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Anadys Pharmaceuticals Nominates ANA598, a Small-Molecule,,Non-Nucleoside Inhibitor of The NS5b Polymerase, as a Candidate for,Clinical Development in Chronic Hepatitis C Virus Infection

SAN DIEGO, June 20, 2007 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. , a biopharmaceutical company committed to the discovery, development and commercialization of novel medicines for the treatment of hepatitis and cancer, announced today that it has nominated ANA598 as a candidate for clinical development as an orally-administered direct antiviral for the treatment of chronic hepatitis C virus (HCV) infection.

"We have identified a small-molecule, non-nucleoside inhibitor of the NS5b polymerase that, based on pre-clinical studies conducted to date, has shown favorable antiviral, metabolic, pharmacokinetic, and preliminary toxicologic properties, and is the culmination of several years of work in our HCV direct antiviral discovery program," said Lawrence C. Fritz, Ph.D., president and chief executive officer of Anadys. "We are now conducting additional pre-clinical studies in anticipation of submitting an Investigational New Drug application (IND) in the second quarter of 2008."

Preclinical Study Results

In a series of in vitro pre-clinical studies ANA598 demonstrated excellent potency against HCV genotype 1 NS5b polymerase and potent activity in HCV replicon assays. The compound also displayed very good in vitro metabolic stability and did not significantly inhibit human CYP enzymes, suggesting a low potential for drug-drug interactions. Extending these in vitro findings, in vivo preclinical studies of ANA598 demonstrated high oral bioavailability and good tolerability. Also, drug levels were sustained in the plasma and in the liver, the principal site of HCV replication.

"The current standard of care is inadequate for many chronic HCV patients, including about half of those with genotype 1 disease," said Steve Worland, Ph.D., president, Pharmaceuticals. "We believe ANA598 possesses favorable characteristics that may enable it to play an important role in future HCV thera
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