Medincell’s Partner Teva Provides Update on Pivotal Clinical Phase 3 of Investigational Olanzapine Long-Acting Injectable (LAI) and UZEDY® Commercial Progress
Olanzapine LAI (mdc-TJK)
- No PDSS* observed after completion of c.95% of the targeted injections for submission
- Full phase 3 safety results on track for H2 2024
-
Positive phase 3 efficacy results have already been announced in
May 2024 (read the full PR)
UZEDY®
-
Reaffirming revenue guidance for 2024: c.
$80 million - Exploring an additional indication for UZEDY® for the treatment of Bipolar I Disorder in adults
MONTPELLIER,
About Olanzapine LAI
Olanzapine LAI is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine. It has the potential to be the first long-acting Olanzapine with a favorable safety profile as other LAIs of olanzapine have been associated with a FDA black box warning for PDSS that limits their use.
About UZEDY® (1-month and 2-month subcutaneous risperidone for treatment of schizophrenia), Teva reaffirmed revenue guidance of
UZEDY® is the first product based on
-
US marketing authorization obtained from the
U.S. FDA onApril 28, 2023 , immediately followed by commercial launch by Teva inMay 2023 -
€1.7 million of royalties already received by
Medincell , calculated on Teva's net sales frommid-May 2023 to end ofMarch 2024
About both partnered programs, Teva is fully responsible for leading the development and commercialization.
*PDSS = Post injection Delirium/Sedation Syndrome
About
UZEDY® and SteadyTeq™ are registered trademarks of
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David Heuzé - Head of
david.heuze@medincell.com / +33 (0)6 83 25 21 86
grace.kim@medincell.com / +1 (646) 991-4023
Investors Relations France
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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