Marks the first Phase III chronic migraine data
to be published within anti-CGRP class
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the publication of data from the pivotal Phase III HALO
study evaluating the efficacy, safety and tolerability of two
subcutaneous dose regimens of fremanezumab for the preventive
treatment of chronic migraine (CM). These data were published
online today by the New England Journal of Medicine (NEJM) and will
appear in a subsequent print issue.
“The burden of illness faced by those with migraine is immense
and can negatively impact every facet of their lives underscoring a
significant unmet need for new preventive treatment options,” said
Stephen D. Silberstein, M.D., Principal Investigator of the HALO
trial, Professor of Neurology and Director of the Jefferson
Headache Center at Thomas Jefferson University Hospital and lead
author of this publication. “Results from the Phase III study of
fremanezumab for the preventive treatment of chronic migraine
highlight the importance of therapies targeting CGRP as a potential
significant advancement in the treatment of patients suffering from
debilitating symptoms.”
“We are very proud that the fremanezumab chronic migraine
results are the first Phase III CM anti-CGRP therapy data
published, especially in such a prestigious and well-renowned
peer-reviewed journal,” said Ernesto Aycardi, M.D., Vice President
& Therapeutic Area Head, R&D, Migraine and Headache at
Teva. “In this article, we are pleased to share with the medical
community data from what we believe is a differentiated,
patient-centric clinical development program, and to advance
understanding of the potential of fremanezumab as a preventive
treatment option for the millions of people suffering from
migraine.”
The article, “Fremanezumab for the Preventive Treatment of
Chronic Migraine,” reports results of a multicenter, randomized,
double-blind, placebo-controlled, parallel-group Phase III study
that evaluated monthly and quarterly doses of fremanezumab versus
placebo for the preventive treatment of chronic migraine in 1,130
patients. These findings, along with findings from the HALO Phase
III study evaluating the efficacy, safety and tolerability of two
subcutaneous dose regimens of fremanezumab for the preventive
treatment of episodic migraine (EM), were included in the Biologics
License Application (BLA) for fremanezumab that Teva submitted to
the U.S. Food and Drug Administration (FDA) in October. The most
common adverse events reported in clinical trials include injection
site induration, erythema, and pruritis.
For the full text of this publication, please visit:
http://www.nejm.org/doi/full/10.1056/NEJMoa1709038
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 the HALO Clinical Research Program
The Phase III HALO episodic migraine (EM) and CM studies are
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 consist 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).
- In the EM study, 875 patients were
enrolled (294, 291, 290 patients in the placebo, quarterly, and
monthly dose groups, respectively). Patients were randomized in a
1:1:1 ratio to receive subcutaneous injections of fremanezumab at
225 mg for three months (monthly dose regimen), fremanezumab at 675
mg (quarterly dose regimen) 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.
- In the CM study, 1,130 patients were
randomized (around 376 patients per treatment group). Patients were
randomized in a 1:1:1 ratio to receive subcutaneous injections of
fremanezumab at 675 mg at initiation followed by monthly 225 mg for
two months (monthly dose regimen), fremanezumab at 675 mg at
initiation followed by placebo for two months (quarterly dose
regimen), or three monthly doses of matching placebo. The primary
efficacy endpoint of the CM study was the mean change from baseline
(28-day run-in period) in the monthly average number of headache
days of at least moderate severity during the 12-week period after
the first dose of fremanezumab.
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% of
people diagnosed with migraine have episodic migraine and 10% 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 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 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 obtaining regulatory
approvals;
- the uncertainty of commercial success
of Fremanezumab;
- 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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version on businesswire.com: http://www.businesswire.com/news/home/20171129006296/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3)
926-7656orPR Contacts:Iris Beck Codner, Israel, 972 (3)
926-7208Denise Bradley, United States,
215-591-8974Michelle Larkin, United States, 610-786-7335
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