JERUSALEM--(BUSINESS WIRE)--Jun. 15, 2018--
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
announced a change in the clinical development program of fremanezumab
in chronic cluster headache. The ENFORCE Phase III clinical development
program includes a chronic cluster headache study, an episodic cluster
headache study, and a long-term safety study. A pre-specified futility
analysis of the chronic cluster headache study revealed that the primary
endpoint of mean change from baseline in the monthly average number of
cluster headache attacks during the 12-week treatment period is unlikely
to be met. There were no safety concerns observed with fremanezumab
treatment in the trial.
Based on the study meeting the futility criteria, the Company will
discontinue the trial for chronic cluster headache. Chronic Cluster
Headache patients who participate in the long-term safety study, will
discontinue their participation in the long-term safety study as well.
The episodic cluster headache study is not affected and continues as
planned.
“While we are disappointed with this outcome, we remain optimistic that
fremanezumab could have clinical benefits in additional conditions,
beyond migraine, where calcitonin gene-related peptide (CGRP) plays a
contributory role in their pathophysiology. We would like to thank the
patients and investigators for their participation in the Chronic
Cluster Clinical Trial,” said Tushar Shah, M.D., Senior Vice President,
Head of Global Specialty Clinical Development at Teva.
Fremanezumab is currently under review by the U.S. Food and Drug
Administration (FDA), with an action date of September 16, 2018, and by
the European Medicines Agency (EMA), as a quarterly or monthly injection
for the preventive treatment of migraine in adults.
About Fremanezumab
Fremanezumab is a monoclonal antibody targeting the CGRP (calcitonin
gene-related peptide) ligand, currently under review by the U.S. Food
and Drug Administration (FDA) and the European Medicines Agency (EMA) as
a quarterly or monthly injection for the preventive treatment of
migraine in adults.
Fremanezumab is also being investigated as a preventive treatment for
several additional disorders including cluster headache and post
traumatic headache disorder.
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 millions of patients 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 a world-leading
position in innovative treatments for disorders of the central nervous
system, including pain, as well as a strong portfolio of respiratory
products. Teva integrates its generics and specialty capabilities in its
global research and development division to create new ways of
addressing unmet patient needs by combining drug development
capabilities with devices, services and technologies. Teva's net
revenues in 2017 were $22.4 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 ability to successfully compete in the marketplace, including:
that we are substantially dependent on our generic products;
competition for our specialty products, especially COPAXONE®, our
leading medicine, which faces competition from existing and potential
additional generic versions and orally-administered alternatives;
competition from companies with greater resources and capabilities;
efforts of pharmaceutical companies to limit the use of generics
including through legislation and regulations; consolidation of our
customer base and commercial alliances among our customers; the
increase in the number of competitors targeting generic opportunities
and seeking U.S. market exclusivity for generic versions of
significant products; price erosion relating to our products, both
from competing products and increased regulation; delays in launches
of new products and our ability to achieve expected results from
investments in our product pipeline; our ability to take advantage of
high-value opportunities; the difficulty and expense of obtaining
licenses to proprietary technologies; and the effectiveness of our
patents and other measures to protect our intellectual property rights;
-
our substantially increased indebtedness and significantly
decreased cash on hand, which may limit our ability to incur
additional indebtedness, engage in additional transactions or make new
investments, and may result in a further downgrade of our credit
ratings; and our inability to raise debt or borrow funds in amounts or
on terms that are favorable to us;
-
our business and operations in general, including: failure to
effectively execute the restructuring plan announced in December 2017;
uncertainties related to, and failure to achieve, the potential
benefits and success of our new senior management team and
organizational structure; harm to our pipeline of future products due
to the ongoing review of our R&D programs; our ability to develop and
commercialize additional pharmaceutical products; potential additional
adverse consequences following our resolution with the U.S. government
of our FCPA investigation; compliance with sanctions and other trade
control laws; 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 failure to recruit or retain key personnel; variations
in intellectual property laws that may adversely affect our ability to
manufacture our products; challenges associated with conducting
business globally, including adverse effects of political or economic
instability, major hostilities or terrorism; significant sales to a
limited number of customers in our U.S. market; our ability to
successfully bid for suitable acquisition targets or licensing
opportunities, or to consummate and integrate acquisitions; and our
prospects and opportunities for growth if we sell assets;
-
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;
governmental investigations into sales and marketing practices;
potential liability for patent infringement; 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;
-
other financial and economic risks, including: our exposure to
currency fluctuations and restrictions as well as credit risks;
potential impairments of our intangible assets; potential significant
increases in tax liabilities; and the effect on our overall effective
tax rate of the termination or expiration of governmental programs or
tax benefits, or of a change in our business;
and other factors discussed in our Annual Report on Form 10-K for the
year ended December 31, 2017, 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.
IR Contacts
United
States
Kevin C. Mannix, 215-591-8912
Ran Meir, 972 (3)
926-7516
or
Israel
Tomer Amitai, 972 (3) 926 7656
or
PR
Contacts
United States
Doris Saltkill, 913-777-3343
or
Israel
Yonatan
Beker, 972 (54) 888 5898