Teva anticipates launching anti-CGRP product in the U.S. for the
prevention of migraine in 2018
JERUSALEM--(BUSINESS WIRE)--Dec. 18, 2017--
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 biprograms 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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171218005506/en/
Source: Teva Pharmaceutical Industries Ltd.
Teva Pharmaceutical Industries Ltd.
IR Contacts:
United States
Kevin
C. Mannix, 215-591-8912
Ran Meir, 215-591-3033
or
Israel
Tomer
Amitai, 972 (3) 926-7656
or
PR Contacts:
Israel
Iris
Beck Codner, 972 (3) 926-7208
or
United States
Denise
Bradley, 215-591-8974
Michelle Larkin, 610-786-7335