Three posters evaluate the long-term safety and efficacy of AUSTEDO^® (deutetrabenazine) tablets as well as the physical, psychological, and social impact of tardive dyskinesia on patients

One study explores the innovative copolymer technology of TV-46000, an extended-release injectable suspension being investigated for the treatment of schizophrenia

Teva will sponsor two educational sessions, examining how social determinants of mental health relate to neuropsychiatric disorders and on the clinical value of long-acting injectables in schizophrenia treatment

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced four data presentations for AUSTEDO^® (deutetrabenazine) tablets and TV-46000/mdc-IRM. These data will be presented at the American Psychiatric Association (APA) Annual Meeting held May 21-25, 2022 in New Orleans, Louisiana, and again virtually June 7-10, 2022.

Featured data at this year’s APA Annual Meeting include findings from a study evaluating long-term treatment with AUSTEDO in postmenopausal women with tardive dyskenisia (TD), as well as two surveys examining the impact of TD on physical, psychological and social aspects of patients’ lives. Teva will also showcase data on an innovative copolymer technology under license from MedinCell that controls the steady release of risperidone in TV-46000, a risperidone extended release injectable suspension formulation.

“We are excited to be back at APA live and in person during Mental Health Awareness Month this year to continue compelling dialogue about unmet need across the mental health spectrum and Teva’s role in helping to meet those needs,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “Our evolving clinical program across diseases of the central nervous system and mental health conditions underscores our ongoing commitment to advancing science for real-world solutions for neurological and psychiatric disorders.”

Teva will also be holding a presentation titled, “Making a Difference for Patients With Tardive Dyskinesia (TD): Proactively Recognizing and Treating an Overlooked Disorder” on Monday, May 23, 2022, from 7:15-8:30 PM CT live at the Hilton New Orleans Riverside and virtually. Expert faculty, Drs. Leslie Citrome and Andrew Cutler, will be discussing the impact that TD can have on patients and the barriers to diagnosis and treatment. This program will also underscore the importance of HCP-patient communication in further uncovering how TD can impact patients’ lives, as well as explore techniques for virtual assessments in screening for TD and clinical data on the efficacy and safety of AUSTEDO in the treatment of adults with TD.

Teva will also host two sponsored in-person sessions:

• “How the Social Determinants of Mental Health Relate to Neuropsychiatric Disorders: What Can We Do About Them in Clinical Practice?”
  • When: Saturday, May 21, 3:00 PM CT
  • Where: Product Showcase #2, Booth #3414
  • Featured speakers: Michael Compton, MD, MPH, DFAPA, Cynthia Armand, MD, Craig Chepke, MD, FAPA
  • What: Social determinants and social consequences associated with neuropsychiatric disorders, including how to best manage and support patients to protect their mental health and optimize health outcomes.

• “Long-Acting Injectables in Schizophrenia: Dispelling Myths, Unlocking Clinical Value”
  • When: Monday, May 23, 2:00 PM CT
  • Where: Product Showcase #2, Booth #3414
  • Featured speakers: John Kane, MD, Leslie Citrome, MD, Christoph Correll, MD, Jose Rubio, MD
  • What: Featured speakers will provide insight into the value of LAIs and benefits of early adoption, before introducing a resource and framework to address clinical dilemmas that may result from common LAI myths.

Teva will also be hosting Meet-the-Expert sessions at Teva’s Medical Affairs booth, #1533, with three expert speakers from the two Teva-sponsored sessions at the following times:

• Leslie Citrome, MD:
  
  Sunday, May 22, 3:00 – 3:30 PM CT
  
  Sunday, May 22, 3:30 – 4:00 PM CT

• Christoph Correll, MD:
  
  Saturday, May 21, 1:00 – 1:30 PM CT
  
  Monday, May 23, 3:30 – 4:00 PM CT

• Craig Chepke, MD:
  
  Saturday, May 21, 4:30 – 5:00 PM CT
  
  Monday, May 23, 9:30 – 10:00 AM CT

Posters are available online and can be accessed via the APA meeting website at: www.psychiatry.org/annualmeeting.

The full set of data sponsored by Teva include:

AUSTEDO:

De novo:

• [Poster #P5-034] Long-Term Efficacy and Safety of Deutetrabenazine in Postmenopausal Women With Tardive Dyskinesia
• [Poster #P7-082] Impact of Tardive Dyskinesia on Physical Aspects of Patient Lives: A Survey of Patients and Caregivers in the United States
• [Poster #P7-083] Impact of Tardive Dyskinesia on Psychological and Social Aspects of Patient Lives: A Survey of Patients and Caregivers in the United States

TV-46000:

De novo:

• [Poster #P8-078] Characterization of novel drug delivery technology utilized in TV-46000, a risperidone extended-release injectable suspension formulation 

About AUSTEDO (deutetrabenazine) Tablets

AUSTEDO is the first and only vesicular monoamine transporter 2 (VMAT2) inhibitor approved by the U.S. Food and Drug Administration in adults for the treatment of tardive dyskinesia and for the treatment of chorea associated with Huntington’s disease. TD is a movement disorder that is characterized by uncontrollable, abnormal, and repetitive movements of the face, torso, and/or other body parts, which may be disruptive and negatively impact individuals. Safety and effectiveness in pediatric patients have not been established.

Indications and Usage

AUSTEDO (deutetrabenazine) tablets is indicated in adults for the treatment of chorea associated with Huntington’s disease and for the treatment of tardive dyskinesia.

IMPORTANT SAFETY INFORMATION

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: AUSTEDO may prolong the QT interval, but the degree of QT prolongation is not clinically significant when AUSTEDO is administered within the recommended dosage range. 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.

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 TV-46000/mdc-IRM

TV-46000/mdc-IRM is an investigational long-acting subcutaneous atypical antipsychotic injection being explored for the treatment of schizophrenia. TV-46000 is a subcutaneous, long-acting formulation of risperidone that utilizes a copolymer technology under license from MedinCell that controls the steady release of risperidone and allows for rapid absorption and sustained release via a subcutaneous injection.

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, biosimilar 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, 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. You can identify these forward-looking statements by the use of words such as “should,” “expect,” “anticipate,” “estimate,” “target,” “may,” “project,” “guidance,” “intend,” “plan,” “believe” and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to the development and commercial success of AUSTEDO; the development of TV-46000/mdc-IRM; our ability to successfully compete in the marketplace, including 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; our business and operations in general, including uncertainty regarding the COVID-19 pandemic and the governmental and societal responses thereto; 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; 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; compliance, regulatory and litigation matters, including failure to comply with complex legal and regulatory environments; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2022 and in our Annual Report on Form 10-K for the year ended December 31, 2021, including in the section captioned “Risk Factors.” 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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