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

e voluntarily terminated our phase 3 studies of clevudine after we became aware of a number of spontaneous Serious Adverse Event reports and Events of Special Interest in patients receiving clevudine as prescribed therapy for HBV in South Korea, where the drug is marketed by Bukwang under the trade name Levovir, and in Hong Kong, where clinical studies were being conducted under the sponsorship of Bukwang. Given the number and severity of cases observed in South Korea and Hong Kong, we determined it was in the best interest of patients to voluntarily terminate our registration studies. All patients have now completed the follow-up period and we anticipate concluding activities by the end of the quarter ending December 31, 2009.

"Pharmasset has had a tremendous year on all fronts," said Schaefer Price, Pharmasset's President and CEO. "In collaboration with Roche, we are advancing our first in class nucleoside analog, RG7128, through a phase 2b trial and also exploring the paradigm-changing model of an all oral (interferon sparing) regimen for HCV. We reported best in class results with our second generation nucleotide analog inhibitor, PSI-7851 and anticipate starting phase 2a trials in the first quarter 2010. We believe nucleosides/tides will have an advantage in the marketplace when used with the current standard of care, due to their high RVR rates, pan-genotype activity and high barrier to resistance. In the future, as we move towards oral combinations, we believe our nucleoside/tides have the potential to be used in combination with one another and with other classes of direct acting antivirals."

Financial Results

For the fiscal year ended September 30, 2009 Pharmasset reported revenues of $13.3 million, compared with revenues of $1.9 million for the fiscal year 2008. The receipt of a $10.0 million milestone from Roche for the initiation of the phase 2b study with RG7128 led to higher reported revenues in the fiscal year
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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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