Details on the New Drug Application Submission

The NDA submission for olanzapine LAI is supported by data from the pivotal Phase 3 SOLARIS trial. This clinical study assessed the efficacy, safety, and tolerability of TEV-'749 in adults aged 18 to 64 diagnosed with schizophrenia. Importantly, the Week 56 results demonstrated that olanzapine LAI successfully met both efficacy and safety endpoints.

“The innovation of olanzapine LAI comes from its delivery of olanzapine, a foundational treatment for schizophrenia, as a once-monthly subcutaneous formulation,” stated Eric Hughes, MD, PhD, Executive Vice President, Global R&D and Chief Medical Officer at Teva. He emphasized Teva's commitment to collaborate closely with the FDA to meet the urgent needs of individuals living with schizophrenia.

Clinical Study Insights: The SOLARIS Trial

The SOLARIS trial is a multinational, multicenter clinical study designed to evaluate the safety and efficacy of TEV-'749. In the first 8 weeks, 675 participants were randomized to receive varying doses of olanzapine LAI or a placebo. Following this initial phase, patients who completed the study were re-randomized for another 48 weeks to assess long-term outcomes.

• Primary Objective: To evaluate the overall efficacy of TEV-'749 in adults with schizophrenia.
• Key Secondary Objective: Further evaluate efficacy using additional parameters.
• Safety and Tolerability: Assessing the long-term safety profile of TEV-'749 in the adult population.

Understanding Schizophrenia and Its Treatment Landscape

Schizophrenia is a chronic and debilitating mental disorder affecting approximately 1% of the global population, with 3.5 million diagnosed in the United States alone. Symptoms can include delusions, hallucinations, and disorganized thinking. The average onset occurs in the late teens to early thirties, leading to significant challenges in patient adherence to treatment.

Relapses are common, with around 80% of patients experiencing multiple episodes in the first five years of treatment. These relapses can result in increased healthcare costs and a loss of functional ability, underlining the need for innovative treatment options like olanzapine LAI.

About Teva Pharmaceuticals

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been a leader in the healthcare sector for over 120 years. As it transitions towards a more innovative biopharmaceutical approach, Teva continues to focus on meeting the needs of patients through a robust portfolio of generic and specialty medicines, including biosimilars.

Looking Ahead: Teva's Forward-Looking Statements

This press release contains forward-looking statements regarding Teva's future results and performance, which are subject to risks and uncertainties. While the company is optimistic about the approval process for TEV-'749, there are critical factors that may impact the success of its development, including competition and regulatory challenges.