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.
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.
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:
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.