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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

ut Optimer

Optimer Pharmaceuticals, Inc. is a biopharmaceutical company focused on discovering, developing and commercializing innovative hospital specialty products that have a positive impact on society. Optimer has two anti-infective product candidates in development, DIFICID™ (fidaxomicin) and Pruvel™ (prulifloxacin). DIFICID is a narrow spectrum antibiotic being developed for the treatment of Clostridium difficile infection (CDI). The FDA granted the Company's request for six-month Priority Review of DIFICID, and has assigned a Prescription Drug User Fee Act (PDUFA) goal date of May 30, 2011. The Company also filed a MAA with the European Medicines Agency (EMA) for DIFICID. Pruvel™ is a prodrug in the fluoroquinolone class of antibiotics being developed as a treatment for infectious diarrhea. Additional information can be found at http://www.optimerpharma.com.  

Forward Looking Statements

Statements included in this press release that are not a description of historical facts are forward-looking statements, including without limitation statements related to expected DIFICID™ increases in the U.S. population over age 65 and the incidence of CDI, DIFICID potential regulatory approval of DIFICID, and the awareness of CDI among healthcare professionals. Words such as "believes," "would," "anticipates," "plans," "expects," "may," "intend," "will," and similar expressions are intended to identify forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Optimer that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Optimer's business including, without limitation, risks relating to: the development of alternative treatments for or means of preventing CDI, whether regulatory authorities will review or
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SOURCE Optimer Pharmaceuticals, Inc.
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Related medicine technology :

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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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