Medincell‘s long-acting injectable technology, BEPO®, has achieved commercial success with its first product, UZEDY® (risperidone LAI), for treating schizophrenia in adults. Approved by the FDA in April 2023 and launched by Teva the following month, UZEDY demonstrates high adherence rates, particularly among patients with unmet social needs, according to real-world data analysis. This analysis examined US claims data from 715 adult schizophrenia patients treated with UZEDY, focusing on social determinants of health and adherence patterns.
A separate investigational drug, TEV-‘749 / mdc-TJK, is a once-monthly subcutaneous olanzapine LAI, also for schizophrenia. Phase 3 SOLARIS study results indicate its potential to be the first long-acting olanzapine with a favorable safety profile, addressing a key limitation of existing olanzapine LAIs. The 8-week, double-blind, placebo-controlled Period 1 of the SOLARIS trial, involving patients aged 18-64, showed TEV-‘749 significantly improved social functioning and quality of life across all three doses compared to placebo. This was followed by a 48-week open-label safety period (Period 2). The primary endpoint, a statistically significant change in Positive and Negative Syndrome Scale (PANSS) total scores from baseline to week 8, was met across all dosing groups. Importantly, the systemic safety profile aligned with approved oral olanzapine formulations, with no new safety signals or Post-Injection Delirium/Sedation Syndrome (PDSS) events.
Medincell’s BEPO® technology enables controlled drug delivery at therapeutic levels for extended periods from a single, bioresorbable subcutaneous injection. This addresses compliance, efficacy, and environmental impact of treatments. Partnering with Teva, Medincell receives royalties on net sales and milestone payments for the development and commercialization of these products. Teva leads the clinical development and regulatory processes.
Medincell, a clinical and commercial-stage biopharmaceutical licensing company, develops long-acting injectables across various therapeutic areas. Their innovative approach aims to improve medication adherence, treatment effectiveness, and accessibility while minimizing environmental impact. Headquartered in Montpellier, France, Medincell employs over 140 individuals representing more than 25 nationalities.
This press release includes forward-looking statements concerning clinical trials, product benefits, regulatory approvals, commercialization, future product portfolio, partnerships, capital needs, and financial matters. While based on reasonable assumptions, these statements are subject to inherent risks and uncertainties. Factors beyond the company’s control and financial capabilities could cause actual results to differ materially. Detailed information on these risks can be found in documents filed with the Autorité des Marchés Financiers (AMF), including the company’s registration document. These forward-looking statements reflect the company’s current perspective and are subject to change. This press release is for informational purposes only and does not constitute an offer to sell or a solicitation to buy shares. It should not be considered investment advice.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
