Optimer third quarter net loss increases to $11.8 million

Nov 2 2010

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) 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.

SOURCE Optimer Pharmaceuticals, Inc.