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Patient Enrollment Completed for Phase 2 Trial of ANA380 in Patients With Lamivudine-Resistant Hepatitis B Virus

SAN DIEGO and SEOUL, Sept. 14 /PRNewswire-FirstCall/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS - News) and LG Life Sciences, Ltd. (KOSPI: 68870) today announced that the first two cohorts have completed enrollment in a Phase II clinical trial of ANA380 (LB80380) in patients with lamivudine- resistant hepatitis B virus (HBV) infection. ANA380 is an antiviral compound that has exhibited potent activity against HBV, including in vitro activity against HBV strains resistant to lamivudine, the current standard of treatment for patients infected with HBV. Previously reported results from a completed Phase I/IIa clinical trial demonstrated that oral administration of ANA380 over four weeks was both well tolerated and reduced HBV viral load by 99.9 percent in the chronic HBV infected patients treated in the study.

The current Phase II trial aims to assess the safety and antiviral activity of ANA380 in chronically infected HBV patients who are clinically and genetically resistant to lamivudine. Genetically altered strains of HBV that are resistant to lamivudine can be detected in 14 to 32 percent of all patients after one year of lamivudine treatment. This proportion rises with the duration of treatment, increasing to 66 percent after four years. The current study design calls for enrollment of three cohorts totaling 36 patients in an open label, multi-center, sequential group dose escalation study, evaluating ANA380 for a period of twelve weeks. Eligible patients have been treated with lamivudine therapy and documented to have genetically encoded lamivudine resistance.

"Direct antiviral therapies have dramatically enhanced the treatment of HBV due to their improved side effect profile and more convenient oral administration," said Kleanthis G. Xanthopoulos, Ph.D., President and Chief Executive Officer of Anadys. "Future improvements in therapy will depend on increased antiviral potencies at well-tolerated doses, and on a resistance profile that suppresses the emergence of new strains while providing treatment for lamivudine-resistant virus. Our goal is to develop a direct antiviral that combines the potency, tolerability and activity against resistant virus to confer these benefits to patients."

"We expect that LB80380 (ANA380) will be a best-in-class drug in HBV treatment with high effectiveness against lamivudine resistant strains. I believe we can accomplish this goal through our collaboration with Anadys," said Heung-Joon Yang, Ph.D., President and Chief Executive Officer of LG Life Sciences.

About ANA380 (LB80380)
ANA380 (LB80380) is an oral prodrug of ANA317 (LB80317), a nucleotide analog for the treatment of chronic HBV infection. Anadys and LG Life Sciences are jointly developing ANA380 on a global basis. In April, Anadys acquired an exclusive license from LG Life Sciences for the commercialization of ANA380 in North America, Europe, Japan and the rest of the world other than China, Korea, India and countries in Southeast Asia. In May, the companies announced summary results of a Phase I/IIa double-blind, randomized, placebo- controlled dose escalation clinical trial of ANA380, which demonstrated that oral administration of ANA380 over four weeks was both well tolerated and reduced HBV viral load by more than 3 log10 units, or 99.9 percent, in the chronic HBV infected patients treated in the study.

About Hepatitis B
Hepatitis B is a growing global health problem that can cause both acute and chronic viral infections. Approximately 350 million people are chronically infected and have become carriers of HBV. Of those, approximately 15 to 40 percent will develop serious consequences of infection during their lifetime, including loss of liver function, cirrhosis, and liver cancer. According to the World Health Organization, approximately 1 million people die each year from chronic HBV or related conditions. The current annual market for HBV therapy is approximately $300 million and is expected to grow to more than $1 billion by 2009.

Source: Anadys Pharmaceuticals, Inc. and LG Life Sciences

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