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

Rhea-AI Summary

Teva Pharmaceuticals' AJOVY shows efficacy in Phase 3 study, reducing migraine days significantly. The drug met primary and secondary endpoints, demonstrating superior efficacy over placebo. AJOVY also displayed a favorable safety profile. The study targeted adult Chinese patients, with positive results indicating potential global impact.

Positive

• AJOVY met primary and secondary efficacy endpoints in the Phase 3 study.
• The drug significantly reduced the number of migraine days per month in adult Chinese patients.
• AJOVY demonstrated superior efficacy over placebo, showing a favorable safety profile.
• Study data supported AJOVY's effectiveness in preventing migraines, aligning with previous Phase 3 results in the U.S. and EU.
• AJOVY is a humanized monoclonal antibody targeting calcitonin gene-related peptide (CGRP).
• The study highlighted the need for preventive treatment options for migraine patients in China, with AJOVY potentially improving patients' quality of life.

Negative

• None.

Medical Research Analyst

The recent Phase 3 study results for AJOVY, a migraine prevention medication, indicate a positive outcome for Teva Pharmaceuticals in the Chinese market. With a significant portion of non-elderly adults in China affected by migraines, the demand for effective treatment options is substantial. The confirmation of AJOVY's efficacy and safety in a large demographic can potentially lead to a growth in market share for Teva within this region.

From a medical research perspective, the successful meeting of all primary and secondary endpoints suggests that AJOVY could become a leading treatment option in China. The data suggests a strong potential for market penetration, given the high prevalence of migraine and low diagnosis rates. Moreover, the humanized monoclonal antibody mechanism of action, targeting the calcitonin gene-related peptide (CGRP), is a modern approach in migraine prophylaxis, which may give AJOVY a competitive edge over existing treatments that have a different mechanism or are less effective.

However, it's essential to consider the long-term adoption and affordability in the Chinese healthcare landscape. While the study's positive results are promising, real-world effectiveness and insurance coverage will play critical roles in the drug's commercial success.

Health Economist

Considering the prevalence of migraine in China and the associated economic burden, the introduction of AJOVY could have significant implications for healthcare spending and resource allocation. Migraine is not only a health issue but also an economic one, with direct costs from medical expenses and indirect costs from lost productivity.

While the efficacy of AJOVY is clear, the cost-effectiveness will be a key factor in its adoption. The Chinese healthcare system's willingness to reimburse such treatments and the pricing strategy adopted by Teva will be important in determining its impact on the market. If AJOVY is priced competitively and included in insurance schemes, it could lead to substantial savings by reducing the frequency of migraines and, consequently, the need for acute treatments and associated healthcare resource utilization.

It will also be interesting to observe how this affects the overall competitive landscape, potentially prompting competitors to innovate or adjust pricing strategies for their migraine treatments.

Market Research Analyst

The successful trial results of AJOVY in China underscore the potential for Teva Pharmaceuticals to solidify its presence in a market with a large patient base. The market for migraine treatments in China is ripe for expansion, especially with the current underdiagnosis and undertreatment of the condition.

Market analysis would focus on the strategic positioning of AJOVY within the Chinese pharmaceutical market, taking into account local competitors, potential barriers to entry and the regulatory environment. The positive trial results may lead to increased investor confidence in Teva's growth prospects in Asia. However, the company's ability to navigate the complex distribution channels and regulatory requirements in China will be pivotal to the success of AJOVY's launch.

Additionally, Teva's global R&D commitment could be seen as a strategic move to leverage international research findings to cater to specific regional health concerns, which may resonate well with both global and local stakeholders.

• AJOVY confirms efficacy in new Phase 3 data significantly reducing the number of migraine days per month
• All critical efficacy endpoints met significance as set out apriori through hierarchical testing
• AJOVY confirmed a favorable safety profile

TEL AVIV, Israel & PARSIPPANY, N.J.--(BUSINESS WIRE)-- 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.

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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).

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Source: Teva Pharmaceutical Industries Limited

FAQ

What were the primary and secondary endpoints met by AJOVY in the Phase 3 study?

AJOVY achieved primary and all secondary efficacy endpoints, significantly reducing the number of migraine days per month.

What is AJOVY's safety profile in the Phase 3 study?

AJOVY displayed a favorable safety profile with no emerging safety signals observed.

What is the mechanism of action of AJOVY?

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

What percentage of non-elderly adults in China are estimated to be living with migraine?

Approximately 14.3% of non-elderly adults in China are estimated to be living with migraine.

What are the common treatment-related adverse events (AEs) observed in the Phase 3 study?

The most common treatment-related adverse events (AEs) were injection site reactions.