MedinCell Provides an Update on Its Product Portfolio, Following the FDA Acceptance of New Drug Application for the Product mdc-IRM
MedinCell and Teva announced yesterday the FDA acceptance of the New Drug Application for mdc-IRM for patients with schizophrenia.
This first long-acting injectable treatment based on MedinCell's technology could be commercialized as early as 2022 by Teva in the U.S.
Upcoming portfolio milestones expected:
- mdc-TJK and mdc-ANG: Announcement of next steps by Teva expected by year-end.
- mdc-CWM: Our partner AIC is targeting FDA approval to initiate Phase 3 efficacy studies before the end of 2021. The start of the safety study has been postponed.
- mdc-TTG: MedinCell is awaiting the approval of health authorities in several European countries, including France, to initiate a multi-center, randomized, double-blind, placebo-controlled Phase 2 clinical trial to confirm the prophylactic efficacy of ivermectin in regular, daily, oral form to simulate the continuous release of the active ingredient by a long-acting injectable.
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About MedinCell
MedinCell is a clinical stage pharmaceutical company 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, MedinCell makes medical treatments more efficient, particularly thanks to improved compliance, i.e. compliance with medical prescriptions, and to a significant reduction in the quantity of medication required as part of a one-off or chronic treatment. The BEPO® technology makes it possible to control and guarantee the regular delivery of a drug at the optimal therapeutic dose for several days, weeks or months starting from the subcutaneous or local injection of a simple deposit of a few millimeters, fully bioresorbable. Based in Montpellier, MedinCell currently employs more than 140 people representing over 25 different nationalities.
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