Idenix Pharmaceuticals Announces Update on Development Program for Its Lead HCV Nucleotide Prodrug Candidate, IDX20963
June 20 2013 - 4:05PM
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
received verbal communication from the U.S. Food and Drug
Administration (FDA) requesting additional preclinical safety
information for IDX20963, Idenix's lead uridine nucleotide prodrug
candidate. Initiation of clinical trials for IDX20963 is on hold
and the Company must provide a satisfactory response to the FDA
before clinical trials can begin in the United States. As a result,
the Company anticipates a delay in the initiation of the clinical
program for IDX20963 while it responds to the FDA's comments.
Idenix recently submitted an Investigational New Drug (IND)
application for IDX20963 to the FDA, including preclinical data
demonstrating potent, pan-genotypic activity.
ABOUT HEPATITIS C
Hepatitis C virus (HCV) is a common blood-borne pathogen
infecting three to four million people worldwide annually. The
World Health Organization (WHO) estimates that more than 170
million people worldwide are chronically infected with HCV,
representing a nearly 5-fold greater prevalence than human
immunodeficiency virus.
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 HCV infection. For further information about Idenix,
please refer to www.idenix.com.
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, including but not limited to the
statements regarding the Company's future business and financial
performance. 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 expressed or implied statements with respect to
the Company's potential pipeline candidates, including any
expressed or implied statements regarding the efficacy and safety
of IDX20963 and the likelihood of any future clinical trials
involving IDX20963. 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
IDX20963 or other clinical product candidate to the clinic, to the
regulatory process or to commercialization; management's
expectations could be affected by unexpected regulatory actions or
delays; uncertainties relating to, or unsuccessful results of,
clinical trials, including additional data relating to future
clinical trials evaluating its product candidates; the Company's
ability to obtain additional funding required to conduct its
research, development and commercialization activities; changes in
the Company's business plan or objectives; competition in general;
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
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 quarterly report
on Form 10-Q for the quarter ended March 31, 2013 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
Teri Dahlman, (617) 995-9807
(MM) (NASDAQ:IDIX)
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