Teva Updates on Phase 3 Trials of Medincell’s Olanzapine LAI

Teva Pharmaceuticals, a U.S. branch of Teva Pharmaceutical Industries Ltd., made significant announcements at the 22nd Annual Global Healthcare Conference. The company revealed that approximately 99% of the planned injections for their submission have been completed. Additionally, Teva expects to have the complete safety results for the submission by the second half of 2024.

One of the key highlights from Teva’s presentation was the ongoing development of Olanzapine LAI, an investigational, once-monthly subcutaneous injection. This long-acting variant of the atypical antipsychotic Olanzapine shows promise, potentially becoming the first such treatment with a favorable safety profile. Existing long-acting Olanzapine treatments have been associated with a significant FDA black box warning related to Post Injection Delirium/Sedation Syndrome (PDSS), which has restricted their use.

Teva is leading the charge in both the development and commercialization of Olanzapine LAI. The pharmaceutical company Medincell is set to receive up to $117 million upon reaching certain developmental and commercial milestones for mdc-TJK, along with royalties on the net sales of both Olanzapine LAI and another product.

Medincell, based in Montpellier, France, is a biopharmaceutical company specializing in long-acting injectable drugs across various therapeutic areas. The company's innovative approach aims to enhance the effectiveness and accessibility of medications while ensuring patient compliance with medical prescriptions. Additionally, Medincell focuses on reducing the environmental impact of its treatments. Their proprietary BEPO® technology allows for the controlled release of a drug at therapeutic levels over several days, weeks, or even months, from a small, entirely bioresorbable subcutaneous or local injection.

The first treatment utilizing BEPO® technology, designed for schizophrenia, received FDA approval in April 2023. This treatment, named UZEDY®, is now distributed in the United States by Teva Pharmaceuticals under the licensed name SteadyTeq™. Medincell collaborates with leading pharmaceutical companies and foundations to develop new treatment options that contribute to improving global health.

Medincell, which employs over 140 people from more than 25 nationalities, strives to provide innovative solutions in the medical field. Their commitment to ensuring medication compliance, enhancing drug efficacy, and minimizing environmental impact underscores their mission to advance healthcare globally.

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