JERUSALEM - Teva Neuroscience, Inc., an affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA)will present new study data on AUSTEDO at the International Parkinson and Movement Disorder Society annual congress (MDS Virtual Congress 2020) and Psych Congress 2020 Virtual Experience evaluating the long-term efficacy and safety of AUSTEDO in patients with tardive dyskinesia (TD), and the safety and tolerability of AUSTEDO during periods of titration and maintenance in patients with TD.

'Tardive dyskinesia causes involuntarily, uncontrollable movements, that can have a significant impact on functioning and emotional well-being of those living with the condition,' said Daniel McBryan, M.D., Senior Vice President, Head of Global Medical Affairs and Pharmacovigilance at Teva. 'The data being presented this year deepen our understanding of the risk-benefit profile of AUSTEDO over the long-term, in patients most severely impacted by TD, and provides context around the dosing schedule.'

Three Year Efficacy and Safety of AUSTEDOfor Treatment of TD

The open-label extension of the pivotal ARM-TD and AIM-TD studies evaluated the long-term efficacy and safety of AUSTEDOfor the treatment of TD. Treatment was titrated up to a maximum daily dose of 48 mg based on control of movements and medication tolerability and results were evaluated measuring change from baseline in Abnormal Involuntary Movement Scale (AIMS) scores and Clinical Global Impression of Change (CGIC). The following outcomes were recorded: At Week 54 (n=249; total daily dose [mean+/-SE]: 38.7+/-0.66 mg), mean change from baseline in AIMS score was -4.8+/-0.28, and physician assessments reported 66% of patients met the 'much improved' or 'very much improved' scores on the CGIC.

At Week 106 (n=194; total daily dose: 39.3+/-0.75 mg), mean change from baseline in AIMS score was -5.4+/-0.33, and physician assessments reported 65% of patients met the 'much improved' or 'very much improved' scores on the CGIC.

At Week 145 (n=160; total daily dose: 39.4+/-0.83 mg), mean change from baseline in AIMS score was -6.6+/-0.37, and physician assessments reported 73% of patients met the 'much improved' or 'very much improved' scores on the CGIC.

No new safety signals were identified in this population that were inconsistent with the known safety profile of AUSTEDO.

Long-Term Efficacy and Safety of AUSTEDOIn Patients Severely Impacted by TD

A post hoc analysis of the open-label extension portion of the pivotal ARM-TD and AIM-TD studies evaluated the efficacy of AUSTEDOin reducing TD in the most severely impacted patients. Using the upper quartile of baseline AIMS scores from the open-label extension, two subgroups were defined as having scores >14 or 14. At all-time points from Week two to Week 145, change from baseline in AIMS score was greater in those with baseline AIMS score >14 versus 14 (mean +/-SE at Wk 145: -10.9+/-0.8, -5.1+/-0.3). Percent change from baseline in patients with AIMS score >14 reached -59.4%+/-3.6% versus -55.2%+/-3.1% for patients with AIMS score 14 at Week 145. The percent of patients with 50% AIMS reduction at each visit was 71% in patients with baseline AIMS score >14 versus 64% in patients with AIMS score 14 at Week 145.

No new safety signals were identified in this population that were inconsistent with the known safety profile of AUSTEDO.

Safety and Tolerability of AUSTEDO During Titration and Maintenance

The study evaluated data from the ARM-TD and AIM-TD studies and the open-label extension through week 15 to examine the safety and tolerability of AUSTEDO during titration and maintenance phases of therapy.

For flexible-dose AUSTEDO, the only common AE during titration was somnolence (11.2%); there were no common AEs during maintenance. Rates of specific AEs in titration and maintenance were (ranges for all groups in both periods: parkinsonism, 0-1.4%; suicidal ideation, 0-2.7%; akathisia, 0-1.8%; restlessness, 0-1.4%).

All abstracts presented at MDS Virtual Congress 2020 will be published in the Movement Disorders journal e-supplement and displayed as an e-poster in the 2020 Virtual Poster. Abstracts at the Psych Congress 2020 Virtual Experience will be available online in the virtual exhibit hall.

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.

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 2,400 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.

Contact:

Kevin C. Mannix

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