Teva Pharmaceuticals USA, Inc., an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the autoinjector device for AJOVY® (fremanezumab-vfrm) injection is now available in the U.S. AJOVY is indicated for the preventive treatment of migraine in adults and is the only anti-CGRP (calcitonin gene-related peptide) preventive migraine treatment with quarterly (675 mg) and monthly (225 mg) subcutaneous dosing options.
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"We are pleased to offer the migraine community the option of an autoinjector device for their AJOVY treatment," said Brendan O’Grady, Executive Vice President, North America Commercial, Teva. "Continuing to advance treatment flexibility for people who suffer from debilitating migraines is another way that we are able to advance the mission of Teva to improve patient lives."
AJOVY is the only long-acting anti-CGRP injection with the option of dosing four times per year using either the autoinjector or prefilled syringe. The new Teva autoinjector also has several features that make it easy-to-use1 including a button-free, push-down mechanism; audible cues that signal progress of administration; and, a window that displays when the dose has been delivered. Additionally, the autoinjector is for one-time use only and locks after use.
Patients should consult their healthcare professionals about how to take AJOVY using the autoinjector. Patients can also visit AJOVY.com for step-by-step instructions for using the autoinjector, or to speak with a nurse to help answer questions about taking AJOVY using the autoinjector. Samples will be made available to healthcare professionals.
The Wholesale Acquisition Cost (WAC or "list price") for the AJOVY autoinjector is $603.20. Actual costs to individual patients and providers for the autoinjector are anticipated to be lower than WAC because WAC does not account for additional rebates and discounts that may apply. Savings on out-of-pocket costs may vary depending on the patient’s insurance payer and eligibility for participation in the assistance program.
In addition to the U.S., the AJOVY autoinjector is currently available in Germany and should soon be available in other select European markets.
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.
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.
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 the U.S. launch of Autoinjector for 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; the increase in the number of competitors targeting generic opportunities and seeking U.S. market exclusivity for generic versions of significant products; competition for our specialty products, especially COPAXONE®, our leading medicine, which faces competition from existing and potential additional generic versions, competing glatiramer acetate products and orally-administered alternatives; the uncertainty of commercial success AUSTEDO®; competition from companies with greater resources and capabilities; delays in launches of new products and our ability to achieve expected results from investments in our product pipeline; ability to develop and commercialize biopharmaceutical products; efforts of pharmaceutical companies to limit the use of generics, including through legislation and regulations 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: implementation of our restructuring plan announced in December 2017; our ability to attract, hire and retain highly skilled personnel; our ability to develop and commercialize additional pharmaceutical products; compliance with anti-corruption, sanctions and trade control laws; manufacturing or quality control problems; interruptions in our supply chain including due to potential effects of the COVID-19 outbreak on our operations in geographic locations impacted by the outbreak and on the business operations of our customers and suppliers; disruptions of information technology systems; breaches of our data security; variations in intellectual property laws; challenges associated with conducting business globally, including adverse effects of political or economic instability, major hostilities or terrorism; 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; our prospects and opportunities for growth if we sell assets and potential difficulties related to the operation of our new global enterprise resource planning (ERP) system;
- compliance, regulatory and litigation matters, including: increased legal and regulatory action in connection with public concern over the abuse of opioid medications in the U.S. and our ability to reach a final resolution of the remaining opioid-related litigation; costs and delays resulting from the extensive governmental regulation to which we are subject; the effects of reforms in healthcare regulation and reductions in pharmaceutical pricing, reimbursement and coverage; governmental investigations into S&M practices; potential liability for patent infringement; product liability claims; increased government scrutiny of our patent settlement agreements; failure to comply with complex Medicare and Medicaid reporting and payment obligations; 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; 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 our Annual Report on Form 10-K for the year ended December 31, 2019, 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 Two Human Factor studies assessed evaluators’ ability to complete critical tasks in order to demonstrate use of the AJOVY Autoinjector in simulated-use sessions. When asked "Was the autoinjector easy to use?", 97% in study 1 (N=30) and 98% in study 2 (N=47) answered "Yes." Data on file, Parsippany, NJ Teva Pharmaceuticals USA, Inc.
Kevin C. Mannix
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