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Pharmasset Reports Fiscal Year End 2009 Financial Results
Date:11/25/2009

PRINCETON, N.J., Nov. 25 /PRNewswire-FirstCall/ -- Pharmasset, Inc. (Nasdaq: VRUS), a clinical stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections, reported financial results for the fiscal year ended September 30, 2009. At September 30, 2009 Pharmasset held $58.4 million in cash, cash equivalents and short term investments.

Pipeline Update and 2009 Highlights

RG7128

Phase 2b Trial

In late November 2009, an independent Data Monitoring Committee (DMC) reviewed the safety and efficacy data from the first approximately 100 patients in cohort 1 and concluded that based on these data the remaining approximately 300 patients can be safely enrolled in the phase 2b study. The DMC reviewed any potential drug discontinuations, incidence and details of adverse events, and selected laboratory assessments. No safety events in the DMC review were considered significantly different from those expected from HCV patients taking peginterferon and ribavirin treatment. The DMC did not recommend modification of dose or duration of any RG7128 dosing regimens. Enrollment of these patients pre-screened for this cohort in the fourth quarter of 2009 has begun and is expected to be complete by the end of the first quarter of 2010.

This phase 2b trial is anticipated to enroll approximately 400 treatment-naive, genotype-1 or genotype-4 HCV-infected patients. The five arm trial, initiated in April 2009, is evaluating the dose and duration of RG7128 in combination with peginterferon plus ribavirin. The primary efficacy endpoint of the trial is the proportion of patients that achieve a sustained virologic response (SVR).

In the first quarter 2010, Roche plans to initiate longer duration, phase 2b studies with
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1. Pharmasset Announces the Continued Enrollment of the Phase 2b Clinical Trial of RG7128 for the Treatment of Hepatitis C
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4. Pharmasset to Present at Goldman Sachs and Needham Healthcare Conferences
5. Roche and Pharmasset Initiate Phase IIb Clinical Trial of R7128, Most Advanced Nucleoside Polymerase Inhibitor in Development for Chronic Hepatitis C
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10. Richard E.T. Smith, Ph.D. Joins Pharmasset as Vice President of Investor Relations and Corporate Communications
11. Pharmasset to Present at the UBS Global Life Sciences Conference on Wednesday, September 24th
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