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Data Presented at Digestive Disease Week Highlights Additional Analysis of DIFICID™ Phase 3 Data
Date:5/9/2011

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DIFICID™ (fidaxomicin), if approved, will be the first new antibiotic for the treatment of Clostridium difficile infection (CDI) in nearly 30 years. In two Phase 3 trials for the treatment of CDI, fidaxomicin was non-inferior in clinical cure when compared to vancomycin, the only FDA approved product for CDI.  DIFICID also demonstrated superiority to vancomycin in global cure, which is defined as a cure without recurrence, or a sustained cure, through the end of the follow up period. This difference was driven by DIFICID's lower rates of relapse of diarrhea following cessation of the CDI treatment.

About Clostridium difficile Infection (CDI)

Clostridium difficile infection (CDI), commonly referred to as "C. difficile" or "c-diff", has become a significant medical problem in hospitals, long-term care facilities, and in the community and is estimated to afflict more than 700,000 people each year in the U.S.  It is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death.  Patients typically develop CDI from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, thus allowing C. difficile bacteria to flourish and produce toxins.

Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the latter being the only FDA-approved treatment.  However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence, defined as a relapse or re-establishment of diarrhea, following cessation of the CDI treatment.

Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), older age (over 65) and exposure to emerging hyper-virulent strains (BI/
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SOURCE Optimer Pharmaceuticals, Inc.
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