Sanofi Pasteur and International Vaccine Institute Partner Against Dengue

LYON, France, Feb. 21 /CNW/ - Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that it is partnering with the International Vaccine Institute (IVI) to support the recently launched Dengue Vaccine Initiative (DVI). Sanofi Pasteur and the IVI will aim to raise awareness and to work to move dengue vaccination higher on the global health agenda.

Currently, there is no specific treatment available for dengue fever, which is a threat to nearly half of the world's population and a public health priority in many countries of Latin America and Asia where epidemics occur. Of the estimated 220 million people infected annually, two million-mostly children-develop dengue hemorrhagic fever (DHF), a severe form of the disease[1]. DHF is a leading cause of hospitalization, placing tremendous pressure on strained medical resources and having a heavy economic and societal impact.

"Each year, an estimated two million people with dengue hemorrhagic fever require hospitalization representing a significant burden on the fragile healthcare systems of developing and endemic nations," said Dr. Ragnar Norrby, Chairman of the Board of Trustees of IVI. "With a dengue vaccine on the short term horizon, this collaboration will focus on accelerating its adoption and introduction and on making it accessible to those at highest risk of dengue."

The International Vaccine Institute (IVI) announced the launch of the DVI on February 10, in collaboration with the Sabin Vaccine Institute, the Johns Hopkins University, and the World Health Organization, to support development of vaccines to control dengue fever.

"The fight against dengue requires a strong global commitment from all public health partners. The first dengue vaccine is now in the final stages of development. The IVI will be a key player in facilitating discussions among policy makers, with the objective of ensuring that once licensed the vaccine will be made available to those populations that need it most in a timely manner," stated Olivier Charmeil, Senior Vice President, sanofi-aventis, Vaccines.

About International Vaccine Institute

The International Vaccine Institute is an international organization devoted exclusively to developing and introducing new and improved vaccines for the world's poorest people, especially children in developing countries. The IVI conducts research in 30 countries in Asia, Africa, and Central and South America on vaccines against diarrheal infections, bacterial meningitis and pneumonia, Japanese encephalitis, and dengue fever, and develops new and improved vaccines, delivery routes and adjuvants at its headquarters in Seoul, Korea.

About Dengue Vaccine Initiative

The Dengue Vaccine Initiative (DVI) was established in 2010 to build on the work of the Pediatric Dengue Vaccine Initiative and to further awareness of the need to support the development and use of dengue vaccines. The goal of the DVI is to accelerate the introduction of safe and broadly protective vaccines into the national immunization programs of endemic and developing countries. DVI works with scientists, vaccine experts and policy makers from concept to implementation, promoting the development of dengue vaccines while also advocating with governments worldwide to ensure the swift adoption and distribution of a vaccine to those most in need.

Sanofi Pasteur's global dengue vaccine clinical study program

Sanofi Pasteur's candidate dengue vaccine-which targets all four virus serotypes- is in Phase 3 clinical study. Phase 3 studies are the ultimate steps in the clinical development of a vaccine before it is submitted to regulatory authorities for evaluation for market authorization.

Sanofi Pasteur candidate dengue vaccine has been evaluated in clinical studies (Phase 1, 2) in adults and children in the U.S., Asia and Latin America. Overall, a balanced immune response against all four serotypes was observed after three doses of the vaccine. The vaccine is well tolerated with a similar safety profile after each dose.[2]

Clinical studies in adults and children are ongoing in Mexico, Colombia, Honduras, Puerto Rico, Peru, the Philippines, Vietnam, Singapore, Australia, and Thailand.

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 (EURONEXT: SAN) and in New York (NYSE: SNY). For more information, please visit: http://www.sanofi-aventis.com

Sanofi Pasteur, the vaccines division of sanofi-aventis Group, 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

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-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 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 products candidates, the absence of guarantee that the products 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 as well as 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, 2009. 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] PDVI Newsletter No. 7, April 2010 accessible at http://www.pdvi.org/PDFs/newsletters/PDVInewsletter7.pdf


[2] Saville et al,
Clinical development of a tetravalent dengue vaccine for endemic areas, ICID Miami, March 2010; Lang et al, Toward a tetravalent dengue vaccine in Brazil, Tropical Medicine meeting, Iguacu Falls, March 2010

SOURCE Sanofi Pasteur

For further information:

Global Media Relations, Pascal Barollier, T. +33-(0)4-37-37-50-38, pascal.barollier@sanofipasteur.com

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