MedinCell’s partner Teva Announces Recruitment Completion of Phase 3 Clinical Study of mdc-TJK / Olanzapine Long-Acting Injectable (LAI)

2024-01-09

临床3期上市批准

MONTPELLIER, France--(BUSINESS WIRE)-- Teva Pharmaceuticals Industries Ltd. announced the successful completion of the enrollment in the EU and US of the anticipated 640 participants of the ongoing Phase 3 clinical trial of mdc-TJK (TEV-44749) at the J.P. Morgan Healthcare Conference. Results of the study are expected in the second half of 2024.1 mdc-TJK is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine for the treatment of schizophrenia. It has the potential to be the first long-acting olanzapine with a favorable safety profile.2 Teva remains fully responsible to lead the development and commercialization of olanzapine LAI globally. MedinCell may receive up to $117 million in development and commercial milestones over the coming years for mdc-TJK, and is eligible for royalties on all net sales. 1 Full webcast of Teva’s presentation at 42nd Annual J.P. Morgan Healthcare Conference, January 8, 2024 is available on ir.tevapharm.com. 2 The only existing LAI of Olanzapine has a FDA black box warning from for PDSS (Post injection Delirium/Sedation Syndrome) that limits its use. About MedinCell MedinCell is a clinical- and commercial-stage biopharmaceutical 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 already known and used active 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 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. UZEDY™ and SteadyTeq™ are trademarks of Teva Pharmaceuticals

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