MEDCL MedinCell SA

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

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

*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

EN
03/09/2024

Underlying

MEDCLMedinCell SA

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
MEDCL MEDINCELL SA

MedinCell: New positive efficacy and safety data presented for mdc-TJK

Teva presented new efficacy, safety, and tolerability results for the phase 3 trial evaluating MedinCell's olanzapine LAI (mdc-TJK) in adult patients diagnosed with schizophrenia. New data presented on secondary endpoints showed that mdc-TJK significantly improved i) Clinical Global Impression-Seve

09/23/24 September 23, 2024 1 EN
 PRESS RELEASE
Free
MEDCL MEDINCELL SA

Medincell’s Partner Teva Provided Treatment Insights into Switching to...

MONTPELLIER, France--(BUSINESS WIRE)-- New data presented by Teva at ECNP 2024* demonstrate switching to UZEDY at four weeks after the last dose of once-monthly Perseris® (RBP-7000) provided the most comparable pharmacokinetic (PK) profile based on relevant simulations, with comparable doses identified. Perseris manufacturer announced in July 2024 the discontinuation of its commercialization. Teva already presented in June 2024 data informing clinical strategies for switching patients to UZEDY from a once-monthly intramuscular injection of Invega Sustenna® (paliperidone palmitate)**. Richar...

September 23, 2024 1 EN
 PRESS RELEASE
Free
MEDCL MEDINCELL SA

Teva, partenaire de Medincell, a présenté de nouvelles données d'effic...

MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: Teva a présenté à l’ENCP 2024* de nouvelles données positives d'efficacité, de sécurité et de tolérance de l’essai de phase 3 (SOLARIS) évaluant l'Olanzapine LAI (TV-‘749/mdc-TJK) pour les patients adultes atteints de schizophrénie. Richard Malamut, Directeur Médical de Medincell, a déclaré : « En plus de la publication des résultats d’efficacité positifs relatifs aux critères d’évaluation primaires et secondaires de l'étude SOLARIS, Teva a révélé les trois doses étudiées, qui correspondent aux trois dosages d'olanzapine actuellement di...

September 23, 2024 1 FR
 PRESS RELEASE
Free
MEDCL MEDINCELL SA

Teva, partenaire de Medincell, a présenté de nouvelles données soutena...

MONTPELLIER, France--(BUSINESS WIRE)-- Regulatory News: Medincell (Paris : MEDCL) : De nouvelles données, présentées par Teva à l’ENCP 2024*, démontrent que le passage à UZEDY quatre semaines après la dernière dose de Perseris® (RBP-7000), administré une fois par mois, présente un profil pharmacocinétique très comparable, en se basant sur des simulations précises, avec des doses comparables définies. Le fabricant de Perseris a annoncé en juillet 2024 l’arrêt de sa commercialisation. En juin 2024, Teva avait déjà présenté des données soutenant la transition des patients d'une injection intr...

September 23, 2024 1 FR
 PRESS RELEASE
Free
MEDCL MEDINCELL SA

Medincell’s Partner Teva Presented New Efficacy, Safety, and Tolerabil...

MONTPELLIER, France--(BUSINESS WIRE)-- Teva presented at ECNP 2024* new positive efficacy, safety, and tolerability results for Phase 3 SOLARIS trial evaluating Olanzapine LAI (TV-‘749 / mdc-TJK) in adult patients diagnosed with schizophrenia. Richard Malamut, Chief Medical Officer of Medincell, said: “In addition to publishing the positive efficacy results for the primary and secondary endpoints of the SOLARIS study, the data presented by Teva unveiled the three doses evaluated, which align with the three doses of oral olanzapine currently available for the treatment of patients with schizop...

September 23, 2024 1 EN

ResearchPool Subscriptions

Get the most out of your insights

Get in touch