MEDCL MedinCell SA

Phase 3 Study to Be Initiated for Second Long-acting Injectable Antipsychotic Using MedinCell’s Technology

Teva Pharmaceuticals has notified MedinCell (Paris:MEDCL) that it made the decision to initiate the clinical Phase 3 trial for mdc‑TJK.

MedinCell will receive immediately a $3 million payment from Teva Pharmaceuticals linked to the project development milestone.

The Phase 3 study will assess the efficacy and safety of potentially the first subcutaneous long-acting Injectable (LAI) formulation of olanzapine for the treatment of patients with schizophrenia.

mdc-TJK follows mdc-IRM (LAI risperidone), the first subcutaneous antipsychotic based on MedinCell’s technology currently under regulatory review by the U.S. FDA, with a launch target set for 2023.

About MedinCell

MedinCell is a pharmaceutical company at premarketing stage that develops a portfolio of long-acting injectable products in various therapeutic areas by combining its proprietary BEPO® technology with active ingredients already known and marketed. Through the controlled and extended release of the active pharmaceutical ingredient, the BEPO® technology is designed to provide the regular delivery of a drug at the desired dose for several days, weeks or months starting from the subcutaneous or local injection of a deposit of a few millimeters, fully bioresorbable. MedinCell collaborate with tier one pharmaceuticals companies and foundations to improve Global Health through new therapeutic options. Based in Montpellier, MedinCell currently employs more than 150 people representing over 30 different nationalities.

EN
29/08/2022

Underlying

To request access to management, click here to engage with our
partner Phoenix-IR's CorporateAccessNetwork.com

Reports on MedinCell SA

Oscar Haffen Lamm
  • Oscar Haffen Lamm

Medincell: Uzedy TRx shows strong demand, mdc-TJK NDA filing expected ...

Yesterday Teva presented its Q1'25 results, with Uzedy sales for the quarter coming in at USD39m (+160% YoY). While beating Teva's css (USD32.5m, +20%), sales appeared relatively flattish compared Q4 (USD43m), which could be attributed to calendar effects and stock adjustments. We remain optimistic

Oscar Haffen Lamm
  • Oscar Haffen Lamm

MedinCell and iM4TB to initiate development of a Macozinone LAI in tub...

MedinCell and iM4TB to initiate the development of a LAI version of Macozinone for the treatment of tuberculosis, a potential first-in-class which has shown promising results in past phase 1/2 studies. The value add of a long-acting formulation in tuberculosis is clear, considering that current tre

Oscar Haffen Lamm
  • Oscar Haffen Lamm

MedinCell: patient and HCP survey highlight key features of its olanza...

Teva presented early clinical feedback from a patient and healthcare professional survey regarding its olanzapine LAI TEV'749 (mdc-TJK), in particular around important schizophrenia treatment factors — dosing schedule, initiation regimen, SC administration, post-injection monitoring requirements an

 PRESS RELEASE

MedinCell : Information relative au nombre d’actions composant le capi...

MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: MedinCell (Paris:MEDCL) : Place de cotation : Euronext Paris, Compartiment B Code ISIN : FR0004065605 Date Nombre de titres composant le capital en circulation Nombre total de droits de vote Total brut (1) Total net (2) 28 février 2025 33 065 845 44 689 724 44 684 224 (1) Le nombre de droits de vote bruts (ou droits de vote “théoriques”) sert de base de calcul pour les franchissements de seuil. Conformément à l’article 223-11 du Règlement Général de l’AMF, ce nombre est calculé sur la base de l’ensembl...

 PRESS RELEASE

Medincell renforce son Conseil d’administration pour accompagner sa cr...

MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: Medincell (Paris:MEDCL): Pascal Touchon rejoint le Conseil d’administration : 40 ans d'expérience internationale dans l'industrie biopharmaceutique à des postes de direction générale et stratégique et en tant que membre de conseils d'administration de sociétés américaines et européennes, Ancien Directeur Mondial de la Stratégie et du Business Development puis de l’activité globale Cell & Gene de Novartis Oncology, il a dirigé le développement et le lancement international de la toute première thérapie cellulaire et génique approuvée...

ResearchPool Subscriptions

Get the most out of your insights

Get in touch