Medincell’s Partner Teva Presented New Efficacy, Safety, and Tolerability Data from Pivotal Phase 3 of Olanzapine LAI for Adult Patients Diagnosed with Schizophrenia

MONTPELLIER, France–(BUSINESS WIRE)–Teva presented at ECNP 2024 new positive efficacy, safety, and tolerability results for Phase 3 SOLARIS trial evaluating Olanzapine LAI (TV-˜749 / mdc-TJK) in adult patients diagnosed with schizophrenia.

Richard Malamut, Chief Medical Officer of Medincell, said: In addition to publishing the positive efficacy results for the primary and secondary endpoints of the SOLARIS study, the data presented by Teva unveiled the three doses evaluated, which align with the three doses of oral olanzapine currently available for the treatment of patients with schizophrenia. This alignment is very important as it should simplify the work for physicians when switching their patients from oral olanzapine to our LAI formulation. All three doses demonstrate systemic safety profile consistent with other approved olanzapine formulations, with no new safety signals identified. Most notably, no PDSS has been observed to date. This is crucial because the risk of PDSS, along with the associated post-injection monitoring requirement, has been a major barrier to the use of the approved intramuscular olanzapine LAI.

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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.

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Source: Medincell