-
TV-45070 4% and 8% did not demonstrate statistically significant
difference from placebo in efficacy endpoints in Phase 2b study in
pain due to osteoarthritis of the knee.
-
TV-45070 demonstrated a favorable safety and tolerability profile,
with no drug-related serious adverse events.
-
Low drug plasma levels coupled with the favorable tolerability
profile support the topical application rationale and continued
development in neuropathic pain.
-
Teva and Xenon remain fully committed to the development of
TV-45070 for neuropathic pain indications and await the results from
the ongoing PHN Phase 2b study, expected in the second half of 2016.
JERUSALEM & BURNABY, British Columbia--(BUSINESS WIRE)--Jul. 1, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and Xenon
Pharmaceuticals Inc. (Nasdaq: XENE) reported today top line results from
the double-blind, placebo-controlled Phase 2b study designed to evaluate
the safety and efficacy of topically applied TV-45070 (4% and 8% w/w
ointment) in patients with chronic pain due to osteoarthritis (OA) of
the knee.
TV-45070 is a small molecule inhibitor of the sodium channel Nav1.7 and
other sodium channels, including those that are expressed in the
pain-sensing peripheral nervous system. Results from this trial showed
that TV-45070 4% and 8% did not demonstrate statistically significant
difference from placebo in efficacy endpoints of reductions in pain due
to OA.
TV-45070 did demonstrate a favorable safety and tolerability profile,
with no drug-related serious adverse events. This is important given the
ongoing Phase 2b study of TV-45070 in post-herpetic neuralgia (PHN). The
most common adverse events were application site dermal skin reactions
which were mostly mild and less frequent than seen with other topical
analgesics. There were no cardiac or CNS safety issues.
“The rationale for development of TV-45070 in OA has unfortunately not
been confirmed with these results. However, neuropathic pain represents
a distinct mechanism of chronic pain to OA and, as such, the potential
for positive study results in PHN is not impacted by these data,” said
Richard Malamut M.D. Teva’s Vice President and Head of Pain Therapeutic
Development. "Given the favorable safety and tolerability profile
demonstrated, we remain hopeful that TV-45070 can offer a new and
valuable option to patients with neuropathic pain."
“While we are disappointed that the Phase 2b trial top-line results did
not indicate efficacy in OA, Teva and Xenon have always been committed
to a broad development plan for TV-45070 in both nociceptive and
neuropathic pain,” said Dr. Simon Pimstone, Xenon's President and Chief
Executive Officer. “The Phase 2b trial in PHN being conducted by Teva is
progressing as planned, and we look forward to seeing top-line results
from that trial in the second half of 2016. In addition, Xenon will
continue to focus on advancing our partnered and proprietary pipeline
programs, and leveraging the potential of our Extreme Genetics platform
and expertise in ion channel target discovery. We look forward to other
near-term milestone opportunities across our diverse product candidate
pipeline.”
About TV-45070
TV-45070 (formerly XEN402) is a topically applied small-molecule
inhibitor of the sodium channel Nav1.7 and other sodium channels,
including those that are expressed in the pain-sensing peripheral
nervous system. Applied topically, TV-45070 acts locally to inhibit
Nav1.7 in the skin and underlying tissue, mitigating systemic absorption
and the potential risks of side-effects that accompany systemic drug
metabolism. The pain target Nav1.7 was identified by Xenon using its
Extreme Genetics discovery platform. Xenon developed TV-45070 through
early clinical development and partnered with Teva through a
collaborative development and license agreement established in 2012,
providing Teva with an exclusive worldwide license to develop and
commercialize TV-45070. A Phase 2b trial in PHN is currently underway,
with results expected in the second half of 2016.
About the TV-45070 Osteoarthritis Phase 2b Trial
The Phase 2b osteoarthritis trial of TV-45070 was a randomized,
double-blind, placebo-controlled study conducted at approximately 40
clinical sites across the US. There were three arms in the study and a
total of 389 patients were randomized on a 1:1:1 basis: experimental
TV-45070 4% administered twice per day; experimental TV-45070 8%
administered twice per day; and placebo comparator (matched ointment
without TV-45070) administered twice per day. Patients were eligible to
participate in the trial if they were 40-85 years of age, had primary OA
in a single knee (target knee), and met pre-specified visual analog
scale (VAS) pain scores and were otherwise medically healthy. The
primary endpoint of the Phase 2b trial was to evaluate the efficacy of
four weeks of topical administration of TV-45070 (4% and 8% ointment)
compared with placebo for the relief of symptoms of primary OA of the
target knee as assessed by the change from baseline to the last five
days of treatment in average evening pain score upon walking on a flat
surface using Question 1 of the Western Ontario and McMasters
Universities Arthritis Index (WOMAC) on a 0-100 mm visual analog scale.
The efficacy endpoints were analyzed on a full analysis set defined as
all patients having received at least one dose of study drug and having
at least one post baseline efficacy assessment. Key secondary objectives
of the trial included changes in WOMAC pain subscale scores, responder
rates, and patient-reported outcome assessments.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading
global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions to millions of patients every day.
Headquartered in Israel, Teva is the world’s largest generic medicines
producer, leveraging its portfolio of more than 1,000 molecules to
produce a wide range of generic products in nearly every therapeutic
area. In specialty medicines, Teva has a world-leading position in
innovative treatments for disorders of the central nervous system,
including pain, as well as a strong portfolio of respiratory products.
Teva integrates its generics and specialty capabilities in its global
research and development division to create new ways of addressing unmet
patient needs by combining drug development capabilities with devices,
services and technologies. Teva's net revenues in 2014 amounted to $20.3
billion. For more information, visit www.tevapharm.com.
About Xenon Pharmaceuticals Inc.
Xenon is a clinical-stage biopharmaceutical company discovering and
developing a pipeline of differentiated therapeutics for orphan
indications that it intends to commercialize on its own and for larger
market indications that the company intends to partner with global
pharmaceutical companies. Xenon has built a core enabling discovery
platform, referred to as Extreme Genetics®, for the discovery of
validated drug targets by studying rare human diseases with extreme
traits, including diseases caused by mutations in ion channels, known as
channelopathies. Xenon's Extreme Genetics® platform has yielded the
first approved gene therapy product in the European Union and a broad
development pipeline and multiple pharmaceutical partnerships, including
with Teva and Genentech. For more information, please visit www.xenon-pharma.com.
Teva's Safe Harbor Statement under the U. S. Private Securities
Litigation Reform Act of 1995:
This release contains forward-looking statements, which are based on
management’s current beliefs and expectations and involve a number of
known and unknown risks and uncertainties that could cause our future
results, performance or achievements to differ significantly from the
results, performance or achievements expressed or implied by such
forward-looking statements. Important factors that could cause or
contribute to such differences include risks relating to: our ability to
develop and commercialize additional pharmaceutical products;
competition for our innovative products, especially Copaxone®
(including competition from orally-administered alternatives, as well as
from potential purported generic equivalents) and our ability to
migrate users to our 40 mg/mL version; the possibility of material
fines, penalties and other sanctions and other adverse consequences
arising out of our ongoing FCPA investigations and related matters; our
ability to achieve expected results from the research and development
efforts invested in our pipeline of specialty and other products; our
ability to reduce operating expenses to the extent and during the
timeframe intended by our cost reduction program; our ability to
identify and successfully bid for suitable acquisition targets or
licensing opportunities, or to consummate and integrate acquisitions;
the extent to which any manufacturing or quality control problems damage
our reputation for quality production and require costly remediation;
increased government scrutiny in both the U.S. and Europe of our patent
settlement agreements; our exposure to currency fluctuations and
restrictions as well as credit risks; the effectiveness of our patents,
confidentiality agreements and other measures to protect the
intellectual property rights of our specialty medicines; the effects of
reforms in healthcare regulation and pharmaceutical pricing,
reimbursement and coverage; governmental investigations into sales and
marketing practices, particularly for our specialty pharmaceutical
products; adverse effects of political or economic instability, major
hostilities or acts of terrorism on our significant worldwide
operations; interruptions in our supply chain or problems with internal
or third-party information technology systems that adversely affect our
complex manufacturing processes; significant disruptions of our
information technology systems or breaches of our data security;
competition for our generic products, both from other pharmaceutical
companies and as a result of increased governmental pricing pressures;
competition for our specialty pharmaceutical businesses from companies
with greater resources and capabilities; the impact of continuing
consolidation of our distributors and customers; decreased opportunities
to obtain U.S. market exclusivity for significant new generic products;
potential liability in the U.S., Europe and other markets for sales of
generic products prior to a final resolution of outstanding patent
litigation; our potential exposure to product liability claims that are
not covered by insurance; any failure to recruit or retain key
personnel, or to attract additional executive and managerial talent; any
failures to comply with complex Medicare and Medicaid reporting and
payment obligations; significant impairment charges relating to
intangible assets, goodwill and property, plant and equipment; the
effects of increased leverage and our resulting reliance on access to
the capital markets; potentially significant increases in tax
liabilities; the effect on our overall effective tax rate of the
termination or expiration of governmental programs or tax benefits, or
of a change in our business; variations in patent laws that may
adversely affect our ability to manufacture our products in the most
efficient manner; environmental risks; and other factors that are
discussed in our Annual Report on Form 20-F for the year ended December
31, 2014 and in our other filings with the U.S. Securities and Exchange
Commission. Forward-looking statements speak only as of the date on
which they are made and we assume no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Xenon Safe Harbor Statement
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934 and the Private Securities
Litigation Reform Act of 1995 and Canadian securities laws. These
forward-looking statements are not based on historical fact, and include
statements regarding the potential efficacy, future development plans
and commercial potential of TV-45070 and our other product candidates;
the importance of the observed safety and tolerability profile of
TV-45070 in the current trial and the ability to replicate these
observed results in the ongoing clinical trial of TV-45070 in PHN; the
timing of the completion of and results from additional clinical trials
of TV-45070 in other indications and our other product candidates; the
plans of our collaboration partners and their interactions with
regulatory agencies; the results of research and development efforts;
the effect of regulation by the FDA and other agencies and the potential
impact of competitive products, product development, commercialization
and technological difficulties. These forward-looking statements are
based on current assumptions that involve risks, uncertainties and other
factors that may cause the actual results, events or developments to be
materially different from those expressed or implied by such
forward-looking statements. These risks and uncertainties, many of which
are beyond our control, include, but are not limited to: ongoing or
additional clinical trials of TV-45070 or our other product candidates
may not demonstrate safety and efficacy; our Extreme Genetics discovery
platform may not yield additional product candidates; any of our or our
collaborators' product candidates, including TV-45070, may fail in
development, may not receive required regulatory approvals, or may be
delayed to a point where they are not commercially viable; we may not
achieve additional milestones pursuant to our collaboration agreements;
the impact of competition; adverse conditions in the general domestic
and global economic markets; as well as the other risks identified in
our filings with the Securities and Exchange Commission and the
securities commissions in British Columbia, Alberta and Ontario. These
forward-looking statements speak only as of the date hereof and we
assume no obligation to update these forward-looking statements, and
readers are cautioned not to place undue reliance on such
forward-looking statements.
The Xenon logo and "Extreme Genetics" are registered trademarks or
trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions.
View source version on businesswire.com: http://www.businesswire.com/news/home/20150701005254/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR:
Kevin C. Mannix, United
States, 215-591-8912
or
Ran Meir, United States,
215-591-3033
or
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or
PR:
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or
Denise
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or
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or
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Investors@xenon-pharma.com