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Optimer Pharmaceuticals and Astellas Receive Positive Opinion from CHMP for European Approval of DIFICID™
Date:9/23/2011

ease," said Pedro Lichtinger, President and CEO of Optimer.

The European Commission generally follows the recommendations of the CHMP and delivers its final decision within three months of the CHMP opinion.

Important Safety Information for DIFICID

  • DIFICID should not be used for systemic infections
  • Only use DIFICID for infection proven or strongly suspected to be caused by C. difficile. Prescribing DIFICID in the absence of a proven or strongly suspected C. difficile infection is unlikely to provide benefit to the patient and increases the risk of the development of drug resistant bacteria
  • The most common adverse reactions are nausea (11%), vomiting (7%), abdominal pain (6%), gastrointestinal hemorrhage (4%), anemia (2%), and neutropenia (2%)

About CDAD

Clostridium difficile-associated diarrhea (CDAD) has become a significant medical problem in hospitals, long-term care facilities and in the community. CDAD is a serious illness resulting from infection of the inner lining of the colon by C. difficile bacteria, which produce toxins that cause inflammation of the colon, severe diarrhea and, in the most serious cases, death. Patients typically develop CDAD from the use of broad-spectrum antibiotics that disrupt normal gastrointestinal (gut) flora, possibly allowing C. difficile bacteria to flourish. Older patients in particular are at risk for CDAD, potentially because of a weakened immune system or the presence of underlying disease. Approximately two-thirds of CDAD patients are 65 years of age or older.

About Optimer Pharmaceuticals

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 developed and is commercializing DIFICID™ (fidaxomicin) tablets
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SOURCE Optimer Pharmaceuticals, Inc.
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5. Clinical Infectious Diseases Publishes Subgroup Analysis Showing Optimers DIFICID™ (fidaxomicin) Tablets Exhibited Higher Clinical Cure and Global Cure Rates Than Vancomycin in Patients with Clostridium difficile-Associated Diarrhea (CDAD) Receivin
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