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Optimer Pharmaceuticals Receives Orphan Drug Designation for Fidaxomicin for the Treatment of Pediatric Clostridium difficile Infection
Date:1/4/2011

SAN DIEGO, Jan. 4, 2011 /PRNewswire/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that fidaxomicin, the Company's lead product candidate, has been granted orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of pediatric Clostridium difficile infection (CDI).  This orphan drug designation applies to the active moiety and covers all formulations of fidaxomicin used to treat Clostridium difficile infection in children 16 years of age or younger.

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Optimer has completed Phase 3 trials in adults and filed applications in the U.S. and the EU for marketing authorization for fidaxomicin for the treatment of CDI and for the prevention of recurrences.

The FDA Orphan Drug Designation is intended to support the clinical development of drugs for diseases and conditions that affect fewer than 200,000 people in the United States.  Orphan Drug Designation gives seven years of market exclusivity for the designated indication in the U.S. from the date the product receives marketing approval for that indication.  Orphan Drug Designation also provides access to regulatory support from the FDA throughout the development process, potential grant funding for clinical studies, potential FDA fee reductions, and tax credits related to development expenses.  This designation does not imply that fidaxomicin has demonstrated the efficacy, safety and quality required for drug approval in the U.S.  

About FidaxomicinFidaxomicin is the first in a new class of antibiotics called macrocycles, which inhibit the bacterial enzyme RNA polymerase, resulting in the rapid killing of C. difficile. The narrow-spectrum profile of fidaxomicin eradicates C.
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SOURCE Optimer Pharmaceuticals, Inc.
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