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
