TEVA Teva Pharmaceutical Industries Ltd

• Teva presents 17 posters and three oral presentations at EHF 2019 highlighting long-term and FOCUS Phase IIIb study data
• The poster presentations highlight FOCUS data in migraine patients who have failed two to four classes of prior migraine preventive medications; as well as present further clinical study data regarding the efficacy and safety results of fremanezumab through 12 months of treatment in patients with chronic and episodic migraine

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that data from the Phase IIIb FOCUS study, which evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate response to two to four classes of migraine preventive treatments, will be available at the 13th European Headache Federation (EHF) Congress. This European Congress for healthcare professionals aims to improve the lives of patients affected by migraine by presenting new scientific evidence on migraine prevention, associated comorbidities and the pathogenesis of migraine. EHF is taking place at the ‘Megaron’ Athens International Conference Centre (MAICC), Athens, Greece on May 30th - June 1st 2019.

The FOCUS study is the largest study to date in patients who inadequately responded to multiple classes of preventive migraine treatments. It is the first study of its type to be conducted in chronic as well as episodic migraine patients.

Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache at Teva said: “Patients with inadequate response to multiple migraine preventive treatment classes have significant unmet need for the management of their disabling migraine. The FOCUS study results demonstrate the benefit of fremanezumab in addressing the burden of disease in this difficult-to-treat patient population. Teva is committed to meet the needs of migraine patients and their families and we will explore undertaking Phase IV studies with fremanezumab in order to increase our understanding of the disease.”

Professor of Neurology and Chair of the Leiden Centre for Translational Neuroscience at Leiden University Medical Centre, Michel D. Ferrari, MD, PhD, FANA, FRCP said: “The FOCUS study data convincingly show that patients with difficult to treat migraine, previously not responding to up to four migraine preventive treatment classes, might still benefit significantly from treatment with fremanezumab. I am delighted that this data will be presented for the first time at the EHF Congress in Athens.”

In the FOCUS study, patients treated with fremanezumab experienced significant reduction in the monthly average number of migraine days versus placebo over the 12-week treatment period, for both monthly and quarterly dosing regimens. In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both quarterly and monthly dosing regimens. Teva will also host a satellite symposium on Friday during the congress.

Notes to the Editor

The full set of Teva-sponsored data to be presented includes:

Oral presentations:

30th May 201912.00pm – 12.15pmPresenter: Prof. Messoud Ashina

Efficacy and safety of fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study.

31st May 201914.45pm – 15.00pmPresenter: Prof. Richard Lipton

Long-term efficacy of fremanezumab in patients who reverted from a chronic to an episodic migraine classification.

31st May 201915.00pm – 15.15pmPresenter: Joshua M. Cohen

Efficacy, clinically meaningful responses, and impact on acute headache medication use with fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study.

e-Poster presentations

FOCUS Study:The FOCUS Study provides data in migraine patients who responded inadequately to two to four classes of prior migraine preventive medications.

Titles of the presentations include:

• Efficacy of fremanezumab in patients with migraine and documented inadequate response to 2, 3, or 4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study
• Early onset of response to fremanezumab in patients with migraine and a documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study
• Impact of age and sex on efficacy of fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study

Long-Term Study:The following presentations will be presented:

Efficacy

• Improvement in response over time with fremanezumab in patients who reverted from a chronic to an episodic migraine classification
• Long-term impact of fremanezumab on patients who reverted from a chronic to an episodic migraine classification
• Long-term efficacy and safety of fremanezumab in migraine: results of a 1-year study
• Long-term efficacy of fremanezumab in patients with chronic migraine with concomitant preventive medication use
• Long-term impact of fremanezumab on response rates: results of a 1-year study
• Long-term safety of fremanezumab: results of a 1-year study
• Quarterly administration of fremanezumab does not show “wearing off” effect during third month after injection

Comorbidity/Disability

• Long-term efficacy of fremanezumab in patients with chronic migraine and comorbid moderate to severe depression
• Long-term impact of fremanezumab on response rates, acute headache medication use, and disability in patients with chronic migraine: results of a 1-year study
• Long-term impact of fremanezumab on headache-related disability, quality of life, and patient satisfaction in episodic migraine and chronic migraine
• Long-term impact of fremanezumab on response rates, acute headache medication use, and disability in patients with episodic migraine: results of a 1-year study

Meta analyses

• Reduction in monthly migraine days (MMDs) with fremanezumab and erenumab among patients with chronic migraine (CM) with 2 to 4 prior treatment failures: A Network Meta-Analysis
• Reduction in monthly migraine days (MMDs) with fremanezumab and erenumab among patients with episodic migraine (EM) with 2-4 prior treatment failures: A Network Meta-Analysis
• Comparison of responder rates between fremanezumab, erenumab and onabotulinumtoxinA among patients with migraine with ≥3 prior treatment failures: A Network Meta-Analysis

Teva Symposium

Migraine Burden in Europe: What Role Can Innovations Play?

Chair: Professor Dimos D. Mitsikostas, MD, PhD, FEAN

Friday 31st May, 15:45 – 17:00, ‘Megaron’ Athens International Conference Centre (MAICC), Alexandra Trianti Hall

Educational Symposium Program Overview:Migraine remains a leading cause of disability in the European Union (EU) and is associated with a substantial economic and societal burden. However, the recent introduction of monoclonal antibodies (mAbs) that target calcitonin gene-related peptide into the treatment armamentarium offers a potential means to ease the burden of migraine on both patients and the EU healthcare system. This program will examine the epidemiology of migraine, along with its social and financial impacts; explain the scientific advancements behind the clinical utility of mAbs; and discuss findings from 2 clinical studies of the mAb fremanezumab for migraine prevention; a long-term study and a study in patients with refractory episodic and chronic migraine.

The full online programme can be accessed via the congresses official website: https://www.ehf2019.com/calendar

About FOCUS

The Phase IIIb FOCUS study is a multicenter, randomized, 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 two to four 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 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 randomized 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 Migraine

Migraine is a disabling neurological disease characterized by severe head pain, nausea and vomiting.i With more than 1 billion people affected worldwidei, migraine is the third most prevalent disease in the world.ii

About Teva

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. 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

Teva 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:

• the uncertainty of commercial success of AJOVY®;
• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions and orally-administered alternatives; the uncertainty of commercial success of AJOVY® and AUSTEDO®; competition from companies with greater resources and capabilities; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations; consolidation of our customer base and commercial alliances among our customers; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; price erosion relating to our products, both from competing products and increased regulation; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; our ability to take advantage of high-value opportunities; the difficulty and expense of obtaining licenses to proprietary technologies; and the effectiveness of our patents and other measures to protect our intellectual property rights;
• our substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
• our business and operations in general, including: failure to effectively execute our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our new senior management team and organizational structure; harm to our pipeline of future products due to the ongoing review of our R&D programs; our ability to develop and commercialize additional pharmaceutical products; potential additional adverse consequences following our resolution with the U.S. government of our FCPA investigation; compliance with sanctions and other trade control laws; 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 failure to recruit or retain key personnel; variations in intellectual property laws that may adversely affect our ability to manufacture our products; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; significant sales to a limited number of customers in our U.S. market; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
• 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; governmental investigations into selling and marketing practices; potential liability for patent infringement; 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;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities; and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;
• 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.

  ▼ Adverse events should be reported.   This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events.  

Reporting forms and information can be found at https://www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. Adverse events should also be reported to Teva – please refer to local numbers.

 

i Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed November 2018.ii Migraine Trust. Facts and Figures. https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/. Accessed November 2018.

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