Medincell’s Partner Teva Unveils New Phase 3 Positive Results for Olanzapine LAI, and Presents Real-World Data on UZEDY® at Psych Congress 20241

Medincell (Paris:MEDCL):

ACCESS HERE THE COMPLETE PRESS RELEASE

TEV-‘749 / mdc-TJK - Investigational Olanzapine Long-Acting Injectable

• Teva presented positive data from the initial period of the Phase 3 SOLARIS trial evaluating Olanzapine LAI in adult patients diagnosed with schizophrenia.
• Findings demonstrate significant improvement in social functioning and quality of life across multiple validated measures from baseline to week 8.
• Data show that Medincell subcutaneous delivery technology underlying olanzapine LAI resulted in no occurrence of Post-Injection Delirium/Sedation Syndrome (PDSS) events to date.
• Richard Malamut, Chief Medical Officer of Medincell, said: "These new data are quite impactful as improvements in social functioning and quality of life would represent a substantial benefit for people living with schizophrenia and their families. This is an important addition to the positive efficacy results for the primary endpoint of the phase 3 study that were announced last May. Teva also confirmed that there are still no cases of PDSS observed. This is crucial because the risk of PDSS, along with the associated post-injection monitoring requirement, has been a major barrier to the use of the approved intramuscular olanzapine LAI product.”

UZEDY^® - Risperidone Long-Acting Injectable

• Real-world analyses of UZEDY reveal high adherence rates and utilization in adults with schizophrenia who have barriers to treatment.
• Christophe Douat, CEO of Medincell, commented: "Data presented on UZEDY usage highlights the significant social vulnerability faced by many individuals with schizophrenia, emphasizing the need for innovative and effective treatments like our risperidone LAI and investigational olanzapine LAI to address this critical societal challenge.”

Extract below from Teva’s press release - November 1^st, 2024: read here the complete press release

¹ Psych Congress 2024, October 29-November 2, 2024, in Boston, MA (USA): www.hmpglobalevents.com/psych-congress

About Medincell

Medincell is a clinical- and commercial-stage biopharmaceutical licensing 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 active pharmaceutical 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 under the name SteadyTeq™).

UZEDY^® and SteadyTeq™ are trademarks of Teva Pharmaceuticals

medincell.com

View source version on businesswire.com: https://www.businesswire.com/news/home/20241104209332/en/