Anadys' Setrobuvir Named One of Windhover's Top 10 Most Interesting Infectious Disease Projects to Watch

SAN DIEGO, Sept. 7, 2011 /PRNewswire/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) announced today that setrobuvir (ANA598), the Company's direct-acting antiviral (DAA) currently in Phase IIb development for hepatitis C, has been selected as one of Windhover's Top 10 Most Interesting Infectious Disease Projects to Watch.

"We are honored to have setrobuvir identified as a Top 10 infectious disease project," said Kevin Eastwood, Anadys' Senior Vice President of Corporate Development.  "This recognition reflects the scarcity of later-stage development assets in hepatitis C and the strong desire on the part of companies to assemble combination regimens to treat this disease.  With a readout next month of the 12-week data from an ongoing Phase IIb trial, Anadys has positioned setrobuvir as a well-characterized agent, ideally suited to complement other DAAs as the treatment of HCV evolves to a DAA combination treatment paradigm."

Setrobuvir was selected by independent experts at Windhover Information and Herndon Company.  The selection criteria included the breadth of business development opportunities, the current size and growth of the targeted market, and the strength of science underlying the program.  Many assets selected in this manner by Windhover in prior years have been the focus of subsequent attractive business transactions.

As a selected company, Anadys will present at Windhover's 6th Annual Therapeutic Area Partnerships conference November 30-December 2, 2011 in Boston, MA.  Windhover is a leading provider of business information to senior executives in the pharmaceutical, biotechnology, and medical device industries.  

About setrobuvir in HCV

Setrobuvir, the Company's wholly-owned direct-acting antiviral or DAA, is an HCV RNA polymerase inhibitor that belongs to a chemical class referred to as non-nucleosides.  Setrobuvir has a well-characterized safety database in which more than 350 subjects have received the agent to date.  Anadys was granted U.S. Patent No. 7,939,524, which recognizes the Company's intellectual property rights to the composition of matter and methods of use for setrobuvir and related compounds. Setrobuvir has also received Fast Track Status from the FDA for the treatment of chronic hepatitis C or HCV.

Setrobuvir is currently in Phase IIb testing in combination with pegylated interferon and ribavirin for the treatment of HCV.  The primary endpoint of the study is Sustained Virological Response 24 weeks after patients complete treatment, known as SVR24.  All patients are scheduled to complete their 12 week visit by the end of the third quarter of 2011 and the Company expects to release preliminary 12 week data shortly thereafter.  Antiviral response data through 24 weeks are expected around year-end.  

In the second quarter this year, Anadys announced a cross-company clinical trial agreement with a large, commercial-stage biopharmaceutical company to study setrobuvir in combination with another DAA in healthy volunteers.

About Anadys

Anadys Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to improving patient care by developing novel medicines for the treatment of hepatitis C.  The Company believes hepatitis C represents a large unmet medical need in which meaningful improvements in treatment outcomes may be attainable with the introduction of new medicines.  Anadys is conducting a Phase IIb study of setrobuvir (ANA598), the Company's DAA, added to current standard of care for the treatment of hepatitis C.  The Company is  also developing ANA773, the Company's oral, small-molecule inducer of endogenous interferons that acts via the Toll like receptor 7, or TLR7, pathway in hepatitis C and plans to initiate a Phase IIa study shortly.

Safe Harbor Statement

Statements in this press release that are not strictly historical in nature constitute "forward-looking statements."  Such statements include, but are not limited to, references to Anadys' expectations regarding data timelines from the setrobuvir Phase IIb study and its belief that setrobuvir is positioned as a well-characterized agent, ideally suited to complement other DAAs as the treatment of HCV evolves to a DAA combination treatment paradigm.  Such forward-looking statements involve known and unknown risks, uncertainties and other factors, which may cause Anadys' actual results to be materially different from historical results or from any results expressed or implied by such forward-looking statements.  For example, the results of preclinical and early clinical studies may not be predictive of future results, and Anadys cannot provide any assurances that setrobuvir or ANA773 will not have unforeseen safety issues, will have favorable results in ongoing or future clinical trials or will receive regulatory approval. In addition, Anadys' results may be affected by competition from other biotechnology and pharmaceutical companies, its effectiveness at managing its financial resources, its ability to enter into transactions around its product candidates, its ability to successfully develop and market products, difficulties or delays in its non-clinical studies or clinical trials, difficulties or delays in manufacturing its clinical trials materials, the scope and validity of patent protection for its products, regulatory developments and its ability to obtain additional funding to support its operations.  Risk factors that may cause actual results to differ are more fully discussed in Anadys' SEC filings, including Anadys' Form 10-Q for the quarter ended June 30, 2011.  All forward-looking statements are qualified in their entirety by this cautionary statement.  Anadys is providing this information as of this date and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

SOURCE Anadys Pharmaceuticals, Inc.