Studies Show Effectiveness of AJOVY ® ▼ (fremanezumab) for Treatment of Migraine in Patients With Co-morbid Depression

Teva Pharmaceutical Industries Ltd. today announces the results of two studies^1,2 presented at the Migraine Trust International Symposium (MTIS) in London, UK, which demonstrate the efficacy of AJOVY▼ (fremanezumab) in migraine patients who also experience depression or anxiety. AJOVY▼ (fremanezumab) is indicated for the prevention of migraine in adults with at least 4 migraine days per month.⁸

In both studies, quarterly and monthly dosing of fremanezumab demonstrated efficacy in reducing monthly migraine attacks by more than 50% compared to placebo.^1,2 This is an important outcome because psychiatric disorders are a common co-morbidity in patients suffering from migraine. Population-based samples of people with migraine show up to 47% have co-morbid depression, and up to 58% have co-morbid anxiety⁴ with many patients experiencing both psychiatric conditions.

The first study¹ relating to this patient cohort was led by Richard Lipton MD, Department of Neurology, Psychiatry and Behavioural Sciences atAlbert Einstein College of Medicine, New York. This study is an analysis of pooled data from two previous six-month studies: HALO and FOCUS. The new study to be presented at MTIS sets out to analyse the efficacy of quarterly or monthly dosing of fremanezumab versus placebo in people with migraine and one or more psychiatric co-morbidities.¹

Results at three months showed that 32% of patients on quarterly fremanezumab (n=61) and 36% of patients on monthly fremanezumab (n=75) achieved a ≥ 50% reduction in monthly-migraine-days (MMD) compared to 19% of those taking placebo (n=42), and that proportion increased after continuing or switching to fremanezumab at month six.¹

The second study² is a sub-analysis of patients from the double-blind, placebo-controlled phase 3b FOCUS study led by Patricia Pozo-Rosich, Vall d’Hebron University Hospital and Vall d’Hebron Institute of Research, Barcelona. The FOCUS study set out to evaluate the efficacy of quarterly or monthly fremanezumab in chronic or episodic migraine patients who had experienced an inadequate response to two to four classes of prior preventive migraine medication. The sub-analysis evaluated treatment efficacy on a sub-group of the migraine patients who had co-morbid depression.²

Reductions were observed in both monthly-migraine-days and monthly-headache-days with both quarterly and monthly fremanezumab compared with placebo. Differences were also seen in patient-reported depressive symptoms using a PHQ-9 questionnaire – a brief self-reporting instrument incorporating recognised depression criteria and other depressive symptoms⁹ suggesting that effective treatment of migraine can also positively impact depressive symptoms in patients with this co-morbidity.

Reflecting on the outcome of his study, Dr. Richard Lipton commented, “Clinicians are becoming increasingly aware of the impact that co-morbidities can have on the management of migraine patients. I believe that we need to move towards more personalised treatment decisions that are tailored to the patient’s profile and co-morbidities. As depression and anxiety are commonly associated with migraine, it will be very important for treatments to demonstrate efficacy and safety in migraine patients with these particular co-morbidities.”

Details of enrolment progress into the UNITE study were also revealed at MTIS.¹⁰ The 28-week study, led by Dr. Richard Lipton and supported by Teva, will be assessing the efficacy and safety of fremanezumab in adult patients with chronic and episodic migraine and major depressive disorder.

Commenting on the study, Dr. Lipton said: “We are pleased to report that a total of237 patients have so far enrolled in the UNITE study with 19% from the U.S., 61% from Europe, and 20% from the rest of the world. Assessing the efficacy of fremanezumab in patients with migraine and major depressive disorder will help inform treatment decisions to improve care in this important patient population. We look forward to sharing the results in due course.”

Dr. Dieter Schultewolter, Vice President of Global Medical Affairs Neuroscience at Teva, said: “Teva is strongly committed to supporting further research into the role of fremanezumab in managing the full spectrum of migraine patients, including those who suffer from co-morbid depression and anxiety. We see this as an important step towards a much needed personalised treatment approach for people suffering from migraine in the future.”

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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.

▼This medicinal product is subject to additional monitoring. Adverse events should be reported. Reporting forms and information can be found at www.hpra.ie. Adverse events should also be reported to Teva UK Limited on +44 (0) 207 540 7117 or medinfo@tevauk.com

About Teva

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, biosimilar 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, 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 the development and commercial success of AJOVY; our ability to successfully compete in the marketplace, including our ability to develop and commercialize biopharmaceutical products, competition for our specialty products, including AUSTEDO^®, AJOVY and COPAXONE^®; our ability to achieve expected results from investments in our product pipeline, our ability to develop and commercialize additional pharmaceutical products, and the effectiveness of our patents and other measures to protect our intellectual property rights; our substantial indebtedness; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; our ability to successfully execute and maintain the activities and efforts related to the measures we have taken or may take in response to the COVID-19 pandemic and associated costs therewith; costs and delays resulting from the extensive pharmaceutical regulation to which we are subject or delays in governmental processing time due to travel and work restrictions caused by the COVID-19 pandemic; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the second quarter of 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the section 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. Lipton et al. Efficacy of Quarterly and Monthly Fremanezumab in Patients With Migraine and Psychiatric Comorbidities. Abstract accepted for MTIS 2022. MTIS2022-229
2. Pozo-Rosich et al. Fremanezumab Efficacy in Migraine Patients With Prior Inadequate Response to ≥3 Preventive Migraine Medication Classes and Depressive Symptoms. Abstract accepted for MTIS 2022. MTIS2022-230
3. Lanteri-Minet et al. Anxiety and depression associated with migraine: Influence on migraine subjects' disability and quality of life, and acute migraine management. Pain. 2005; 118: 319- 326.
4. Minen et al. Migraine and its psychiatric comorbidities. J Neurol Neurosurg Psychiatry. 2016; 87: 741- 749.
5. Lipton et al. Long-Term Efficacy of Fremanezumab in Patients with Chronic Migraine and Comorbid Moderate to Severe Depression. Presented at the American Academy of Neurology 61st Annual Meeting Philadelphia, Pennsylvania, USA May 4–10, 2019. P144
6. Winner et al. Long-Term Efficacy of Fremanezumab in Chronic and Episodic Migraine Patients Who Failed at Least One Prior Migraine Preventive Medication: Results of a 1-Year Study. Presented at the American Headache Society 61st Annual Scientific Meeting, Philadelphia, Pennsylvania, USA July 11–14, 2019. P151
7. Silberstein et al. Long-Term Efficacy of Fremanezumab in Chronic and Episodic Migraine Patients with Acute Medication Overuse at Baseline: Results of a 1-Year Study. Presented at the American Headache Society 61st Annual Scientific Meeting, Philadelphia, Pennsylvania, USA July 11–14, 2019. P107
8. Ajovy EU SmPC https://www.ema.europa.eu/en/documents/product-information/ajovy-epar-product-information_en.pdf [accessed 26 August 2022]
9. PHQ-9 assessment tool. https://www.apa.org/pi/about/publications/caregivers/practice-settings/assessment/tools/patient-health [accessed 26 August 2022]
10. Lipton et al. A Phase 4 Study of Fremanezumab for Preventive Migraine Treatment in Patients With Major Depressive Disorder: Baseline Patient Characteristics in UNITE. Abstract accepted for MTIS 2022. MTIS2022-231

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Contact information

Fiona Cohen, Teva Corporate Communications Europe: +31 6 2008 2545