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News breaking: 2017-09-10

Teva to Present Fremanezumab Data on Migraine Prevention at the 18th..


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Teva to Present Fremanezumab Data on Migraine Prevention at the 18th Congress of the International Headache Society
JERUSALEM--(BUSINESS WIRE)--Sep. 5, 2017--
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today
announced that 12 scientific abstracts and two platform presentations
evaluating fremanezumab will be presented at the 18th
Congress of the International Headache Society (IHC) in Vancouver,
Canada from September 7-10, 2017. Fremanezumab is an anti-calcitonin
gene-related peptide (anti-CGRP) monoclonal antibody being investigated
as a preventive treatment for migraine. These presentations include new
data and analyses from the pivotal Phase III study in chronic migraine,
as well as results from the Phase III study in episodic migraine, which
will be presented for the first time.
“It is an extremely exciting time for the migraine community as new data
emerge on investigational CGRP-targeted therapies,” said Michael Hayden,
M.D., Ph.D., President of Global R&D and Chief Scientific Officer at
Teva. “We are very proud and pleased to present the results of our
fremanezumab clinical trials in chronic and episodic migraine at IHC
this year, which highlight the onset of action of fremanezumab, in
addition to data on migraine-related disability and quality of life in
migraine patients.”
Teva-sponsored platform presentations:
[PO-01-196] Efficacy and Safety of 2 Dose Regimens of Subcutaneous
Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment
of Chronic Migraine (Platform Presentation, September 8, 2017,
7:20 p.m. to 7:30 p.m.)
[PO-01-201] Efficacy and Safety of 2 Dose Regimens of Subcutaneous
Administration of Fremanezumab (TEV-48125) Versus Placebo for the
Preventive Treatment of Episodic Migraine (Platform Presentation,
September 8, 2017, 7:30 p.m. to 7:40 p.m.)
Additional Teva-sponsored data to be presented:
[PO-01-183] Early Onset of Action of Fremanezumab (TEV-48125)
Versus Placebo for the Preventive Treatment of Chronic Migraine (Poster
Session 1, September 8, 2017, 11:00 a.m. to 12:00 p.m.)
[PO-01-186] The Impact of Fremanezumab on Headache-Related
Disability in Patients With Chronic Migraine Using the Headache Impact
Test (HIT-6) (Poster Session 1, September 8, 2017, 11:00 a.m. to
12:00 p.m.)
[PO-01-181] The Impact of Fremanezumab on Migraine-Specific
Health-Related Quality of Life and Overall Health Status in Chronic
Migraine (Poster Session 1, September 8, 2017, 11:00 a.m. to 12:00
p.m.)
[PO-01-182] The Positive Impact of Fremanezumab on Work
Productivity and Activity Impairment in Patients With Chronic Migraine (Poster
Session 1, September 8, 2017, 11:00 a.m. to 12:00 p.m.)
[PO-01-067] Burden of illness among treated migraine patients with
≥4 headache days in the past month (Poster Session 1, September
7-8, 2017, 11:00 a.m. to 12:00 p.m.)
[PO-01-068] The impact of headache free days on quality of life and
costs among people with migraine with ≥4 headache days in the past
month (Poster Session 1, September 7-8, 2017, 11:00 a.m. to 12:00
p.m.)
[EP-01-017] Fremanezumab (formerly TEV-48125) reduces headache pain
within the first week of beginning treatment in the phase 2 episodic
migraine study (Poster Session 1, September 7-8, 11:00 a.m. to
12:00 p.m.)
[PO-01-072] Sustained Reduction in Days Using Acute Medications
with Fremanezumab (TEV-48125) (Poster Session 1, September 7-8,
11:00 a.m. to 12:00 p.m.)
[PO-01-080] Treatment-Induced Improvement in Migraine
Classification in the Fremanezumab HFEM Study (Poster Session 1,
September 7-8, 11:00 a.m. to 12:00 p.m.)
[PO-01-082] Fremanezumab (formerly TEV-48125) decreases migraine
symptoms such as nausea, vomiting, photophobia and phonophobia and
reduces the need for acute medications in the first week of treatment
in the HFEM study (Poster Session 1, September 7-8, 11:00 a.m. to
12:00 p.m.)
[PO-01-190] A Phase 1 Study to Assess the Pharmacokinetics, Safety,
Tolerability and immunogenicity of Fremanezumab (formerly TEV-48125)
doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian Healthy
Subjects (Poster Session 1, September 7-8, 11:00 a.m. to 12:00
p.m.)
[PO-02-091] Current gaps and challenges in migraine care in Canada:
a multi-stakeholder perspective (Poster Session 2, September 9-10,
2017, 11:00 a.m. to 12:00 p.m.)
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 the HALO Clinical Research Program
The Phase III HALO EM and CM studies are 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 consist 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 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 the potential benefits and commercialization of 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 commercial success of Fremanezumab;
challenges inherent in product research and development, including
uncertainty of obtaining regulatory approvals;
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20170905005734/en/
Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.IR Contacts:Kevin C.
Mannix, United States, 215-591-8912Ran Meir, United
States, 215-591-3033Tomer Amitai, Israel, 972 (3) 926-7656orPR
Contacts:Iris Beck Codner, Israel, 972 (3) 926-7208Denise
Bradley, United States, 215-591-8974
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