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Optimer Pharmaceuticals Reports Second Quarter 2011 Financial Results
Date:8/4/2011

rter culminated with the FDA approval of DIFICID for the treatment of C. difficile-associated diarrhea, or CDAD, in patients over the age of 18, which includes clear differentiation and superiority over oral vancomycin in sustained clinical response 25 days after the end of therapy," said Pedro Lichtinger, President and CEO of Optimer.  "Our success with the FDA approval and the recent launch of DIFICID can be attributed to thorough preparation and execution by our team. We remain highly focused on the successful introduction of DIFICID to physicians and patients, and on establishing DIFICID, based on the clinical experience to date, as the preferred treatment for CDAD patients."

Second Quarter and Recent Highlights

  • On May 27, the U.S. Food and Drug Administration approved Optimer's antibacterial drug DIFICID™ (fidaxomicin) Tablets for the treatment of CDAD in adults 18 years of age and older. CDAD is a significant medical problem in hospitals and long-term care facilities, and is beginning to emerge in the community among people previously at low risk for the disease.
  • On July 18, Optimer announced the commercial launch of DIFICID™ Tablets for the treatment of CDAD in patients 18 years of age and older.
  • Optimer entered into a co-promotion agreement with Cubist Pharmaceuticals to market DIFICID for the treatment of CDAD in the U.S. to help maximize the impact of, and de-risk, the commercial launch of DIFICID.
  • Optimer also presented additional data analysis from the DIFICID Phase 3 clinical trials highlighting risk factors associated with negative outcomes in patients with CDAD such as advanced age and immunosuppression. Data were presented at key scientific conferences including the European Congress of Clinical Microbiology and Infectious Diseases, Digestive Disease Week and the Annual Meeting of the American Geriatric Society.

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