Teva & Xenon Announce Phase II Study of Topical TV-45070 in Patients with Post-Herpetic Neuralgia (PHN) Did Not Meet Primary ...
June 27 2017 - 8:15AM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) and
Xenon Pharmaceuticals Inc. (Nasdaq: XENE) announce top-line results
in a Phase II study of topical TV-45070 in patients with
post-herpetic neuralgia (PHN). TV-45070 did not meet the primary
endpoint of a statistically significant change in pain from
baseline to week four as assessed by the numeric rating scale
(NRS). Secondary endpoints were also not met. There were no safety
concerns in the study.
This was a Phase II proof of concept study seeking to understand
the potential for a topical route of Nav1.7 blockade in PHN. Dr.
Simon Pimstone, Xenon’s President and Chief Executive Officer,
said: “While these results are disappointing for us from a
scientific perspective and for patients needing new therapies to
treat chronic neuropathic pain, Xenon remains focused on advancing
its pipeline of neurology-related development candidates, with
multiple programs anticipated to enter clinical development in
2017.”
The companies plan to further analyze the data from this study
to determine the next steps for TV-45070, and may look to present
study data at a relevant forthcoming scientific conference.
About TV-45070
TV-45070 is a small-molecule inhibitor of the sodium channel
Nav1.7, and other sodium channels, expressed in the pain-sensing
peripheral nervous system. TV-45070 was licensed by Xenon to Teva
in December 2012.
This Phase II trial was a randomized, double-blind, placebo
controlled, parallel group, multicenter study to evaluate the
efficacy and safety of TV-45070 in patients with PHN. The study
included three treatment groups that received topical ointment
containing 4% or 8% TV-45070 or placebo, dosed twice daily. The
primary endpoint of this study was the change of average daily pain
scores from baseline to week four, measured using an 11-point
(0-10) numeric rating scale (NRS).
Secondary endpoints included the percentage of patients with
greater than 30% and greater than 50% improvement in pain scores,
quality of life measurements and adverse events measurements. The
study was carried out at 48 centers in the US and involved 300
patients randomized to 100 patients receiving 4% TV-45070, 100
patients receiving 8% TV-45070 and 100 patients receiving
placebo.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a
leading global pharmaceutical company that delivers high-quality,
patient-centric healthcare solutions used by approximately 200
million patients in 100 markets every day. Headquartered in Israel,
Teva is the world’s largest generic medicines producer, leveraging
its portfolio of more than 1,800 molecules to produce a wide range
of generic products in nearly every therapeutic area. In specialty
medicines, Teva has the world-leading innovative treatment for
multiple sclerosis as well as late-stage development programs for
other disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions, as well
as a broad portfolio of respiratory products. Teva is leveraging
its generics and specialty capabilities in order to seek new ways
of addressing unmet patient needs by combining drug development
with devices, services and technologies. Teva's net revenues in
2016 were $21.9 billion. For more information, visit
www.tevapharm.com.
About Xenon Pharmaceuticals Inc.
Xenon is a clinical stage biopharmaceutical company focused on
developing innovative therapeutics to improve the lives of patients
with neurological disorders. Building upon our extensive knowledge
of human genetics and diseases caused by mutations in ion channels,
known as channelopathies, we are advancing – both independently and
with our pharmaceutical collaborators – a novel product pipeline of
ion channel modulators to address therapeutic areas of high unmet
medical need, such as pain and epilepsy. For more information,
please visit www.xenon-pharma.com.
Teva Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of 1995
regarding TV-45070 which are based on management’s current beliefs
and expectations and are subject to substantial risks and
uncertainties, both known and unknown, that could cause our future
results, performance or achievements to differ significantly from
that expressed or implied by such forward-looking statements.
Important factors that could cause or contribute to such
differences include risks relating to:
- challenges inherent in product research
and development, including uncertainty of clinical success and
obtaining regulatory approvals;
- our specialty medicines business,
including: competition for our specialty products, especially
Copaxone®, our leading medicine, which faces competition from
existing and potential additional generic versions and
orally-administered alternatives; our ability to achieve expected
results from investments in our product pipeline; competition from
companies with greater resources and capabilities; and the
effectiveness of our patents and other measures to protect our
intellectual property rights;
- our business and operations in general,
including: our ability to develop and commercialize additional
pharmaceutical products; manufacturing or quality control problems,
which may damage our reputation for quality production and require
costly remediation; interruptions in our supply chain; disruptions
of our or third party information technology systems or breaches of
our data security; the restructuring of our manufacturing network,
including potential related labor unrest; the impact of continuing
consolidation of our distributors and customers; and variations in
patent laws that may adversely affect our ability to manufacture
our products;
- compliance, regulatory and litigation
matters, including: costs and delays resulting from the extensive
governmental regulation to which we are subject; the effects of
reforms in healthcare regulation and reductions in pharmaceutical
pricing, reimbursement and coverage; potential additional adverse
consequences following our resolution with the U.S. government of
our FCPA investigation; governmental investigations into sales and
marketing practices; potential liability for sales of generic
products prior to a final resolution of outstanding patent
litigation; product liability claims; increased government scrutiny
of our patent settlement agreements; failure to comply with
complex Medicare and Medicaid reporting and payment
obligations; and environmental risks;
and other factors discussed in our Annual Report on Form 20-F
for the year ended December 31, 2016 (“Annual Report”),
including in the section captioned “Risk Factors,” and in our other
filings with the U.S. Securities and Exchange Commission,
which are available at www.sec.gov and www.tevapharm.com.
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 statements or other information contained herein,
whether as a result of new information, future events or otherwise.
You are cautioned not to put undue reliance on these
forward-looking statements.
Xenon’s 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 anticipated timing of
IND submissions with regulatory agencies, the initiation of future
clinical trials, the future development plans for TV-45070 and the
progress and potential of ongoing development programs. 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: clinical trials may not
demonstrate safety and efficacy of any of our or our collaborators'
product candidates; our discovery platform or ongoing
collaborations may not yield additional product candidates; our
efforts to expand our current pipeline may not be successful; any
of our or our collaborators' product candidates 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; the impact of expanded
product development and clinical activities on operating expenses;
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..
“Xenon” and the Xenon logo are registered trademarks or
trademarks of Xenon Pharmaceuticals Inc. in various jurisdictions.
All other trademarks belong to their respective owner.
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version on businesswire.com: http://www.businesswire.com/news/home/20170627005763/en/
Teva Contacts:IR Contacts:United StatesKevin C.
Mannix, (215) 591-8912Ran Meir, (215)
591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7208orUnited
StatesDenise Bradley, (215) 591-8974Nancy Leone,
(215) 284-0213orXenon Contact:IR & PR Contact:North
AmericaJodi Regts,
604-484-3353investors@xenon-pharma.com
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