SYDNEY,
1 August 2021 – TEVA Pharma Australia is pleased to announce the listing of AJOVY® (fremanezumab) – a new anti-CGRP (or calcitonin gene-related peptide) for the prevention of chronic migraine in adults – on the Pharmaceutical Benefits Scheme (PBS) from 1 August 2021.1

People experiencing 15 or more headache days, or at least eight migraine days, per month will now be reimbursed for AJOVY if they have failed three other medications and are not receiving Botox (botulinum toxin type A).1 It is approved to be administered as a single dose injection via a prefilled syringe with no requirement for a loading dose.1,13

In Australia, over 492,000 people live with chronic migraine, a severely debilitating and unpredictable neurological disease that can cause people to spend an estimated 180 days (~half a year) experiencing an attack.2,3 At a time when up to 15 million Australians (~62%) are in lockdown due to COVID-19,4,5 experts are pointing to emerging studies that suggest people with migraine are experiencing close to a 60% increase in migraine frequency, and 60% increase in migraine severity in comparison to the pre-COVID-19 period.6,7,8,9

Currently discontinuation of treatment is common, with most (90%) people changing treatments within one year due to lack of efficacy and side effects, leaving them in constant search for new options that will work for them.10

Associate Professor Susan Tomlinson, Neurologist says “There is real opportunity for migraine- specific preventative anti-CGRP therapies to reduce the burden of difficult-to-treat migraine. Emotional stress and changes in lifestyle habits can worsen the clinical course of migraine, and it is acknowledged that COVID-19 could be adding to the already significant burden of migraine in Australia. Response to migraine treatments varies between individuals and the good news is that today’s listing of AJOVY provides an additional option for the Australians who are still yet to optimally manage this debilitating and complex neurological condition.”

For people living with chronic migraine, daily life is a constant battle and many struggle to manage the complex neurological disease, often for decades.3 Women are disproportionately affected, accounting for 71% of diagnoses in Australia.11 This can have a devastating impact on a person’s social and professional life, with 50% of people living with chronic migraine stating that the condition has prevented them from being able to exercise, hold a career, or has even impacted their ability to provide parental support to their children.12

Carl Cincinnato, Migraine & Headache Australia says “While we wait for State lockdowns to relax, there is no better time for people with migraine to book an appointment with their doctor to discuss options now available to them. Any new options that can offer patients hope and a better quality of life are vital. This class of treatment is the first specifically designed to prevent migraine. For Australians with chronic migraine living in fear from unpredictable attacks, affordable access to this new treatment cannot come soon enough.”

Benet Irish, General Manager, TEVA Pharma Australia, said, “The approval of AJOVY is an important step forward for the Australian migraine community and we congratulate the Government for providing Australians an additional treatment option. At TEVA, we believe that innovation does not end at scientific discovery. It extends to ensuring our treatments are accessible to the people who need it most. We are truly passionate and committed to improving health and creating better days for the migraine community now and in the future.”

AJOVY is in the class of anti-CGRP medicines that are specifically designed to target the underlying causes of migraine.13 This is the first and only monoclonal antibody in the anti-CGRP class to be listed on the PBS that does not require patients to take a loading dose when commencing treatment.1,13

AJOVY is also approved for use in Australia for quarterly (675 mg) dosing option for private prescription. AJOVY is available for episodic migraine under private prescription.14

IMPORTANT SAFETY INFORMATION14

Contraindications: Hypersensitivity to the active substance or to any other component of the product. Very common side effects: Local skin reactions at the injection site: pain, hardening or redness; itching; rash. Uncommon side effects: Symptoms of an allergic or hypersensitivity reaction may include: chest tightness, cough, wheezing or difficulty breathing; drop in blood pressure (fainting, dizziness, feeling lightheaded); swelling of the face, lips, tongue or other parts of the body; rash, itching or hives on the skin; stomach pain or discomfort; vomiting. Precautions: Hypersensitivity; consider discontinuation and initiate appropriate treatment, Major Cardiovascular Disease; some patient groups with major cardiovascular disease were excluded from clinical trials. No safety data is available in these patients. No data available in elderly or paediatric patients. No data available in Renal or hepatic impairment. See Full PI. Pregnancy Category B1; may cross placenta. Lactation, unknown whether fremanezumab is excreted in human milk. No or negligible influence on the ability to drive or operate machinery.

The AJOVY® (fremanezumab) Consumer Medicine Information should be referred to for more information. It is available from GuildLink or from TEVA Medical Information on 1800 288 382.

Media enquiries: Contact Angus Hastie on angus.hastie@tevapharm.com.

For more information about TEVA Pharma Australia visit www.tevapharma.com.au or telephone (02) 8061 9900.

Notes to the editor

Associate Professor Susan Tomlinson has served on a steering committee for TEVA for which compensation was received. In relation to this TEVA media announcement, no compensation was provided to Associate Professor Tomlinson, and the opinions expressed are their own. Associate Professor Tomlinson has been briefed by TEVA on the approved use of this product.

No compensation was provided to Carl Cincinnato for participation in this media announcement, and the opinions expressed are his own. Carl Cincinnato has been briefed by TEVA on the approved use of this product. In 2020, Headache Australia were provided an unrestricted educational grant from TEVA.

About chronic migraine

Chronic migraine is a complex and debilitating neurological condition in which patients experience 15 or more headache days, or at least eight migraine days, per month.3 People living with chronic migraine experience moderate to severe head pain, nausea, vomiting, and sensory sensitivity to light and sound.11

In Australia, 492,000 people live with chronic migraine, with 71% women representing the majority of the group.2,11 Further, 80% of people who meet the classification of chronic migraine are undiagnosed.3

Although the World Health Organisation recognises migraine and chronic migraine among the most disabling illnesses, comparable to dementia, quadriplegia and active psychosis, the physical, emotional, and economic burdens of migraine are under-acknowledged.2,11 People living with migraine and chronic migraine experience reductions in social activities and work capacity.11 The condition costs Australia $704 million per annum, with 62.7 million workforce days lost each year due to chronic migraine, resulting in $16.3 billion in lost productivity.2

About AJOVY® (fremanezumab)

AJOVY is a humanized monoclonal antibody that binds to calcitonin gene-related peptide (CGRP) molecule and blocks its binding to the receptor.14 CGRP levels have been shown to increase significantly during migraine attacks.14

AJOVY is administered as a single dose injection via a prefilled syringe with no requirement for a loading dose.14

AJOVY can be administered subcutaneously (under the skin) by a health professional, or self-injection at home by a patient or caregiver after receiving appropriate training from a health professional.14

AJOVY is reimbursed on the Pharmaceutical Benefits Scheme (PBS) for the prevention of chronic migraine in adults, as a 225 mg/1.5mL monthly injection.1

AJOVY has been available in Australia since September 2019 when it was listed on the Australian Register of Therapeutic Goods (ARTG) for the prevention of migraine in adults, with quarterly (675mg) and monthly (225mg) dosing options.14

PBS Information: Authority required (STREAMLINED) for the treatment of chronic migraine.
This product is not listed on the PBS for the treatment of episodic migraine.


The AJOVY® (fremanezumab) Product Information can be accessed at online or from Medical Information on 1800 AU TEVA (1800 28 8382). Sponsored in Australia by TEVA Pharma Australia Pty Ltd, ABN 41 169 715 664, Level 1, 37 Epping Road, Macquarie Park, Sydney, NSW 2113.

About TEVA

TEVA (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 specialty and generic medicines with a portfolio consisting of over 3,500 products in nearly every therapeutic area. We are committed to providing innovative and high-quality medicines to the 200 million people we serve around the world every day by one of the largest and most complex supply chains in the pharmaceutical industry. Learn more at www.tevapharma.com.au.

TEVA Pharma Australia Pty. Ltd, ABN 41 169 715 664. Level 1, 37 Epping Road, Macquarie Park,

NSW 2113. Tel: 1800 288 382 Fax: +61 2 8061 9999 Email: au.teva@tevapharm.com Date of Preparation July 2021: Document Number Ajov-AU-00190

_________________________________________________________________________

References:

[1] Pharmaceutical Benefits Scheme. AJOVY® (fremanezumab) listing. https://www.pbs.gov.au/medicine/item/12603H-12611R Accessed 1 August 2021

[2] Headache Australia. Strategic Action on Chronic Migraine. https://headacheaustralia.org.au/chronic-migraine-strategy/. Accessed July 2021

[3] Headache Australia. Chronic migraine. https://headacheaustralia.org.au/headachetypes/chronic-migraine/ Accessed July 2021

[4] ABS Australian Bureau of Statistics. https://www.abs.gov.au/. Accessed July 2021

[5] Australian Government. Department of Health. https://www.health.gov.au/news/health-alerts/novel-coronavirus-2019-ncov- health-alert/coronavirus-covid-19-news-and-media. Accessed July 2021

[6] Gonzalez-Martinez A, Planchuelo-Gómez Á, Guerrero ÁL, García-Azorín D, Santos-Lasaosa S, Navarro-Pérez MP, Odriozola-González P, Irurtia MJ, Quintas S, de Luis-García R, Gago-Veiga AB. Evaluation of the Impact of the COVID-19 Lockdown in the Clinical Course of Migraine. Pain Med. 2021 Feb 28:pnaa449. doi: 10.1093/pm/pnaa449. Epub ahead of print. PMID: 33659991; PMCID: PMC8108628

[7] Al-Hashel, J.Y., Ismail, I.I. Impact of coronavirus disease 2019 (COVID-19) pandemic on patients with migraine: a web- based survey study. J Headache Pain 21, 115 (2020). https://doi.org/10.1186/s10194-020-01183-6

[8] Kuruvilla, Deena E. MD. How Has COVID-19 Affected People with Migraine? Medscape & American Headache Society. 12 May 2021. https://www.medscape.com/viewarticle/950452. Accessed July 2021

[9] Jenkins, Bronwyn and Cincinnato, Carl. The effect of a sudden change in lifestyle on migraine attacks during the Covid-19 pandemic: an Australian perspective. Migraine & Headache Australia. https://headacheaustralia.org.au/covids-impact-on-headache-migraine/ Accessed July 2021

[10] Hepp Z, Dodick DW, Varon SF, Chia J, Matthew N, Gillard P, Hansen RN, Devine EB. Persistence and switching patterns of oral migraine prophylactic medications among patients with chronic migraine: A retrospective claims analysis. Cephalalgia.

2017 Apr;37(5):470-485. doi: 10.1177/0333102416678382. Epub 2016 Nov 12. PMID: 27837173; PMCID: PMC5405847.

[11] Deloitte. Migraine in Australia Whitepaper. https://www.painaustralia.org.au/static/uploads/files/deloitte-au-economics- migraine-australia-whitepaper-101018-wfsydysdysky.pdf. Accessed July 2021

[12] TEVA Data on file. InSite Consulting, 2019. TEVA Beyond Migraine. The Real You Research. Data collection Nov-Dec 2019  

[13] Therapeutic Goods Administration. AJOVY® (fremanezumab) Product Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2019-PI-01962-1 Accessed July 2021

[14] Therapeutic Goods Administration. AJOVY® (fremanezumab) Consumer Medicine Information. https://www.ebs.tga.gov.au/ebs/picmi/picmirepository.nsf/pdf?OpenAgent&id=CP-2020-CMI-01901-1&d=20210723172310101 Accessed July 2021