Findings evaluate efficacy and safety of AUSTEDO in postmenopausal women with tardive dyskinesia (TD) for up to 3 years

Two studies evaluate the psychological, social and physical impact of TD on U.S. patients and caregivers

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced new efficacy and safety data from a 3-year open-label extension (OLE) study on AUSTEDO^® (deutetrabenazine) tablets in postmenopausal women with tardive dyskinesia (TD). These data will be presented at the 2022 American Psychiatric Association (APA) Annual Meeting, held May 21-25 in New Orleans and online June 7-10. In addition, new data assessing the psychological, social and physical impact of TD on patients and caregivers will also be featured in two posters at APA.

“TD is a persistent and often debilitating disorder that can be disruptive to patients in their daily lives. These studies offer important insights about TD, notably that long-term treatment with AUSTEDO demonstrated improvements in symptoms in postmenopausal women, an at-risk population for TD,” said Denisa Hurtukova, MD, VP, Head of North America Medical Affairs. “Furthermore, findings from two additional studies being presented at APA show TD symptoms can significantly impact patients’ emotional and social health and daily functioning. Healthcare providers should routinely screen patients to better understand their disease burden.”

Long-Term Efficacy and Safety of AUSTEDO in Postmenopausal Women with TD

In a post-hoc analysis of the long-term OLE study of AUSTEDO, 137 women with TD who were postmenopausal were evaluated to determine the efficacy and safety of AUSTEDO in this patient population. The analysis found AUSTEDO provided improvements in TD-related movements in postmenopausal women.

Key Findings

• Mean change in total motor Abnormal Involuntary Movement Scale (AIMS) score, a clinician-rated assessment tool, was –4.5 ± 0.42 and –7.2 ± 0.52 at Week 15 (n=123) and Week 145 (n=77), respectively .
• A majority of patients showed improvement across two patient outcome measures, Patient Global Impression of Change (PGIC), and Clinical Global Impression of Change (CGIC):
  • For PGIC, 61% and 68% of patients showed improvement at Week 15 and Week 145, respectively.
  • For CGIC, 63% and 82% of patients achieved “much improved” or “very improved” ratings at Week 15 and Week 145, respectively.
• AUSTEDO safety findings were consistent with findings from the overall OLE study population (n=337), with no new safety concerns from long-term treatment.
  • Poster [P5-034]: Long-Term Efficacy and Safety of Deutetrabenazine in Postmenopausal Women with Tardive Dyskinesia

Psychological, Social and Physical Impact of TD

The physical, psychological and social impact of TD was examined in two studies that assessed the burden and stigma of TD, regardless of the underlying condition, from the perspectives of both patients and caregivers in the U.S.

Data were collected from a literature review and two online surveys conducted among 269 patients with TD and 162 caregivers. Impact was measured across different domains over the previous seven days in all categories. Findings demonstrate that TD has a significant psychological and social impact on patients and the patient experience can provide insight into stigma associated with TD.

Key Findings-Psychological & Social Impact

• Over half of patients (51.3%-58.7%) reported often/always feeling psychological impacts of TD, such as low self-esteem, fear of being rejected, being anxious/worried, being embarrassed, and being irritable/frustrated/angry.
  • Caregivers rated low self-esteem, fear of being rejected, and being unable to focus as having a higher impact on patients.
• For social domains, 48.7%-55.8% of patients reported TD often/always impacted their ability to socialize with friends and join social activities, take public transportation, and appear on video, among other domains.
  • Caregivers rated joining social activities, running errands and taking public transportation as having a higher social impact on patients.
  • Over half (51.6%–68.0%) of patients reported being bothered quite a bit/very much by reactions from spouses, children, classmates or colleagues.
  • 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

Key Findings-Physical Impact

• Over 90% of patients reported TD impacted physical functioning, with over two-thirds reporting moderate-to-severe impact on 15 of 24 impact measures, including: ability to fall asleep (86.3%), ability to exercise and do household chores (77%, 76.6%), ability to hold items such as glass or fork (76.3%), worry about choking (76.2%), and feeling self-conscious about speech difficulties (74.8%).
• Caregivers rated ability to fall asleep, do household chores and work due to speech difficulties, as having a greater impact; and worry about choking and trouble eating because of choking as having a lower impact.
• These findings demonstrate that TD has a substantial burden on patients’ physical functioning regardless of the underlying condition, and reinforce the need for healthcare providers to routinely assess the impact of TD symptoms on eating, speaking, sleeping, and other activities of daily living.
  • Poster [P7-082]: Impact of Tardive Dyskinesia on Physical Aspects of Patient Lives: A Survey of Patients and Caregivers in the United States

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

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: 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 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, 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; 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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