New Data For Teva AJOVY® (fremanezumab-vfrm) Injection and AUSTEDO® (deutetrabenazine) Tablets Included in Neurology

Teva Pharmaceuticals USA, Inc., an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that new data for AJOVY^® (fremanezumab-vfrm) injection and AUSTEDO^® (deutetrabenazine) tablets have appeared in an online supplement to Neurology. The data includes 23 abstracts that highlight a diverse set of data evaluating the efficacy and safety of AJOVY and AUSTEDO.

The abstracts were originally planned for presentation at the recently cancelled 2020 American Academy of Neurology (AAN) annual meeting. In addition to the online supplement, the abstracts are also available through the AAN online abstracts website.

“We are pleased to have an opportunity to share this important data with the neurology community which build upon our understanding of the efficacy and safety of AJOVY and AUSTEDO across various patient populations, and further demonstrate Teva’s commitment to the CNS space,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “Teva is committed to ongoing evaluation of these significant therapies to help physicians, healthcare providers and most importantly, patients, make informed decisions about their treatments.”

The featured abstracts include new AJOVY and AUSTEDO data, including results from an open-label extension of the FOCUS study, a Phase IIIb study that evaluated the efficacy and safety of quarterly and monthly treatment with AJOVY compared to placebo in adult patients with migraine and documented inadequate response to 2-4 classes of prior preventive treatments. Another analysis using the FDA Adverse Events Reporting System (FAERS) provides patient and healthcare professional insight into the real-world experience with CGRP pathway-targeted therapies. In addition, new data is available from a long-term, open-label extension study which examined the safety of AUSTEDO at higher doses beyond the approved maximum dose to treat chorea associated with Huntington’s disease, as well as the long-term experience with AUSTEDO in both younger and older patients with tardive dyskinesia.

The full list of Teva abstracts in the Neurology supplement includes:

AUSTEDO^® (deutetrabenazine) Tablets:

De Novo:

• Evaluation of the Safety of Deutetrabenazine at Higher Doses to Treat Chorea in Huntington's Disease
• Long-term Safety and Efficacy of Deutetrabenazine in Younger and Older Patients with Tardive Dyskinesia

Encore:

• Minimal Clinically Important Difference in AIMS Score Based on Clinical and Patient Global Impression of Change in Patients With Tardive Dyskinesia Treated With Deutetrabenazine
• Effect of Deutetrabenazine on Metabolic Parameters in the Treatment of Tardive Dyskinesia

AJOVY^® (fremanezumab-vfrm) Injection:

De Novo:

• Impact of Fremanezumab on Headache-related Disability in Patients With Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medication Classes in the Open–label Extension of the Phase 3b FOCUS Study
• Efficacy and Safety of Fremanezumab in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications During the Open-label Period of the Phase 3b FOCUS Study
• Safety and Tolerability of Fremanezumab in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications: Results From the Open-label Period of the Phase 3b FOCUS Study
• Clinically Meaningful Responses to Fremanezumab in Patients With Migraine and Documented Inadequate Response to 2–4 Migraine Preventive Medication Classes in the Open–label Period of the International, Multicenter Phase 3b FOCUS Study
• Impact of Fremanezumab on Migraine-associated Symptoms in Patients With Episodic and Chronic Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications During the Open-label Period of the Phase 3b FOCUS Study
• Safety and Tolerability of Fremanezumab in Patients With Episodic and Chronic Migraine: a Pooled Analysis of Phase 3 Studies
• Adverse Event Profiles of Therapies that Target the Calcitonin Gene-Related Peptide (CGRP) Pathway, During the First Six Months After Launch: A Real-World Data Analysis Using the FDA Adverse Events Reporting System (FAERS)
• Cardiovascular Safety of Fremanezumab in Patients With Episodic and Chronic Migraine: a Pooled Analysis of Phase 3 Studies
• Assessment of the Patient Experience Across All Phases of Migraine

Encore:

• Efficacy with Fremanezumab in Migraine Patients with Comorbid Moderate to Severe Depression and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Treatments: Subgroup Analysis of the Randomized, Placebo-Controlled FOCUS Study
• Early Onset of Response to Fremanezumab in Migraine Patients with Moderate to Severe Depression and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Treatments: Subgroup Analysis of the Randomized, Placebo-Controlled FOCUS Study
• Efficacy of Fremanezumab in Migraine Patients with Medication Overuse and Documented Inadequate Response to 2-4 Migraine Preventive Medication Classes: Subgroup Analysis of the Randomized, Placebo-Controlled FOCUS Study
• Clinically Meaningful Responses to Fremanezumab in Migraine Patients with Medication Overuse and Documented Inadequate Response to 2-4 Migraine Preventive Medications in the Randomized, Placebo-Controlled FOCUS Study
• Efficacy of Fremanezumab in Male Patients with Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medication Classes: Results of the Randomized, Placebo-Controlled FOCUS Study
• Very Early Onset of Action of Fremanezumab in Patients with Migraine and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Medications: Results of the International, Multicenter, Randomized, Placebo-Controlled FOCUS Study
• Early Onset of Efficacy with Fremanezumab in Patients with Medication Overuse and Documented Inadequate Response to 2-4 Classes of Migraine Preventive Treatments: Subgroup Analysis of the Randomized, Double-Blind FOCUS Study
• Patient Preference for Dosing Regimen and Perception of Dosing Flexibility with Fremanezumab for Migraine: Results From a Patient Survey Following Completion of a 1-Year Extension Study
• Burden of Comorbid Depression and Anxiety on Migraine-Specific Health-Related Quality of Life in Adult Migraine Patients in the United States
• 10-Year Cost-Effectiveness Analyses of Fremanezumab Compared to Erenumab as Preventive Treatment in Episodic Migraine for Patients with Inadequate Response to Prior Preventive Treatments

About AJOVY^® (fremanezumab-vfrm) injection

AJOVY is available as a 225 mg/1.5 mL single dose injection in a prefilled syringe 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. The AJOVY autoinjector has been approved by the FDA and is available in the U.S. In addition to the U.S., the AJOVY autoinjector is currently available in Germany and should soon be available in other select European markets.

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.

About AUSTEDO^® (deutetrabenazine)

AUSTEDO^® is a vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration for the treatment of tardive dyskinesia in adults and for the treatment of chorea associated with Huntington’s disease. Safety and effectiveness in pediatric patients have not been established.

AUSTEDO^® Indications and Usage

AUSTEDO^® is indicated for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia in adults.

Important Safety Information About AUSTEDO^®

Depression and Suicidality in Patients with Huntington’s Disease: AUSTEDO^® can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Balance the risks of depression and suicidality with the clinical need for treatment of chorea. Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior. Inform patients, their caregivers, and families of the risk of depression and suicidality and instruct them to report behaviors of concern promptly to the treating physician. Exercise caution when treating patients with a history of depression or prior suicide attempts or ideation. AUSTEDO^® is contraindicated in patients who are suicidal, and in patients with untreated or inadequately treated depression.

Contraindications: AUSTEDO^® is contraindicated in patients with Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. AUSTEDO^® is also contraindicated in: patients with hepatic impairment; patients taking reserpine or within 20 days of discontinuing reserpine; patients taking monoamine oxidase inhibitors (MAOIs), or within 14 days of discontinuing MAOI therapy; and patients taking tetrabenazine (Xenazine^®) or valbenazine (Ingrezza^®).

Clinical Worsening and Adverse Events in Patients with Huntington’s Disease: AUSTEDO^® may cause a worsening in mood, cognition, rigidity, and functional capacity. Prescribers should periodically re-evaluate the need for AUSTEDO^® in their patients by assessing the effect on chorea and possible adverse effects.

QTc Prolongation: Tetrabenazine, a closely related VMAT2 inhibitor, causes an increase in the corrected QT (QTc) interval. A clinically relevant QT prolongation may occur in some patients treated with AUSTEDO^® who are CYP2D6 poor metabolizers or are co-administered a strong CYP2D6 inhibitor. Dose reduction may be necessary. The use of AUSTEDO^® in combination with other drugs known to prolong QTc may result in clinically significant QT prolongations. For patients requiring AUSTEDO^® doses greater than 24 mg per day who are using AUSTEDO^® with other drugs known to prolong QTc, assess the QTc interval before and after increasing the dose of AUSTEDO^® or the other drugs. AUSTEDO^® should be avoided in patients with congenital long QT syndrome and in patients with a history of cardiac arrhythmias.

Neuroleptic Malignant Syndrome (NMS), a potentially fatal symptom complex reported in association with drugs that reduce dopaminergic transmission, has been observed in patients receiving tetrabenazine. The risk may be increased by concomitant use of dopamine antagonists or antipsychotics. The management of NMS should include immediate discontinuation of AUSTEDO^®; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems.

Akathisia, Agitation, and Restlessness: AUSTEDO^® may increase the risk of akathisia, agitation, and restlessness. The risk of akathisia may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops akathisia, the AUSTEDO^® dose should be reduced; some patients may require discontinuation of therapy.

Parkinsonism: AUSTEDO^® may cause parkinsonism in patients with Huntington’s disease or tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. The risk of parkinsonism may be increased by concomitant use of dopamine antagonists or antipsychotics. If a patient develops parkinsonism, the AUSTEDO^® dose should be reduced; some patients may require discontinuation of therapy.

Sedation and Somnolence: Sedation is a common dose-limiting adverse reaction of AUSTEDO^®. Patients should not perform activities requiring mental alertness, such as operating a motor vehicle or hazardous machinery, until they are on a maintenance dose of AUSTEDO^® and know how the drug affects them. Concomitant use of alcohol or other sedating drugs may have additive effects and worsen sedation and somnolence.

Hyperprolactinemia: Tetrabenazine elevates serum prolactin concentrations in humans. If there is a clinical suspicion of symptomatic hyperprolactinemia, appropriate laboratory testing should be done and consideration should be given to discontinuation of AUSTEDO^®.

Binding to Melanin-Containing Tissues: Deutetrabenazine or its metabolites bind to melanin-containing tissues and could accumulate in these tissues over time. Prescribers should be aware of the possibility of long-term ophthalmologic effects.

CYP2D6 Metabolism: In patients who are poor CYP2D6 metabolizers or are taking strong CYP2D6 inhibitors, the total daily dosage of AUSTEDO^® should not exceed 36 mg (maximum single dose of 18 mg).

Common Adverse Reactions: The most common adverse reactions for AUSTEDO^® (>8% and greater than placebo) in a controlled clinical study in patients with Huntington’s disease were somnolence, diarrhea, dry mouth, and fatigue. The most common adverse reactions for AUSTEDO^® (4% and greater than placebo) in controlled clinical studies in patients with tardive dyskinesia were nasopharyngitis and insomnia.

Please see accompanying full Prescribing Information, including Boxed Warning.

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® and AUSTEDO^®, 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 and AUSTEO;
• our ability to successfully compete in the marketplace; 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; 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 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;

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.

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