Teva’s Fremanezumab Meets all Primary & Secondary Endpoints Across Both Monthly and Quarterly Dosing Regimens in Phase III Study in Episodic Migraine Prevention

JERUSALEM–(BUSINESS WIRE)– Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) today announced
positive results from the second Phase III HALO study of fremanezumab
(TEV-48125), an investigational treatment for the prevention of
migraine. In the episodic migraine (EM) study, patients treated with
monthly and quarterly fremanezumab experienced clinically and
statistically significant improvements in all endpoints and 12
pre-specified analyses.

Participants in this trial had a mean of 9.1 migraine days per month and
reported 39 days with functional impairment per quarter. In this
severely affected population, Fremanezumab given monthly improved the
average number of migraine days, relative to baseline, by 41.6% for the
duration of the trial (-3.7 days vs. -2.2 days for placebo, p < 0.0001).
Number of days with disability were decreased by 64.7% (p =0.0021) and
medication consumption was decreased by 39.0%( p < 0.0001). The
quarterly SC dose, which was uniquely tested in this program, also
yielded highly significant results for decrease in migraine days (-3.4
days or 37.0%, p < 0.0001) and for all other comparisons. Also unique to
this development, both dose regimens highly significantly improved
migraine in subjects on stable doses of other prophylactic medications
(-4.0 days for monthly dose vs -2.0 days for placebo, p = 0.001; -3.7
days for quarterly dose, p = 0.006).

All other pre-specified analyses were met and were highly statistically
significant. The most commonly-reported adverse event in the study was
injection site pain, with similar rates in the placebo and active groups.

“This is an extremely important development for Teva in our desire to
make a meaningful difference to the millions of patients who suffer from
migraine around the world,” said Dr. Yitzhak Peterburg, Interim
President and CEO at Teva. “Based on these data, we are confident in the
potential for fremanezumab to be a differentiated treatment within the
migraine marketplace, and these results are a testament to the strength
of Teva’s development capabilities.”

“Teva’s HALO trials are the only Phase III anti-CGRP studies to
demonstrate efficacy with both monthly and quarterly dosing for chronic
and episodic patients and in patients already receiving prevention
therapies. This is a major advance on existing data. The efficacy and
rapid onset, as both add-on and monotherapy, quarterly dosing, and
effect on disability and quality of life indicate that this therapy has
the potential to set new and different benchmarks in the relief of
migraine suffering, » said Michael Hayden, M.D., Ph.D., President of
Global R&D and Chief Scientific Officer at Teva. “We are immensely proud
to be able to bring to the migraine community the hope that they might
soon have a new option that could provide a meaningful reduction in the
migraine burden patients habitually suffer.”

With topline readout of pivotal trials for fremanezumab in both episodic
and chronic migraine complete, Teva is conducting full analysis across
all endpoints with plans to present more detailed findings in
peer-reviewed publications and at future scientific congresses. This
includes results from the pivotal trial in chronic migraine at the
upcoming American Headache Society (AHS) Annual Scientific Meeting this
week and results from both pivotal chronic and episodic migraine trials
at the Congress of the International Headache Society (IHC) later this
year.

The data in this size of population of challenging patients, and the
meeting of all 25 endpoints and analyses is unmatched in this field.
Based on these results, Teva plans to submit a Biologics License
Application to the U.S. Food and Drug Administration (FDA) for
fremanezumab later this year in both episodic and chronic migraine with
anticipated approval and launch in the second half of 2018.

« The terrible impact of migraine is often not fully recognized across
the world, » said Marcelo Bigal, M.D., Ph.D., Chief Medical Officer and
Head of Specialty Clinical Development at Teva. « Our unique development
program will hopefully lead to patients having access to a new treatment
option, either for use as stand-alone or as add-on therapy, as well as
monthly or quarterly dosing. »

About the HALO Clinical Research Program

The Phase III HALO EM and CM studies were 16-week, multicenter,
randomized, double-blind, placebo-controlled, parallel-group studies to
compare the safety, tolerability, and efficacy of four dose regimens of
subcutaneous fremanezumab compared to placebo in adults with episodic
and chronic migraine. The studies consisted of a screening visit, a
28-day run-in period, and a 12-week (84-day) treatment period, including
a final evaluation at week 12 (end-of-treatment [EOT] visit, four weeks
[28 days] after the final dose of study drug). More than 2,000 patients
received at least one dose of fremanezumab in the HALO clinical program,
the largest of any of the anti-CGRP compounds.

In the EM study, 873 patients were enrolled (256 per treatment group).
Patients were randomized in a 1:1:1 ratio to receive subcutaneous
injections of fremanezumab at 225 mg as a monthly dose for three months,
fremanezumab at 675 mg at initiation followed by placebo for two months,
or three monthly doses of matching placebo. The primary efficacy
endpoint of the EM study was the mean change from baseline (28-day
run-in period) in the monthly average number of migraine days during the
12-week period after the first dose of fremanezumab. Similar to the
Phase II trials, both patients that were on monotherapy and stable doses
of prophylactic medications were included in the trial.

About Fremanezumab (TEV-48125)

Fremanezumab is a fully-humanized monoclonal antibody targeting the CGRP
ligand, a well-validated target in migraine. With limited availability
of preventive treatment options, fremanezumab represents a potential new
option to address a significant unmet medical need.

About Migraine

Migraine is an unpredictable neurological condition with symptoms such
as severe head pain and physical impairment that can impact quality of
life and productivity. There are two clinical manifestations of migraine
– chronic, where patients suffer 15 or more headache days per month, and
episodic, where patients have 14 or less headache days per month.
Worldwide, approximately 90 percent of people diagnosed with migraine
have episodic migraine and 10 percent have chronic migraine.

With more than 1 billion people affected worldwide, migraine is the
third most prevalent illness in the world and the 6th most disabling
illness in the world. In the U.S., EU5 and Japan, nearly 75 million
people suffer from episodic and chronic migraine – more than 38 million
in the U.S. alone. Of the approximately 40% of patients suffering from
migraine for whom prevention is appropriate, only 13% are currently
receiving therapy. There remains a significant medical need for
treatments designed specifically to prevent migraine. According to
recent analysis, the economic burden for migraine patients reaches
approximately $78 billion per year in the U.S.

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.

Cautionary Statements Regarding Forward-Looking Information:

This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995
regarding the potential benefits and commercialization of Fremanezumab,
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:

• the uncertainty of commercial success of Fremanezumab;
• challenges inherent in product research and development, including
  uncertainty of 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.

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