May 25, 2010 (FinancialWire) — Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) a California-based biopharmaceutical company focused on the treatment of infections and India-based Biocon Ltd. (NSE: BIOCON) said that they have entered into a long-term supply agreement for the commercial manufacturing of the active pharmaceutical ingredient fidaxomicin, Optimer's lead product candidate for the treatment of CDI.

CDI is caused by Clostridium difficile, a spore-forming bacterium that can cause serious infection of the colon in humans by multiplying and producing toxins resulting in inflammation, severe diarrhea and, in serious cases, death.

The primary risk factor for the development of CDI is the use of broad-spectrum antibiotics, as they can disrupt normal gastrointestinal flora, promoting C. difficile overgrowth. C. difficile typically affects older or severely ill patients who are hospital inpatients or residents of long-term-care facilities.

Fidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the death of C. difficile.

The company hopes that the narrow-spectrum profile of fidaxomicin may eradicate C. difficile selectively with minimal disruption to the normal intestinal flora, while most broad-spectrum antibiotics, including metronidazole and vancomycin, disrupt these flora.

Optimer has completed two Phase 3 trials for the drug, claiming 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 said it expects to submit an NDA in the second half of the year.

According to Optimer, Biocon's expertise in fermentation technology and the team's prior analytical development work with fidaxomicin made Biocon the most suited manufacturer for Optimer's product requirements.

California-based Optimer Pharmaceuticals is a biopharmaceutical company focused on discovering, developing and commercializing anti-infectives.

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