Sanofi Pasteur Initiates Phase III Study of Investigational Vaccine in Canada to Prevent Clostridium difficile

Sanofi Pasteur Initiates Phase III Study of Investigational Vaccine in Canada 
to Prevent Clostridium difficile 
Cdiffense trial to evaluate vaccine against a leading cause of 
life-threatening, healthcare-associated infections worldwide 
TORONTO, Aug. 26, 2013 /CNW/ - Sanofi Pasteur, the vaccines division of Sanofi 
(EURONEXT: SAN and NYSE: SNY), announced today the initiation of its Phase III 
clinical program called Cdiffense to evaluate the safety, immunogenicity and 
efficacy of an investigational vaccine for the prevention of primary 
symptomatic Clostridium difficile infection (CDI). Clostridium difficile (C. 
diff) is a potentially life-threatening, spore-forming bacterium that causes 
intestinal disease. The risk of C. diff increases with age, antibiotic 
treatment and time spent in hospitals or nursing homes, where multiple cases 
can lead to outbreaks. The investigational vaccine is designed to protect 
at-risk individuals from C. diff, which is emerging as a leading cause of 
life-threatening, healthcare-associated infections (HAIs) worldwide.(1) 
C. diff toxins cause gastrointestinal disease that can lead to death in 
approximately eight to 15 percent of infected people.(2) Since 20 to 30 
percent of patients experience recurrences of CDI, re-hospitalizations and 
longer hospital stays remain common. From 1997 to 2005, the CDI-related 
mortality rate in Canadian hospitals increased from 1.5 to 5.7 percent.(4) An 
important contributor to this spike in cases was the spread of a more virulent 
strain of C. diff throughout the country.(5) The investigational C. diff 
vaccine is designed to produce an immune response that targets the toxins 
generated by C. diff bacteria, which can cause inflammation of the gut and 
lead to diarrhea. The investigational vaccine stimulates a person's immune 
system to fight C. diff toxins upon exposure and ultimately may help prevent a 
future infection from occurring. 
"With the emergence of difficult-to-manage strains of C. diff, CDI has become 
more frequent, more severe and more difficult to treat in recent years, 
raising concerns about how to control it and prevent transmission," explained 
John Shiver PhD, Senior Vice President for Research & Development at Sanofi 
Pasteur. "Vaccination could be an efficacious, cost-effective and important 
public-health measure to protect individuals from C. diff." 
The Cdiffense Phase III clinical program has just started recruiting 
volunteers in Canada for a randomized, observer-blind, placebo-controlled, 
multi-center, multi-national trial that will include up to 15,000 adults at 
200 sites across 17 countries. Volunteers for the study should be age 50 or 
older and planning an upcoming hospitalization or have had at least two 
hospital stays and have received systemic antibiotics in the past year. For 
more information on the Cdiffense trial, please visit www.Cdiffense.org. 
About C. diff
Clostridium difficile (C. diff) is a potentially life-threatening, 
spore-forming bacterium that causes intestinal disease. The risk of C. diff 
increases with age, antibiotic treatment and time spent in hospitals or 
nursing homes, where multiple cases can lead to outbreaks.(1) A main source of 
C. diff is infected patients who release spores into the environment that can 
then infect other people. When antibiotics disrupt the gut's normal flora and 
a person has ingested C. diff spores, the C. diff bacteria multiply and 
release potent toxins that can damage a person's intestinal lining and cause 
C. diff disease.(6) 
About Sanofi
Sanofi, an integrated global healthcare leader, discovers, develops and 
distributes therapeutic solutions focused on patients' needs. Sanofi has core 
strengths in the field of healthcare with seven growth platforms: diabetes 
solutions, human vaccines, innovative drugs, consumer healthcare, emerging 
markets, animal health and the new Genzyme. Sanofi is listed in Paris 
(EURONEXT: SAN) and in New York (NYSE: SNY). 
Sanofi Pasteur, the vaccines division of Sanofi, 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: 
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 
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and potential, and statements regarding future performance. Forward-looking 
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"believes", "intends", "estimates", "plans" and similar expressions. Although 
Sanofi's 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, 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 product candidates, the absence of guarantee that 
the product 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, trends in exchange 
rates and prevailing interest rates, the impact of cost containment policies 
and subsequent changes thereto, the average number of shares outstanding as 
well as those discussed or identified in the public filings with the SEC and 
the AMF made by Sanofi, including those listed under "Risk Factors" and 
"Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual 
report on Form 20-F for the year ended December 31, 2012. Other than as 
required by applicable law, Sanofi does not undertake any obligation to update 
or revise any forward-looking information or statements. 
___________________________________ 
(1) Centers for Disease Control and Prevention. Frequently Asked Questions 
about Clostridium difficile for Healthcare Providers. Centers for Disease 
Control and Prevention. 
http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html. Last Updated March 
6, 2013. Accessed June 26, 2013 
(2) Mitchell BG and Gardner A. (2012) Mortality and Clostridium difficile 
infection: a review. Aric journal. 
(3) Garey KW, et al. (2008). Meta-analysis to assess risk factors for 
recurrent Clostridium difficile infection. Journal Hospital Infection, 70, p. 
298-304. 
(4) Gravel D. Miller M, Simor A, et al. Healthcare-associated Clostridium 
difficile infection in adults admitted to acute care hospitals in Canada: A 
Canadian nosocomial infection surveillance program study. Clin Infect Dis 
2009;48:568-576. 
(5) Miller M, Gravel D, Mulvey M, et al. Healthcare-associated Clostridium 
difficile infection in Canada: Patient age and infecting strain type are 
highly predictive of severe outcome and mortality. Clin Infect Dis 
2010;50:194-201. 
(6) Delmee M and Warny M. (1995). Clostridium difficile colitis: recent 
therapeutical and immunological considerations. Acta Gastroenterol Belg, 58 
(3-4), p. 313-317.  
 Global Media Relations  Susan Watkins T. +570-957-2563 
susan.watkins@sanofipasteur.com www.sanofipasteur.com 
Media Relations in Canada Nancy Simpson 416-667-2955 
nancy.simpson@sanofipasteur.com www.sanofipasteur.us 
SOURCE: Sanofi Pasteur 
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CO: Sanofi Pasteur
ST: Ontario
NI: BTC MTC  
-0- Aug/26/2013 14:00 GMT