Teva Canada announces the launch of AJOVY™ for the preventive treatment of migraine in adults who have at least four migraine days per month

AJOVY^TM is the first and only anti-CGRP treatment with both quarterly and monthly dosing for the preventive treatment of migraine in adults

• AJOVY^TM has been studied in patients with chronic or episodic migraine and was shown to significantly reduce patients' mean monthly migraine days—with some patients achieving a 50% reduction or more.^1–3
  
  
• Migraine is a prevalent neurological disorder, affecting more than 760,000 people in Canada and 1 billion worldwide.^4,5

MONTRÉAL, April 29, 2020 /CNW/ - Teva Canada, a subsidiary of Teva Pharmaceutical Industries Ltd., announced today that Health Canada has recently granted a notice of compliance (NOC) to AJOVY^TM (fremanezumab) 225 mg solution for subcutaneous injection in a pre-filled syringe for the preventive treatment of migraine in adults who have at least four migraine days per month. AJOVY^TM is a humanized monoclonal antibody (mAb) that binds to the calcitonin gene-related peptide (CGRP) ligand and blocks its binding to the receptor. AJOVY^TM is the first and only anti-CGRP drug approved in Canada, the European Union, and the United States that offers quarterly or monthly dosing regimens for the prophylactic treatment of migraine.

Christine Poulin, general manager of Teva Canada, said: "Migraine places a significant burden on Canadians and the people they love, and I'm so pleased to be preparing the launch of this new preventive therapy that could change so many lives for the better. With the launch of AJOVY^TM in Canada, patients will have more preventive treatment options than ever before—and AJOVY^TM could give them greater flexibility in how they manage their condition. AJOVY^TM is a major launch for Teva, and we are looking forward to making a difference for patients across the country when the product becomes available this summer."

AJOVY^TM was evaluated in two pivotal Phase III clinical trials that enrolled patients with disabling migraine and studied fremanezumab as a prophylactic treatment. In these trials, efficacy assessments included the change from baseline in the number of average monthly migraine days and the proportion of patients achieving at least a 50% reduction in migraine. The safety profile was also assessed in these trials.^1–3

About migraine

Migraine is a disabling chronic neurological disease that causes head pain so severe that sufferers often cannot function during an attack. Migraine reduces quality of life and disrupts migraineurs' ability to perform daily activities.^6,7 It is among the top 10 causes of disability worldwide and the seventh cause of years of life lost to disability.^8–10 In Canada, migraine is most common in women and most common between the ages of 30 and 49.¹¹ Migraine therefore reduces patients' quality of life, ability to work, and overall productivity right at the prime of their life. While acute treatment modalities are used to treat migraines when they occur, they do not prevent them. Novel treatments like AJOVY^TM were specifically designed to actually prevent migraine from occurring.

Dr. Elizabeth Leroux, founder of the websites Migraine Québec and Migraine Canada and president of the Canadian Headache Society, said: "Migraine is both underdiagnosed and poorly treated. Part of that was due to limitations of available preventive therapies. With the launch of AJOVY^TM, patients will have more choice than ever before. With more treatments comes more awareness, which means we may finally be breaking the stigma and suffering of migraine. It's a wonderful time to be working in this field, and I'm so pleased to be part of this revolutionary moment."

AJOVY^TM Teva Support Solutions® Patient Support Program

AJOVY^TM patients and prescribers are supported by the Teva Support Solutions® Patient Support Program, which was developed in collaboration with Canadian migraine experts and offers services such as injection training, insurance/coverage investigation, and paperwork assistance.

About AJOVY^TM

AJOVY^TM (fremanezumab) is indicated for the preventive treatment of migraine in adults who have at least four migraine days per month. AJOVY^TM is available as a 225 mg/1.5 mL single-dose injection in a pre-filled syringe with two dosing options: 225 mg monthly, administered as one subcutaneous injection; or 675 mg every three months (quarterly), administered as three subcutaneous injections. AJOVY^TM is intended for patient self-administration after the patient or their caretaker has been trained to administer the product.

Helping people live better days

At Teva, we care deeply about the well-being of the patients, caregivers, and communities that rely on us. We serve 200 million people every day, with a promise to help them take better control of their health. From our role as a global leader in generic and brand-name medicines to the innovative solutions we create for our healthcare partners, we offer a unique perspective on health—here in Canada and around the world.

About Teva Canada

Teva Canada, headquartered in Toronto, has provided affordable healthcare solutions to Canadians for over 50 years, building their trust one prescription at a time with now more than 220,000¹²  prescriptions filled each day with our products. Originally Novopharm Limited, Teva Canada specializes in the development, production, and marketing of high-quality generic prescription pharmaceuticals and, through our branded division, focuses on a diverse line of innovative products in a variety of therapeutic areas. Teva Canada employs more than 900 professionals, had sales of nearly $1.3 billion¹² in 2019, and markets more than 385 products in 1,000 SKUs¹² in Canada. We are a proud subsidiary of Teva Pharmaceutical Industries Ltd. Learn more at www.tevacanada.com.

About Teva Pharmaceutical Industries Ltd.

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.

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CGRP: calcitonin gene-related peptide; SKU: Stock Keeping Unit

1. AJOVY^TM Product Monograph. Teva Canada Limited, Montréal, Quebec. April 9, 2020.

2. Dodick DW et al. JAMA. 2018;319(19):1999–2008.

3. Silberstein SD et al. N Engl J Med. 2017;377(22):2113–2122.

4. Migraine Canada. You are not alone. Available from: https://migrainecanada.org/you-are-not-alone/. Accessed on March 25, 2020.

5. Migraine Research Foundation. Migraine facts. Available from: http://migraineresearchfoundation.org/about-migraine/migraine-facts/. Accessed on March 25, 2020.

6. Buse DC, Rupnow MF, Lipton RB. Assessing and managing all aspects of migraine: migraine attacks, migraine-related functional impairment, common comorbidities, and quality of life. Mayo Clin Proc. 2009;84:422–435.

7. Lipton RB, Liberman JN, Kolodner KB, et al. Migraine headache disability and health-related quality-of-life: a population-based case-control study from England. Cephalalgia. 2003;23:441–450.

8. Steiner TJ, Stovner LJ, Birbeck GL. Migraine: the seventh disabler. J Headache Pain. 2013;14:1.

9. Global Burden of Disease Study Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in 188 countries, 1990–2013: a systematic analysis for the Global Burden of Disease Study 2013. Lancet. 2015;386:743–800.

10. Institute for Health Metrics and Evaluation. Global burden of diseases visualization tools. Available from: http://vizhub.healthdata.org/gbd-compare/. Accessed January 2016.

11. Ramage-Morin PL, Gilmour H. Prevalence of migraine in the Canadian household population. Health Rep. 2014;25(6):10–16.

12. Source: IQVIA CDH & Compuscript MAT. December 2019.

SOURCE Teva Canada

IR Contacts: United States Kevin C. Mannix, [phone]; Israel Ran Meir, 972 (3) 926-7516; PR Contacts: United States, Doris Li, [phone]; Israel Yonatan Beker, 972 (54) 888-5898