JERUSALEM & BURNABY, British Columbia--(BUSINESS WIRE)--Apr. 2, 2015--
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Xenon
Pharmaceuticals Inc. (Nasdaq:XENE)
today announced that the first patient has been enrolled into the Phase
2b study designed to evaluate the safety and efficacy of the novel
topically applied TV-45070, (4% and 8% w/w ointment) in patients with
postherpetic neuralgia (PHN).
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. It is being developed for the
treatment of patients with various pain indications, including
neuropathic and osteoarthritis pain.
"Postherpetic neuralgia leaves patients with lasting and very painful
sensations that seriously impact the ability to function. It is often
highly refractory to existing treatments and there is a significant need
for new treatment options," said Dr. Jon Isaacsohn, Teva’s Chief Medical
Officer. “The field of pain management in general is in need of new
options. Teva is making advances with a range of innovative new
treatments that will hopefully improve the lives of millions of people
suffering from pain caused by debilitating conditions such as PHN and
osteoarthritis.”
"The initiation of this TV-45070 Phase 2b clinical trial is an important
step on the way to fully understanding the potential for Nav1.7
inhibition in relieving patients from the suffering caused by
neuropathic pain. This trial, together with the ongoing study in
osteoarthritis pain, from which we expect results later this year,
should give us a better indication of the value of this novel approach
to pain management,” said Dr. Simon Pimstone, Xenon's President and
Chief Executive Officer.
The Phase 2b clinical study in PHN is a randomized, double-blind,
placebo controlled, multi-site study that will evaluate the safety and
efficacy of topically applied TV-45070 ointment compared with placebo.
Additional information about the trial is available at www.clinicaltrials.gov/ct2/show/NCT02365636.
About Postherpetic Neuralgia (PHN)
PHN is a painful complication of Herpes Zoster or "shingles" in which
pain persists for more than 3 months after resolution of the rash. It
affects approximately 20% of people who have herpes zoster and increases
with age. Elderly patients tend to have more severe and longer lasting
PHN. Despite the numerous compounds available for treating PHN, 40% to
50% of PHN patients do not respond to any treatment. The negative impact
of PHN on the quality of life can be similar to that caused by
life-threatening diseases or serious psychological conditions. PHN can
have a significant effect on many aspects of a patient’s life, causing
chronic fatigue, sleep disorders, difficulty in concentrating,
depression and anxiety, anorexia, loss of bodyweight and social
isolation.
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. TV-45070 has potentially broad application in
nociceptive pain, mediated by damage or injury to tissues, including the
pain sensitivity caused by inflammation, and neuropathic pain mediated
by damage, dysfunction or injury of nerves. 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. Teva is currently conducting a
300-patient, randomized Phase 2b clinical trial of TV-45070 in
osteoarthritis of the knee, with data expected in the third quarter of
2015.
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: the possibility
that the transaction with Auspex will not be completed, including due to
the failure to obtain the minimum tender condition; uncertainties as to
the timing of the transaction; the possibility that the expected
benefits of the transaction will not be fully realized by us or may take
longer to realize than expected; 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 timing of the initiation of and completion of
clinical trials, the timing of and results from ongoing clinical trials,
the design and enrollment goals for clinical trials and the plans of our
collaboration partners and their interactions with regulatory agencies.
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 Extreme
Genetics discovery platform may not yield additional product candidates;
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; 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.
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.:
IR:
Kevin C. Mannix,
215-591-8912
United States
or
Ran Meir,
215-591-3033
United States
or
Tomer Amitai, 972
(3) 926-7656
Israel
or
PR:
Iris Beck Codner,
972 (3) 926-7687
Israel
or
Denise Bradley,
215-591-8974
United States
or
Nancy Leone,
215-284-0213
United States
or
Xenon Pharmaceuticals Inc.:
Ian
Mortimer, 604-484 3300
Canada
investors@xenon-pharma.com