Sanofi Pasteur introduces new option for flu vaccination - tiny needle, same
effectiveness as traditional flu shots

TORONTO, Sept. 14 /CNW/ - Sanofi Pasteur, the vaccines division of sanofi-aventis Group (EURONEXT : SAN and NYSE : SNY), announced today that Canadians now have a new option to protect themselves against the seasonal flu.(1) INTANZA(TM), which has a tiny microneedle more than 10 times smaller than regular flu shot needles, pierces only the skin without penetrating the muscle, and is designed for patients' comfort.(1)

INTANZA 9(micro)g is proven to be as effective as the traditional intramuscular flu vaccine in provoking an immune response in the body.(1) INTANZA is an inactivated influenza vaccine (does not contain live virus) indicated for people 18 to 59 years of age, which can also be used for people with asthma and those who have weakened immune systems, while offering a minimally invasive option for flu vaccination. No other influenza vaccine in Canada can offer these two combined benefits.

"Most Canadians recognize common flu symptoms such as fever, headache, fatigue and aches and pains, but they don't realize how serious flu from influenza virus can really be," said Dr. Jay Keystone, Director of the Medisys Travel Health and Immunization Clinic in Toronto and Professor of Medicine at the University of Toronto.

"Influenza can cause serious illness, absenteeism from work and, in the most severe cases, even hospitalization or death - that's why immunization is so important, even for healthy adults. Despite all this, many Canadians are reluctant to get the flu shot because of the pain associated with having an injection in the muscle."

Influenza immunization is the most effective way to avoid getting the flu. Despite this, in 2008, less than one-third of Canadians aged 12 years and over had a seasonal flu shot in the previous year.(2) According to a recent Canadian survey, up to 1 in 4 people experienced anxiety when they were shown the traditional 25 mm needle used for intramuscular influenza vaccination.(2) With its 1.5 mm microneedle, INTANZA provides people with the option of a minimally invasive vaccination, and more than 80 per cent of patients reported no pain or hardly any pain upon injection.

"The H1N1 outbreak created a heightened awareness of influenza and the importance of immunization, but it also exposed the confusion among Canadians about the flu," said Dr. Keystone. "Canadians need to be educated about the seriousness of influenza, the importance of immunization, and that they have choices beyond the traditional flu shot, such as INTANZA. I'm optimistic that this new option will encourage more Canadians to protect themselves."

INTANZA will be available this fall and can be purchased through local pharmacies. Canadians are encouraged to ask their health care provider for more information.

Flu Facts

    
    -   The flu is a common respiratory infection that affects millions of
        Canadians each year and is a significant cause of serious illness and
        death.

    -   There are more than 13,600 hospitalizations each year in Canada
        attributed to the seasonal flu.(3)

    -   Flu and pneumonia (which is a common complication of influenza)
        combined was the seventh leading cause of death in Canada, causing
        5,845 of the 230,132 deaths in Canada in 2005. While most of these
        deaths are in seniors, there are deaths in every age group.(4)

    -   Flu immunization has been shown to reduce episodes of upper
        respiratory illnesses (URIs), as well as absenteeism from work and
        visits to GPs offices due to URIs.(5)
    

About INTANZA(TM)

INTANZA(TM) is the only intradermal influenza vaccine with a minimally invasive microneedle specifically designed for improved patient comfort.(1) Clinical studies have proven that INTANZA 9(micro)g is at least as immunogenic as conventional 15(micro)g intramuscular flu vaccine.(1) INTANZA takes advantage of the immune potential of the skin to provide effective flu protection. The skin is particularly rich in dendritic cells, which control the magnitude, quality and memory of the immune response.(1) Skin also has a high density of both lymphatic vessels and blood capillaries, which help facilitate the immune response.(1) As expected with injection into the skin, visible injection site reactions such as redness, hardness and swelling of the skin were increased when compared with intramuscular influenza vaccination; these reactions are generally mild and transient, resolving spontaneously within one to three days after onset.(1)

INTANZA has a systemic safety profile comparable to that of intramuscular influenza vaccinations. INTANZA does not contain thimerosol or latex, and is adjuvant-free.

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: www.sanofi-aventis.com

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: www.sanofipasteur.com or www.sanofipasteur.ca.

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.

References:

    
    (1) INTANZA(TM) Product Monograph. Sanofi Pasteur. 2010.
    (2) Statistics Canada.
http://www.statcan.gc.ca/pub/82-221-x/2009001/tblstructure/3sp/3ay/aces3ii-eng.htm.
        Last accessed February 17, 2010.
    (3) Schanzer DL, et al. Influenza and Other Resp Viruses. 2008;2:1-8.
    (4) Statistics Canada.
http://www.statcan.gc.ca/pub/84-215-x/2009000/tbl/tbl1-eng.htm.
        Last accessed July 7, 2010.
    (5) Nichol KL, et al. N Engl J Med. 1995;333:889-893.
    

For further information: Nancy Simpson, Director, Communications, Sanofi Pasteur Limited, Toronto, Ontario, 416-667-2955, [email protected]; Laura Grice, MS&L, 416-847-1319, [email protected]