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Optimer Announces that the U.S. Food and Drug Administration's Anti-Infective Drugs Advisory Committee Voted Unanimously to Recommend Approval of Novel Antibiotic Dificid™ for Treatment of Patients with Clostridium difficile infection (CDI)
Date:4/5/2011

Optimer will host a conference call tomorrow at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time) to discuss this announcement. To participate in the conference call, please dial (877) 280-7280 from the U.S., or (678) 825-8232 for international callers. Please specify to the operator that you would like to join "Optimer's Conference Call." The conference call will be webcast live under the Investors section of Optimer's website at www.optimerpharma.com, where it will be archived for 30 days following the call. Please connect to Optimer's website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary. 

About DIFICID™ (Fidaxomicin)

DIFICID™ (fidaxomicin) is a new antibiotic with a novel mechanism of action, which inhibits the bacterial enzyme RNA polymerase, resulting in the rapid killing of C. difficile. The narrow-spectrum profile of DIFICID eradicates C. difficile selectively with minimal disruption to the normal intestinal flora, while the alternative antibiotics used to treat CDI, metronidazole and vancomycin, have been shown to disrupt the gut flora. DIFICID facilitates the return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence rates. In two Phase 3 trials for the treatment of CDI, DIFICID was equally effective in clinical cure when compared to vancomycin, the only FDA approved product for CDI.  DIFICID also demonstrated statistically significant reduction in recurrences and an increase in global cure rate, defined as cure without recurrence. Importantly, DIFICID reduced the risk of recurrence by 47% compared to vancomycin. The New England Journal of Medicine has published results from the first Phase 3 trial in an article titled, "Fidaxomicin versus Vancomycin for Clostridium difficile Infection," which
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SOURCE Optimer Pharmaceuticals, Inc.
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Related medicine technology :

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4. Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI)
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9. Optimer Pharmaceuticals Announces Presentations of Additional Fidaxomicin Phase 3 Data at Upcoming ICAAC Annual Meeting
10. Optimer Pharmaceuticals Announces Combined Data From Fidaxomicin Phase 3 Trials for the Treatment of Clostridium difficile Infection (CDI) Presented at IDSA
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