Teva and Xenon Announce Phase II Study of Topical TV-45070 in Patients with Post-Herpetic Neuralgia (PHN) Did Not Meet Primary Endpoint

JERUSALEM & BURNABY, British Columbia–(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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