Medincell Achieves Major Milestone with U.S. FDA Approval of WELTRUZA™ (olanzapine)
Medincell Achieves Major Milestone with U.S. FDA Approval of WELTRUZA™ (olanzapine)
MONTPELLIER, France--(BUSINESS WIRE)--Medincell (Paris:MEDCL)
Medincell will host Investor webcast today to discuss the implications of the approval for the Company and answer questions from analysts.
Webcast Details
A replay of the webcast will be available on Medincell's website following the event. |
Medincell (Euronext: MEDCL) achieves major milestone with the announcement by its partner Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd, of the U.S. Food and Drug Administration (FDA) approval of WELTRUZA™ (olanzapine) for extended-release injectable suspension, as the first and only once-monthly subcutaneouslong-acting injectable (LAI) formulation of olanzapine for adults with schizophrenia that can help support stabilization for people living with schizophrenia.
WELTRUZA™ does not require loading doses or oral supplementation at treatment initiation and eliminates the need for post-injection monitoring, addressing a major, long-standing gap in schizophrenia care.
The approval of WELTRUZA™ marks the second FDA-approved medicine utilizing Medincell's long-acting injectable technology, following UZEDY® (risperidone) in 2023.
Teva Pharmaceuticals plans to make WELTRUZA™ available in the United States in the coming weeks.
Medincell is entitled to mid- to high-single digit royalties on worldwide net sales of WELTRUZA™. Medincell is also eligible to receive up to $112 million in development and commercial milestones, including a $4 million payment upon U.S. approval and up to $105 million in sales-based commercial milestones upon achievement of specified sales thresholds.
Christophe Douat, CEO of Medincell, said: “Beyond its clinical significance, the FDA approval of WELTRUZA™ represents a major milestone in the execution of Medincell’s Shift to Growth strategy, with the emergence of a second significant growth engine for the Company. This approval provides further validation of our technology and demonstrates our ability to transform innovation into differentiated medicines that create long-term value for patients, partners and shareholders.”
For additional information regarding WELTRUZA™, please refer to Teva Pharmaceuticals' press release: https://ir.tevapharm.com/news-and-events/press-releases/default.aspx
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Contacts
David Heuzé
Head of Corporate and Financial Communications, and ESG
david.heuze@Medincell.com / +33 (0)6 83 25 21 86
Grace Kim
Chief Strategy Officer, U.S. Finance
grace.kim@medincell.com / +1 (646) 991-4023
