Idenix Pharmaceuticals Announces Collaboration With Janssen to Initiate Phase II All-Oral Combination Studies Including IDX719,
28 January 2013 - 11:00PM
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 a non-exclusive
collaboration with Janssen Pharmaceuticals, Inc. for the clinical
development of all-oral direct-acting antiviral (DAA) HCV
combination therapies. The collaboration will evaluate combinations
including IDX719, Idenix's once-daily pan-genotypic NS5A inhibitor,
simeprevir (TMC435), a once-daily protease inhibitor jointly
developed by Janssen and Medivir AB, and TMC647055, a once-daily
non-nucleoside polymerase inhibitor, boosted with low dose
ritonavir, being developed by Janssen.
Clinical development plans include an initial drug-drug
interaction study to begin in the first quarter of 2013, followed
by phase II studies as agreed between the companies, and pending
approval from regulatory authorities. The phase II program is
expected to first evaluate the two-DAA combination of IDX719 and
simeprevir plus ribavirin for 12 weeks in treatment-naïve
HCV-infected patients. Subsequently, the companies plan to evaluate
a three-DAA combination of IDX719, simeprevir and TMC647055/r, with
and without ribavirin. The clinical trials will be conducted by
Idenix. Both companies retain all rights to their respective
compounds under this agreement.
"We are very pleased to be working with Janssen and look forward
to initiating a phase II study in the first quarter of this year,"
said Ron Renaud, Idenix's President and Chief Executive Officer.
"This will allow us to achieve a key goal of ours for 2013, which
is to advance the development of IDX719 as part of all-oral HCV
combinations in two- and three-drug regimens."
ABOUT IDX719
IDX719 is an NS5A inhibitor with low picomolar, pan-genotypic
antiviral activity in vitro. To date, IDX719 has been safe and well
tolerated after single and multiple doses of up to 100 mg in
healthy volunteers (n=36; up to 7 days duration) and HCV-infected
patients (n=69; up to 3 days duration). There have been no
treatment-emergent serious adverse events reported in the program.
IDX719 has demonstrated potent pan-genotypic antiviral activity in
HCV-infected patients with mean maximal viral load reductions up to
approximately 4.0 log10 IU/mL across HCV genotypes 1-4 in a
proof-of-concept, three-day monotherapy study.
ABOUT SIMEPREVIR (TMC435)
Simeprevir is a once-daily potent investigational hepatitis C
protease inhibitor in late Phase 3 clinical development being
jointly developed by Janssen R&D Ireland and Medivir
AB to treat chronic hepatitis C virus infections. Simeprevir is
being investigated in combination with PegIFN/RBV in Phase 3 trials
and is also being evaluated with Direct-acting Antiviral (DAA)
agents in three other Phase 2 interferon-free combinations both
with and without ribavirin (RBV). For further details please
visit http://www.medivir.com.
ABOUT TMC647055
TMC647055 is a potent non-nucleoside hepatitis C polymerase
inhibitor with broad genotypic coverage. TMC647055 is in Phase 2
clinical development and is developed by Janssen R&D Ireland to
treat chronic hepatitis C virus infections. TMC647055 is being
investigated in combination with other DAA agents in all oral
interferon-free regimens. There have been no treatment-emergent
serious adverse events reported in the program.
ABOUT HEPATITIS C
Hepatitis C virus 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 hepatitis C 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," "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 IDX719 and the likelihood and
success of any future clinical trials involving IDX719. 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;
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 clinical trials evaluating its product candidates; the
Company's ability to obtain additional funding required to conduct
its research, development and commercialization activities;
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 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:
Kelly Barry (617) 995-9033 (media)
Teri Dahlman (617) 995-9807 (investors)
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