Idenix Pharmaceuticals Provides Update on IDX184 and IDX19368 Development Programs
05 February 2013 - 8:05AM
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical
company engaged in the discovery and development of drugs for the
treatment of human viral diseases, today announced the Company has
elected not to continue its clinical development program for
IDX184, a nucleotide polymerase inhibitor in phase IIb testing for
the treatment of hepatitis C virus (HCV) infection, or to continue
its development of IDX19368, an HCV nucleotide polymerase inhibitor
for which the Company had previously filed an IND but had not
initiated patient dosing. In August 2012, the U.S. Food and Drug
Administration (FDA) placed IDX184 on partial clinical hold and
IDX19368 on clinical hold due to cardiac adverse events seen in a
competitor's phase II clinical trial of BMS-986094. All three drug
candidates are 2′-methyl guanosine nucleotide prodrugs. In
December, Idenix completed the submission of requested cardiac
safety data for IDX184 to the FDA. Idenix has found no evidence of
severe cardiac findings to date. In February, the FDA communicated
that the IDX184 and IDX19368 programs would remain on clinical
hold, and, as a result, the Company has determined it will not
continue the development of these programs.
"Although we are choosing not to continue our IDX184 and
IDX19368 programs, we intend to maintain our strong presence in
developing nucleotide polymerase inhibitors for HCV based on our
broad discovery platform," said Ron Renaud, Idenix's President and
Chief Executive Officer. "We are completing IND-enabling studies
for a uridine nucleotide analog, which is in a sub-class of
nucleotide polymerase inhibitors distinct from IDX184, IDX19368 and
BMS-986094. We anticipate filing an IND for this next-generation
compound during the first half of 2013, and we also plan to
continue to advance other preclinical nucleotide prodrugs in
earlier-stage development."
Mr. Renaud continued, "Further, we are pleased with the progress
of IDX719, our potent, pan-genotypic NS5A inhibitor for HCV. In
January 2013, we entered into a non-exclusive collaboration with
Janssen Pharmaceuticals, Inc. for the development of all-oral
direct-acting antiviral (DAA) HCV combination therapies
incorporating IDX719. Following an initial drug-drug interaction
study to begin in the first quarter of 2013 and pending approval
from regulatory authorities, we expect to begin the first phase II
study under this program of a two-DAA regimen, including
IDX719."
ABOUT IDENIX
Idenix Pharmaceuticals, Inc., headquartered in Cambridge,
Massachusetts, is a biopharmaceutical Company engaged in the
discovery and development of drugs for the treatment of human viral
diseases. Idenix's current focus is on the treatment of patients
with hepatitis C infection. For further information about Idenix,
please refer to www.idenix.com.
CONFERENCE CALL AND WEBCAST INFORMATION
Idenix will hold a conference call today at 4:30 p.m. ET. To
access the call please dial (877) 640-9809 U.S./Canada or (914)
495-8528 International and enter passcode 97346472 or to listen to
a live webcast go to "Events & Presentations" in the Idenix
Investor Center at www.idenix.com. A replay of the call will also
be available from February 4, 2013, at 7:30 p.m. ET until February
10, 2013, at 11:59 p.m. ET. To access the replay, please dial
(855) 859-2056 U.S./Canada or (404) 537-3406 International and
enter passcode 97346472. An archived webcast will also be available
for two weeks after the call on the Idenix website.
FORWARD-LOOKING STATEMENTS
This press release contains "forward-looking statements" for
purposes of the safe harbor provisions of The Private Securities
Litigation Reform Act of 1995. For this purpose, any statements
contained herein that are not statements of historical fact may be
deemed forward-looking statements. Without limiting the foregoing,
the words "expect," "plans," "anticipates," "intends," "will," and
similar expressions are also intended to identify forward-looking
statements, as are any expressed or implied statements with respect
to: the Company's plans to continue to developing nucleotide
polymerase inhibitors for HCV; its clinical development plans for
its uridine nucleotide analog drug candidate and IDX719; its plans
to advance other preclinical nucleotides; and statements regarding
the efficacy and safety of its clinical compounds. Actual results
may differ materially from those indicated by such forward-looking
statements as a result of risks and uncertainties, including but
not limited to the following: there can be no guarantees that the
Company will advance any clinical product candidate or other
component of its potential pipeline to the clinic, to the
regulatory process or to commercialization due to numerous risks
inherent in pharmaceutical research and development; management's
expectations could be affected by unexpected regulatory actions or
delays; uncertainties relating to, or unsuccessful results of,
preclinical and clinical trials, including additional data relating
to the ongoing clinical trials evaluating its product candidates;
the Company's ability to obtain additional funding required to
conduct its research, development and commercialization activities;
competition; and the Company's ability to obtain, maintain and
enforce patent and other intellectual property protection for its
product candidates and its discoveries. Such forward-looking
statements involve known and unknown risks, uncertainties and other
important factors that may cause actual results to be materially
different from any future results, performance or achievements
expressed or implied by such statements. These and other risks
which may impact management's expectations are described in greater
detail under the heading "Risk Factors" in the Company's annual
report on Form 10-K for the year ended December 31, 2011 and the
quarterly report on Form 10-Q for the quarter ended September 30,
2012, each as filed with the Securities and Exchange Commission
(SEC) and in any subsequent periodic or current report that the
Company files with the SEC.
All forward-looking statements reflect the Company's estimates
only as of the date of this release (unless another date is
indicated) 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. While Idenix may elect to update these
forward-looking statements at some point in the future, it
specifically disclaims any obligation to do so, even if the
Company's estimates change.
CONTACT: Idenix Pharmaceuticals Contacts:
Teri Dahlman (617) 995-9807
or dahlman.teresa@idenix.com
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