Teva to Present New Fremanezumab Data, Including Long-Term Data, at the American Headache Society’s 60th Annual Scientific Meeting

One late breaker, three platform presentations and 23 posters showcase fremanezumab as an investigational treatment for the prevention of migraine

JERUSALEM--(BUSINESS WIRE)--Jun. 28, 2018-- Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced 23 abstracts, one late-breaking poster and three oral presentations of fremanezumab for the preventive treatment of migraine which will be presented at the American Headache Society’s (AHS) 60th Annual Scientific Meeting in San Francisco from June 28-July 1, 2018. This is the first time that one-year analyses of fremanezumab are being presented. The new data include long-term response rates, acute headache medication use, and disability. Additional data presentations from clinical trials of fremanezumab examine efficacy, safety, quality-of-life impact, and reversion of patients from chronic to episodic migraine. Fremanezumab is an investigational therapy currently under review by the U.S. Food and Drug Administration (FDA) as a quarterly or monthly injection for the preventive treatment of migraine in adults.

“Migraine remains a challenging disease with considerable unmet need, due to availability of few therapeutic innovations over the past 25 years,” said Tushar Shah, M.D., Senior Vice President, Head of Global Specialty Clinical Development at Teva. “Teva is committed to developing novel treatments for patients with migraine headaches. We are excited to share additional data at the meeting on fremanezumab, particularly over the long-term, which is critical to patients.”

Antibodies targeting calcitonin gene-related peptides (anti-CGRPs), such as fremanezumab, are a new class of therapies developed for the prevention of migraine in adults.

Teva-sponsored abstracts at the AHS Annual Scientific Meeting include:

Late-Breaking Poster Presentation:

  • Response Over Time with Fremanezumab in the Treatment of Chronic and Episodic Migraine (Poster PF111)
    • Friday, June 29, poster Q&A, 1:15 - 2:15 pm PT

Platform Presentations:

  • The Impact of Fremanezumab on Medication Overuse in Patients with Chronic Migraine (IOR07)
    • Saturday, June 30, 8:00 am - 10:00 am PT
    • Presentation time: 9:00 am - 9:10 am PT
  • Response with Fremanezumab in the Treatment of Chronic Migraine (IOR11)
    • Saturday, June 30, 8:00 am - 10:00 am PT
    • Presentation time: 9:40 am - 9:50 am PT
  • Reversion of Patients with Chronic Migraine to an Episodic Migraine Classification with Fremanezumab Treatment (OR15)
    • Saturday, June 30, 2:15 pm - 3:45 pm PT
    • Presentation time: 2:15 pm - 2:25 pm PT

Long-Term Impact of Fremanezumab Posters (Yerba Buena Ballroom in the San Francisco Marriott Marquis):

  • Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients with Chronic Migraine: Interim Results of a One-Year Study (Poster PF14)
    • Friday, June 29, 1:15 - 2:15 pm PT
  • Fremanezumab Long-Term Efficacy and Safety: Interim Results of a One-Year Study (Poster PS30)
    • Saturday, June 30, 1:15 - 2:15 pm PT
  • Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients with Episodic Migraine: Interim Results of a One-Year Study (Poster PS35)
    • Saturday, June 30, 1:15 - 2:15 pm PT

Friday, June 29 Poster Sessions (Yerba Buena Ballroom in the San Francisco Marriott Marquis); presentations between 1:15 - 2:15 pm PT

  • Impact of Fremanezumab on the Number of Days with Use of Acute Headache Medications in Chronic Migraine (Poster PF08)
  • Efficacy of Fremanezumab in Patients with Chronic Migraine Who Had Prior Use of Topiramate or OnabotulinumtoxinA (Poster PF09)
  • The Impact of Fremanezumab on Headache-related Disability in Patients with Chronic Migraine Using the Headache Impact Test (HIT-6) (Poster PF12)
  • The Impact of Fremanezumab on Symptoms Associated with Migraine in Patients with Chronic Migraine (Poster PF15)
  • Onset of Action with Fremanezumab versus Placebo for the Preventive Treatment of Chronic Migraine (Poster PF19)
  • The Impact of Fremanezumab on Migraine-specific Health-related Quality of Life and Overall Health Status in Chronic Migraine (Poster PF23)
  • Efficacy of Fremanezumab on Migraine Frequency and Depression in Patients with Chronic Migraine and Comorbid Moderate to Moderately Severe Depression (Poster PF24)
  • The Impact of Fremanezumab on Work Productivity and Activity Impairment in Patients with Chronic Migraine (Poster PF33)
  • Onset of Action with Fremanezumab versus Placebo for the Preventive Treatment of Episodic Migraine (Poster PF43)
  • Impact of Fremanezumab on the Number of Days with Use of Acute Headache Medications in Episodic Migraine (Poster PF44)
  • Burden of Illness Among Treated Migraine Patients with ≥4 Headache Days in the past Month (Poster PF79)
  • The Impact of Fremanezumab on Headache-related Disability in Patients with Episodic Migraine Using the Migraine Disability Assessment (Poster PF82)
  • The Impact of Fremanezumab on Migraine-Specific Health-Related Quality of Life in Episodic Migraine (Poster PF87)

Saturday, June 30 Poster Sessions; (Yerba Buena Ballroom in the San Francisco Marriott Marquis); presentations between 1:00 - 2:15 pm PT

  • Relationship Between Fremanezumab Exposure and Efficacy in Preventive Therapy of Chronic Migraine in Adults (Poster PS31)
  • Relationship Between Fremanezumab Exposure and Efficacy in Preventive Therapy of Episodic Migraine in Adults (Poster PS32)
  • Efficacy of Fremanezumab in Patients with Episodic Migraine Who Had Prior Use of Topiramate or OnabotulinumtoxinA (Poster PS34)
  • Overview of Fremanezumab Pooled Safety Data from Placebo-Controlled Phase 2 and 3 Studies (Poster PS40)
  • Fremanezumab Cardiovascular Safety Profile: Pooled Data from Placebo-controlled and Long-term Studies (Poster PS41)
  • Lack of Relationship Between Fremanezumab Exposure and Cardiovascular Adverse Events in Phase 2 and 3 Data Including Chronic and Episodic Migraine Patients (Poster PS47)
  • The Impact of Fremanezumab on Symptoms Associated with Migraine in Patients with Episodic Migraine (Poster PS59)

About Fremanezumab

Fremanezumab is an investigational therapy currently under review by the FDA as a quarterly or monthly injection for the preventive treatment of migraine in adults.

Fremanezumab is a monoclonal antibody targeting the CGRP (calcitonin gene-related peptide) ligand, currently being investigated as a preventive treatment for migraine. With limited availability of preventive treatment options, fremanezumab represents a potential new option to address a significant unmet medical need.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients 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 a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2017 were $22.4 billion. For more information, visit 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, 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 obtaining regulatory approvals for Fremanezumab;
  • the uncertainty of commercial success of Fremanezumab;
  • 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; 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 substantially increased indebtedness and significantly decreased cash on hand, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, and 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 the 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 sales 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, 2017, 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.

Source: Teva Pharmaceutical Industries Ltd.

Teva Pharmaceutical Industries Ltd.
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