JERUSALEM--(BUSINESS WIRE)--Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that 12 new analyses will be presented at the 24th World Congress of Neurology (WCN), taking place in Dubai, United Arab Emirates on October 27-31, 2019. Among the analyses, Teva will present on fremanezumab’s efficacy by country in one of the three oral presentations from the international, multicenter, randomized, placebo-controlled Phase IIIb FOCUS study. The company will also provide data in an oral presentation on the burden of migraine across China, Israel, Russia, South Korea and Turkey, as well as a poster presentation evaluating the burden of migraine across Argentina, Brazil, Chile and Mexico.
“As the largest international study to date evaluating patients with an inadequate response to multiple classes of preventive migraine treatments, we are proud to be presenting the FOCUS results to a global audience,” said Joshua M. Cohen, MD, MPH, FAHS, Global Medical Lead for Migraine & Headache, Teva. “This broad range of data highlights our global commitment to helping patients with difficult to treat migraine as well as our leadership in the CNS therapeutic area of research.”
The FOCUS 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 treatments. Additional FOCUS data to be presented at WCN include data on reversion from chronic to episodic migraine, data on the odds of achieving meaningful response rates on fremanezumab as compared to placebo, and an analysis demonstrating a significant reduction in the frequency of migraine aura in patients treated with fremanezumab compared to placebo.
Data to be presented include:
- [WCN19-1409] Efficacy of fremanezumab by country in patients with documented inadequate response to 2-4 classes of migraine preventive medications in the multicentre, randomised, placebo-controlled FOCUS study (October 30, 2019, 9:10 GST)
- [WCN19-1417] Burden of migraine across China, Israel, Russia, South Korea, and Turkey: Results from a systematic literature review (October 30, 2019, 9:20 GST)
- [WCN19-1330] Odds ratios for response to fremanezumab in migraine patients with inadequate response to 2-4 migraine preventive medication classes: Results of the FOCUS Phase 3b study (October 30, 2019, 10:10 GST)
- [WCN19-1372] Reversion from chronic to episodic migraine in patients with inadequate response to 2-4 classes of migraine preventive treatments in the FOCUS Phase 3b study (October 30, 2019, 10:20 GST)
- [WCN19-1351] Reduction in migraine days with aura with fremanezumab in patients with documented inadequate response to 2-4 classes of migraine preventive medications in the FOCUS study (October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1380] Reversion from chronic to episodic migraine and clinically meaningful responses to fremanezumab in patients with inadequate response to 2-4 classes of migraine preventive medications (October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1432] Burden of migraine across Argentina, Brazil, Chile, and Mexico: Results from a systematic literature review (October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1590] Reductions in migraine and headache days in chronic migraine patients with and without prior migraine preventive treatment use: Subgroup analysis of the HALO CM study (October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1043] Long-term effect of fremanezumab on the overall number of headache hours and on the duration of remaining headaches in patients with chronic or episodic migraine(October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1339] Fremanezumab impact on disability and MSQoL in patients with inadequate response to 2-4 classes of preventive medications who reverted from chronic to episodic migraine (October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1504] Reductions in headache impact test (HIT-6) scores with fremanezumab and erenumab among patients with episodic migraine (EM) and 2-4 prior treatment failures: A network meta-analysis (October 30, 2019, 9:30 – 15:00 GST)
- [WCN19-1574] Reduction in acute headache medication use with fremanezumab in chronic migraine patients by prior migraine preventive treatment use: Subgroup analysis of the HALO CM study (October 30, 2019, 9:30 – 15:00 GST)
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.
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 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 commercial success of AJOVY;
- challenges inherent in product research and development, including obtaining regulatory approvals for additional indications for Fremanezumab;
- 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.