JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced positive topline results from the Phase IIIb FOCUS study that evaluated the efficacy and safety of fremanezumab for the preventive treatment of migraine in adult patients who previously experienced inadequate responses to two to four classes of preventive treatments. In the study of 838 patients, including those who suffer from either chronic or episodic migraine, patients treated with fremanezumab experienced highly significant reduction in the monthly average number of migraine days versus placebo (-0.6 days) over the 12 week assessment period, for both monthly (-4.1 days, p<0.0001) and quarterly (-3.7 days, p<0.0001) dosing regimens.
In addition, patients treated with fremanezumab experienced significant improvement compared to placebo on all secondary endpoints for both quarterly and monthly dosing regimens. There were no safety signals detected in the study.
“We are pleased to share the topline results of this study,” said Danny McBryan, M.D., Senior Vice President, Head of Global Medical Affairs and Pharmacovigilance at Teva. “This study design is distinct in that it is the largest trial to date in patients who failed to respond to multiple classes of preventive migraine treatments, and is the first study of its type to be conducted in chronic, as well as episodic, migraine patients.”
Teva plans to submit the full results for medical meetings in 2019, as well as peer-reviewed publication.
“With robust effect sizes for the primary endpoint, the FOCUS trial produced clinically meaningful results that demonstrated the effectiveness of fremanezumab in a population of patients that are difficult to treat and who require other treatment options,” said Matthias Mueller, M.D. MSc, Vice President Global Medical Affairs, Head of Therapeutic Areas and Scientific Communications at Teva. “We look forward to bringing forward additional insights from the study in the future.”
The Phase IIIb FOCUS study is a multicenter, randomized, 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 two to four 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; or the patient cannot tolerate the drug; or the drug is contraindicated; or the drug is not suitable for the patient. The classes of 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 randomized 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.
Migraine is a disabling neurological disease characterized by severe head pain, nausea and vomiting.1 With more than 1 billion people affected worldwidei, migraine is the third most prevalent illness in the world.2
Fremanezumab is a humanized monoclonal antibody that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor.
In the U.S., it is marketed as AJOVYTM (fremanezumab-vfrm) injection, indicated for the preventive treatment of migraine in adults, and 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. No starting dose is required to begin treatment.
IMPORTANT SAFETY INFORMATION
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 AJOVYTM (fremanezumab-vfrm) injection.
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global leader in generic medicines, with innovative treatments in select areas, including CNS, pain and respiratory. We deliver high-quality generic products and medicines in nearly every therapeutic area to address unmet patient needs. We have an established presence in generics, specialty, OTC and API, building on more than a century-old legacy, with a fully integrated R&D function, strong operational base and global infrastructure and scale. We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 45,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.
Teva 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 AJOVYTM), 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 AJOVYTM;
- 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, 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 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.
i. Migraine Research Foundation. Migraine Facts. https://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed November 2018.
ii. Migraine Trust. Facts and Figures. https://www.migrainetrust.org/about-migraine/migraine-what-is-it/facts-figures/. Accessed November 2018.