Teva anticipates launching anti-CGRP product in
the U.S. for the prevention of migraine in 2018
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced the U.S. Food and Drug Administration (FDA) has accepted
for review the company’s Biologics License Application (BLA) for
fremanezumab, an anti-calcitonin gene-related peptide (anti-CGRP)
monoclonal antibody for the preventive treatment of migraine.
Additionally, the FDA has granted fast track designation for
fremanezumab for the prevention of cluster headache.
“The progression of these clinical programs for fremanezumab
underscores the potential to advance the treatment paradigm for a
large portion of the migraine and headache patient community in
need,” said Dr. Marcelo Bigal, M.D., Ph.D., Chief Scientific
Officer and Head of Specialty R&D at Teva. “These two critical
regulatory milestones, along with the initiation of our Phase II
clinical program in post-traumatic headache, and our ongoing
migraine program in patients who failed up to four classes of prior
preventive treatment, reaffirm Teva’s leadership in migraine and
headache disorders and highlight our mission to keep severely
affected patients at the forefront of everything we do. We look
forward to the potential to make fremanezumab commercially
available for the prevention of migraine for patients in the U.S.
next year.”
In order to bring this much-needed therapy to the migraine
community, Teva acquired a priority review voucher to expedite the
review of fremanezumab, which, if approved, would be a new
preventive option for patients suffering from this debilitating
disease. Regulatory action is anticipated by mid-2018.
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 quarterly and monthly
dose regimens, in which fremanezumab achieved statistically
significant results across all trial endpoints. Results of the HALO
CM trial were recently published in The New England Journal of
Medicine. The most common adverse events reported in clinical
trials include injection transient and mild site induration,
erythema, and itching at the injection site.
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 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
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.
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 Cluster Headache
Cluster headache is a rare, severely disabling, primary headache
disorder consisting of relentless headaches on one side of the head
affecting fewer than 1 in 1,000 adults. It is considered to be the
most severe form of recurrent pain. The term cluster headache comes
from the recurrence of headache attacks in cluster periods lasting
for weeks or months, separated (episodic ) or not (chronic) by
remission periods lasting months or years. The age of onset of
cluster headache is most often between 20 and 40 and they are more
common in men than women. There are two clinical manifestations of
cluster headache – episodic and chronic. Cluster headache is
diagnosed as “episodic” when the attacks occur in periods lasting 7
days to 1 year separated by pain-free periods lasting 1 month or
longer, while “chronic” cluster headache attacks occur for more
than 1 year without remission or with remissions lasting less than
1 month. More than 80% have the episodic cluster headache form.
Cluster headache is often referred to as “suicide headache” since
the severity of the pain is linked to a significant risk of suicide
among those affected. There remains a lack of treatment options for
this debilitating condition.
About Post-Traumatic Headache
Nearly 1.7 million traumatic brain injuries (TBI) occur every
year in the US having a significant impact on the lives of patients
and their families. Post-traumatic headache (PTH) is defined by the
International Headache Society as a headache developing within
seven days of the injury or after regaining consciousness. The
headache usually resolves within three months, however, in 18-65%
of cases, it may last longer and is then referred to as persistent
PTH. Several factors may increase the risk of persistent PTH
including pre-existing headache, being female and family history of
migraine. Head-injured patients can have a lower quality of life,
experience difficulty performing daily activities, and may miss
school or work.
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 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 for Fremanezumab;
- 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: uncertainties relating to the potential benefits and
success of our new organizational structure and recent senior
management changes; the potential success and our ability to
effectively execute a restructuring plan; 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/20171218005506/en/
Teva Pharmaceutical Industries Ltd.IR Contacts:United
StatesKevin C. Mannix, 215-591-8912Ran Meir,
215-591-3033orIsraelTomer Amitai, 972 (3) 926-7656orPR
Contacts:IsraelIris Beck Codner, 972 (3) 926-7208orUnited
StatesDenise Bradley, 215-591-8974Michelle Larkin,
610-786-7335
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