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ANA598 Demonstrates Potent Antiviral Activity in an Early Clinical Study in HCV-Infected Patients
Date:1/8/2009

at this first dose tested in the Phase Ib study," commented James Freddo, M.D., Anadys' Senior Vice President, Drug Development and Chief Medical Officer. "We believe this early data continues to position ANA598 as a leading non-nucleoside polymerase inhibitor in development for the treatment of HCV and we look forward to investigating ANA598 in longer-term studies in combination with current standard of care."

"The clinical and preclinical profile of ANA598 observed to date is very impressive," said Steve Worland, Ph.D., President and CEO of Anadys. "The magnitude of viral load drop reported today for ANA598 is greater than has been reported for any other non-nucleoside HCV inhibitor in a monotherapy study. Furthermore, the rate of initial viral load decline, believed to be associated with direct inhibition of viral replication, is greater than has been reported previously for all classes of HCV polymerase inhibitors, including nucleosides. This demonstrated antiviral potency holds significant promise for the future use of ANA598 in combination with other anti-HCV agents."

About ANA598

Anadys retains worldwide rights to ANA598, which was fully discovered at the Company. Preclinical evaluation of ANA598 was completed in the first quarter of 2008, leading to submission of an Investigational New Drug Application (IND) to the U.S. Food and Drug Administration (FDA), subsequent allowance of the IND by the FDA and initiation of clinical investigation in the second quarter of 2008. In December 2008, Anadys announced that the FDA granted fast track designation to ANA598 for the treatment of chronic HCV.

In October 2008, Anadys initiated patient dosing in the Phase Ib study of ANA598 in HCV patients. In the double-blind, randomized placebo-controlled Phase Ib study, treatment-naive genotype 1a and 1b patients are to receive oral capsules of ANA598 over three days at doses of 200 mg bid (twice
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SOURCE Anadys Pharmaceuticals, Inc.
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1. Anadys Pharmaceuticals Presents Preclinical Results on ANA598, a Non-Nucleoside Inhibitor of the NS5B Polymerase, at the 14th International Symposium on Hepatitis C Virus and Related Viruses
2. Anadys Pharmaceuticals Announces Positive Results for ANA598 in Animal Model of Chronic Hepatitis C Virus Infection
3. Anadys Pharmaceuticals Presents Data on ANA598, a Non-Nucleoside Inhibitor of the HCV Polymerase, at the 21st International Conference on Antiviral Research
4. Anadys Pharmaceuticals Initiates Phase I Clinical Trial of ANA598
5. Anadys Pharmaceuticals Announces Successful Outcome of ANA598 Healthy Volunteer Study and Finalization of Study Design for Phase Ib Trial in HCV Patients
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