Contacts

First FDA approval and US commercial launch, MedinCell enters new era 

May 2, 2023

 MedinCell will hold a video conference for its shareholders and the financial community on May 2nd, 2023 

6:30pm CEST in French, to connect: www.medincell.com/fr/investisseurs/#events_ 

7:30pm CEST in English, to connect: www.medincell.com/en/investors/#events_ 

 MedinCell and its partner Teva have announced FDA approval of mdc-IRM, the first product based on MedinCell’s BEPO® technology

The new treatment for schizophrenia will be available in the U.S. in the coming weeks under the brand name UZEDY™ 

MedinCell is entitled to receive royalties on all sales and is eligible for up to $105 million in commercial milestones 

Two other products based on the same MedinCell’s BEPO® technology are currently in Phase 3 and several others are in development 

Christophe Douat, CEO of MedinCell declared: “It is an emotional moment at Medincell. We are at a turning point, an inflection point, and this is just the beginning. FDA approval of UZEDY is an important validation of our technology and know-how. We now have a product reaching market with significant commercial potential in the US. Given UZEDY’s differentiating features and positive Phase 3 results, we believe it has the potential to establish a new standard of care for patients with schizophrenia. This major development in the evolution of our company will benefit all the products of our portfolio and increase our visibility. Our team and our partner have done an exceptional job together. This success goes beyond MedinCell, it is also major news for the French biotechnology sector.” 

Jaime Arango, Chief Financial Officer of MedinCell said: “We are reaching the commercial stage with an ideal partner to exploit the full potential of UZEDY. Teva is building a schizophrenia franchise. Its American sales force has recently demonstrated its effectiveness on the same target of prescribers as UZEDY. We are entitled to receive royalties from the first sales and eligible for up to $105 million in commercial milestones in the coming years. In the short term, this approval triggers a $4 million payment from Teva to MedinCell and gives us access to the third tranche of the EIB loan for an amount of €10 million2.” 

UZEDY is the first product based on MedinCell’s proprietary BEPO technology (licensed to Teva under the name SteadyTeq™) to reach market. It is part of MedinCell’s growing portfolio that includes other breakthrough treatments, all of which aim at offering innovative therapeutic options that may ensure patient compliance and adherence and provide other benefits that address unmet medical need for existing medications. 

Session en français

Mardi 19 décembre, 18h30 : Présentation des résultats du premier semestre de l'année fiscale 2023-24

English session

Tuesday, December 19, 6:30 pm: Half-year earnings call (April 1st - September 30th)

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