Pharmasset Voluntarily Halts Clinical Studies with Clevudine in Hepatitis B Infecte...(to continue to collect safety data and t...),Health

Date:4/20/2009

to continue to collect safety data and to monitor patients after discontinuation of clevudine in the QUASH studies, but does not plan to submit study results to regulators as pivotal studies. Clevudine was licensed from Bukwang Pharmaceuticals of South Korea, where the drug is marketed under the trade name Levovir.

"While we are obviously disappointed with the outcome, we believe the decision to stop dosing is an appropriate one," stated Schaefer Price, President and Chief Executive Officer. "Our full energy and resources in research and development will now be focused on our promising HCV pipeline. Our partner Roche will shortly initiate dosing in a phase 2b trial with R7128, and will report interim data from the INFORM-1 trial at the upcoming EASL meeting. Pharmasset's unpartnered second generation HCV nucleoside, PSI-7851, is progressing well in a phase I trial and we expect to report the first antiviral data in the second half of 2009. In addition, we are collecting preclinical data from our research efforts to select a purine nucleos(t)ide for clinical development."

Phase III QUASH Studies

The QUASH studies are international, multi-center, randomized, double-blind clinical trials of 30mg once daily clevudine compared with 10mg once daily adefovir for 96 weeks in patients with chronic hepatitis due to infection with e-antigen positive hepatitis B virus (QUASH 305) or e-antigen positive (QUASH 306) who have never been treated with drugs of the nucleoside class. The primary objective of the studies are to assess the effect of clevudine on reducing levels of virus in the blood and normalization of liver function at 48 weeks after initiating therapy.

Conference Call and Webcast

Members of Pharmasset's management team will host a conference call today, Monday, April 20, 2009, at 8:00 a.m. ET to discuss the decision to terminate the studies. Investors may listen to the webcast of the c
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SOURCE Pharmasset, Inc. Copyright©2009 PR Newswire. All rights reserved

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