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Optimer Pharmaceuticals Announces Combined Data From Fidaxomicin Phase 3 Trials for the Treatment of Clostridium difficile Infection (CDI) Presented at IDSA
Date:10/23/2010

se 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, and thus allowing C. difficile bacteria to flourish.

Current therapeutic options for CDI include the off-label use of metronidazole and oral vancomycin, the only FDA-approved treatment.  However, approximately 20% to 30% of CDI patients who initially respond to these treatments experience a clinical recurrence following cessation of antibiotic administration.

Primary risk factors for CDI include broad-spectrum antibiotic use (such as cephalosporins and fluoroquinolones), advanced age (over 65) and exposure to emerging hyper-virulent strains (BI/NAP1/027, 078, 001) of C. difficile. Increasing incidence, higher treatment failures and recurrence with current therapies have resulted in greater awareness and concern of CDI among medical professionals and public health officials. Learn more about CDI at www.cdiinfo.org.

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 under development, fidaxomicin and Pruvel™ (prulifloxacin). Fidaxomicin is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). We recently initiated a rolling submission of our NDA filing to the FDA, and filed a MAA to the EMA (Europe) for fidaxomicin.  Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. We plan to have an NDA submitted to the FDA in the first quarter of 2011.
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SOURCE Optimer Pharmaceuticals, Inc.
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1. Optimer Pharmaceuticals Receives Production Patent for Lead Product Candidate Fidaxomicin
2. Optimer Pharmaceuticals Presents Results From Fidaxomicin Phase 3 Study for the Treatment of Clostridium difficile Infection
3. Data From Optimers Second Phase 3 Study of Prulifloxacin Presented at Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC)
4. Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI)
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11. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
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