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

eks of PSI-7977 400 mg QD with PEG/RBV, 43/44, or 98% (91% ITT), achieved SVR12, confirming selection of the PSI-7977 400 mg QD dose for Phase3 studies.  

At the company's investor event on November 6th, interim data from the open-label ATOMIC trial provided preliminary confirmation of the 12-week duration of PSI-7977 for all HCV genotypes, with an initial 15 of 15 subjects with HCV GT1 remaining HCV RNA "undetectable" at the SVR4 timepoint.  Interferon-free assessments of PSI-7977/RBV in HCV GT1 are ongoing in ELECTRON and QUANTUM.  

Collaborative Trials with PSI-7977In the third calendar quarter, Bristol-Myers Squibb completed enrollment of a collaborative trial of 24 weeks of PSI-7977 with the BMS NS5a inhibitor, daclatasvir (with and without ribavirin) in patients with HCV GT1, GT2 or GT3. Recently, Bristol-Myers Squibb announced that four 12-week cohorts of the combination had been added in patients with HCV GT1 who: 1) are naive to prior therapy, or 2) had previously failed an HCV protease inhibitor with Peg-IFN/RBV.

In the fourth calendar quarter of 2011, Tibotec started screening patients in a collaborative study of their HCV protease inhibitor, TMC435, in combination with PSI-7977, in patients with HCV GT1 with a prior "null" response to prior Peg-IFN/RBV therapy.  All subjects will be treated for 12 or 24 weeks, and will be randomized to therapies with or without ribavirin.

A collaborative study with the National Institutes of Health initiated in the third calendar quarter of 2011, evaluating 24 weeks of PSI-7977 with or without ribavirin in patients with HCV GT1

PSI-938In September 2011, QUANTUM was initiated, a phase 2b study of Pharmasset's purine, PSI-938, administered as monotherapy and in combination with PSI-7977 (with and without ribavirin). Two treatment arms of PSI-7977 and RBV without PSI-938 are also included. All combinations will be evaluated for 12 and 24 weeks. 
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