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Sanofi Pasteur Expands Study of Vaccine Against Clostridium Difficile Into the U.S.

Novel vaccine approach tested against one of the most common causes of hospital-acquired infection in Europe and North America

Dec 15, 2009

Lyon, France and Swiftwater, Pa – December 15, 2009 - Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that it is expanding its phase II clinical study of a vaccine against Clostridium difficile infection (CDI) into the United States. The trial started in the United Kingdom earlier this year.

 

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 $7 billion a year. The recent emergence and spread of a hyper-virulent strain of C.difficile further highlights the importance of tackling CDI.

 

“While the target indication for the vaccine is prevention, this trial - in recently infected patients - aims to provide early proof-of-concept of a vaccine approach to preventing recurring infection,” said Michel DeWilde, Ph.D., Senior Vice President, Research and Development, Sanofi Pasteur. Recurring infection occurs in at least 20 percent of patients experiencing a first CDI episode and even higher frequency in those who have had multiple episodes,” he explained.

 

CDI is among the most common causes of nosocomial (hospital-acquired) infection in North America and Europe. Current treatment of C.difficile infection involves the use of one of the two antibiotics recommended for CDI management. The trial is investigating the safety and efficacy of Sanofi Pasteur’s CDI candidate vaccine in the U.S. population.

 

“Non-antibiotic approaches for managing CDI are badly needed since antibiotics alter the gut micro- flora and permit the infection in the first place,” said Dr. DeWilde. “There is also considerable concern about the emergence of antibiotic-resistance in various bacterial species, including C.difficile. Vaccination has the potential to be a very effective strategy to combat the gastrointestinal symptoms caused by C.difficile in conjunction with better antibiotic stewardship and infection control practices,” he added.

Sanofi Pasteur’s candidate vaccine uses a toxoid-based approach, which has been used extensively in 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.

 

About the Clinical Trial

The phase IIb trial hopes to recruit approximately 600 participants with acute CDI across the United Kingdom and in the U.S. Participants will be randomized to four 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. For more information on the trial and the sites conducting the study, go to www.fightCDI.com .

 

About C.difficile

C.difficile is an anaerobic spore-forming bacterium, present asymptomatically in approximately 60 percent of infants but only approximately three percent 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 for other illnesses, and a patient ingests C.difficile spores, the bacteria can multiply and release the two toxins, which cause a broad range of gastrointestinal symptoms in humans known collectively as CDI.

Hospital-acquired infections caused by C.difficile are a considerable problem in many industrialized countries, including the U.S., Canada, and Europe. It is estimated that there are about 500,000 cases of CDI in the US alone1, with annual costs to the healthcare system of $3.2 billion2. In the EU, assuming a population of about 460 million people, the healthcare costs of CDI are estimated to be around $4.4 billion per year.3 Additional information is available at the US Centers for Disease Control and Prevention and UK Health Protection Agency C.difficile information pages1,4.

 

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 the 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 EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us

 

References:

1. CDC: 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: 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, 2008. Other than as required by applicable law, sanofi-aventis does not undertake any obligation to update or revise any forward-looking information or statements. 

For further information: Global Media Relations Pascal Barollier T.: +33-(0)4-37-37-50-38 pascal.barollier@sanofipasteur.com www.sanofipasteur.com US Media Relations Susan Watkins T.: +1-570-957-2563 susan.watkins@sanofipasteur.com www.sanofipasteur.us