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Optimer Pharmaceuticals Announces FDA Acceptance of NDA for Filing and Designation of Priority Review for Fidaxomicin for the Treatment of Clostridium difficile Infection (CDI)
Date:1/24/2011

fluoroquinolones), older age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. The increasing incidence of CDI, along with higher rates of both treatment failures and recurrences with current therapies have resulted in greater awareness and concern about CDI among medical professionals and public health officials. You may learn more about CDI at www.cdiinfo.org, a website of Optimer.

About FidaxomicinFidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the rapid killing of C. difficile. The narrow-spectrum profile of fidaxomicin 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. Fidaxomicin facilitates the return of normal physiological conditions in the colon which may be responsible for reducing CDI recurrence rates. Optimer has filed applications in the U.S. and the EU for marketing authorization for fidaxomicin for the treatment of CDI and reducing risk of recurrence when used for treatment of initial CDI.

About Optimer PharmaceuticalsOptimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing hospital specialty products to treat serious infections and address unmet medical needs. Optimer has two anti-infective product candidates in development, fidaxomicin and Pruvel™ (prulifloxacin).  Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI).  The Company has submitted an NDA to the FDA, and filed a MAA with the European Medicines Agency (EMA) for fidaxomicin. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being deve
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