- HCV Collaboration to Continue With Potential New Development Candidates -
FOSTER CITY, Calif. and NEW HAVEN, Conn., Feb. 8 /PRNewswire-FirstCall/
-- Gilead Sciences (Nasdaq: GILD) and Achillion Pharmaceuticals (Nasdaq:
ACHN) today announced their decision to discontinue the development of GS
9132, also known as ACH-806, for the treatment of hepatitis C viral (HCV)
infection, based upon preliminary data from a Phase 1b/2 trial. Preliminary
data from the first cohort of the Phase 1b/2 trial indicated that the
compound demonstrated antiviral activity, validating the novel anti-HCV
mechanism that involves inhibition of a viral protein called NS4A, which
binds to a portion of HCV protease. However, based on small elevations of
serum creatinine (a marker of kidney function), which were reversible after
completion of dosing, Gilead and Achillion have elected to shift their
focus to the evaluation of other NS4A antagonists developed by Achillion to
identify a lead candidate for development.
"GS 9132 has demonstrated antiviral activity in patients with genotype
1 HCV infection. Even at the low dose studied, we observed significant
reductions in hepatitis C viral load. This validation of the mechanism of
action is encouraging as we evaluate next-generation compounds for
potential development," said Norbert Bischofberger, Ph.D., Executive Vice
President, Research and Development, Gilead Sciences. "We look forward to
our continued collaboration with Achillion."
"As part of our collaboration with Gilead, we have worked diligently to
generate a number of compounds belonging to a different chemical class that
demonstrate the same mechanism of action and similar in vitro potency to GS
9132. One of the most promising of these has been designated by Achillion
as ACH-1095, and we are evaluating this and other compounds in preclinical
studies to determine if one has the right profile to advance into clinical
development," stated Milind Deshpande, Ph.D., Chief Scientific Officer of
Achillion. "Our goal is to develop a novel, efficacious and safe
therapeutic for HCV, and the data indicate that candidates with this
mechanism may be complementary to both protease and polymerase inhibitors,
as well as interferon therapies."
The GS 9132 Phase 1b/2 trial was a double-blind, randomized,
placebo-controlled dose-escalation study initiated in 2006. The goal of the
trial was to evaluate the antiviral activity, safety and pharmacokinetics
of GS 9132 in patients with HCV genotype 1 infection. Gilead and Achillion
are continuing to analyze the data from this trial. Following completion of
analysis, these data will be submitted for possible presentation at an
upcoming scientific conference.
In November 2004, Gilead and Achillion established an agreement
granting Gilead worldwide rights for the research, development and
commercialization of certain Achillion compounds for the treatment of
hepatitis C. GS 9132 and ACH-1095 are small molecule inhibitors of HCV
replication, which target a viral protein called NS4A. NS4A antagonism is a
novel mechanism of action for HCV treatment distinct from that of protease
or polymerase inhibitors currently in development. GS 9132 and ACH-1095
were discovered by Achillion, and the company completed the initial work
necessary to move GS 9132 into clinical development.
Conference Call Access Information
Achillion will hold a conference call and simultaneous webcast today,
Thursday, February 8, 2007 at 4:45 p.m. Eastern time. To participate in the
conference call, please dial (877) 707-9632 in the U.S. or (785) 830-7982
for international callers. A live audio webcast of the call will be
accessible at http://www.achillion.com, under the Investor Relations
section of the website. Please connect to Achillion's website several
minutes prior to the start of the broadcast to ensure adequate time for any
software download that may be necessary.
A replay of the webcast will be available on http://www.achillion.com
through March 8, 2007. Alternatively, the replay will be available starting
at 8:00 p.m. Eastern time today through 11:59 p.m. eastern time Thursday,
February 15, 2007 by dialing (888) 203-1112 or (719) 457-0820. The replay
passcode is 4731223.
About Hepatitis C
Hepatitis C is a viral liver disease, caused by infection with the
hepatitis C virus. Globally, it is estimated that more than 170 million
people have chronic hepatitis C, including about three million in the
United States. Chronic hepatitis C is a leading cause of cirrhosis, a
common cause of hepatocellular carcinoma, and is the leading cause of liver
transplantation in the United States.
About Gilead Sciences
Gilead Sciences is a biopharmaceutical company that discovers, develops
and commercializes innovative therapeutics in areas of unmet medical need.
The company's mission is to advance the care of patients suffering from
life-threatening diseases worldwide. Headquartered in Foster City,
California, Gilead has operations in North America, Europe and Australia.
About Achillion
Achillion is a biopharmaceutical company focused on the discovery,
development and commercialization of innovative treatments for infectious
diseases. Achillion is currently developing treatments for HIV infection,
chronic hepatitis C infection and serious hospital-based bacterial
infections.
As an investigational compound, ACH-1095 has not yet been determined
safe or efficacious in humans for its ultimate intended use.
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including statements
with respect to completion and success of Achillion's preclinical studies
and clinical trials of Achillion's drug candidates. Among the factors that
could cause actual results to differ materially from those indicated by
such forward-looking statements are: unexpected regulatory actions or
delays; uncertainties relating to results of clinical trials, including
additional data relating to ongoing clinical trials; Achillion's ability to
obtain additional funding required to conduct its research, development and
commercialization activities and Achillion's dependence on its
collaboration with Gilead Sciences. These and other risks are described in
the reports filed by Achillion and Gilead with the U.S. Securities and
Exchange Commission, including their Quarterly Reports on Form 10-Q for the
quarter ended September 30, 2006.
All forward-looking statements reflect Gilead's and Achillion's
expectations only as of the date of this release and should not be relied
upon as reflecting the parties' views, expectations or beliefs at any date
subsequent to the date of this release. Gilead and Achillion anticipate
that subsequent events and developments may cause these views, expectations
and beliefs to change. However, while Gilead and Achillion may elect to
update these forward-looking statements at some point in the future, they
specifically disclaim any obligation to do so.
For more information on Gilead Sciences, please visit the company's web
site at http://www.gilead.com or call the Gilead Public Affairs Department
at 1-800-GILEAD-5 or 1-650-574-3000.
For more information on Achillion Pharmaceuticals, please visit the
company's web site at http://www.achillion.com or call Achillion at
1-203-624-7000. ACHN-G
Gilead Contacts: Achillion Contacts:
Amy Flood, Media Kari Watson, Media
(650) 522-5643 (508) 647-0209
Susan Hubbard, Investors Mary Kay Fenton, Investors
(650) 522-5715 (203) 624-7000
SOURCE Achillion Pharmaceuticals, Inc.
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Related links:
http://www.achillion.com
http://www.gilead.com
CONTACT:
Kari Watson, Media, +1-508-647-0209, or Mary
Kay Fenton, Investors, +1-203-624-7000, both of Achillion; or Amy
Flood, Media, +1-650-522-5643, or Susan Hubbard, Investors,
+1-650-522-5715, both of Gilead
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