The European Medicines Agency Accepts Teva’s Marketing Authorization Application for Olanzapine Long-Acting Injectable (TEV-‘749) for the Treatment of Schizophrenia in Adults

• The olanzapine long-acting injectable (TEV-’749) is designed to deliver the efficacy of olanzapine in a subcutaneous formulation¹administered every four weeks.
• If approved, TEV-‘749 could help fill a significant unmet need in available schizophrenia treatment options by addressing the lack of a viable long-acting olanzapine formulation.
• Teva is committed to advancing this innovative treatment option, strengthening its scientific leadership in complex neurological conditions as part of its Pivot to Growth strategy.
  
  

TEL AVIV, Israel and PARIS, May 21, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE: and TASE: TEVA) and Medincell (Euronext: MEDCL), today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for olanzapine long-acting injectable (TEV-‘749) for the treatment of schizophrenia in adults. TEV-‘749 aims to address treatment adherence in real-world settings and contribute to long-term disease management in people living with schizophrenia.¹

“Treatment adherence remains a challenge for people living with schizophrenia including those who rely on oral forms of Olanzapine. TEV-‘749, our investigational subcutaneously delivered olanzapine LAI, has the potential to help provide stability by offering the proven efficacy and safety of olanzapine as a once-every four weeks treatment,” said Eric Hughes, MD, PhD, Executive Vice President, and Chief Medical Officer at Teva. “For too long, treatment options have been limited by the lack of a viable long-acting olanzapine formulation, and we look forward to working with the EMA to help address this gap in care.”

“Daily oral olanzapine is one of the most commonly prescribed antipsychotics in Europe for people living with schizophrenia, and long-acting injectables are already well established in managing serious psychiatric conditions across the region,” said Christophe Douat, CEO of Medincell. “We believe a practical long-acting olanzapine option that fits more naturally into patients’ lives can help address a real and persistent need in schizophrenia.”

Schizophrenia affects 0.3 - 1.5% of the population in Europe², yet those living with the condition often face profound challenges of social isolation, unstable employment ³, and a life expectancy reduced by 15–20 years ⁴.

TEV-‘749 is not approved by any regulatory authority worldwide at this time. The submission to the EMA is supported by an extensive clinical development program, including the Phase 3 SOLARIS study. Across clinical development, TEV-‘749 demonstrated efficacy, a systemic safety profile, and exposure consistent with oral olanzapine.

TEV-‘749 utilizes SteadyTeq™, a copolymer technology proprietary to Medincell that provides a controlled, steady, prolonged release of olanzapine.

About Schizophrenia
Schizophrenia is a chronic, progressive and severely debilitating mental disorder that affects how one thinks, feels and acts.² Patients experience an array of symptoms, which may include delusions, hallucinations, disorganized speech or behavior and impaired cognitive ability.^2,3,4 Approximately 1% of the world’s population will develop schizophrenia in their lifetime, and 0.3 - 1.5% of the population in Europe are currently diagnosed with the condition.^3,4 Although schizophrenia can occur at any age, the average age of onset tends to be in the late teens to the early 20s for men, and the late 20s to early 30s for women.⁴ The long-term course of schizophrenia is marked by episodes of partial or full remission broken by relapses that often occur in the context of psychiatric emergency and require hospitalization.⁴ Approximately 80% of patients experience multiple relapses over the first five years of treatment, and each relapse carries a biological risk of loss of function, treatment refractoriness, and changes in brain morphology.^5,6,7 Patients are often unaware of their illness and its consequences, contributing to treatment nonadherence, high discontinuation rates, and ultimately, significant direct and indirect healthcare costs from subsequent relapses and hospitalizations.^2,3,4,5,6,7

About Teva
Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva’s commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars and pharmacy brands worldwide, Teva is dedicated to addressing patients’ needs, now and in the future. At Teva, We Are All In For Better Health. To learn more about how, visit www.tevapharm.com.

Teva Media Inquiries:
Comms@tevaeu.com
Teva Investor Relations Inquiries:
TevaIR@tevapharm.com

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY® (BEPO® technology is licensed to Teva under the name SteadyTeq™). We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, Medincell currently employs more than 140 people representing more than 25 different nationalities.

Medincell Media Inquiries:
Contact: communication@medincell.com

Teva Cautionary Note Regarding Forward-Looking Statements

This Press Release may contain 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,” “intend,” “plan,” “believe,” “aim” 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: our ability to successfully develop olanzapine LAI (TEV-‘749) for the treatment of adult patients diagnosed with schizophrenia and to obtain regulatory approvals; our ability to successfully compete in the marketplace, including our ability to successfully execute our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development; our significant indebtedness; our business and operations in general; compliance, regulatory and litigation matters; other financial and economic risks; and other factors discussed in our Quarterly Report on Form 10-Q for the first quarter of 2026, and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned “Risk Factors” and “Forward-Looking Statements.” 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.

References

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¹ Data on file. Parsippany, NJ: Teva Neuroscience, Inc.
² European Brain Council. Rethinking Schizophrenia. 2024. Available at https://www.braincouncil.eu/projects/rethinking-schizophrenia/#:~:text=Rethinking%20Schizophrenia%20is%20a%20research,that%20of%20the%20general%20population. Last accessed March 2026³ Teva What lies beneath: Uncovering the hidden drivers and impact of Stigma in Schizophrenia White Paper 2025. Available at https://www.tevapharm.com/globalassets/tevapharm-vision-files/teva-white-paper-uncovering-hidden-drivers-and-impact-stigma-in-schizophrenia.pdf Last accessed March 2026
⁴ Thornicroft G. British Journal of Psychiatry. 2011;199(6):441-442.