Company provides update on product development programs
Nov. 3, 2009 (PR Newswire) -- SAN DIEGO, Nov. 3 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) today reported financial results for the third quarter ended September 30, 2009. Optimer reported a net loss for the third quarter of 2009 of $9.4 million, or $0.28 per share, which was in line with the Company's expectations. This compares to a net loss for the third quarter of 2008 of $9.2 million, or $0.31 per share. Research and development expenses in the third quarter of 2009 were $7.2 million, compared to $7.9 million in the third quarter of 2008. The decrease was primarily due to the completion of the Pruvel(TM)(prulifloxacin) Phase 3 trials. The decrease was partially offset by an increase in expenses to prepare regulatory filings related to fidaxomicin and Pruvel.
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As of September 30, 2009, Optimer held cash, cash equivalents and short-term investments of $42.5 million.
"It's been another strong quarter for Optimer, marked by significant interaction with the medical community on the Phase 3 data profiling the characteristics and attributes of fidaxomicin and Pruvel," said Michael N. Chang, Ph.D., Optimer's President and Chief Executive Officer. "Additional data from the North American Phase 3 fidaxomicin trial were recently presented at the ICAAC and IDSA medical conferences further demonstrating why we believe fidaxomicin has the potential to be the optimal treatment for CDI."
Corporate Updates
-- Following discussions with the FDA, Optimer has elevated global cure to
a secondary endpoint from an exploratory endpoint in the second Phase 3
fidaxomicin trial. Given the significant problem with recurrence in CDI
patients, Optimer believes that the medical community is placing greater
emphasis on global cure, defined as a cure without a recurrence. The
global cure rate of fidaxomicin versus vancomycin was 77.7% versus 67.1%
(p=0.006) in Optimer's North American Phase 3 trial.
-- Optimer expects to complete enrollment of the second Phase 3 trial of
fidaxomicin in 2009, and anticipates reporting top-line data in the
first quarter of 2010. The Company continues to engage in partnering
discussions regarding fidaxomicin to maximize its value.
-- Optimer recently entered into a number of transactions involving OBI,
the Company's Taiwan subsidiary, to provide OBI with funding for the
development of two of Optimer's early-stage, non-core programs, OPT-88
and OPT-822/821, and to allow Optimer to focus on its late-stage
anti-infective programs, fidaxomicin and Pruvel. Pursuant to these
transactions, Optimer assigned to OBI certain patent rights, information
and know-how related to OPT-88, a preclinical product candidate for the
treatment of osteoarthritis, and OPT-822/821, a carbohydrate-based
cancer immunotherapy product candidate. Optimer is eligible to receive
up to $10 million in milestone payments and single-digit royalties on
net sales for any product developed and commercialized under the
programs. To provide capital for OBI's development of OPT-88 and
OPT-822/821, Optimer and a group of new investors purchased
approximately $3.7 million and $2.5 million, respectively, in new OBI
common shares. Also in connection with the transactions, Optimer sold
forty percent of its pre-transaction OBI common shares to the new
investors for proceeds of $2.1 million.