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Optimer Pharmaceuticals Phase 3 Clinical Trials show Fidaxomicin is Superior to Vancomycin in Treatment of Recurrent Clostridium difficile Infection (CDI); Data Presented at ICAAC
Date:9/14/2010

also superior to vancomycin in the treatment of CDI patients suffering a recurrence," said Sherwood Gorbach, Optimer's Chief Medical Officer and Senior Vice President of Medical Affairs.  "This is an important finding given that the medical community has not found a successful and reliable treatment for recurrent CDI.  With our recent MAA filing and anticipated NDA filing, we continue to work diligently to make fidaxomicin available to the medical community for treating acute CDI and for preventing and treating recurrences."

For a complete list of posters, please visit the Resources page on our website: www.optimerpharma.com

Fidaxomicin Clinical StudiesThe two fidaxomicin Phase 3 clinical studies were multi-center, randomized, double-blind trials, which enrolled a total of 1,164 adult subjects.  Subjects with confirmed CDI received either fidaxomicin (200 mg q12h) or Vancocin® (125 mg q6h), the only FDA approved product for the treatment of CDI. These studies were designed to evaluate safety and compare the response to treatment in subjects during and after a 10-day course of therapy. The primary endpoint was non-inferiority compared to Vancocin in clinical cure (defined as patients requiring no further CDI therapy two days after completion of study medication, as determined by the investigator).  If cured, subjects were monitored for a subsequent four-week period to evaluate recurrence, which was a secondary endpoint.  Global cure, also a secondary endpoint, was defined as patients who were cured and did not have a recurrence during this subsequent four-week period. In both of these studies, fidaxomicin achieved its primary endpoint of non-inferiority compared to Vancocin.  Fidaxomicin was also statistically superior to Vancocin in global cure rate and in reducing recurrences of CDI.

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