Key milestone reached for Teva to advance global fremanezumab program
for the preventive treatment
of migraine
Fremanezumab aims to address unmet need in migraine community, a
disease with currently limited
preventive therapeutic
options
JERUSALEM--(BUSINESS WIRE)--Oct. 17, 2017--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE:TEVA) today
announced the submission of a Biologics License Application (BLA) to the
U.S. Food and Drug Administration (FDA) for fremanezumab, an
anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody for
the preventive treatment of migraine.
“The BLA submission for fremanezumab marks a very important milestone
for the migraine community,” said Michael Hayden, M.D., Ph.D., President
of Global R&D and Chief Scientific Officer at Teva. “There have been few
therapeutic innovations for migraine patients in over 25 years. If
approved, fremanezumab will be among the first to enter the market in a
new class of drugs for the preventive treatment of migraine. We are
immensely proud of the progress we have made in the fremanezumab
development program, and look forward to the potential to make this
therapy available to the millions of people around the world who live
with the debilitating effects of migraine.”
“Phase III clinical studies of fremanezumab demonstrated a significant
reduction in the number of migraine and headache days, acute medication
use and disability, in addition to demonstrating improvement in quality
of life in patients living with episodic and chronic migraine,” said
Ernesto Aycardi, M.D., Vice President, Therapeutic Area Head, Migraine &
Headache at Teva. “We are very excited to have submitted the BLA to the
FDA as an important step in being able to introduce a new therapy that
may help to address a significant need in the migraine community for
targeted, preventive treatment options.”
The BLA 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 monthly and quarterly dose
regimens of fremanezumab. Results from these trials were recently
presented at the Congress of the International Headache Society (IHC) in
September and will be published in future peer-reviewed publications.
The most common adverse events reported in clinical trials include
injection site induration, erythema, and pruritis.
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, 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 (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% 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 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 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 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:
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the uncertainty of obtaining regulatory approvals;
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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: 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.
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