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GEN News Highlights : May 24, 2010

Optimer Taps Biocon to Supply Commercial-Scale API for C. Difficile Treatment

Fidaxomicin is part of a new class of antibiotics called macrocycles.

Optimer Pharmaceuticals and Biocon inked a long-term supply agreement for the commercial manufacturing of fidaxomicin, Optimer's lead candidate for the treatment of Clostridium difficile infection (CDI). Biocon's expertise in fermentation technology and the team's prior analytical development work with fidaxomicin prompted Optimer to enter this arrangement with Biocon.

Fidaxomicin is part of a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of C. difficile. The narrow-spectrum profile of fidaxomicin may eradicate C. difficile selectively with minimal disruption to the normal intestinal flora, Optimer reports.

The company has successfully completed two Phase III trials showing superiority in global cure rates as well as a reduction in recurrences of up to 50% when compared with Vancomycin, the only FDA-approved product for CDI. Optimer expects to submit an NDA in the second half of this year.