PRINCETON, N.J., Feb. 9 /PRNewswire-FirstCall/ -- Pharmasset, Inc. , a clinical stage pharmaceutical company committed to discovering, developing, and commercializing novel drugs to treat viral infections, today reported financial results and operational highlights for the fiscal quarter ended December 31, 2009.
Revenues were $0.3 million during the quarter ended December 31, 2009 compared to $0.5 million for the quarter ended December 31, 2008 and reflect the amortization of up-front and subsequent collaborative and license payments received from Roche.
Total operating expenses for the quarter ended December 31, 2009 were $13.4 million as compared to $18.1 million for the same period in 2008. The decrease in operating expenses for the quarter ended December 31, 2009 was primarily the result of a decrease in clinical development expenses for clevudine, our discontinued hepatitis B virus (HBV) product candidate.
Recent Highlights:
“Pharmasset continues to make solid progress across all of its clinical programs.” stated Schaefer Price, President and Chief Executive Officer. “2010 is shaping up to be an important year for the company with phase 2a data from our proprietary PSI-7977 program and phase 1 data with our first purine analog, PSI-938, coming in the third quarter. We believe nucleoside/tide analogs have the potential to become the backbone of treatment regimens, not only for genotype 1, but also across a broad range of HCV genotypes. We look forward to reporting data from all our programs throughout 2010.”
-- Roche has initiated a 24 week Phase 2b study with RG7128 in combination with pegylated interferon and ribavirin
-- Roche anticipates completion of enrollment of the RG7128 Phase 2b trial by the end of the first quarter of 2010
-- Roche expects to initiate INFORM-2 in the first quarter of 2010
-- Roche expects to initiate longer duration INFORM studies to investigate SVR in the first half of 2010
-- Roche expects to initiate an RG7128 Phase 2 study in HCV GT2 and GT3 patients in the second half of 2010
-- Pharmasset anticipates reporting topline data from its 28-day Phase 2a study with PSI-7977 in the third quarter of 2010
-- Pharmasset expects to initiate a PSI-7977 Phase 2b program in the second half of 2010
-- Pharmasset expects to submit an IND or foreign regulatory equivalent for PSI-938 in the first quarter of 2010 with topline phase 1 data available in the third quarter of 2010
-- Pharmasset expect to submit an IND or foreign regulatory equivalent for its next purine nucleotide, PSI-879 in the fourth quarter of 2010
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
Forward-Looking Statements
Pharmasset “Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995: Statements in this press release regarding our business that are not historical facts are “forward-looking statements” that involve risks and uncertainties, including, without limitation, the risk that adverse events could cause the cessation or delay of any of the ongoing or planned clinical trials and/or our development of our product candidates, the risk that the results of previously conducted studies involving our product candidates will not be repeated or observed in ongoing or future studies involving our product candidates, the risk that our collaboration with Roche will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of these and other risks and uncertainties, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section of our Annual Report on Form 10-K for the fiscal year ended September 30, 2009 filed with the Securities and Exchange Commission entitled “Risk Factors” and discussions of potential risks and uncertainties in our subsequent filings with the Securities and Exchange Commission.
CONTACT: Richard E. T. Smith, Ph.D., VP, Investor Relations and Corporate
Communications, Pharmasset, +1-609-613-4181, richard.smith@pharmasset.com
Web site: http://www.pharmasset.com/
