April 24, 2019 PR-M04-19-NI-077
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.
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 statements.
IR Contacts
United States
Kevin C. Mannix, (215) 591-8912
Ran Meir, 972 (3) 926-7516
PR Contacts
United States
Doris Saltkill, (913) 777-3343
Israel
Yonatan Beker, 972 (54) 888 5898
Nice Insight, established in 2010, is the research division of That’s Nice, A Science Agency, providing data and analysis from proprietary annual surveys, custom primary qualitative and quantitative research as well as extensive secondary research. Current annual surveys include The Nice Insight Contract Development & Manufacturing (CDMO/CMO), Survey The Nice Insight Contract Research - Preclinical and Clinical (CRO) Survey, The Nice Insight Pharmaceutical Equipment Survey, and The Nice Insight Pharmaceutical Excipients Survey.
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.