Late-breaking abstract highlights a network meta-analysis on monthly migraine day reductions with AJOVY, Nurtec^® ODT (Rimegepant) and Atogepant in the preventive treatment of episodic migraine

Showcasing Teva’s Commitment to Helping Patients Have More Migraine-Free Days, 18 Abstracts will be presented, Including One Late-Breaker, on AJOVY^® (fremanezumab-vfrm) Injection at the International Headache Society and European Headache Federation Joint Congress 2021

Teva Pharmaceuticals USA, Inc., a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that 17 presentations, including one late-breaker, examining post hoc, real-world and survey data for AJOVY (fremanezumab-vfrm) injection will be presented at the International Headache Society and European Headache Federation Joint Congress, taking place virtually on Sept. 8-12, 2021.

“Migraine affects over a billion people worldwide¹, and its impact is felt by patients, caregivers, and society as a whole all around the world. We continue to advance the clinical understanding of how AJOVY can help more people have more days free from migraine,” said Matthias Mueller, MD MSc, VP Global Medical Affairs - Global Therapeutic Areas and Scientific Communications at Teva. “The data to be presented at the joint congress bring us one step closer to understanding how AJOVY might extend the time between migraine attacks to help lessen the impact of migraine worldwide.”

Late-breaking data being presented include a fixed-effect Bayesian network meta-analysis (NMA) assessing relative efficacy for monthly and quarterly AJOVY, daily and twice daily Atogepant and every other day Rimegepant for the preventive treatment of episodic migraine (EM).

Additional data being presented include Phase 3 post hoc analyses assessing:

• Headache-free days (HFD) and migraine-free days (MFD) gained in patients using fremanezumab from a one-year extension study of the HALO long-term study (LTS).
• The maximum number of consecutive MFD for patients treated with fremanezumab after inadequate response to 2-4 prior migraine preventive medication classes in the FOCUS trial.
• The shift in migraine frequency category for participants treated with fremanezumab from a pooled analysis of three Phase 3, double-blind, placebo-controlled trials: HALO CM, HALO EM and FOCUS.

Teva will host an online symposium, “The Spectrum of CGRP Monoclonal Antibodies: Bringing the science to clinical practice,” on Thursday, September 9 from 17:45-19:15 CEST, after which will be available for on-demand viewing. The symposium will be led by Simona Sacco, Professor of Neurology, University of L'Aquila, Italy, and feature perspectives from Professor Zaza Katsarava, Dr. Deb Friedman and Dr. Larry Charleston, IV on topics including the right patients and timing for treatment with CGRP mAbs, effective migraine prevention beyond headache, and real-world study efficacy, with a focus on complementing clinical trials and validating use in clinical practice.

Teva will also host a Meet the Expert Live session on September 10 from 17:30-18:00 CEST, after which will be available for on-demand viewing, that will discuss the current state of healthcare disparities in headache medicine both in practice and in research. The focus will include diversity, equity and inclusion disparities across diverse populations, as well as a discussion on potential solutions leading to optimal outcomes. “Migraine does not discriminate, and we’ll discuss disparities in headache medicine across diverse populations during our Meet the Expert session. Every patient should have an opportunity to experience fewer days with migraine and headache, and addressing disparities in migraine management is a core value of our work at Teva,” said Matthias Mueller, MD MSc, VP Global Medical Affairs - Global Therapeutic Areas and Scientific Communications at Teva.

This year’s joint IHC/EHF meeting is fully virtual. Data presentations can be accessed by registering for the meeting.

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

De novo

• Network Meta-analysis on Monthly Migraine Day Reductions With Fremanezumab, Rimegepant, and Atogepant in the Prevention of Episodic Migraine
• Time Gained With Long-term Fremanezumab Treatment in Patients With Chronic and Episodic Migraine
• Pooled analysis of the timing and location of injection-site adverse events with fremanezumab in patients with migraine
• Changes in the Number of Non-headache Days and Functioning on Those Days With Fremanezumab Treatment in Patients With Migraine: A Pooled Analysis
• Efficacy of Fremanezumab in Migraine Patients With Pain or Psychiatric Comorbidities and Documented Inadequate Response to 2-4 Prior Migraine Preventive Medication Classes
• Responder Rates for Reductions in Nausea or Vomiting and Photophobia and Phonophobia in Patients Treated With Fremanezumab in the HALO CM, HALO EM, HALO LTS, and FOCUS Studies
• Long-term Tolerability and Improvements in Disability and Quality of Life With Fremanezumab in Patients With Chronic or Episodic Migraine and Documented Inadequate Response to 2-4 Prior Classes of Migraine Preventive Medications
• Reductions in Migraine Frequency With Fremanezumab Treatment in Individuals With Chronic and Episodic Migraine
• Long-term Fremanezumab Treatment Over 6 to 12 Months Shows No Effect on Blood Pressure in Migraine Patients
• Consecutive Migraine-free Days With Fremanezumab Treatment: Results of the Double-blind, Placebo-controlled FOCUS Study
• Long-term Efficacy of Fremanezumab in Patients With Chronic or Episodic Migraine and Documented Prior Inadequate Response to 2-4 Classes of Migraine Preventive Medications
• FINESSE: Fremanezumab for Preventive Treatment in Migraine

Encore

• Migraine Burden and Impact: Survey Results From 6 Countries in South America, Asia, and Australia
• Impact of Fremanezumab Treatment on Clinical Outcomes Among Migraine Patients With Comorbid Depression, Anxiety or Hypertension in a Real-World Setting
• Pooled Analysis of the Effectiveness of Fremanezumab in Patients With Lower- and Higher-frequency Chronic Migraine
• Pooled Analysis of the Efficacy of Fremanezumab in Persons With Moderate- and Higher-frequency Episodic Migraine
• Patient Perception of Migraine Impact and Burden: Survey Results From 10 European Countries
• Primary Headache Disorders and Acute Medications Associated With Medication Overuse Headache: Analysis of US Claims Data

Information for Europe about AJOVY▼ can be found here.

▼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.hpra.ie. Adverse events should also be reported to Teva – please refer to local numbers.

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. Reactions have included anaphylaxis and angioedema.

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. Cases of anaphylaxis and angioedema have been reported in the postmarketing setting. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions in clinical trials (≥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, 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. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the commercial success of AJOVY; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO^®, AJOVY and COPAXONE^®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general, 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, costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the section 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.

References

¹Migraine Facts. Migraine Research Foundation. Accessed June 2021. https://migraineresearchfoundation.org/about-migraine/migraine-facts/

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