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Optimer Pharmaceuticals Reports Fourth Quarter and Full Year 2010 Financial Results
Date:3/10/2011

ere published in The New England Journal of Medicine in an article titled, "Fidaxomicin versus Vancomycin for Clostridium difficile infection," in the February 3, 2011 issue.
  • New Drug Application for fidaxomicin for the treatment of CDI was accepted by the U.S. Food and Drug Administration (FDA) for filing and received a six-month priority review. The FDA plans to discuss the NDA at a meeting of its Anti-Infective Drugs Advisory Committee currently scheduled for April 5, 2011 and also assigned a Prescription Drug User Fee Act goal date of May 30, 2011.
  • Patent which covers additional dosage forms of fidaxomicin was issued by the U.S. Patent and Trademark Office.
  • Strengthened the management team in preparation for the potential commercial launch of fidaxomicin with the appointments of Gregory E. Papaz, as Senior Vice President of U.S. Commercial Operations, Kurt M. Hartman, as General Counsel and Senior Vice President of Access, Linda Amper, Ph.D., as Senior Vice President of Human Resources, Hemal Shah as Senior Vice President of Health, Economics & Outcomes Research (HEOR), John Womelsdorf, Ph.D., as Vice President of Business Development and most recently, Glenn S. Tillotson, Ph.D., as Senior Vice President of Medical Affairs.  
  • Announced appointment of former Chief Executive Officer and Chairman of the Board of Directors of Pfizer, Hank McKinnell, Ph.D. to Optimer's Board of Directors.
  • Optimer's Marketing Authorization Application (MAA) for fidaxomicin for the treatment of CDI was accepted for review by the European Medicines Agency (EMA).
  • A publication in the peer-reviewed journal, Microbiology, a journal of the Society for General Microbiology, highlighted fidaxomicin's narrow spectrum of activity and minimal disruption of microflora in patients with CDI compared to vancomycin.
  • Combined data from Optimer's two fidaxomicin Phase 3 trials in patients with CDI was prese
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  • SOURCE Optimer Pharmaceuticals, Inc.
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    Related medicine technology :

    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)
    5. Optimer Pharmaceuticals to Present at the 21st Annual Piper Jaffray Health Care Conference
    6. Optimer Pharmaceuticals to Present at the 28th Annual J.P. Morgan Healthcare Conference
    7. Optimer Pharmaceuticals Fidaxomicin Marketing Authorization Application Accepted for Review by European Medicines Agency
    8. Optimer Pharmaceuticals to Present at September 2010 Investor Conferences
    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
    11. Optimer Pharmaceuticals to Host Investor and Analyst Event on November 18
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