Sanofi Pasteur Starts a Phase II Study of a Vaccine Against Clostridium Difficile



    
    Novel Vaccine Approach Tested in the UK Against One of the Most Common
    Causes of Hospital-Acquired Infection in Europe and North America
    

    LYON, France, Feb. 17 /CNW/ - Sanofi Pasteur, the vaccines division of
sanofi-aventis Group (EURONEXT : SAN and NYSE : SNY), announced today that it
is sponsoring a phase II clinical study of a vaccine against Clostridium
difficile, which is among the most common causes of hospital-acquired
infection in Europe and North America.
    The trial currently conducted in the United Kingdom is investigating the
safety and efficacy of sanofi pasteur's C. difficile candidate vaccine. While
the target indication for the vaccine is primary prevention of C. difficile
infection (CDI), this trial in infected patients aims at providing early proof
of concept of the vaccine approach.
    "Treatment of C. difficile infection includes the use of one of two
antibiotics. Non-antibiotic approaches for managing C. difficile infection are
badly needed since the alteration of the gut flora associated with antibiotics
triggers the infection in the first place. There is also considerable concern
about the emergence of antibiotic-resistance in C. difficile and other
bacteria. Vaccination has the potential to be a very effective strategy to
combat gastrointestinal pathologies caused by C. diff. along with better
antibiotic stewardship and infection control practices," said Barry Cookson,
Director, Laboratory of Healthcare Associated Infections, Centre for
Infections, Health Protection Agency and the lead investigator of the trial.
    Sanofi Pasteur's candidate vaccine uses a toxoid-based approach, which
has been used extensively in sanofi pasteur's licensed vaccines against
tetanus, diphtheria and pertussis (whooping cough). This candidate vaccine has
successfully completed phase I clinical trials in more than 200 participants
to evaluate its safety and immunogenicity.
    The incidence of CDI has increased significantly in recent years in both
North America and Europe. CDI-related treatments in these two regions of the
world are estimated to be costing more than $7bn a year. The emergence of a
hyper-virulent strain of C. difficile in 2002 further highlighted the
importance of tackling CDI.

    About the Clinical Trial

    The phase IIb trial involves about 600 participants with acute CDI at
about 30 centers across the United Kingdom. Participants will be randomized to
4 study groups, where three groups will receive vaccine, while the fourth
group will be given a placebo vaccine. All subjects will receive standard of
care antibiotics.

    About C. difficile

    C. difficile is an anaerobic spore-forming bacterium, present
asymptomatically in approximately 60% of infants but only about 3% of healthy
adults. It belongs to the Clostridium family of bacteria, which also includes
C. tetani (tetanus) and C. botulinum (botulism). The C. difficile bacteria
produce two potent toxins: A and B. When the natural microbial flora of the
gut is disturbed, usually as a result of antibiotic treatment, and a patient
ingests C. difficile spores, the bacteria can multiply and release the two
toxins, which cause gastrointestinal pathologies in humans known collectively
as CDI.
    Hospital-acquired infections caused by C. difficile bacteria are a
considerable problem in many industrialized countries, including the U.S.,
Canada, and Europe. It is estimated that C. difficile causes about 500,000
cases in the US alone (1) with annual costs to the healthcare system of
$3.2bn.(2) In the EU, assuming a population of about 460 million people, the
healthcare costs of CDI are estimated to be around $4.4bn per year.(3)
Additional information is available at the UK Health Protection Agency C.
difficile information page (4) and at http://www.sanofipasteur.com/cdiff

    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).
    Sanofi Pasteur, the vaccines division of sanofi-aventis Group, provided
more than 1.6 billion doses of vaccine in 2008, 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: http://www.sanofipasteur.com or http://www.sanofipasteur.us

    
    References:

    1.  CDC: http://www.cdc.gov/ncidod/dhqp/id_Cdiff.html

    2.  O'Brien et al, The Emerging Infectious Challenge of Clostridium
    difficile-Associated Disease in Massachusetts Hospitals: Clinical and
    Economic Consequences. Infection Control and Hospital Epidemiology, 2007;
    28(11):1219-1227

    3.  European Centre for Disease Prevention and Control, Emergence of
    Clostridium difficile-associated disease in North America and Europe,
    Clinical Microbiology and Infectious Diseases, 2006; 12 (Suppl. 6): 2-18

    4.  HPA:
http://www.hpa.nhs.uk/webw/HPAweb&Page&HPAwebAutoListName/Page/1179744911867
    

    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 product development, product potential 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 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 EMEA, 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 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, 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.

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





For further information:

For further information: Global Media Relations, Pascal Barollier, T.
+33(0)4-37-37-50-38, pascal.barollier@sanofipasteur.com; US Media Relations,
Len Lavenda, T. (570) 957-4446, len.lavenda@sanofipasteur.com

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