Announcement • Sep 20

Teva Pharmaceuticals Presents New Olanzapine Lai Tev-749 Post Hoc Data Highlighting High Rates of Stabilization and Long-Term Efficacy as Once-Monthly Subcutaneous Injectable for the Treatment of Schizophrenia in Adults

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. announced the presentation of new olanzapine LAI (TEV-'749) post hoc data from the pivotal SOLARIS Phase 3 trial as well as analyses supporting treatment switch strategies. The SOLARIS data highlighted the acute and long-term durability, efficacy and safety of TEV-'749 as a once-monthly subcutaneous long-acting injectable (LAI) formulation of olanzapine for the treatment of schizophrenia in adults. In a post hoc analysis of the long-term treatment open-label period of the Phase 3 SOLARIS trial, more than half of all participants receiving TEV-'749 achieved stabilization, more than one-fifth of long-term trial participants met criteria for remission (defined as maintaining a Positive and Negative Syndrome Scale [PANSS] item score of 3 or lower for at least six consecutive months across eight specific remission items), and few that had reached stabilization relapsed. Among 411 participants, 231 (56% [61%, 54%, and 54% with 318-, 425-, and 531-mg dose groups, respectively]) achieved stabilization. Among 231 participants who achieved stabilization, only 10 (4% [6%, 1%, and 5%]) experienced relapse. Among 183 participants who were treated with TEV-'749 for six or more months, 39 (21% [26%, 13%, and 26%]) achieved remission. In separate analyses simulating potential switching scenarios in the inpatient, initiation of TEV-'749 one day after the last dose of oral or short-acting intramuscular olanzapine resulted in predictable olanzapine exposures that remained within established oral therapeutic ranges. An analysis of metabolic outcomes found that the metabolic profile of TEV-'749 was consistent with daily oral olanzapine formulations, with no clear dose-dependent pattern observed. TEV-'749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled steady, sustained release of olanzapine. A PDUFA decision from the FDA is expected for TEV-'749 in Fourth Quarter 2026. In the EU, the European Medicines Agency accepted the Marketing Authorization Application for TEV-'749 in May 2026. SOLARIS was a multinational, multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of olanzapine extended-release injectable suspension for subcutaneous use as a treatment in patients (ages 18-64 years) with schizophrenia. For period one of the study (first 8 weeks), 675 patients were randomized to receive a subcutaneous injection of once-monthly olanzapine LAI (low, medium or high dose) or placebo in a 1:1:1:1 ratio. For period two (next 48 weeks), patients who completed period one on placebo were re-randomized and equally allocated to one of the three olanzapine LAI treatment groups, while patients who completed period one on active olanzapine LAI remained on their established dose strength. The end-of-treatment and follow-up visits were 4 and 8 weeks after administration of the last treatment dose, respectively. The primary objective of the Phase 3 SOLARIS study was to evaluate the efficacy of olanzapine LAI in adult patients with schizophrenia, as measured by PANSS. A key secondary objective was to further evaluate the efficacy of olanzapine LAI based on additional parameters in adult patients with schizophrenia, as measured by CGI-S and PSP. A secondary objective of period two of the study was to evaluate the safety and tolerability of olanzapine LAI in adult patients with schizophrenia.

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Teva Reports Positive Phase 3 Data for Once-Monthly Olanzapine Injectable in Schizophrenia

Teva Pharmaceuticals Presents New Olanzapine Lai Tev-749 Post Hoc Data Highlighting High Rates of Stabilization and Long-Term Efficacy as Once-Monthly Subcutaneous Injectable for the Treatment of Schizophrenia in Adults

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