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Pharmasset Reports Fiscal Year End 2011 Financial Results
Date:11/14/2011

PRINCETON, N.J., Nov. 14, 2011 /PRNewswire/ -- Pharmasset, Inc. (Nasdaq: VRUS), 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 year ended September 30, 2011. At fiscal year end Pharmasset held $166.5 million in cash and cash equivalents and used $21.7 million of our cash and cash equivalents during the fourth quarter of fiscal 2011.

Pipeline Update and 2011 HighlightsPSI-7977The recently-announced registrational program for PSI-7977, the once-a-day nucleotide analog for hepatitis C virus (HCV) infection, is the first to pursue an interferon-free, all-oral regimen, and the first to include patients with all HCV genotypes (GT). The three core studies will evaluate the all-oral two-drug combination of PSI-7977 and ribavirin (RBV) administered for 12 weeks.

The first trial, FISSION, is a pivotal study of PSI-7977 with RBV for 12 weeks in approximately 500 patients with HCV GT2 or GT3. FISSION is designed to demonstrate the superiority of PSI-7977/RBV over the current standard-of-care for HCV GT2/3, pegylated interferon (Peg-IFN) and ribavirin for 24 weeks. The second Phase 3 trial, POSITRON, is planned to begin in early 2012. POSITRON will enroll approximately 225 patients with HCV GT2 or GT3 who cannot take interferon, thus supporting a placebo comparator arm for this trial. During the first quarter of 2012, data from ongoing open-label assessments of PSI-7977/RBV in subjects with HCV GT1 in ELECTRON and QUANTUM will be reviewed and incorporated into the final design for the third registrational trial, NEUTRINO. This trial will also investigate a 12-week regimen of PSI-7977/RBV versus a placebo comparator, and will enroll approximately 280 patients with HCV regardless of viral genotype, inclu
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