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Four oral presentations and eight posters highlight Teva’s commitment to patients with migraine worldwide
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that 12 new analyses will be presented at the 24th World Congress of Neurology (WCN), taking place in Dubai, United Arab Emirates on October 27-31, 2019. Among the analyses, Teva will present on fremanezumab’s efficacy by country in one of the three oral presentations from the international, multicenter, randomized, placebo-controlled Phase IIIb FOCUS study. The company will also provide data in an oral presentation on the burden of migraine across China, Israel, Russia, South Korea and Turkey, as well as a poster presentation evaluating the burden of migraine across Argentina, Brazil, Chile and Mexico.
“As the largest international study to date evaluating patients with an inadequate response to multiple classes of preventive migraine treatments, we are proud to be presenting the FOCUS results to a global audience,” said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache, Teva. “This broad range of data highlights our global commitment to helping patients with difficult to treat migraine as well as our leadership in the CNS therapeutic area of research.”
The FOCUS study evaluated the efficacy and safety of quarterly and monthly treatment with fremanezumab compared to placebo in adult patients with migraine and documented inadequate response to 2-4 classes of prior preventive treatments. Additional FOCUS data to be presented at WCN include data on reversion from chronic to episodic migraine, data on the odds of achieving meaningful response rates on fremanezumab as compared to placebo,and an analysis demonstrating a significant reduction in the frequency of migraine aura in patients treated with fremanezumab compared to placebo.
Data to be presented include:
The Phase IIIb FOCUS study is a multicentre, randomised, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy, safety, and tolerability of quarterly and monthly treatment with fremanezumab, compared to placebo. Adult patients with chronic migraine or episodic migraine who have responded inadequately to 2-4 classes of prior preventive treatments were enrolled in the study.
Inadequate response is defined as: lack of efficacy after at least three months of therapy at a stable dose; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient. The classes of prior preventive medications include: beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, and valproic acid.
In the study, chronic migraine and episodic migraine patients were randomised in blinded-fashion 1:1:1 into one of three treatment groups – a quarterly dosing regimen, a monthly dosing regimen or matching placebo. An open-label extension of three months (weeks 13-24) followed the placebo-controlled portion of the study.
About the HALO Clinical Research Program
The Phase III HALO EM and CM studies were 16-week, multicentre, randomised, double-blind, placebo-controlled, parallel-group studies to compare the safety, tolerability, and efficacy of four dose regimens (two for EM [quarterly and monthly] and two for CM [quarterly and monthly]), of subcutaneous fremanezumab compared to placebo in adults with episodic and chronic migraine. The studies consisted 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).
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 3,500 products in nearly every therapeutic area. Around 200 million people around the world take a Teva medicine every day, and are 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 Fremanezumab (commercialized as AJOVY®), 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 Quarterly Reports on Form 10-Q for the first and second quarter of 2019 and in our Annual Report on Form 10-K for the year ended December 31, 2018, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” 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.
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Source: Teva Pharmaceutical Industries Ltd.