U.S. FDA Grants Fast-Track Designation to Sanofi Pasteur's Investigational Clostridium difficile Vaccine
SWIFTWATER, Pennsylvania, November 9, 2010 /PRNewswire via COMTEX/ -- Sanofi Pasteur, the vaccines division of sanofi-aventis Group , announced today that the U.S. Food and Drug Administration (FDA) has granted fast-track designation to the company's investigational Clostridium difficile vaccine candidate. The fast-track program of the FDA is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.
The incidence of Clostridium difficile infection (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 preventing CDI.
C. difficile 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.
"Our C. difficile vaccine candidate is in phase II," according to Michel DeWilde, Ph.D., Senior Vice President, Research and Development. "The FDA fast-track designation recognizes that a C. difficile vaccine could address an important unmet medical need. Under this program," he explained, "the FDA can accept for review completed portions of the licensing application prior to receipt of the entire application."
About Clostridium difficile infection
C difficile is an anaerobic spore-forming bacterium, present asymptomatically in approximately 60 percent of infants but only approximately three percent of healthy adults. When the natural microbial flora of the gut is disturbed, usually as a result of antibiotic treatment for other infections, 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 alone, with annual costs to the healthcare system of $3.2 billion. In the EU the healthcare costs of CDI are estimated to be around $4.4 billion per year. Additional information is available at the US Centers for Disease Control and Prevention and UK Health Protection Agency C difficile information pages[1,4].
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 /quotes/comstock/24s!e:san (FR:SAN 50.44, -0.75, -1.47%) and in New York /quotes/comstock/13*!sny/quotes/nls/sny (SNY 34.62, -0.70, -1.97%) . For more information, please visit: http://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: http://www.sanofipasteur.com or http://www.sanofipasteur.us
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
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.