Teva seeking EU regulatory approval for anti-CGRP therapy for the
prevention of migraine
JERUSALEM--(BUSINESS WIRE)--Feb. 2, 2018--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced that the European Medicines Agency (EMA) has accepted the
Marketing Authorization Application (MAA) for fremanezumab, an
anti-calcitonin gene-related peptide (CGRP) antibody for the prevention
of episodic and chronic migraine in adults. Fremanezumab is a quarterly
or monthly injection that may be administered by a healthcare
professional, or self-administered by the patient.
“The successful filing of the MAA for fremanezumab with the EMA builds
on the momentum of the global fremanezumab program, following acceptance
of the Biologics License Application with the U.S. Food and Drug
Administration,” said Ernesto Aycardi, MD, Vice President Head of
Clinical Trial Execution, Data Sciences and Biometrics & Clinical
Pharmacology at Teva. “With limited availability of preventive therapy
options that target the underlying biological mechanisms of migraine,
the MAA acceptance represents a major step toward advancing the
treatment paradigm for the migraine community. These two significant
regulatory milestones in the migraine indication, combined with our
clinical development programs for fremanezumab in cluster headache and
post-traumatic headache, highlight Teva’s commitment to patients
worldwide with these debilitating conditions.”
The MAA includes data from the HALO clinical trial program, which
enrolled more than 2,000 patients with episodic migraine (EM) and
chronic migraine (CM), evaluating both quarterly and monthly dosing
regimens, in which fremanezumab achieved statistically significant
results across all trial endpoints. The most common adverse events
reported in clinical trials include injection site pain, induration, and
erythema.
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).
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In the EM study, 875 patients were enrolled (294, 291, and 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 at initiation followed
by placebo for two months (quarterly dose regimen), 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.
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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 Fremanezumab
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.
Fremanezumab is also being investigated for the prevention of chronic
and episodic cluster headache as part of the Phase III ENFORCE clinical
research program, which has been granted fast track designation by the
FDA. Trial participant recruitment is now underway and the studies are
expected to conclude in early 2019. Fast track designation is intended
to facilitate development and expedite review of drugs to treat serious
or life-threatening conditions. Additionally, Teva has also recently
initiated a fremanezumab Phase II clinical program for the treatment of
post-traumatic headache disorder.
About Migraine
Migraine is an unpredictable neurological disease 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. In the EU5,
more than 15 million people suffer from episodic and chronic migraine.
According to the most recent Cost of Brain Disorders in Europe paper,
migraine costs the economy €18 billion annually in reduced productivity
and work days lost. 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.
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 over 60 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 the Fremanezumab Marketing Authorization Application, 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:
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the uncertainty of obtaining regulatory approvals for Fremanezumab;
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the uncertainty of commercial success of Fremanezumab;
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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;
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our business and operations in general, including: failure to
effectively execute the recently announced restructuring plan;
uncertainties relating to the potential benefits and success of our
new organizational structure and recent senior management changes; the
potential success; 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;
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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;
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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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Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix, 215-591-8912
or
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR Contacts:
Yonatan
Beker, 972 (54) 888-5898
or
United States
Kaelan
Hollon, 202-412-7076
or
Michelle Larkin,
610-786-7335