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.