Optimer Pharmaceuticals, Inc.

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Msg  21 of 79  at  11/2/2010 3:39:26 PM  by

zanispetros


3Q results in line

SAN DIEGO, Nov. 2, 2010 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (OPTR:$9.37,00$0.10,001.08%) today reported financial results for the third quarter ended September 30, 2010. Optimer reported a net loss for the third quarter of 2010 of $11.8 million, or $0.30 per share, which was in line with the Company's expectations. This compares to a net loss for the third quarter of 2009 of $9.4 million, or $0.28 per share. The increase in net loss was primarily due to an increase in research and development and marketing expenses.
Research and development expenses in the third quarter of 2010 were $8.1 million, compared to $7.2 million in the third quarter of 2009. The increase was due to expenses to prepare fidaxomicin regulatory filings offset by lower clinical trial expenses. The increase in marketing expenses of $1.7 million, was due to increased market research and pre-launch commercialization efforts related to our fidaxomicin program.
As of September 30, 2010, Optimer held cash, cash equivalents and short-term investments of $58.7 million.
"We have made tremendous progress during the past quarter on our regulatory milestones for fidaxomicin by initiating the rolling submission of our New Drug Application in the U.S. and our Marketing Authorization Application in the EU," said Pedro Lichtinger, Optimer's President and Chief Executive Officer. "We also presented data demonstrating that fidaxomicin is a superior therapy at preventing recurrences compared to vancomycin, particularly in at-risk patients such as those suffering a CDI recurrence and requiring concomitant antibiotics."
Recent Corporate Highlights
   -- The first section of a rolling New Drug Application (NDA) was submitted
      to the U.S. Food and Drug Administration (FDA) for fidaxomicin as a
      treatment for patients with Clostridium difficile infection (CDI) and
      prevention of recurrences.

-- Optimer's Marketing Authorization Application (MAA) for fidaxomicin for
      the treatment of CDI and for the prevention of recurrences of CDI was
      accepted for review by the European Medicines Agency (EMA).

   -- A publication in the peer-reviewed journal, Microbiology, a journal of
      the Society for General Microbiology, highlighted fidaxomicin's narrow
      spectrum of activity and minimal disruption of microflora in patients
      with CDI compared to vancomycin.

   -- Combined data from Optimer's two fidaxomicin Phase 3 trials in patients
      with CDI was presented at the 48th Annual Meeting of the Infectious
      Diseases Society of America (IDSA) in October 2010. Clinical investigator
      Derrick Crook, M.D., presented data showing that CDI patients treated
      with fidaxomicin experienced 47% fewer recurrences than patients treated
      with vancomycin.

-- Five abstracts from Optimer's fidaxomicin Phase 3 study in patients with
      CDI were presented at the 50th Interscience Conference on Antimicrobial
      Agents and Chemotherapy (ICAAC) in September 2010. Data from these
      abstracts highlighted that fidaxomicin was shown to be superior to
      vancomycin in treating CDI recurrences and reducing the chance of another
      relapse.  Other conference presentations highlighted data showing that
      for patients taking concomitant antibiotics, fidaxomicin was a superior
      therapy to vancomycin in preventing recurrence and promoting global cure.

   -- Awarded $244,000 in the form of a cash grant from the Qualifying
      Therapeutic Discovery Project program of the U.S. Treasury Department for
      expenditures related to the fidaxomicin development program.



 
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