study, transfer of Pharmasset's IND to Roche, timely progress on agreed
development timelines, completion of all required Phase 2b study
preclinical and clinical preparation activities, manufacture of
clinical trial drug supply and agreement on the trial design from the
FDA and foreign regulatory authorities. An update will be provided as
soon as additional information is available.
-- Nominating a lead product candidate from a new series of potent anti
HCV molecules for IND or foreign regulatory equivalent filing and
first-in-human clinical trials.
Pharmasset is a clinical-stage pharmaceutical company committed to discovering, developing and commercializing novel drugs to treat viral infections. Pharmasset's primary focus is on the development of oral therapeutics for the treatment of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV).
Pharmasset is currently developing three product candidates. Clevudine,
for the treatment of chronic HBV infection, is enrolling Phase 3 clinical
trials for registration in North, Central and South America and Europe.
Clevudine is already approved for HBV in South Korea and marketed by
Bukwang Pharmaceuticals in South Korea under the brand name Levovir. R7128,
an oral treatment for chronic HCV infection, is in a 4-week Phase 1
clinical trial in combination with Pegasys(R) plus Copegus(R) through a
strategic collaboration with Roche. Racivir, which is being developed for
the treatment of HIV in combination with other approved HIV drugs, has
completed a Phase 2 clinical trial.
Pegasys(R) and Copegus(R) are registered trademarks of Roche.
Alan Roemer, Vice President
Investor Relations & Corporate Communications
|SOURCE Pharmasset, Inc.|
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