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Pharmasset Reports Fiscal Year End 2008 Financial Results
Date:12/11/2008

aive and treatment experienced HCV patients. In addition, the company was issued a US patent covering R7128.

Results from the 28 day study were presented at the recent American Association for the Study of Liver Diseases (AASLD) that demonstrated that R7128 combined with the standard of care (pegylated interferon and ribavirin) provided significant short-term antiviral activity with safety and tolerability comparable to the standard of care alone. Results from the 500mg BID, 1000mg BID, 1500mg BID dose cohorts in 81 treatment-naive patients chronically infected with HCV genotype 1 indicated rapid virological response (RVR) rates of 30% (6 of 20), 88% (22 of 25) and 85% (17 of 20), respectively compared to 19% (3 of 16) in the control group. Further results in genotype 2 and 3, non responder patients treated with 1500mg BID generated RVR rate of 90% (18 of 20) versus 60% (3 of 5) in the control group. Across all studies, safety and tolerability of R7128 combined with peginterferon and ribavirin was similar to the standard of care alone.

Based on these results and other data, Pharmasset's partner, Roche, plans to move R7128 into a phase 2b trial in HCV-1 infected patients in the first calendar quarter of 2009. Pharmasset has submitted the necessary briefing documents to the FDA and both Roche and Pharmasset plan to meet with the agency in early January to review the preclinical and clinical data and to discuss the phase 2b design and future studies.

In addition to planning for phase 2b, Roche initiated the INFORM-1 trial, a potentially ground-breaking study to investigate the activity of a combination of two oral antiviral molecules in the absence of interferon. The study began in November 2008, and will investigate the combination of Pharmasset's R7128 with InterMune's R7227, a protease inhibitor. The first cohort of patients has been enrolled and preliminary results from this study are expected in fi
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SOURCE Pharmasset, Inc.
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3. Pharmasset to Present at the UBS Global Life Sciences Conference on Wednesday, September 24th
4. Pharmasset Reports Financial Results for Quarter Ended June 30, 2008
5. Pharmasset Reports Preliminary Results of a 4-week Combination Study of R7128 for the Treatment of Chronic Hepatitis C
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