Optimer Pharmaceuticals Submits Rolling New Drug Application to FDA for Fidaxomicin (OPTR)

Optimer Pharmaceuticals, Inc. OPTR today announced that it has submitted the first section of a rolling New Drug Application (NDA) to the U.S. Food and Drug Administration for fidaxomicin to treat patients with Clostridium difficile infection (CDI) and to prevent recurrences of CDI. Optimer anticipates completing the submission in the fourth quarter of 2010 and plans to request priority review, which, if granted, could lead to an FDA decision on the NDA in the second quarter of 2011. "With our NDA submission underway, we continue on the path of bringing this much needed therapy to CDI patients," said Pedro Lichtinger, President and CEO of Optimer. "CDI is a serious health threat and the incidence of the infection continues to increase. We believe fidaxomicin may become the best therapeutic option for this critical illness and we look forward to its commercialization, if approved."