PRINCETON, N.J., Aug. 10 /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 June 30, 2009.
Revenues were $10.5 million during the quarter ended June 30, 2009 compared to $0.5 million for the quarter ended June 30, 2008 and reflect the receipt of a $10.0 million milestone payment from Roche, following the initiation of the phase 2b study with RG7128, and the amortization of up-front and subsequent collaborative and license payments received from Roche.
Total operating expenses for the quarter ended June 30, 2009 were $16.7 million as compared to $15.0 million for the same period in 2008. The increase in operating expenses for the quarter ended June 30, 2009 was primarily the result of an increase in clinical development expenses for PSI-7851, our second generation hepatitis C virus (HCV) product candidate, and preclinical development expenses for our purine series of compounds. Partially offsetting these increases were reduced expenses for our clevudine Phase 3 registration studies that were terminated during the quarter.
Recent Highlights:
-- On July 7, 2009, Pharmasset announced the nomination of PSI-938 as a development candidate from two series of purine analogs for the treatment of chronic HCV infection. PSI-938 is a proprietary nucleotide analog polymerase inhibitor of HCV that is being advanced into studies required for submission of an Investigational New Drug (IND) application with the FDA or equivalent foreign regulatory application;
-- On April 25, 2009, Pharmasset announced positive results from the INFORM-1 study of the combination of RG7128 and another oral antiviral medicine, in the absence of interferon and ribavirin, for the treatment of HCV patients; and
"Pharmasset had another productive quarter, as we continued to make progress on all three of the nucleoside/tide analogs comprising our current portfolio of HCV product candidates", stated Schaefer Price, President and Chief Executive Officer. "We believe HCV therapy is evolving toward combinations of oral antiviral drugs. While we believe combinations of a nucleoside/tide with a drug having a different mechanism of action are very promising, we also believe combinations of two complementary nucleoside/tides have the potential for both a superior resistance profile and activity across all genotypes based on the in vitro evidence to date."
-- Provide an update on safety from the first 100 patients in the Phase 2b trial of RG7128 in second half of 2009;
-- Report additional phase 1 antiviral data with PSI-7851 in second half of 2009;
-- Report further data from the INFORM-1 trial in fourth quarter of 2009.
Pegasys((R)) and Copegus((R) )are registered trademarks of Roche.
SOURCE Pharmasset, Inc.
CONTACT: Richard E. T. Smith, Ph.D., VP, Investor Relations and Corporate
Communications, +1-609-613-4181, richard.smith@pharmasset.com
Web site: http://www.pharmasset.com/
