Sanofi Pasteur's Dengue Vaccine In Final Stage Of Clinical Development

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MEDIA RELEASE PR42035


Sanofi Pasteur's Dengue Vaccine in Final Stage of Clinical Development


LYON, France, Nov. 4 /PRNewswire-AsiaNet/ --


    

    - First Phase 3 Study Underway in Australia


    Sanofi Pasteur, the vaccines division of sanofi-aventis Group

(EURONEXT: SAN and NYSE: SNY), announced today that its dengue vaccine is in

final stage of clinical development. Sanofi Pasteur's dengue vaccine, the

world's most clinically advanced dengue vaccine candidate(1,2), entered its

first phase 3 clinical study in Australia.


    This study is part of a global phase 3 clinical study program

aimed at advancing the development of a novel vaccine for the prevention of

dengue disease in children and adults. Currently, there is no specific

treatment available for dengue fever, which is a threat to nearly three

billion people and a public health priority in many countries of Latin

America and Asia where epidemics occur.(3)


    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's candidate dengue

vaccine is the first to reach phase 3 of clinical development.


    "To address the global health challenge represented by dengue

fever, we are conducting an unprecedented dengue vaccine research and

development program as well as a scale up of the vaccine production," said

Wayne Pisano, President and Chief Executive Officer of Sanofi Pasteur. "We

are now entering the final laps of a long run that Sanofi Pasteur started

almost 20 years ago. If successful, we are committed to introducing the

vaccine in countries where dengue is of highest public health priority."


    The study in Australia is the first to use dengue vaccine

doses produced with industrial scale processes. The study is aimed at

demonstrating that production of the vaccine at industrial scale will meet

consistency criteria required for market authorization by regulatory

authorities. Details of the phase 3 study in Australia as well as results of

already completed studies are presented at the 59th annual conference of

ASTMH (American Society of Tropical Medicine and Hygiene), held in Atlanta

(Georgia, United States), November 3-7.


    Sanofi Pasteur's global dengue vaccine clinical study program


    Sanofi Pasteur's candidate dengue vaccine-which targets all

four virus serotypes-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.(4)


    Clinical studies in adults and children are ongoing in Mexico,

Colombia, Honduras, Puerto Rico, Peru, the Philippines, Vietnam, Singapore,

Australia, and Thailand.


    About dengue fever


    Dengue fever is a mosquito-borne disease caused by four dengue

virus serotypes (1 to 4). Overall, the disease is a potential threat to

almost half of the world's population. Of the estimated 220 million people

infected annually, two million-mostly children-develop dengue hemorrhagic

fever (DHF), a severe form of the disease.(5) DHF is a leading cause of

hospitalization, placing tremendous pressure on strained medical resources

and having a heavy economic and societal impact. Many factors have

contributed to the re-emergence and dramatic increase in dengue fever

including urbanization and increased travel which facilitates dissemination

of dengue viruses and the circulation of all four dengue virus serotypes.


    For continuous up to date information about dengue fever

outbreaks, visit http://www.denguewatch.org, a news hub reporting worldwide

alerts on dengue, provided by the Pediatric Dengue Vaccine Initiative.


    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:



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

provided more than 1.6 billion doses of vaccine in 2009, 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



    1. Dengue vaccine efficacy trials in progress,

http://www.thelancet.com/infection, vol 9, November 2009


    2. Jean Lang, Recent progress on Sanofi Pasteur's dengue vaccine

candidate. Journal of Clinical Virology 46, S2 (2009) 20-24


    3. WHO Fact sheet No117, March 2009 Dengue and dengue haemorrhagic fever


    4. 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


    5. PDVI Newsletter No 7, April 2010 accessible at



    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,

Misc Miscellaneous Sanofi Pasteur 3 image

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.






    SOURCE: Sanofi Pasteur


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