Idenix Provides Update on Clinical Development Program for Valopicitabine (NM283) for the Treatment of Hepatitis C
December 02 2005 - 11:02AM
PR Newswire (US)
CAMBRIDGE, Mass., Dec. 2 /PRNewswire-FirstCall/ -- Idenix
Pharmaceuticals, Inc., (NASDAQ:IDIX), announced today that the
company met with the United States Food and Drug Administration
(FDA) on November 30, 2005 to discuss the clinical development
program for valopicitabine (NM283) for the treatment of hepatitis
C. Based upon this meeting, the company anticipates finalizing the
study design for a phase III clinical trial in treatment-refractory
patients by the end of the first quarter of 2006 and starting to
enroll patients thereafter. At the meeting, the FDA requested
additional information from the two ongoing phase IIb clinical
trials evaluating valopicitabine. In response, Idenix plans to
provide the FDA with comprehensive 24-week data from the ongoing
phase IIb clinical trial in treatment-refractory patients. Idenix
also expects to provide initial data from the ongoing phase IIb
trial evaluating valopicitabine in treatment-naive patients, which
includes a patient cohort receiving valopicitabine 800 mg plus
pegylated interferon beginning on day 1 of treatment. This is the
treatment regimen that the company currently expects may be
evaluated in phase III clinical trials. The company anticipates
that it will provide in January 2006 these additional data that
have been requested and thereafter meet with the FDA to review such
additional data. At that meeting, the company anticipates further
discussing with the FDA the proposed phase III clinical trial
protocol. "We are pleased with the interaction we have had with the
FDA to date regarding valopicitabine development," said Jean-Pierre
Sommadossi, chief executive officer of Idenix. "We are optimistic
that we will continue to advance the valopicitabine clinical
program, particularly in view of the serious unmet need in the
treatment-refractory patient population in hepatitis C," he said.
About Valopicitabine Valopicitabine, which is administered orally
once a day, is intended to block HCV replication by specifically
inhibiting the HCV RNA polymerase, the enzyme that makes new copies
of HCV viral chromosome inside infected cells. Initial phase I
clinical trials sponsored by Idenix showed that valopicitabine is
active in patients infected with the genotype 1 strain of HCV, the
strain that infects the majority of patients in North America,
Europe, and Japan. The ongoing clinical trials are designed to
evaluate the combination of valopicitabine and pegylated interferon
in hepatitis C genotype 1 patients who previously failed to respond
to antiviral treatment, as well as in genotype 1 patients who have
not been treated previously. Preliminary results from phase II
clinical trials to date have demonstrated that the antiviral effect
of valopicitabine is enhanced when this agent is used in
combination with pegylated interferon. About Hepatitis C Hepatitis
C is an infectious liver disease caused by the hepatitis C virus.
The World Health Organization estimates that 170 million
individuals worldwide carry chronic HCV infection, with 3 to 4
million new infections occurring globally each year. It is the most
common chronic blood-borne infection in the United States, with 2.7
million people chronically infected. Chronic HCV infection causes
inflammation of the liver, which may cause progressive liver damage
that can lead to liver scarring, liver cancer, liver failure, and
death. Patients infected with HCV genotype 1 are difficult to
treat, with half or fewer such patients achieving sustained
responses to current standard treatment regimens involving a
combination of pegylated interferon plus ribavirin. These
"non-responders" or treatment-refractory patients comprise a
growing patient population, who have no proven alternative
treatments available and who are at risk for progressive
HCV-associated liver disease. As the prevalence of severe liver
disease attributable to chronic hepatitis C rises, deaths due to
complications from hepatitis C infection, currently 8,000 to 10,000
per year in the United States, are expected to increase
dramatically over the next 15 to 20 years. About Idenix Idenix
Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the
discovery and development of drugs for the treatment of human viral
and other infectious diseases. Idenix's current focus is on the
treatment of infections caused by hepatitis B virus, hepatitis C
virus and human immunodeficiency virus (HIV). Idenix's headquarters
are located in Cambridge, Massachusetts and it has drug discovery
and development operations in Montpellier, France and drug
discovery operations in Cagliari, Italy. For further information
about Idenix, please refer to http://www.idenix.com/.
Forward-looking Statements This press release contains
"forward-looking statements" within the meaning of The Private
Securities Litigation Reform Act of 1995. Such forward- looking
statements can be identified by the use of forward-looking
terminology such as, "anticipates," "plans," "expects," "we are
optimistic," "will continue to," or similar expressions or by
express or implied discussions regarding the company's planned
actions in response to the discussions with the FDA, the potential
therapeutic benefits and successful development of valopicitabine,
or the potential future revenues from valopicitabine. Such
forward-looking statements are subject to numerous factors, risks
and uncertainties that may cause actual events or results to differ
materially from the company's current expectations. There can be no
guarantee that valopicitabine will be successfully developed or
approved for sale in any market, or that it will reach any
particular level of revenue. In particular, management's
expectations regarding valopicitabine could be affected by risks
and uncertainties relating to the results of further discussions
with the FDA; the timing and success of any submissions to the FDA
and other regulatory bodies around the world; the results of
clinical trials and other studies with respect to valopicitabine,
including any new clinical data, or additional analysis of existing
clinical data; the company's dependence on its collaboration with
Novartis Pharma AG; the company's ability to obtain additional
funding required to conduct its research, development and
commercialization activities; the ability of the company to attract
and retain qualified personnel; competition in general; and the
company's ability to obtain, maintain and enforce patent and other
intellectual property protection for valopicitabine. These and
other risks which may impact management's expectations regarding
valopicitabine are described in greater detail under the caption
"Factors That May Affect Future Results" in the company's quarterly
report on Form 10-Q for the quarter ended September 30, 2005 and
filed with the Securities and Exchange Commission and other filings
that the company makes with the Securities and Exchange Commission.
All forward-looking statements reflect the company's expectations
only as of the date of this release and should not be relied upon
as reflecting the company's views, expectations or beliefs at any
date subsequent to the date of this release. Idenix anticipates
that subsequent events and developments may cause these views,
expectations and beliefs to change. However, while Idenix may elect
to update these forward-looking statements at some point in the
future, it specifically disclaims any obligation to do so. Idenix
Pharmaceuticals' Contact: Teri Dahlman: 617-995-9905 DATASOURCE:
Idenix Pharmaceuticals, Inc. CONTACT: Teri Dahlman of Idenix
Pharmaceuticals, Inc., +1-617-995-9905 Web site:
http://www.idenix.com/
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