Medincell Announces Progress in the Development of its Products Portfolio and R&D Pipeline

In collaboration with AbbVie, initiation of preclinical and supportive CMC* work to advance a first Long-Acting Injectable candidate into clinical development

MONTPELLIER, France--(BUSINESS WIRE)--Collaboration with AbbVie

• Initiation of preclinical and supportive CMC* work to advance LAI candidate into clinical development

Collaboration with Teva

• UZEDY^® (risperidone LAI)

• Reaffirming revenue guidance for 2024 by Teva: c.$80 million
• Exploring an additional indication for the treatment of Bipolar I Disorder in adults

• Olanzapine LAI

• No PDSS^** observed after completion of c.95% of the targeted injections for submission (July 31, 2024)
• Full phase 3 safety results on track for H2 2024

Other in-house and partnered assets

• mdc-CWM (post operative pain): ongoing review of completed phase 3 study by Medincell partner Arthritis Innovation Corporation (AIC) with plans to meet with FDA in Q4 2024 to discuss additional studies required for approval
• mdc-WWM (contraception): CMC activities ongoing for initiation of clinical phase 1 activities in 2025
• mdc-STM (malaria): CMC activities ongoing for initiation of clinical phase 1 activities in 2025
• Over 10 in-house or partnered active programs currently at formulation stage

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*CMC (Chemistry, Manufacturing, and Controls) in the pharmaceutical industry refers to the essential documentation and processes related to the chemical composition, manufacturing methods, and quality control measures of a drug, ensuring it meets regulatory standards for safety, efficacy, and quality.

**PDSS = Post injection Delirium/Sedation Syndrome