Teva Announces Ministry of Health, Labour and Welfare Approves AJOVY® (fremanezumab) Injection in Japan for the Preventive Treatment of Migraine in Adults

AJOVY Developed by Otsuka in Japan through Exclusive License Agreement

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Ministry of Health, Labour and Welfare (MHLW) has approved the use of AJOVY (fremanezumab) injection for the preventive treatment of migraine in adults in Japan.

“In Japan, the annual prevalence of migraine is 8.4% of adults¹ and now, together with our partner, Teva is able to offer people living with migraine in Japan this biopharmaceutical treatment with flexible dosing options to help manage this unpredictable disease,” said Sven Dethlefs, PhD, Executive Vice President, International Markets Commercial Region and Global Marketing and Portfolio at Teva. “Driven by our global mission to improve patients’ lives, we are pleased to offer this new treatment option to people living with migraine in Japan.”

AJOVY is the first and only long-acting anti-CGRP subcutaneous injection that is designed for the preventive treatment of migraine and offers both quarterly and monthly dosing options.^2,3,4

AJOVY was developed in Japan by Otsuka Pharmaceutical Co., Ltd. with the assistance and cooperation of Teva as part of a May 2017 exclusive license agreement. In 2020, the two companies announced outcomes from two pivotal studies of AJOVY in people living with episodic and chronic migraine in Japan. The primary endpoints were achieved in both trials with clinical and statistical significance versus placebo. Statistically significant improvements versus placebo also were demonstrated for all secondary endpoints. AJOVY was well tolerated with a similar adverse events profile compared to placebo.

Makoto Inoue, President and Representative Director of Otsuka Pharmaceutical, commented, “Patients with migraine not only suffer the pain of headaches, but also endure a range of disabling symptoms impacting their daily lives, such as the uncertainty of when the next migraine attack will occur, and the difficulty of communicating with those around them when they are suffering the symptoms of an attack. While using the experience we have accumulated to address the problems faced by patients, we hope to give support to the lives of many patients by providing AJOVY as a new treatment option to those in need.”

Teva, who holds (through its Japanese affiliates) with Takeda a joint business venture in the Japanese market, focuses on commercializing a selection of complex generics and specialty assets to address the wide-ranging needs of patients and healthcare professionals in Japan.

About AJOVY (fremanezumab-vfrm) injection

AJOVY is available as a 225 mg/1.5 mL single dose injection in a prefilled syringe or autoinjector with two dosing options – 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), which is administered as three subcutaneous injections. AJOVY can be administered in office by a healthcare professional or at home by a patient or caregiver. No starting dose is required to begin treatment.

Indications and Usage

AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.

U.S. Important Safety Information about AJOVY (fremanezumab-vfrm) injection

Contraindications: AJOVY is contraindicated in patients with serious hypersensitivity to fremanezumab-vfrm or to any of the excipients.

Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials. Most reactions were mild to moderate, but some led to discontinuation or required corticosteroid treatment. Most reactions were reported from within hours to one month after administration. If a hypersensitivity reaction occurs, consider discontinuing AJOVY and institute appropriate therapy.

Adverse Reactions: The most common adverse reactions (≥5% and greater than placebo) were injection site reactions.

Please click here for full U.S. Prescribing Information for AJOVY (fremanezumab-vfrm) injection.

Information for Europe about AJOVY can be found here.

Adverse events should be reported.

This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse events.

Reporting forms and information can be found at https://www.hpra.ie. Adverse events should also be reported to Teva – please refer to local numbers.

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 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 regarding AJOVY, 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. Important factors that could cause or contribute to such differences include risks relating to:

• the commercial success of AJOVY;
• our ability to successfully compete in the marketplace, including: that we are substantially dependent on our generic products; consolidation of our customer base and commercial alliances among our customers; delays in launches of new generic products; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; 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, which may limit our ability to incur additional indebtedness, engage in additional transactions or make new investments, may result in a further downgrade of our credit ratings; and our inability to raise debt or borrow funds in amounts or on terms that are favorable to us;
• our business and operations in general, including: uncertainty regarding the COVID-19 pandemic and its impact on our business, financial condition, operations, cash flows, and liquidity and on the economy in general; 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; effectiveness of our optimization efforts; our ability to attract, hire and retain highly skilled personnel; manufacturing or quality control problems; interruptions in our supply chain; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including political or economic instability, major hostilities or terrorism; 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; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; significant sales to a limited number of customers; our ability to successfully bid for suitable acquisition targets or licensing opportunities, or to consummate and integrate acquisitions; and our prospects and opportunities for growth if we sell assets;
• compliance, regulatory and litigation matters, including: failure to comply with complex legal and regulatory environments; increased legal and regulatory action in connection with public concern over the abuse of opioid medications and our ability to reach a final resolution of the remaining opioid-related litigation; scrutiny from competition and pricing authorities around the world, including our ability to successfully defend against the U.S. Department of Justice criminal charges of Sherman Act violations; potential liability for patent infringement; product liability claims; failure to comply with complex Medicare and Medicaid reporting and payment obligations; compliance with anti-corruption sanctions and trade control laws; and environmental risks;
• other financial and economic risks, including: our exposure to currency fluctuations and restrictions as well as credit risks; potential impairments of our intangible assets; potential significant increases in tax liabilities (including as a result of potential tax reform in the United States); and the effect on our overall effective tax rate of the termination or expiration of governmental programs or tax benefits, or of a change in our business;

and other factors discussed in this press release and in our Quarterly Report on Form 10-Q for the first quarter of 2021 and in our Annual Report on Form 10-K for the year ended December 31, 2020, including in the sections captioned "Risk Factors” and “Forward Looking Statements.” 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.

¹ Sakai F, Igarashi H. Prevalence of migraine in Japan: a nationwide survey. Cephalalgia 1997; 17(1): 15-22.

² AJOVY (fremanezumab-vfrm) injection Current Prescribing Information. North Wales, PA: Teva Pharmaceuticals USA, Inc.

³ “Long-acting” defined as efficacy measured over a 12-week period following a 675 mg (225 mg x 3) SC dose.

⁴ 225 mg monthly administered as one subcutaneous injection, or 675 mg every three months (quarterly), which is administered as three subcutaneous injections.

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