SAN DIEGO, May 7 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today announced its financial results for the first quarter ended March 31, 2009. Optimer reported a net loss for the first quarter of 2009 of $10.9 million, or $0.36 per share which was in line with the Company's expectations. This compares to a net loss for the first quarter of 2008 of $7.9 million, or $0.28 per share. Research and development expenses in the first quarter of 2009 were $8.8 million compared to $6.9 million in the first quarter of 2008. The increase is primarily due to an increase in clinical development and regulatory expenses related to Optimer's fidaxomicin and prulifloxacin programs.
As of March 31, 2009, Optimer held cash, cash equivalents and short-term investments of $62.6 million.
'We are off to a strong start in 2009,' said Michael N. Chang, Ph.D., Optimer's President and CEO. 'We announced plans to prepare a marketing application in Europe based on the results of the first fidaxomicin Phase 3 trial for Clostridium difficile infection. We also reported positive top-line results from the second prulifloxacin Phase 3 trial for the treatment of infectious diarrhea.'
Recent Corporate Highlights
- Announced plans to prepare a Marketing Authorization Application (MAA) for submission with the European Medicines Agency (EMEA) for approval of fidaxomicin as an oral treatment for Clostridium difficile infection (CDI) based on the results from the Company's first Phase 3 fidaxomicin trial.
- Production patent for fidaxomicin issued by the United States Patent and Trademark Office.
- Announced positive results from the second pivotal Phase 3 trial of prulifloxacin for the treatment of infectious diarrhea. The trial achieved the primary endpoint of median Time to Last Unformed Stool (TLUS). Median TLUS for patients treated with prulifloxacin was 32.8 hours which was statistically significant compared to the TLUS for placebo with a p-value of less than 0.0001. Prulifloxacin was generally well tolerated and had a similar safety profile compared to placebo. This is the second of two pivotal Phase 3 clinical studies which will be used to support an NDA submission with the U.S. Food and Drug Administration.
- Raised $32.9 million in gross proceeds through the sale of 3.3 million shares and warrants to purchase 91,533 shares in a registered direct offering in March 2009.
- Appointed Francois-Xavier Frapaise, M.D., as Senior Vice President and Chief Scientific Officer and Peter E. Grebow, Ph.D., Executive Vice President of Worldwide Technical Operations at Cephalon, Inc.