Teva to Present Fremanezumab Data on Migraine Prevention at the 18th Congress of the International Headache Society
Teva Pharmaceutical Industries Ltd., (NYSE and TASE: TEVA) today announced that 12 scientific abstracts and two platform presentations evaluating fremanezumab will be presented at the 18th Congress of the International Headache Society (IHC) in Vancouver, Canada from September 7-10, 2017. Fremanezumab is an anti-calcitonin gene-related peptide (anti-CGRP) monoclonal antibody being investigated as a preventive treatment for migraine. These presentations include new data and analyses from the pivotal Phase III study in chronic migraine, as well as results from the Phase III study in episodic migraine, which will be presented for the first time.
“It is an extremely exciting time for the migraine community as new data emerge on investigational CGRP-targeted therapies,” said Michael Hayden, M.D., Ph.D., President of Global R&D and Chief Scientific Officer at Teva. “We are very proud and pleased to present the results of our fremanezumab clinical trials in chronic and episodic migraine at IHC this year, which highlight the onset of action of fremanezumab, in addition to data on migraine-related disability and quality of life in migraine patients.”
Teva-sponsored platform presentations:
- [PO-01-196] Efficacy and Safety of 2 Dose Regimens of Subcutaneous Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine (Platform Presentation, September 8, 2017, 7:20 p.m. to 7:30 p.m.)
- [PO-01-201] Efficacy and Safety of 2 Dose Regimens of Subcutaneous Administration of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Episodic Migraine (Platform Presentation, September 8, 2017, 7:30 p.m. to 7:40 p.m.)
Additional Teva-sponsored data to be presented:
- [PO-01-183] Early Onset of Action of Fremanezumab (TEV-48125) Versus Placebo for the Preventive Treatment of Chronic Migraine (Poster Session 1, September 8, 2017, 11:00 a.m. to 12:00 p.m.)
- [PO-01-186] The Impact of Fremanezumab on Headache-Related Disability in Patients With Chronic Migraine Using the Headache Impact Test (HIT-6) (Poster Session 1, September 8, 2017, 11:00 a.m. to 12:00 p.m.)
- [PO-01-181] The Impact of Fremanezumab on Migraine-Specific Health-Related Quality of Life and Overall Health Status in Chronic Migraine (Poster Session 1, September 8, 2017, 11:00 a.m. to 12:00 p.m.)
- [PO-01-182] The Positive Impact of Fremanezumab on Work Productivity and Activity Impairment in Patients With Chronic Migraine (Poster Session 1, September 8, 2017, 11:00 a.m. to 12:00 p.m.)
- [PO-01-067] Burden of illness among treated migraine patients with ≥4 headache days in the past month (Poster Session 1, September 7-8, 2017, 11:00 a.m. to 12:00 p.m.)
- [PO-01-068] The impact of headache free days on quality of life and costs among people with migraine with ≥4 headache days in the past month (Poster Session 1, September 7-8, 2017, 11:00 a.m. to 12:00 p.m.)
- [EP-01-017] Fremanezumab (formerly TEV-48125) reduces headache pain within the first week of beginning treatment in the phase 2 episodic migraine study (Poster Session 1, September 7-8, 11:00 a.m. to 12:00 p.m.)
- [PO-01-072] Sustained Reduction in Days Using Acute Medications with Fremanezumab (TEV-48125) (Poster Session 1, September 7-8, 11:00 a.m. to 12:00 p.m.)
- [PO-01-080] Treatment-Induced Improvement in Migraine Classification in the Fremanezumab HFEM Study (Poster Session 1, September 7-8, 11:00 a.m. to 12:00 p.m.)
- [PO-01-082] Fremanezumab (formerly TEV-48125) decreases migraine symptoms such as nausea, vomiting, photophobia and phonophobia and reduces the need for acute medications in the first week of treatment in the HFEM study (Poster Session 1, September 7-8, 11:00 a.m. to 12:00 p.m.)
- [PO-01-190] A Phase 1 Study to Assess the Pharmacokinetics, Safety, Tolerability and immunogenicity of Fremanezumab (formerly TEV-48125) doses (225 mg, 675 mg and 900 mg) in Japanese and Caucasian Healthy Subjects (Poster Session 1, September 7-8, 11:00 a.m. to 12:00 p.m.)
- [PO-02-091] Current gaps and challenges in migraine care in Canada: a multi-stakeholder perspective (Poster Session 2, September 9-10, 2017, 11:00 a.m. to 12:00 p.m.)
About Fremanezumab (TEV-48125)
Fremanezumab is a fully-humanized monoclonal antibody targeting the CGRP ligand, a well-validated target in migraine. With limited availability of preventive treatment options, fremanezumab represents a potential new option to address a significant unmet medical need.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies are 16-week, multicenter, randomized, double-blind, placebo-controlled, parallel-group studies to compare the safety, tolerability, and efficacy of four dose regimens of subcutaneous fremanezumab compared to placebo in adults with episodic and chronic migraine. The studies consist of a screening visit, a 28-day run-in period, and a 12-week (84-day) treatment period, including a final evaluation at week 12 (end-of-treatment [EOT] visit, four weeks [28 days] after the final dose of study drug).
- In the EM study, 875 patients were enrolled (294, 291, 290 patients in the placebo, quarterly, and monthly dose groups, respectively). Patients were randomized in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 225 mg for three months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo. The primary efficacy endpoint of the EM study was the mean change from baseline (28-day run-in period) in the monthly average number of migraine days during the 12-week period after the first dose of fremanezumab.
- In the CM study, 1,130 patients were randomized (around 376 patients per treatment group). Patients were randomized in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 675 mg at initiation followed by monthly 225 mg for two months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo. The primary efficacy endpoint of the CM study was the mean change from baseline (28-day run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of fremanezumab.
Migraine is an unpredictable neurological condition with symptoms such as severe head pain and physical impairment that can impact quality of life and productivity. There are two clinical manifestations of migraine – chronic, where patients suffer 15 or more headache days per month, and episodic, where patients have 14 or less headache days per month. Worldwide, approximately 90% of people diagnosed with migraine have episodic migraine and 10% have chronic migraine.
With more than 1 billion people affected worldwide, migraine is the third most prevalent illness in the world and the 6th most disabling illness in the world. In the U.S., EU5 and Japan, nearly 75 million people suffer from episodic and chronic migraine – more than 38 million in the U.S. alone. Of the approximately 40% of patients suffering from migraine for whom prevention is appropriate, only 13% are currently receiving therapy. There remains a significant medical need for treatments designed specifically to prevent migraine. According to recent analysis, the economic burden for migraine patients reaches approximately $78 billion per year in the U.S.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by approximately 200 million patients in over 60 markets 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 the world-leading innovative treatment for multiple sclerosis as well as late-stage development programs for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products. Teva is leveraging its generics and specialty capabilities in order to seek new ways of addressing unmet patient needs by combining drug development with devices, services and technologies. Teva's net revenues in 2016 were $21.9 billion. For more information, visit www.tevapharm.com.
Cautionary Statements Regarding Forward-Looking Information:
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the potential benefits and commercialization of 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:
- the uncertainty of commercial success of Fremanezumab;
- challenges inherent in product research and development, including uncertainty of obtaining regulatory approvals;
- our specialty medicines business, including: competition for our specialty products, especially Copaxone®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; our ability to achieve expected results from investments in our product pipeline; competition from companies with greater resources and capabilities; and the effectiveness of our patents and other measures to protect our intellectual property rights;
- our business and operations in general, including: our ability to develop and commercialize additional pharmaceutical products; 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 restructuring of our manufacturing network, including potential related labor unrest; the impact of continuing consolidation of our distributors and customers; and variations in patent laws that may adversely affect our ability to manufacture our products;
- 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; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; governmental investigations into sales and marketing practices; potential liability for sales of generic products prior to a final resolution of outstanding patent litigation; 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;
- and other factors discussed in our Annual Report on Form 20-F for the year ended December 31, 2016 (“Annual Report”), 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.
Teva Pharmaceutical Industries Ltd.
Kevin C. Mannix, United States, 215-591-8912
Ran Meir, United States, 215-591-3033
Tomer Amitai, Israel, 972 (3) 926-7656
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Denise Bradley, United States, 215-591-8974