Business Wire

Teva to Present New AJOVY® (fremanezumab) Analyses and Latest COPAXONE® Data (glatiramer acetate injection) at European Academy of Neurology Congress

Share

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:

Disease Burden

  • 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

Efficacy

  • 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

Tolerability

  • 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

Patient Satisfaction

  • 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

Cardiovascular Safety

  • 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

COPAXONE Data:

  • 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.

About COPAXONE®
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.

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 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.

Contact information

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

About Business Wire

Business Wire
Business Wire



Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

Spirit of Wipro Run Brings Together Thousands of Participants Globally27.9.2020 08:52:00 CESTPress release

Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO), a leading global information technology, consulting and business process services company, today organized the 15th edition of the ‘Spirit of Wipro’ (SOW) Run globally with thousands of participants across 35 countries, running separately, yet together in spirit, at a time of their choosing. The theme for this year’s Run was “United. Unstoppable”, which celebrated camaraderie, resilience and a shared sense of community among several thousands of Wipro employees, their friends and families, alumni, customers, partners and suppliers. The SOW Run is an annual, global tradition at Wipro and has been held every year since its inception. This year too, the Run was organized on schedule despite the pandemic induced constraints. The runners strictly adhered to the local COVID-19 guidelines and safety protocols in various countries while participating in the event. Commenting on the Run, Thierry Delaporte, Chief Executive Officer and Managing

BCG Collaborates with Tencent Marketing Insight to Release 2020 BCG x Tencent Digital Luxury Report25.9.2020 12:21:00 CESTPress release

Since early 2020 when the COVID-19 pandemic broke out worldwide, the luxury market has been hit hard and is expected to decline 25% to 45% compared to the previous year. The Chinese luxury market, however, which has benefitted from successful domestic control of the pandemic and has taken the lead in recovery against a depressed global market environment, is forecast to grow from 20% to 30% in the whole year of 2020. Thanks to its stunning market performance, China has become the main battleground of each major luxury brand. In was in this environment that Boston Consulting Group (BCG) joined hands with Tencent Marketing Insight (TMI) to release the 2020 BCG x Tencent Digital Luxury Report, drawing on deep insights into post COVID-19 trends in the luxury market and consumers based on BCG and TMI’s quantitative consumer research and industry experience, as well as TMI’s marketing and big data capabilities. Crystal Hao, Managing Director & Partner of BCG said, “The luxury market in China

U.S. MRTP Authorization Pathway Explored in PMI’s Latest Scientific Update25.9.2020 12:15:00 CESTPress release

Philip Morris International (PMI) (NYSE: PM) has released the 11th edition of its Scientific Update, a regularly issued publication on its research efforts to develop and scientifically assess a range of smoke-free alternatives to cigarettes. The latest edition features an overview of the historic decision made by the U.S. Food and Drug Administration (FDA) to authorize the marketing of the IQOS Tobacco Heating System with reduced exposure information. The Scientific Update explains the various MRTP decisions under U.S. law; the steps, processes, and timeline PMI undertook; and the ongoing post-market surveillance and studies that will monitor the impact of the orders on consumer perceptions, behavior, and health. “The FDA undertook a scientific and regulatory evaluation of IQOS and determined that it is ‘appropriate for the promotion of public health’” said Dr. Gizelle Baker, director of Global Scientific Engagement at PMI. “In this edition of our Scientific Update, we describe how th

Palladio Completes $20 Million Series B Financing25.9.2020 12:09:00 CESTPress release

Palladio Biosciences, Inc. (Palladio), a privately-held, clinical stage biopharmaceutical company developing medicines for orphan diseases of the kidney, announced today the completion of a $20 million Series B investment. The financing was led by new investor, Samsara BioCapital, with participation from new investor, the Roche Venture Fund and existing investors, Medicxi and Osage University Partners. Proceeds from the financing will fund Palladio’s Phase 3 ALERT Study and advance operations. Srinivas Akkaraju M.D, Ph.D, Managing General Partner of Samsara BioCapital, stated, "We are very excited about our investment in Palladio to support the development of lixivaptan, a drug that has the potential to deliver a meaningful therapeutic advancement in the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD). The ALERT Study is an important step in assessing the safety differential of lixivaptan.” “We are very pleased that Samsara and the Roche Venture Fund recognize the opp

Ant Group Launches “Trusple,” an AntChain-Powered Global Trade and Financial Services Platform for SMEs and Financial Institutions25.9.2020 09:54:00 CESTPress release

Ant Group, a leading provider in the development of open platforms for technology-driven inclusive financial services, and the parent company of China’s largest digital payment platform Alipay, today unveiled Trusple, an international trade and financial service platform powered by AntChain, the company’s blockchain-based technology solutions. Trusple aims to make it easier and less costly for all participants – especially Small-to-Medium Enterprises (SMEs) – to sell their products and services to customers around the world. It also reduces costs for financial institutions so they can better serve SMEs in need. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200925005110/en/ (Photo: Business Wire) Based on the concept of “Trust Made Simple,” Trusple works by generating a smart contract once a buyer and a seller upload a trading order on the platform. As the order is executed, the smart contract is automatically updated with k

Ipsen Appoints Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer25.9.2020 07:00:00 CESTPress release

Regulatory News: This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200924005822/en/ Philippe Lopes-Fernandes, Executive Vice President, Chief Business Officer, Ipsen (Photo: Business Wire) Ipsen (Euronext: IPN; ADR: IPSEY) today announced the appointment of Philippe Lopes-Fernandes as Executive Vice President, Chief Business Officer, effective 1 October 2020. Based in Cambridge, Massachusetts, USA, he will be responsible for business development and alliance management, reporting directly to David Loew, CEO, Ipsen. Philippe will serve on the Executive Leadership Team. “As Chief Business Officer, Philippe will play a crucial role in our external innovation strategy. The ELT and I are delighted to welcome Philippe to Ipsen and look forward to working closely with him. His extensive and impressive track record in international business development, his outstanding reputation and his ability to work closely with the scientific comm

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom