New AJOVY® (fremanezumab) Migraine Prevention Data Challenges Treatment Pauses

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announces new data from the 4th interim analysis of the PEARL migraine prevention study with AJOVY^® (fremanezumab) that may challenge the rationale for treatment pauses with calcitonin gene-related peptide monoclonal antibodies (CGRP mAbs) mandated or recommended by some reimbursement authorities after one year of continuous use.

The sub-analysis from the PEARL real world data explored the impact of fremanezumab treatment cessation and reinitiation on monthly migraine days (MMD) in adult patients with episodic or chronic migraine. The data¹ show that pausing treatment of fremanezumab, a CGRP-pathway mAb, may result in a potential rise in monthly migraine days (MMD) following treatment cessation and reduced effectiveness upon reinitiation compared to the first treatment cycle, adding to the burden of the individual living with migraine:

• Over 40% of patients experienced a rapid worsening of their migraine (>=50% increase in MMD) at Months 1 and 2 post-cessation.
• The proportion of patients achieving >=50% reduction in MMD at Month 1 and Month 3, respectively, was 49.0% and 58.9% in the first treatment period (before cessation) versus a lower effectiveness of 35.7% and 45.5% in the second treatment period (after treatment reinitiation).

Presenting the data, Dimos Mitsikostas, Professor of Neurology, Aeginition Hospital, Medical School of the National & Kapodistrian University of Athens said “The PEARL Study analysis is significant for clinicians treating people with episodic and chronic migraine as it shows that treatment cessation and reinitiation can disrupt the progress made in managing the condition in some of them. It is important that we are guided by the evidence and adopt a more personalised treatment approach and not a ‘one size fits all’ strategy in helping people with migraine long-term.”

Although leading headache societies provide guidelines and consensus for beginning and escalating migraine prophylactic therapies, robust evidence to guide therapy discontinuation is currently lacking. The European Headache Federation (EHF) guidelines suggest considering a pause after 12-18 months of continuous treatment, but if deemed necessary, treatment should be continued as long as is necessary.² A review of literature suggests stopping prophylaxis with CGRP-pathway mAbs when there appears to be a lack of remaining need for migraine prevention, which would be less than four MMDs.³ Differing reimbursement conditions across Europe also contribute to these inconsistencies, with some countries mandating one-year treatment pauses, despite limited supporting data.³

“This new sub-analysis may challenge the rationale for mandatory treatment pauses and highlights the potential for these breaks to diminish the benefits achieved in reducing migraine for some patients," said Pinar Kokturk, M.D. Vice President & Head of Medical Affairs Europe at Teva. “The PEARL study demonstrates the long-term effectiveness and safety of fremanezumab in preventing both episodic and chronic migraine in a real-world setting and underscores the benefit of treatment continuity and individualised, uninterrupted patient management strategies.”

About AJOVY (fremanezumab-vfrm) injection

AJOVY is indicated for prophylaxis of migraine in adults who have at least 4 migraine days per month. 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. No starting dose is required to begin treatment. AJOVY European SmPC can be found here.

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 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, in our quarterly report on Form 10-Q for the first quarter of 2024, 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.

References:

1. Mitsikostas, D., et al. Impact of Fremanezumab Cessation and Reinitiation in Migraine Management: PEARL Study 4th Interim Analysis. Presented at European Academy of Neurology (EAN); 29 June-2 July 2024, Helsinki. EAN-EPR-196
2. Sacco, S. et al. European Headache Federation guideline on the use of monoclonal antibodies targeting the calcitonin gene related peptide pathway for migraine prevention – 2022 update. The Journal of Headache and Pain. 2022 23:67
3. Al-Hassany, L. et al. The sense of stopping migraine prophylaxis. The Journal of Headache and Pain. 2023 24:9 

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