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Teva to Present New Data on AJOVY® (fremanezumab-vfrm) Injection Open-Label Extension Study at American Headache Society Annual Meeting

June 15, 2020 Off By BusinessWire

TEL AVIV & PARSIPPANY, N.J.–(BUSINESS WIRE)–Teva Pharmaceuticals USA, Inc., an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced 24 abstracts featuring data on AJOVY® (fremanezumab-vfrm) injection will be presented at the American Headache Society (AHS) Virtual Annual Scientific Meeting which began June 13. AJOVY, indicated for the preventive treatment of migraine in adults, is the only long-acting anti-CGRP subcutaneous injection with the option of dosing only four times per year.i*+

The data presented at AHS will focus on disability, quality-of-life and work productivity during the 12-week open label extension of the FOCUS Phase IIIb clinical trial, which evaluated AJOVY in adult patients with migraine and documented inadequate response to 2-4 classes of prior preventive treatments. Additional abstracts examine disability outcome measurements from pooled analyses of three AJOVY Phase III trials – FOCUS, HALO-Episodic Migraine, and HALO-Chronic Migraine.

“Migraine is the second leading cause of years lived with disability and imposes physical, emotional, and societal burdens worldwide,” said Denisa Hurtukova, MD, Vice President, Head of North America Medical Affairs. “We are committed to advancing the understanding of the AJOVY patient experience by continuing to examine patients with difficult-to-treat migraine.”

All presentations can be accessed through the AHS website.

The full list of Teva abstracts being presented includes:

FOCUS Study Including Open-Label Extension

Disability, Quality of Life, Patient Satisfaction & Depression

  • Health-Related Quality of Life Outcomes With Fremanezumab in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medication: Open-label Extension of the FOCUS Phase 3b Study
  • Work Productivity and Activity Impairment Outcome With Fremanezumab in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications: Open-label Extension of the Phase 3b FOCUS Study
  • Patient Satisfaction With Fremanezumab During the Open-label Period of the Phase 3b FOCUS Study in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications
  • Effect of Fremanezumab on Depression Status in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications During the Open-label Period of the Phase 3b FOCUS Study
  • Impact of Fremanezumab on Headache-related Disability in Patients With Migraine Who Failed 2-4 Classes of Preventive Medication: Results of the Open–label Extension of the Phase 3b FOCUS Study
  • Impact of Fremanezumab on Migraine-specific Quality of Life in Patients With Medication Overuse and Documented Inadequate Response to 2-4 Migraine Preventive Medication Classes in the FOCUS Study

Efficacy and Safety

  • Efficacy of Fremanezumab by Prior Number of Preventive Treatments With Inadequate Response in Patients With Episodic Migraine and Chronic Migraine: Results of the International, Multicenter Phase 3b FOCUS Study
  • Efficacy and Safety of Fremanezumab in Patients With Episodic and Chronic Migraine and Inadequate Response to 2-4 Classes of Preventive Medications: Results of the Open-label Period of the Phase 3b FOCUS Study
  • Clinically Meaningful Responses to Fremanezumab in Patients With Migraine Who Failed 2–4 Classes of Migraine Preventive Medication: Results of the Open–label Period of the Phase 3b FOCUS Study
  • Impact of Fremanezumab on Migraine-associated Symptoms in Patients With Migraine Who Failed 2-4 Classes of Preventive Medications: Results of the Open-label Period of the Phase 3b FOCUS Study

Subgroup Analyses

  • Impact of Fremanezumab on Disability in Migraine Patients With Medication Overuse and Documented Inadequate Response to 2-4 Classes of Preventive Treatments: Subgroup Analysis of the FOCUS Study
  • Efficacy of Fremanezumab in Male Patients With Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Treatments: Results of the Randomized, Placebo-controlled FOCUS Study

Pooled Phase III Results

  • Impact of Fremanezumab on Disability Severity According to the AHS Consensus: Pooled Results of 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies
  • Disability Severity Category Shift with Fremanezumab Treatment: Pooled Results of 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies
  • Efficacy of Fremanezumab Treatment in Patients ≥60 Years of Age With Episodic or Chronic Migraine: Pooled Results of 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies
  • Improvements in Headache-related Disability With Fremanezumab in Patients ≥60 Years of Age With Migraine: Pooled Results of 3 Randomized, Double-blind, Placebo-controlled Phase 3 Studies
  • Improvements in Quality-of-Life, Productivity, and Satisfaction With Fremanezumab in Migraine Patients ≥60 Years of Age: Pooled Results of 3 Randomised, Double-blind, Placebo-controlled Phase 3 Studies
  • Pooled Analysis of Cardiovascular Safety With Fremanezumab Treatment in Patients With Migraine by Number of Cardiovascular or Cerebrovascular Risk Factors
  • Pooled Analysis of Tolerability With Fremanezumab Treatment in Patients With Episodic or Chronic Migraine and Cardiovascular Medication Use at Baseline
  • Pooled Analysis of Cardiovascular Safety With Fremanezumab Treatment in Patients With Migraine and Concomitant Triptan Use

Migraine & Headache Disease State

  • Depression and Migraine – a Double Whammy on Patient-reported Health
  • Narrative Review of Risk Factors and the Burden of Medication Overuse Headache on Quality-of-life and Co-morbidities

Real-World Perspectives

  • A Real-World Perspective of Patients With Episodic Migraine or Chronic Migraine Prescribed AJOVY in the United States

Patient Characteristics

  • Treatment Patterns and Characteristics of Patients Prescribed AJOVY, Emgality, or Aimovig

About AJOVY® (fremanezumab-vfrm) injection

AJOVY is available as a 225 mg/1.5 mL single dose injection in a prefilled syringe with two dosing options – 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), which is administered as three subcutaneous injections. AJOVY can be administered in office by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment. The AJOVY autoinjector has been approved by the FDA and is available in the U.S. In addition to the U.S., the AJOVY autoinjector is currently available in Germany and should soon be available in other select European markets.

U.S. Important Safety Information about AJOVY® (fremanezumab-vfrm) injection

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

Please click here for full U.S. Prescribing Information for AJOVY® (fremanezumab-vfrm) injection.

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 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 AJOVY® (fremanezumab-vfrm) Injection, 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:

  • our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; 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; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success of AJOVY or AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations and the effectiveness of our patents and other measures to protect our intellectual property rights;
  • our business and operations in general, including: duration, and geographic reach of the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; interruptions in our supply chain, including due to potential effects of the COVID-19 pandemic on our operations and business in geographic locations impacted by the pandemic and on the business operations of our customers and suppliers; adequacy of and our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; implementation of our restructuring plan announced in December 2017; challenges associated with conducting business globally, including adverse effects of the COVID-19 pandemic, political or economic instability, major hostilities or terrorism; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption sanctions and trade control laws; manufacturing or quality control problems; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
  • compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject or delays in governmental processing time including due to modified government operations due to the COVID-19 pandemic and effects on product and patent approvals; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M 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 Quarterly Report on Form 10-Q for the first quarter of 2020 and our Annual Report on Form 10-K for the year ended December 31, 2019, 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.

i AJOVY(fremanezumab-vfrm) injection Current Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.

* “Long-acting” defined as efficacy measured over a 12-week period following a 675 mg (225 mg x 3) SC dose.i

+ 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), which is administered as three subcutaneous injections.

Contacts

IR Contacts

United States
Kevin C. Mannix

(215) 591-8912

Ran Meir

972 (3) 926-7516

PR Contacts
United States
Doris Li

(973) 265-3752

Israel
Yonatan Beker

972 (54) 888 5898