Teva Completes Enrollment for Phase 3 mdc-TJK LAI Study

Teva Pharmaceuticals has achieved a significant milestone in its Phase 3 clinical trial for a novel schizophrenia treatment. The company has completed enrollment of the expected 640 participants across the European Union and the United States for the trial of mdc-TJK (TEV-44749), an investigational long-acting injection of the atypical antipsychotic olanzapine. This announcement was made at the prestigious J.P. Morgan Healthcare Conference, with results anticipated to be released in the latter part of 2024.

The mdc-TJK injection is a groundbreaking once-monthly subcutaneous treatment that could revolutionize schizophrenia management. It is poised to become the inaugural long-acting formulation of olanzapine with a promising safety profile, offering a new option for patients and healthcare providers.

Teva Pharmaceuticals is at the forefront of this development, taking full responsibility for leading the global development and commercialization efforts for the olanzapine long-acting injection. In a collaborative effort, MedinCell, a clinical and commercial-stage biopharmaceutical company, stands to receive up to $117 million in development and commercial milestones for their contribution to mdc-TJK. Additionally, MedinCell is eligible to receive royalties based on the net sales of the product.

MedinCell is renowned for developing long-acting injectable drugs across various therapeutic areas. Their innovative approach focuses on enhancing medication compliance, effectiveness, and accessibility while minimizing the environmental impact. Their proprietary BEPO® technology is central to this mission, allowing for the controlled release of medication over an extended period following a simple subcutaneous injection. This technology was instrumental in the development of the first FDA-approved treatment for schizophrenia in April 2023, now marketed in the United States by Teva as UZEDY™.

MedinCell's commitment to improving global health is evident through their partnerships with leading pharmaceutical companies and foundations. With a diverse workforce of over 140 employees from more than 25 different nationalities, the company is well-positioned to make a significant impact in the pharmaceutical industry.

UZEDY™, along with the SteadyTeq™ technology licensed to Teva, are trademarks of Teva Pharmaceuticals. MedinCell's dedication to innovation and collaboration is a testament to their role as a key player in the advancement of healthcare solutions.