Business Wire

Teva to Present New Analyses of Fremanezumab Efficacy and Safety in Adult Patients with Difficult-to-Treat Migraine at 19th Congress of the International Headache Society

Share

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Company will present more than 30 analyses on fremanezumab, at the 19th Congress of the International Headache Society (IHC), taking place in Dublin, Ireland on September 5-8, 2019. Teva will present late-breaking data evaluating the 10-year cost effectiveness of fremanezumab and post hoc subgroup analyses as well as secondary and exploratory endpoint data from the international, multicentre, randomised, placebo-controlled Phase IIIb FOCUS study. This study evaluated the efficacy and safety of quarterly and monthly treatment with fremanezumab compared to placebo in adult patients with migraine and documented inadequate response to 2-4 classes of prior preventive migraine treatments. Also being presented are five posters based on a patient survey following the one-year Phase III HALO long-term study that examined the impact of fremanezumab on functioning and productivity in migraine patients. The presentation of data at this congress follows the publication of FOCUS study data in The Lancet last month.

“Migraine is one of the most prevalent diseases in the world, with more than 1 billion people living with it globally,”1 said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache, Teva. “We are committed to studying this burdensome disease and strive to lead the way in migraine research. We are proud to share a broad range of new fremanezumab data at this year’s IHC from, amongst others, the largest study to date in patients who have responded inadequately to 2-4 classes of prior preventive migraine treatments.”

The FOCUS data analyses at IHC evaluated onset of action, medication overuse, depression, quality of life, and reversion from chronic to episodic migraine, and demonstrated a significant reduction in the number of headache hours and days, and migraine days, suffered by difficult-to-treat patients with migraine when treated with monthly or quarterly fremanezumab, compared to placebo. The most common adverse events included injection site reactions. A patient survey following the one-year Phase III HALO long-term study evaluated patient satisfaction with fremanezumab treatment, and impact on quality of life, and patient preferences for dosing regimens in the preventive treatment of migraine.

Below is a selection of accepted abstracts being presented at IHC 2019:

Later Breaking Data:

  • [IHC-LB-006] Burden of comorbid depression and anxiety on migraine-specific health-related quality of life in adult migraine patients in the United States (September 6, 2019, 11 – 12pm IST)
  • [IHC-LB-030] 10-year cost-effectiveness analyses of response-based fremanezumab use in migraine patients with inadequate response to prior preventive treatments (September 6, 2019, 11 – 12pm IST)
  • [IHC-LB-037] 10-year cost-effectiveness analyses of fremanezumab compared to erenumab as preventive treatment in episodic migraine for patients with inadequate response to prior preventive treatments (September 6, 2019, 11 – 12pm IST)
  • [IHC-OR-040] (de novo): Efficacy and safety of fremanezumab for the prevention of episodic cluster headache: results of a randomized, double-blind, placebo-controlled, phase 3 study (September 8, 2019, 8:20am IST)

Oral Presentation:

  • [IHC-OR-012] Very early onset* of action of fremanezumab in patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the international, multicentre, randomised, placebo-controlled FOCUS study (September 7, 2019, 10:30am IST)

Poster Presentations:

  • [IHC-PO-138] Efficacy with fremanezumab in migraine patients with comorbid moderate to severe depression and documented inadequate response to 2-4 classes of migraine preventive treatments: subgroup analysis of the randomised, placebo-controlled FOCUS study(September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-137] Early onset* of response to fremanezumab in migraine patients with moderate to severe depression and documented inadequate response to 2-4 classes of migraine preventive treatments: subgroup analysis of the randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-156] Efficacy of fremanezumab in migraine patients with medication overuse and documented inadequate response to 2-4 migraine preventive medications: subgroup analysis of the randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-148] 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 randomised, double-blind FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-149] Impact of fremanezumab on migraine-specific quality of life in patients with medication overuse and documented inadequate response to 2-4 classes of migraine preventive treatments: subgroup analysis of the international, multicentre, randomised, double-blind FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-150] Early onset* of efficacy with fremanezumab in patients with medication overuse and documented inadequate response to 2-4 classes of migraine preventive treatments: subgroup analysis of the randomised, double-blind FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-157] Clinically meaningful responses to fremanezumab in migraine patients with medication overuse and documented inadequate response to 2-4 migraine preventive medications in the randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-171] A pharmacokinetic bioequivalence study of fremanezumab administered subcutaneously using an autoinjector and a prefilled syringe (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-172] Impact of fremanezumab on any acute headache medication use in migraine patients with medication overuse and documented inadequate response to 2-4 migraine preventive medications in the multicentre, randomised, placebo-controlled FOCUS study(September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-151] Reversion from chronic to episodic migraine in patients with documented inadequate response to 2-4 classes of migraine preventive treatments: results of the randomised, placebo-controlled FOCUS study (September 6, 2019, 11 – 12pm IST)
  • [IHC-PO-384] Efficacy of fremanezumab in male patients with migraine and documented inadequate response to 2-4 classes of migraine preventive treatments: results of the randomised, placebo-controlled FOCUS study (September 7, 14:45 – 15:45pm IST)
  • [IHC-PO-404] Patient preference and satisfaction following completion of a 1-year extension study (September 7, 14:45 – 15:45pm IST)
  • [IHC-PO-388] Functioning and productivity impact of fremanezumab in migraine patients: a patient survey study following completion of a 1-year extension study (September 7, 14:45 – 15:45pm IST)

*Early onset of efficacy (efficacy measures: reduction in migraine days, reduction in headache days, response rate) is defined as week one following treatment initiation.

About FOCUS

The Phase IIIb FOCUS study is a multicentre, randomised, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy, safety, and tolerability of quarterly and monthly treatment with fremanezumab, compared to placebo. Adult patients with chronic migraine or episodic migraine who have responded inadequately to 2-4 classes of prior preventive treatments were enrolled in the study.

Inadequate response is defined as: lack of efficacy after at least three months of therapy at a stable dose; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient. The classes of prior preventive medications include: beta-blockers, anticonvulsants, tricyclics, calcium channel blockers, angiotensin II receptor antagonists, onabotulinumtoxinA, and valproic acid.

In the study, chronic migraine and episodic migraine patients were randomised in blinded-fashion 1:1:1 into one of three treatment groups – a quarterly dosing regimen, a monthly dosing regimen or matching placebo. An open-label extension of three months (weeks 13-24) followed the placebo-controlled portion of the study.

About the HALO Clinical Research Program

The Phase III HALO EM and CM studies were 16-week, multicentre, randomised, double-blind, placebo-controlled, parallel-group studies to compare the safety, tolerability, and efficacy of four dose regimens (two for EM [quarterly and monthly] and two for CM [quarterly and monthly]), of subcutaneous fremanezumab compared to placebo in adults with episodic and chronic migraine. The studies consisted of a screening visit, a 28-day run-in period, and a 12-week (84-day) treatment period, including a final evaluation at week 12 (end-of-treatment [EOT] visit, four weeks [28 days] after the final dose of study drug).

  • In the EM study, 875 patients were enrolled (294, 291, 290 patients in the placebo, quarterly, and monthly dose groups, respectively). Patients were randomised in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 225 mg for three months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo. The primary efficacy endpoint of the EM study was the mean change from baseline (28-day run-in period) in the monthly average number of migraine days during the 12-week period after the first dose of fremanezumab.
  • In the CM study, 1,130 patients were randomised (375, 376, 379 patients in the placebo, quarterly, and monthly groups, respectively). Patients were randomised in a 1:1:1 ratio to receive subcutaneous injections of fremanezumab at 675 mg at initiation followed by monthly 225 mg for two months (monthly dose regimen), fremanezumab at 675 mg at initiation followed by placebo for two months (quarterly dose regimen), or three monthly doses of matching placebo. The primary efficacy endpoint of the CM study was the mean change from baseline (28-day run-in period) in the monthly average number of headache days of at least moderate severity during the 12-week period after the first dose of fremanezumab.

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

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.

Information for Europe about AJOVY® can be found here.

In the EU, AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month

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 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 2,400 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 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:

  • challenges inherent in product research and development, including uncertainty of clinical success and obtaining regulatory approvals;
  • 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; the uncertainty of commercial success of AJOVY® or AUSTEDO®; 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 substantial indebtedness, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, 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 our restructuring plan announced in December 2017; uncertainties related to, and failure to achieve, the potential benefits and success of our 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; implementation of a new enterprise resource planning system that, if deficient, could materially and adversely affect our operations and/or the effectiveness of our internal controls; 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; increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S.; governmental investigations into selling 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 Quarterly Reports on Form 10-Q for the first and second quarter of 2019 and in our Annual Report on Form 10-K for the year ended December 31, 2018, 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.

References

  1. GBD 2016 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 328 diseases and injuries for 195 countries, 1990‐2016: a systematic analysis for the Global Burden of Disease Study 2016. Lancet. 2017;390:1211‐1259

Contact information

IR Contacts  
United States  

Kevin C. Mannix (215) 591-8912  
Ran Meir 972 (3) 926-7516

PR Contacts  
United States  
Doris Saltkill (913) 777-3343  
Israel  
Yonatan Beker 972 (54) 888 5898

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

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

Andersen Global Enters Chile With the Addition of Two Collaborating Firms4.8.2020 16:30:00 EESTPress release

Andersen Global enters the Chilean market through Collaboration Agreements with two Santiago-based firms: law firm Chirgwin Peñafiel and tax firm SPASA Consulting. The firms are in close partnership with each other and add depth and breadth to the organization’s Latin American platform as it continues its steady expansion. Founded in 2009, Chirgwin Peñafiel, led by Office Managing Partner Andrés Chirgwin, is a full-service law firm specializing in commercial and corporate law, M&A, energy, labor law and banking & finance. The firm works with a variety of corporate clients, being strongly focused on providing legal support to multinational companies with operations in Chile, while also assisting Chilean-based companies with local and international legal needs. Chirgwin Peñafiel has been recognized by IFLR1000, Leaders League and Best Lawyers. “Our firm is committed to delivering quality, comprehensive solutions to our local and international clients,” Andrés said. “Andersen Global’s cap

Lam Research and VELO3D Strike Strategic Agreement to Use Metal Additive Manufacturing Applications for Production of Semiconductor Capital Equipment4.8.2020 16:25:00 EESTPress release

Digital manufacturing innovator VELO3D and Lam Research Corporation (Nasdaq: LRCX) today announced a joint development agreement that includes collaboration on novel materials and designs in metal additive manufacturing (AM) or 3D printing applications for the semiconductor industry. Lam plans to significantly increase the volume of parts produced by AM over the next five years. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005187/en/ The VELO3D Sapphire 3D metal printer (Photo: Business Wire) Additive manufacturing allows transformation of the supply chain from production of parts typically manufactured by subtractive methods, to higher performance, innovative designs that enable agile supply chains to adopt Industry 4.0 principles. VELO3D will develop new metal alloys on its Sapphire® printer that are critical to Lam designs and technologies. Lam Capital will also invest an undisclosed amount in VELO3D. “Lam Researc

Latest Generation YellowScan Mapping Systems Rely on Velodyne Lidar Sensors to Meet Demanding Needs of Survey Professionals4.8.2020 15:00:00 EESTPress release

Velodyne Lidar, Inc. today announced two new generation YellowScan mobile mapping systems use Velodyne’s lidar sensors to help achieve the high precision and accuracy needed in aerial 3D mapping. Velodyne’s powerful lidar sensors generate real-time georeferenced point cloud data that allows YellowScan systems to accurately measure and analyze an area so customers can avoid time-intensive, costly manual surveys. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005168/en/ The YellowScan Surveyor Ultra is a high density and long range mapping solution equipped with a Velodyne Ultra Puck™ sensor. (Photo: YellowScan) The YellowScan Surveyor Ultra is a high density and long range mapping solution equipped with a Velodyne Ultra Puck™ sensor and ideally suited for high speed unmanned aerial vehicles (UAV), such as VTOL and helicopter drones. The YellowScan Surveyor is the company’s lightest system – at 1.6 kg including the batte

Imricor Announces First Sales Collaboration With Philips4.8.2020 15:00:00 EESTPress release

Imricor Medical Systems, Inc. (Company or Imricor) (ASX:IMR) the worldwide leader in MRI-guided cardiac ablation products, is pleased to announce the first sales collaboration with Philips, a global leader in healthcare technology. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005317/en/ Imricor announces first sales partnership with Philips. (Photo: Business Wire) The sales collaboration provides Philips non-exclusive rights to re-sell Imricor’s Advantage-MR System, along with Philips’ industry-leading MRI scanners in European countries that recognize the CE mark. This agreement is the first such agreement signed by Imricor. Imricor’s Chair and CEO, Steve Wedan said: “This agreement is a major milestone for Imricor, allowing Philips to take the lead on driving iCMR lab adoption and enabling us to focus on supporting utilization, growing our portfolio of consumable devices and expanding our indications for use. In thi

L&T Technology Services Expands Collaboration With Microsoft to Offer Eco-friendly Solutions for Workplace Transformation4.8.2020 15:00:00 EESTPress release

L&T Technology Services Limited (BSE: 540115, NSE: LTTS), a leading global pure-play engineering services company, today announced that it has expanded its collaboration with Microsoft Corporation and launched its latest and enhanced version of the state-of-the-art i-BEMS™ solution on Microsoft Azure to transform buildings into future-ready smart campuses. With growing digital transformation, there has been a clear impetus on the need for organizations to revamp their office premises to be eco-friendly, taking into consideration sustainability aspects including greenhouse gas and carbon emissions. Another important aspect for office and facility administrators today is to find balance in their buildings to ensure health, safety and wellbeing of their workforce. LTTS’ award-winning Intelligent Building Experience Management System i-BEMS™ is a system-of-systems solution that focuses on creating digital experiences and intelligent space management. The cloud-based smart buildings/campus/

Sumitomo Corporation of Americas Makes Strategic Investment in Sintavia4.8.2020 14:59:00 EESTPress release

Sumitomo Corporation of Americas (“SCOA”), the largest subsidiary of Sumitomo Corporation, one of the world’s largest traders of goods and services, announced today that it entered into an agreement to increase its investment in Sintavia, LLC (“Sintavia”), the Aerospace and Space industry’s leading Tier One metal additive manufacturer, based in Hollywood, FL. The parties jointly announced that the minority investment, which follows an initial investment by SCOA in 2018, will be used to fund Sintavia’s rapidly growing business of providing additively manufactured parts to the world’s largest Aerospace and Space companies. Terms of the deal were not disclosed. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200804005311/en/ Brian Neff (left), CEO of Sintavia, and Kevin Hyuga (right), SVP and General Manager of Sumitomo Corporation of Americas (2018 file photo) (Photo: Business Wire) The investment will help Sintavia scale its p

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