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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

ACCESS HERE FOR THE FULL PRESS RELEASE

*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

Contacts

David Heuzé - Head of Corporate and Financial Communications, and ESG
david.heuze@medincell.com / +33 (0)6 83 25 21 86

Grace Kim - Head of US Financial Strategy and IR
grace.kim@medincell.com / +1 (646) 991-4023

Investors Relations France
Louis-Victor Delouvrier/Alban Dufumier
medincell@newcap.eu / +33 (0)1 44 71 94 94

Media Relations
Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94

Industry:

Medincell

BOURSE:MEDCL
Release Versions
English

Contacts

David Heuzé - Head of Corporate and Financial Communications, and ESG
david.heuze@medincell.com / +33 (0)6 83 25 21 86

Grace Kim - Head of US Financial Strategy and IR
grace.kim@medincell.com / +1 (646) 991-4023

Investors Relations France
Louis-Victor Delouvrier/Alban Dufumier
medincell@newcap.eu / +33 (0)1 44 71 94 94

Media Relations
Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94

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