Anadys和LG公布ANA380的I/II数据

zasxz

Anadys Pharmaceuticals and LG Life Sciences Report Results From Completed
Phase I/II Clinical Trial of ANA380 (LB80380) for Hepatitis B
New Data Presented at AASLD Annual Meeting in Boston Show Safety and Viral
Load Reduction in Treated HBV Patients
SAN DIEGO, and SEOUL, Korea, Nov 1, 2004 /PRNewswire-FirstCall via
COMTEX/ -- Anadys Pharmaceuticals, Inc. (Nasdaq: ANDS) and LG Life Sciences,
Ltd. (KOSPI: 68870) reported results from a recently completed Phase I/II
clinical trial of ANA380 (LB80380), an orally available compound for the
treatment of hepatitis B virus (HBV) infection, at the American Association
for the Study of Liver Diseases (AASLD) Annual Meeting yesterday in Boston.

In a presentation entitled "hase I/II Double-Blind, Randomized,
Placebo-Controlled Study of the Novel Anti-HBV Agent LB80380/ANA380 in
Patients with Chronic HBV Infection," Dr. Man-Fung Yuen of the University of
Hong Kong reported that ANA380 reduced viral load by an average of 3.4 log10
units, or more than 99.9 percent, in the chronically HBV-infected patients
receiving doses of 60 mg or more for four weeks. The data also demonstrated
that oral administration of ANA380 for 28 days was well tolerated and safe
at all doses studied, although definitive conclusions regarding product
safety cannot be made until the results of future clinical trials of longer
duration in more patients are known.

The Phase I/II clinical trial was designed to assess the safety,
pharmacokinetics and antiviral activity of ANA380 in patients chronically
infected with HBV. The study was a double-blind, randomized,
placebo-controlled, multiple ascending dose evaluation of ANA380 dosed once
daily for 28 days at 30 mg, 60 mg, 120 mg and 240 mg. Cohorts of seven
patients were randomized to treatment or placebo in a ratio of six to one at
each dose level, and safety was established at each dose prior to dose
escalation. Viral load reduction was greater for doses of 60 mg and above
than for the 30 mg dose, with individual viral load reductions ranging from
2 to 6 log10 units in the treated patients.

Patients participating in the study were monitored for a period of 12 weeks
after completing the dosing phase. Viral load in all treated patients
returned to pre-treatment levels during follow-up, confirming that the viral
load declines were associated with ANA380 administration.

"This compound has demonstrated substantial anti-HBV effects at all doses
studied," said Dr. Yuen. "The excellent tolerability and potent activity of
ANA380, which includes in vitro activity against HBV strains resistant to
lamivudine, encourages additional clinical investigation."

Anadys and LG Life Sciences recently announced that the first two cohorts
have completed enrollment in a new clinical trial to assess the safety and
antiviral activity of ANA380 in patients with lamivudine-resistant HBV
infection. Prof. Ching-Lung Lai of the University of Hong Kong is scheduled
to review several investigational compounds as part of his presentation at
the Therapies for Viral Hepatitis Workshop in Boston on November 3, 2004,
including preliminary data from this ongoing study that appear to support
the observation that ANA380 exhibits activity against lamivudine-resistant
strains.

About ANA380 (LB80380)

ANA380 (LB80380) is an oral prodrug of ANA317 (LB80317), a nucleotide analog
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. 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.

About Hepatitis B

Hepatitis B virus infections are 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.
Approximately 15 to 40 percent of these patients will develop serious
consequences of infection during their lifetime, including loss of liver
function, cirrhosis, and liver cancer. According to World Health
Organization, around 1 million people die each year from chronic HBV or
related conditions.

About Anadys

Anadys Pharmaceuticals, Inc. (www.anadyspharma.com) is a biopharmaceutical
company committed to advancing patient care by discovering, developing and
commercializing novel small molecule, anti-infective medicines for the
treatment of hepatitis C virus (HCV), hepatitis B virus (HBV) and bacterial
infections. Anadys is advancing its anti-infective portfolio through the
development of its two clinical programs, the isatoribine family of
compounds including the oral prodrug ANA975 for the treatment of HCV, and
ANA380 for the treatment of HBV. In addition, Anadys' anti-infective
therapeutic platform is designed to advance a strong and continual pipeline
of drug candidates into the clinic.

About LG Life Sciences

LG Life Sciences, Ltd (LGLS, www.lgls.co.kr), an LG affiliate, is an R&D
based biopharmaceutical company based in Seoul, Korea that discovers,
develops and commercializes new medicines in anti-infectives, cancer,
diabetes and other chronic diseases. In year 2003, LGLS had approximately
$150 million in revenue and 1000 employees. LGLS aims to become a leading
life science company by utilizing its R&D capabilities to develop global
brand products such as Factive(R) (gemifloxacin) and by expanding its
marketing presence in key Asian markets.

Statements in this press release that are not strictly historical in nature
constitute "forward-looking statements." Such statements include, but are
not limited to, the effects of administration of ANA380 (LB80380) in HBV
infected patients, including ANA380 (LB80380)'s safety profile, potency, and
activity against HBV strains resistant to lamivudine, as well as
expectations regarding further clinical trials of ANA380 (LB80380). Such
forward-looking statements involve known and unknown risks, uncertainties
and other factors which may cause the actual results of LGLS and/or Anadys
Pharmaceuticals to be materially different from historical results or from
any results expressed or implied by such forward-looking statements. In
particular, the results of initial clinical trials may not be predictive of
future results, and Anadys and LGLS cannot provide any assurances that
ANA380 (LB80380) will have favorable results in later clinical trials, or
that ANA380 (LB80380) 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 successfully develop and market products,
difficulties or delays in its clinical trials, difficulties or delays in
manufacturing its clinical trials materials, the scope and validity of
patent protection for its products, regulatory developments involving future
products and its ability to obtain additional funding to support its
operations. These and other factors that may cause actual results to differ
are more fully discussed in the "Risk Factors" section of Anadys' Form 10-Q
for the quarter ended June 30, 2004. 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.; LG Life Sciences, Ltd.

Michael Kamdar, Sr. VP, Corporate Development and Finance, +1-858-530-3667,
[email protected], or Pete De Spain, Manager, Corporate Communications,
+1-858-530-3653, [email protected], both of Anadys Pharmaceuticals,
Inc.; or In-Chull Kim, Ph.D., VP, Business Development, +82-2-3773-7009,
[email protected], or Jay J.H. Kwon, Head of IR, +82-2-3773-3358,
[email protected], both of LG Life Sciences, Ltd.

http://www.lgls.co.kr