JERUSALEM & PARSIPPANY, N.J.--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Company will present 31 scientific abstracts for AJOVY® (fremanezumab-vfrm) injection at the 61st Annual Scientific Meeting of the American Headache Society, taking place in Philadelphia from July 11-14, 2019. AJOVY is indicated for the preventive treatment of migraine in adults.
“Migraine continues to be a difficult to treat disease and as the migraine treatment landscape evolves, we remain committed to improving the lives of patients,” said Hafrun Fridriksdottir, Executive Vice President, Global R&D at Teva. “We are pleased to be presenting 31 posters and presentations at AHS this year, and our presence underscores Teva’s ongoing focus on addressing the treatment challenges that migraine patients face.”
The data to be presented include findings from the FOCUS study, a multicenter, randomized, double-blind, parallel-group, placebo-controlled study that evaluated the efficacy and safety of quarterly and monthly treatment with AJOVY, compared to placebo. The FOCUS study is the largest study to date in patients who inadequately responded to 2-4 classes of preventive migraine treatments, and is the first study of its type to be conducted in chronic as well as episodic migraine patients. Of note, this year’s AHS meeting is the first time that FOCUS data will be presented at a U.S. meeting.
Additionally, two late-breaking poster presentations will detail findings from a web-based patient survey following completion of an AJOVY 1-year extension study.
Teva-sponsored data to be presented includes:
- [IOR08] Clinically Meaningful Responses to Fremanezumab in Patients With Migraine and Documented Inadequate Response to 2-4 Classes Of Migraine Preventive Medications in the Multicenter, Randomized, Placebo-Controlled FOCUS Study
Late-Breaking Poster Presentations:
- [P272LB] Data on Patient Satisfaction With Fremanezumab Treatment for Chronic or Episodic Migraine: Results From a Web-Based, Patient Survey Following Completion of a 1-Year Extension Study
- [P274LB] Data on Patient Preference for Dosing Regimen and Perception of Dosing Flexibility With Fremanezumab for Chronic or Episodic Migraine: Results From A Web-Based, Patient Survey Following Completion of a 1-Year Extension Study
- [P273LB] Simulated Use of a Fremanezumab Autoinjector: Use as Intended, Ease of Use, and Comfort With Using the Autoinjector
- [P128] The Impact of Fremanezumab on the Maximum Number of Consecutive Days Without Headaches of at Least Moderate Severity in Patients with Chronic Migraine
- [P139] The Impact of Fremanezumab on the Maximum Number of Consecutive Days Without Migraine in Patients with Episodic Migraine
- [P129] Long-term Efficacy of Fremanezumab in Migraine Patients With and Without Concomitant Oral Preventive Medication Use: Results of a 1-Year Study
- [P130] Long-Term Impact of Fremanezumab on Migraine-Specific Health-Related Quality of Life in Migraine Patients With Concomitant Preventive Medication Use: Results of a 1-Year Study
- [P110] Long-term Response Rates in Chronic and Episodic Migraine Patients With Concomitant Preventive Medication Use: Results from 1-Year Study
- [P107] Long-Term Efficacy of Fremanezumab in Chronic and Episodic Migraine Patients With Acute Medication Overuse at Baseline: Results of a 1-Year Study
- [P140] Long-Term Impact of Fremanezumab on Response Rate, Acute Headache Medication Use, and Disability in Chronic Migraine Patients With Acute Medication Overuse at Baseline: Results of a 1-Year Study
- [P141] Long-Term Impact of Fremanezumab on Response Rate, Acute Headache Medication Use, and Disability in Episodic Migraine Patients With Acute Medication Overuse at Baseline: Results of a 1-Year Study
- [P151] Long-Term Efficacy of Fremanezumab in Chronic and Episodic Migraine Patients Who Failed at Least One Prior Migraine Preventive Medication: Results of a 1-Year Study
- [P152] Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients With Chronic Migraine Who Have Failed at Least One Prior Preventive Migraine Medication: Results of a 1-Year Study
- [P153] Long-Term Impact of Fremanezumab on Response Rates, Acute Headache Medication Use, and Disability in Patients With Episodic Migraine Who Have Failed at Least One Prior Preventive Migraine Medication: Results of a 1-Year Study
- [P105] Efficacy and Safety Of Fremanezumab in Patients With Migraine And Documented Inadequate Response to 2-4 Classes Of Migraine Preventive Medications: Results of the Multicenter, Randomized, Placebo-Controlled FOCUS Study
- [P136] Improvement in Headache-Related Disability With Fremanezumab in Patients With Migraine and Documented Inadequate Response to 2-4 Migraine Preventive Medication Classes in the International, Multicenter, Randomized FOCUS Study
- [P148] Safety and Tolerability Outcomes of the Multicenter, Randomized, Placebo-Controlled FOCUS Study of Fremanezumab in Patients With Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications
AJOVY is indicated for the preventive treatment of migraine in adults. AJOVY is available as a 225 mg/1.5mL single dose injection in a prefilled syringe with two dosing options – 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), administered as three subcutaneous injections. AJOVY can be administered in office by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.
Important Safety Information about AJOVY®
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 Prescribing Information for AJOVY® (fremanezumab-vfrm) injection.
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 35,000 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 (commercialized as AJOVY®), 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 commercial success of AJOVY®;
- 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® and 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 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 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 Annual Report on Form 10-K for the year ended December 31, 2018, including the sections thereof 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.