, products and services, 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-aventis' 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-aventis, 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 those discussed or identified in the public filings with the SEC and the AMF made by sanofi-aventis, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in sanofi-aventis' annual report on Form 20-F for the year ended December 31, 2007. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.

CONTACT: Global Media Relations, Pascal Barollier, +33-(0)4-37-37-50-38,
pascal.barollier@sanofipasteur.com; or US Media Relations, Len Lavenda,
+1-570-839-4446, Len.lavenda@sanofipasteur.com, both of Sanofi Pasteur

Web site: http://www.sanofipasteur.us/
http://www.sanofipasteur.com/


Read at BioSpace.com


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