Teva Confirms Efficacy and Safety of AJOVY® (fremanezumab) for the Prevention of Migraine With Results from Phase 3 Trial in China

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced results from a Phase 3 study evaluating the efficacy and safety of AJOVY for the prevention of migraine in adult Chinese patients.

In the study, AJOVY achieved primary endpoint and all secondary endpoints, significantly reducing the number of migraine days experienced per month, demonstrating superior efficacy over placebo. All key secondary endpoints were also met including measures for early onset of efficacy during the first month, responder rate analysis defined as 50% reduction of migraine days and reduction of acute headache medication use over 3 months after first use. Study data also show AJOVY was safe and well tolerated with no emerging safety signals. This data is consistent with the previous Phase 3 data for AJOVY which was approved for the preventive treatment of migraine in adults in the U.S. in 2018 and in the EU in 2019.

In China, an estimated 14.3% of non-elderly adults are living with migraine.¹ From this population, approximately 52.9% will visit hospitals and only 13.8% of them will be diagnosed with migraine.²

“Migraine and its debilitating symptoms impact people around the world, and these study results from Chinese migraine patients reinforce AJOVY as a proven preventive medicine that can safely and effectively help reduce the burden of migraine,” said Eric Hughes, MD, PhD, Executive Vice President of Global R&D and Chief Medical Officer at Teva. "China has the largest migraine population worldwide,³ and Teva is committed to research on a global scale that helps address unmet need where it exists and ensure that the role of treatment innovations like AJOVY are better understood.”

Migraine attacks cause disabling pain, nausea, vomiting and sensitivities to light and sound, resulting in serious effects on the ability to complete daily tasks. The burden of migraine and the fear of the next one can lead to a significant negative impact on quality of life, including family, social and professional relationships. People who experience migraine are more likely to suffer from anxiety and depression compared to healthy individuals.⁴

AJOVY is a humanized monoclonal antibody (mAb) which selectively binds the calcitonin gene-related peptide (CGRP).

In the Phase 3 double-blind study in China, 365 adult participants were randomized 1:1:2 to receive AJOVY subcutaneously 225mg once-monthly for three months or a single dose of 675mg once-quarterly or placebo.

"For the many millions of migraine patients in China,¹ there is a need for preventive treatment options that may help reduce the number of migraine days they experience and support the alleviation of the incapacitating symptoms migraine can cause,” said Shengyuan Yu, MD, PhD, Director and Professor, Department of Neurology, Chinese PLA General Hospital. "These Phase 3 data indicate that fremanezumab has the potential to significantly improve life quality of the patients with migraine in China.”

In the study, AJOVY was safe and well tolerated with no safety signals observed. The most common treatment-related (≥5%) AEs were injection site reactions.

Additional findings from this study are planned for presentation at a medical meeting later this year.

About AJOVY Phase 3 Study in China

This multicenter, randomized, double-blind, placebo-controlled study is evaluating the efficacy, safety and tolerability of fremanezumab injection for subcutaneous use as a treatment in patients (ages 18-70 years) with episodic or chronic migraine vs placebo. The study enrolled 365 patients who were randomized to receive a subcutaneous injection of fremanezumab once-monthly or once-quarterly, or placebo in a 1:1:2 ratio. The primary objective is to demonstrate the efficacy of fremanezumab administered as once-monthly and once-quarterly subcutaneous injections to adult Chinese participants with migraine. The secondary objectives are to further demonstrate the efficacy of fremanezumab administered as once-monthly and once-quarterly subcutaneous injections and to evaluate the safety and tolerability of fremanezumab administered as once-monthly and once-quarterly subcutaneous injections. The study consists of a screening visit, a baseline period (4 weeks), a 12-week double-blind treatment period, a 12-week open-label treatment period when all patients receive 225mg of AJOVY monthly, and a follow-up period lasting 3 months after the last dose of treatment. The open label phase of the trial is still ongoing.

About AJOVY▼ (fremanezumab-vfrm) injection

AJOVY is indicated for the preventive treatment of migraine in adults. AJOVY is available as a 225 mg/1.5 mL single dose injection in a pre-filled syringe or, in some countries, in a pre-filled pen. Two dosing options are available: 225 mg once monthly administered as one subcutaneous injection (monthly dosing), or 675 mg every three months (quarterly dosing), which is administered as three subcutaneous injections. AJOVY can be administered either by a healthcare professional or at home by a patient or caregiver.

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit 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, 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. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully develop and commercialize AJOVY for the prevention of migraine in adult Chinese patients; our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to sustain and focus our portfolio of generics medicines; and other factors discussed in this press release, and in our Annual Report on Form 10-K for the year ended December 31, 2023, including in the sections 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.

______________________

1. Takeshima, T., Wan, Q., Zhang, Y. et al. Prevalence, burden, and clinical management of migraine in China, Japan, and South Korea: a comprehensive review of the literature. J Headache Pain 20, 111 (2019). https://doi.org/10.1186/s10194-019-1062-4
2. Guidelines for the diagnosis and treatment of migraine in China (2022 edition) Chinese Journal of Pain Medicine Chinese Journal of Pain Medicine 2022, 28 (12)
3. Wang Y, Huang X, Yue S, Liu J, Li S, Ma H, Hu L, Wu J. Secular Trends in the Incidence of Migraine in China from 1990 to 2019: A Joinpoint and Age-Period-Cohort Analysis. J Pain Res. 2022 Jan 14;15:137-146. doi: 10.2147/JPR.S337216. PMID: 35058715; PMCID: PMC8765540.
4. Jaimie D Steinmetz, Katrin Seeher, Nicoline Schiess, Emma Nichols, Bochen Cao, Chiara Servili, Vanessa Cavallera, Christopher J L Murray, Kanyin Liane Ong, Valery L Feigin, Theo Vos, and Tarun Dua on behalf of the GBD network. Global, regional, and national burden of disorders affecting the nervous system, 1990–2021: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Neurol. (in press).

View source version on businesswire.com: https://www.businesswire.com/news/home/20240411323269/en/