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

RG7128 in combination with peginterferon and ribavirin. An additional study in patients infected with HCV genotypes 2 and 3 is being planned to initiate later in 2010.

INFORM-1 Trial

In November 2008, Roche initiated the INFORM-1 trial, a ground-breaking study to investigate the activity of a combination of two oral antiviral molecules in the absence of interferon and ribavirin. The study investigated the combination of Pharmasset's RG7128 with InterMune's RG7227, an HCV protease inhibitor.

In April 2009, Pharmasset, Roche and InterMune reported interim results from this study at the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark. These interim results demonstrated for the first time that the combination of an oral protease inhibitor and an oral nucleoside polymerase inhibitor resulted in significant HCV viral load reduction in patients with HCV over 13 days of dosing of the combination of RG7227 and RG7128 (without peginterferon or ribavirin). No treatment-related serious adverse events, no dose reductions and no discontinuations were reported during the study. Pharmacokinetic analysis confirmed that there were no drug-drug interactions between the compounds.

Roche expects to initiate a Phase 2 program of multiple INFORM studies during the first calendar quarter of 2010. Roche expects these INFORM-2 studies to investigate rapid virologic response (RVR) achieved by twice-daily dosing of RG7128 and RG7227 alone, in combination with peginterferon, in combination with ribavirin, or in combination with both peginterferon and ribavirin. Roche expects to initiate longer term studies evaluating SVR during the first half of 2010.

PSI-7851

PSI-7851 is a pro-drug of a pyrimidine nucleotide analog polymerase inhibitor and is currently in development for the treatment of chronic HCV infection. During March 2009, we initiated a Phase 1 study for PSI-7851. A si
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Related medicine technology :

1. Pharmasset Announces the Continued Enrollment of the Phase 2b Clinical Trial of RG7128 for the Treatment of Hepatitis C
2. Pharmasset to Present at Lazard Capital Markets Healthcare Conference
3. Pharmasset Reports Positive Preliminary Antiviral Data With PSI-7851 for the Treatment of Hepatitis C
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
6. Pharmasset Voluntarily Halts Clinical Studies with Clevudine in Hepatitis B Infected Patients
7. Pharmasset Initiates First Time in Human Study of PSI-7851 for the Treatment of Hepatitis C (HCV)
8. Pharmasset Reports Fiscal Year End 2008 Financial Results
9. Roche, InterMune and Pharmasset Announce Initiation of INFORM-1, the First Dual-Combination Clinical Trial with Oral Antivirals in Hepatitis C
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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