Teva updates on Phase 3 trial of Medincell’s Olanzapine LAI and UZEDY® progress

8 August 2024

Medincell, a biopharmaceutical company based in Montpellier, France, is making significant strides in the development of long-acting injectable drugs. Their innovative approach focuses on improving medication compliance, effectiveness, and accessibility while minimizing environmental impact. Their current projects span various therapeutic areas and employ their proprietary BEPO® technology, which ensures the controlled release of drugs over days, weeks, or even months with a single subcutaneous or local injection.

A key development from Medincell is Olanzapine LAI (mdc-TJK), which has shown promising results. Nearly 95% of the intended injections for its submission have been completed without any instances of Post Injection Delirium/Sedation Syndrome (PDSS). Full phase 3 safety results are expected to be available in the second half of 2024, following the positive phase 3 efficacy results announced in May 2024.

Another significant product in Medincell's portfolio is UZEDY®, which is already on the market in the United States for the treatment of schizophrenia. This drug, also based on BEPO® technology, was approved by the FDA in April 2023 and is distributed by Teva Pharmaceuticals under the name SteadyTeq™. Medincell has reaffirmed its revenue guidance for UZEDY® in 2024 at approximately $80 million and is exploring an additional indication for the treatment of Bipolar I Disorder in adults.

Medincell's BEPO® technology is a cornerstone of their product innovation. This technology enables the sustained release of active pharmaceutical ingredients from a small, fully bioresorbable depot, thereby maintaining therapeutic levels of the drug for extended periods. This approach not only ensures better patient compliance but also maximizes the drug's efficacy and minimizes the frequency of medical interventions.

The company's mission extends beyond just developing new drugs; they aim to address broader health challenges by collaborating with leading pharmaceutical companies and foundations. These partnerships are designed to introduce new treatment options that can have a significant impact on global health.

Currently, Medincell employs over 140 individuals from more than 25 different nationalities, reflecting its commitment to diversity and global health improvement. This multicultural workforce is instrumental in driving the company's innovative projects and maintaining its competitive edge in the biopharmaceutical industry.

In summary, Medincell is at the forefront of developing long-acting injectable treatments that promise to enhance patient compliance and treatment efficacy. With products like Olanzapine LAI and UZEDY®, along with their proprietary BEPO® technology, the company is well-positioned to make significant contributions to global health. As they continue to explore new indications and expand their market presence, Medincell remains committed to its mission of improving the accessibility and effectiveness of medical treatments.

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