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The European Commission Grants Marketing Authorization for DIFICLIR™ (fidaxomicin) Tablets for Treatment of Clostridium difficile Infections
Date:12/12/2011

SAN DIEGO, Dec. 12, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) and Astellas Pharma Europe Ltd., a European subsidiary of Tokyo-based Astellas Pharma Inc. (Tokyo: 4503) announced today that the European Commission has granted Marketing Authorization (MA) for DIFICLIR™ (fidaxomicin) tablets for the treatment of adults with Clostridium difficile infections (CDI) also known as Clostridium difficile-associated diarrhea (CDAD). CDI is a significant problem in hospitals and long-term care facilities all over the world. EMA approval was based on two large, multi-national, Phase 3 clinical trials that demonstrated that DIFICLIR was as effective as oral vancomycin in treating CDI. DIFICLIR had a significantly lower rate of recurrence (including relapses) compared to vancomycin in the 30 days following treatment.  DIFICLIR is the only drug approved by the EMA proven to significantly lower the rate of recurrence of CDI compared to oral vancomycin. The clinical trials included patients over the age of 65 and those taking concomitant antibiotics to treat multiple infections.

"The European approval is a key step in making fidaxomicin more widely available to patients across the globe to treat this very serious disease," said Pedro Lichtinger, President and Chief Executive Officer of Optimer. "We believe we have obtained a very strong label recognizing the benefits of DIFICLIR versus vancomycin, including significant reductions in recurrence."

The European approval affirms the recent positive opinion from the Committee of Medicinal Products for Human Use (CHMP) and is based on two Phase 3 clinical trials that were conducted to ensure the safety and efficacy of 400mg/day DIFICLIR (fidaxomicin) tablets compared to 500mg/day oral vancomycin for 10 days in subjects with CDI. The first Phase 3 study was carried out in 629 subjects in No
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SOURCE Optimer Pharmaceuticals, Inc.
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