Teva Announces Submission of Biologics License Application for Fremanezumab to the U.S. FDA
October 17 2017 - 8:00AM
Business Wire
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
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).
- 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.
- 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:
- 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/20171017005667/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912orRan Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7208orUnited
StatesDenise Bradley, 215-591-8974orMichelle Larkin,
610-786-7335
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