Statistically and clinically significant
results demonstrate fremanezumab's efficacy and safety, including
unique quarterly subcutaneous dosing regimen, and in patients
already on preventive therapy
Follows positive results in chronic migraine
announced by Teva last week, together representing major advance in
the development of new treatment options for the millions of
patients who suffer from this debilitating disease
Teva’s Phase III HALO program now complete,
encompassing more than 2000 patients, meeting all 25 primary and
secondary analyses across both monthly and quarterly dosing
regimens in episodic and chronic migraine studies
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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Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
MannixUnited States(215) 591-8912orRan MeirUnited
States(215) 591-3033orTomer AmitaiIsrael972 (3) 926-7656orPR
Contacts:Iris Beck CodnerIsrael972 (3) 926-7208orDenise
BradleyUnited States(215) 591-8974orNancy LeoneUnited
States(215) 284-0213
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