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Optimer Pharmaceuticals' Fidaxomicin Marketing Authorization Application Accepted for Review by European Medicines Agency
Date:8/19/2010

SAN DIEGO, Aug. 19 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced that the European Medicines Agency (EMA) has accepted for review Optimer's Marketing Authorization Application (MAA) for fidaxomicin for the treatment of patients with Clostridium difficile infection (CDI) and for the prevention of recurrences of CDI in the European Union (EU).  Optimer announced the submission of its MAA for fidaxomicin to the EMA on August 2, 2010.

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"An independent survey recently conducted by Decision Resources indicates that CDI is on the rise and that nearly 70% of surveyed infectious disease specialists and internists would use fidaxomicin in first- and second-line treatment of CDI, if approved," said Pedro Lichtinger, President and CEO of Optimer. "We believe the potential demand for a narrow spectrum antibiotic with lower recurrence rates for the treatment of CDI is significant. The acceptance for review of the fidaxomicin marketing application by the EMA is an important step in bringing this much needed therapy to Europe, where treatment options are limited.  With the validation of this MAA, we believe we have significantly improved the risk profile of our European program that when combined with our growing excitement and understanding of CDI incidence, access and prescribing intentions across the region, present an enhanced value proposition for fidaxomicin."  

Given these developments, the Company is increasing its focus on its European partnering process for fidaxomicin. J.P. Morgan has been engaged to advise and assist Optime
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SOURCE Optimer Pharmaceuticals, Inc.
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