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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.
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.
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:
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
View source version on businesswire.com:
Kevin C. Mannix, (215)
591-8912Ran Meir, 972 (3) 926-7516
Doris Saltkill, (913)
777-3343IsraelYonatan Beker, 972 (54) 888 5898
Source: Teva Pharmaceutical Industries Ltd.