CategoryMiddle East and North Africa news

Teva drops clinical development program for use of fremanezumab in episodic cluster headache

April 24, 2019 Off By BusinessWire

JERUSALEM–(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.