Teva Announces Update on Fremanezumab Clinical Development for use in Episodic Cluster Headache
April 23 2019 - 9:00AM
Business Wire
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today
provided an update that the Company is discontinuing the clinical
development program for use of fremanezumab in cluster headaches. A
pre-specified futility analysis of a Phase III study in episodic
cluster headache revealed that the study’s primary endpoint of mean
change from baseline in the weekly average number of cluster
headache attacks during the 4-week treatment period is unlikely to
be met.
As a result of the above, Teva is discontinuing the ENFORCE
Phase III clinical trial program, which also includes a long-term
safety study. The program previously included a chronic cluster
headache study, which was discontinued in June of 2018. Teva
continues to explore other uses for fremanezumab, including the
treatment of post-traumatic headache (currently being studied in a
Phase II trial).
“We’d like to thank the patients and investigators for their
immense contributions to this study. Despite these results, we are
continuing to evaluate if fremanezumab treatment can provide
clinical benefits in additional diseases where anti-calcitonin
gene-related peptide (CGRP) therapy may play a role in its
pathophysiology,” said Tushar Shah, M.D., Senior Vice President,
Head of Global Specialty Clinical Development at Teva.
About Fremanezumab
Fremanezumab is a humanized monoclonal antibody that binds to
the calcitonin gene-related peptide (CGRP) ligand and blocks its
binding to the receptor. Fremanezumab is considered an
investigational compound in the treatment of cluster headache or
post-traumatic headache and is not approved by any regulatory
agency for those uses.
About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has
been developing and producing medicines to improve people’s lives
for more than a century. We are a global leader in generic and
specialty medicines with a portfolio consisting of over 35,000
products in nearly every therapeutic area. 200 million people
around the world take a Teva medicine every day, served by one of
the largest and most complex supply chains in the pharmaceutical
industry. Along with our established presence in generics, we have
significant innovative research and operations supporting our
growing portfolio of specialty and biopharmaceutical products.
Learn more at 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 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:
- challenges inherent in product research
and development, including uncertainty of clinical success and
obtaining regulatory approvals for additional indications 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; the uncertainty of commercial
success of AJOVY® and AUSTEDO®; 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 substantial indebtedness, which may
limit our ability to incur additional indebtedness, engage in
additional transactions or make new investments, 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 our 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 selling 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, 2018, including the sections
thereof captioned "Risk Factors." 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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IR ContactsUnited StatesKevin C. Mannix, (215)
591-8912Ran Meir, 972 (3) 926-7516
PR ContactsUnited StatesDoris Saltkill, (913)
777-3343IsraelYonatan Beker, 972 (54) 888 5898
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