AJOVY data highlight efficacy and safety in difficult-to-treat migraine
GALA open-label extension study evaluates 7-year efficacy and safety results of COPAXONE
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that new data on AJOVY® (fremanezumab) and the burden of migraine in Europe will be presented at the 6th Congress of the European Academy of Neurology (EAN), being held virtually from 23-26 May 2020. Additionally, Teva will present data on the long-term safety and efficacy of COPAXONE® (glatiramer acetate injection). This year’s EAN congress is a virtual meeting due to the global coronavirus pandemic. All Teva abstracts will be published in a supplement to the European Journal of Neurology.
The new data, shared across nine ePresentations and three ePosters, reinforce the importance of continuing to study therapies that impact large patient populations. As the third-most prevalent disease in the world, affecting over one billion people globallyi, migraine imposes physical, emotional and societal burdens worldwideii,iii,iv,v,vi with limited treatment options available to many patients.
"Teva has a deep history in neurology and these data demonstrate our continued commitment to advancing solutions for patients with unmet needs," said Matthias Mueller, MD MSc, VP Global Medical Affairs - Global Therapeutic Areas and Scientific Communications, Teva. "We look forward to presenting these new data, which include pooled results of our AJOVY Phase 3 trials and a 7-year evaluation of COPAXONE. We are proud of our ongoing efforts in evaluating the social impact and burden of migraine. It is critically important to understand the global impact of migraine and we are committed to collecting real-world data that can educate the broader healthcare population. We are also committed to evaluating treatment options for patients living with multiple sclerosis (MS), as demonstrated by our analysis of the long-term efficacy and safety of COPAXONE."
The AJOVY data highlight data on safety, efficacy and quality-of-life for patients experiencing difficult-to-treat migraine as well as challenges posed by comorbidities and advancing age. The post-hoc analyses to be presented examine the data on AJOVY as reflected in the pooled analyses:
- Efficacy and safety in patients of advanced age
- Quality-of-life, productivity and satisfaction
- Cardiovascular safety
across the FOCUS, HALO-episodic migraine (EM) and HALO-chronic migraine (CM) Phase 3 clinical trials.
Teva will host an online symposium "Pathways to Change: Anti-CGRP Monoclonal Antibodies & the Evolving Migraine Prevention Landscape," on Sunday, 24 May from 13:45-14:45 CET. The symposium will be led by Messoud Ashina, Professor of Neurology in the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark, and will review the considerable burden of migraine from a patient perspective, discussing insights for targeted prevention that can be gained from the latest research on the neurovascular pathophysiology of migraine.
Approximately 2.5 million people live with multiple sclerosis (MS) worldwidevii, and relapsing-remitting is the most common MS disease courseviii. Teva will also share new long-term efficacy and safety results of COPAXONE from the 7-year Glatiramer Acetate Low‑Frequency Administration (GALA) open‑label extension study.
The complete list of Teva presentations to be available at the congress can be found below. All ePresentations and ePoster sessions will be recorded in advance and available through the EAN conference website. The sessions will be available at no cost and will also be on-demand for EAN members from 27 May onward.
Please note presentation times below reflect the schedule at the time of publication; please refer to the EAN conference website for the final schedule.
AJOVY and Migraine Data:
- The humanistic disease burden of episodic and chronic migraine in France, Spain and the United Kingdom (EPR1095)
- Presenter: S Díaz-Insa; Headache & Pain 1 EPR109, Vienna, Saturday, 18:30-19:20
- Healthcare resource utilization and economic burden of migraine in the United Kingdom, France, and Spain: results of a real-world study (EPR1106)
- Presenter: P Irimia; Headache & Pain 2 EPR110, Lisbon, Saturday, 18:30-19:20
- Early efficacy in patients ≥60 years of age with episodic or chronic migraine: pooled results of 3 randomised, double-blind, placebo-controlled phase 3 studies (EPR1104)
- Presenter: D Holle-Lee; Headache & Pain 2 EPR110, Lisbon, Saturday, 18:30-19:20
- Efficacy of fremanezumab treatment in patients ≥60 years of age with episodic or chronic migraine: pooled results of 3 randomised, double-blind, placebo-controlled phase 3 studies (EPR2077)
- Presenter: SJ Nahas; Headache & Pain 4 EPR208, Oslo, Sunday, 18:30-19:20
- Pooled analysis of tolerability with fremanezumab treatment in patients with episodic or chronic migraine and cardiovascular medication use at baseline (EPR1092)
- Presenter: G Coppola; Headache & Pain 1 EPR109, Vienna, Saturday, 18:30-19:20
- 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 (EPR2075)
- Presenter: P McAllister; Headache & Pain 4 EPR208, Oslo, Sunday, 18:30-19:20
- Improvements in headache-related disability with fremanezumab in patients ≥60 years of age with migraine: pooled results of 3 randomised, double-blind, placebo-controlled phase 3 studies (EPO2152)
- Presenter: S Joshi; Headache & Pain 2 EPO210, available throughout the conference
- Pooled analysis of cardiovascular safety with fremanezumab treatment in patients with migraine by number of cardiovascular or cerebrovascular risk factors (EPR1107)
- Presenter: T Jürgens; Headache & Pain 2 EPR110, Lisbon, Saturday, 18:30-19:20
- Pooled analysis of cardiovascular safety with fremanezumab treatment in patients with migraine and concomitant triptan use (EPR2065)
- Presenter: L Padzera; Headache & Pain 3 EPR207, Main Auditorium, Sunday, 18:30-19:20
- Pooled analysis of cardiovascular safety of fremanezumab in patients ≥60 years of age with migraine: pooled results of 3 randomised, double-blind, placebo-controlled phase 3 studies (EPO3105)
- Presenter: S Naegel; Headache & Pain 3 EPO307, available throughout the conference
Clinical Trial Protocol
- The PEARL study protocol: a pan-European prospective observational study of fremanezumab effectiveness in patients with chronic or episodic migraine in the real world (EPO1144)
- Presenter: M Ashina; Headache & Pain 1 EPO110, available throughout the conference
- Long-term follow-up of three-times-weekly glatiramer acetate: 7-year results of the Glatiramer Acetate Low-Frequency Administration (GALA) open-label extension study (EPR1146)
- Presenter: P Rieckmann; MS & Related Disorders 1 EPR113, Berlin, Saturday, 18:30-19:30
Teva Online Symposium:
- Pathways to Change: Anti-CGRP Monoclonal Antibodies & the Evolving Migraine Prevention Landscape
- Presenter: Messoud Ashina, Professor of Neurology in the Faculty of Health and Medical Sciences, University of Copenhagen, Denmark, Sunday, 13:45–14:45
Teva Expert Sessions:
The below sessions are available as on-demand video presentations at the Teva medical affairs virtual booth on the EAN congress webpage.
- Anti-CGRP monoclonal antibodies for migraine prevention – myths and facts
- Presenter: G Coppola
- Migraine and comorbid depression: exploring the role of anti-CGRP monoclonal antibodies
- Presenter: G Gossrau
- Disease modifying therapy and COVID-19: Navigating therapeutic approaches for M S management
- Presenter: S Sørensen
- Bridging therapy during the pre-pregnancy period to minimise disease activation in MS
- Presenter: M Sandberg
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.
COPAXONE® (glatiramer acetate injection) is indicated for the treatment of patients with relapsing forms of multiple sclerosis. The most common side effects of COPAXONE® are redness, pain, swelling, itching, or a lump at the site of injection, flushing, rash, shortness of breath, and chest pain. See additional important information at: https://www.medicins.org.uk/emc/product/7046/smpc. For hardcopy releases, please see enclosed full prescribing information. The COPAXONE® brand is approved in more than 50 countries worldwide, including the United States, Russia, Canada, Mexico, Australia, Israel, and all European countries.
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 new analysis of fremanezumab Injection and COPAXONE®, 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 uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data;
- 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;
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 Global Burden of Disease 2016 Disease and Injury Incidence and Prevalence Collaborators. Lancet 2017;390:1211–59.
ii Martelletti P, et al. J Headache Pain 2018;19:115.
iii D'Amico D, Tepper SJ. Neuropsychiatr Dis Treat 2008;4:1155–67
iv Lipton RB, et al. Neurology 2007;68:343–9.
v Gooch CL, et al. Ann Neurol 2017;81:479–84.
vi Linde M, et al. Eur J Neurol 2012;19:703–11.
vii Prevalence and incidence of multiple sclerosis. Multiple Sclerosis Trust. Updated February 2020. Accessed May 2020.
viii Types of MS. National Multiple Sclerosis Society. https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed May 2020.
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