Optimer Pharmaceuticals, Inc. (OPTR)

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Optimer Pharmaceuticals and Astellas Receive Positive Opinion from CHMP for European Approval of DIFICID

Press Release Source: Optimer Pharmaceuticals, Inc. On Friday September 23, 2011, 8:00 am

SAN DIEGO, Sept. 23, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (NASDAQ:OPTR - News) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for DIFICLIR™ (fidaxomicin) tablets for the treatment of adults suffering with a Clostridium difficile infection (CDI), also known as C. difficile-associated diarrhea (CDAD).

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DIFICLIR, which is known as DIFICID™ in the United States (US), was approved by the US FDA in May 2011 for the treatment of CDAD in adults 18 years of age and older. Astellas is Optimer's exclusive licensee to develop and commercialize DIFICLIR in Europe and certain other countries in the Middle East, Africa and the Commonwealth of Independent States.

The CHMP positive opinion is based on Phase 3 clinical studies that were conducted to compare the safety and efficacy of 400mg/day fidaxomicin with 500mg/day oral vancomycin for 10 days in subjects with CDI. The first Phase 3 study was carried out in 629 subjects in North America (US and Canada). The second Phase 3 study was carried out in 535 subjects in North America and Europe. The results of the studies showed that the proportion of subjects in which clinical cure was achieved at the end of 10 days of treatment were similar for both treatments; thus fidaxomicin met its primary endpoint of non-inferiority to vancomycin. Furthermore in both trials, fidaxomicin had a significantly lower rate of recurrence of CDI compared to vancomycin at 30 days after completion of treatment.

"A positive CHMP opinion is an important milestone for Optimer and is a key step to making fidaxomicin more widely available to patients around the globe for this serious disease," 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.