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Sanofi Pasteur Presents Positive Results of Tetravalent Dengue Candidate Vaccine
Lyon, France, November 6 (ots/PRNewswire) - Sanofi Pasteur, the vaccines division of sanofi-aventis Group, announced today positive results in the development of a vaccine for the global prevention of dengue fever, one of the most widespread tropical diseases. The results are being presented today at the American Society of Tropical Medicine and Hygiene (ASTMH)'s 56th annual meeting held in Philadelphia, Pennsylvania, USA.
These results have prompted Sanofi Pasteur to immediately expand ongoing clinical trials in Asia and Latin America. Submission to health authorities for registration is anticipated in 2012.
"Sanofi Pasteur made research for a vaccine against dengue fever one of its top priorities by investing in the most promising technology and dedicating top scientists to this lifesaving project," said Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "Sanofi Pasteur's goal is to make dengue fever a vaccine-preventable disease as quickly as possible with a vaccine available to people living in endemic countries or traveling to tropical destinations."
Immunization with Sanofi Pasteur's tetravalent dengue candidate vaccine generated a sero-neutralizing antibody response against all four serotypes of the virus responsible for dengue fever in 100 percent of adults who participated in a trial in the United States.(1)
"Developing a dengue vaccine has been a major challenge for over a decade, and we are very pleased with the breakthrough progress made by Sanofi Pasteur with its tetravalent dengue vaccine," said Harold Margolis, MD, Director of the Pediatric Dengue Vaccine Initiative (PDVI). "We believe this moves the world closer to a dengue vaccine that will be available for people who most need it."
Dengue fever is a mosquito-borne disease affecting up to 100 million people each year and resulting in 24,000 deaths, mostly among children, according to estimates from the World Health Organization (WHO).(2),(3) Overall, the disease is a potential threat for close to half the world's population. Dengue disease if often cyclical and causes spikes in demand on local medical resources and places tremendous pressure on strained hospitals and clinics located in endemic countries.
Dengue fever occurs mostly in tropical and subtropical countries and it is spreading to new parts of the globe each year. For example, outbreaks recently have been observed in Paraguay and the Middle East. In addition, dengue affects countries such as Australia (Queensland) and the United States (Puerto Rico, Texas-Mexico border, Hawaii and the US-affiliated Pacific Islands). A substantial number of people traveling to endemic regions are also infected each year.
Sanofi Pasteur's tetravalent dengue candidate vaccine is based on a new technology incorporating the protein envelopes that provide immunity against the four virus types responsible for dengue fever and the most severe forms of the disease-dengue hemorrhagic fever and dengue shock syndrome.
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 a billion doses of vaccine in 2006, 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 http://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, 2006. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements.
(1) Data analyzed by the WHO Flavivirus Laboratory Reference Center, Mahidol University, Bangkok, Thailand
(2) State of the art of vaccine research and development. WHO/IVB/06.01
(3) World Health Organization, What is dengue? What is dengue haemorrhagic fever? Available at: http://whqlibdoc.who.int/hq/2001/WHO_CDS_CPE_SMT_2001.9.pdf
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