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MedinCell’s Partner Teva Provides Guidance for UZEDY in 2024 and an Update on the Treatment-Candidate of Olanzapine Long-Acting Injectable (LAI)

BusinessWire_EN 
0 0 31.01.24
MedinCell’s Partner Teva Provides Guidance for UZEDY in 2024 and an Update on the Treatment-Candidate of Olanzapine Long-Acting Injectable (LAI): https://mms.businesswire.com/media/20191128005494/en/700687/5/MedinCell-Logo-notagline.jpg
 

MedinCell (Paris:MEDCL):

Access here the complete press release

About UZEDY

During the Q4 2023 earnings call held today by Teva Pharmaceutical Industries Ltd., President and CEO Richard Francis stated that he expects a strong uptake and significant growth for UZEDY in 2024. He notably provided the annual revenue guidance for UZEDY, projecting approximately $80 million for 2024.

This revenue projection is aligned with MedinCell's forecasted earnings from UZEDY, as the company receives royalties on sales and may earn up to $105 million in commercial milestones.

UZEDY is the first product based on MedinCell's long-acting injection technology, BEPO, to reach commercial stage

  • US marketing authorization obtained from the U.S. FDA on April 28, 2023
  • Commercial launch by Teva in May 2023
  • MedinCell has already received first royalties of €0.6 million, calculated on Teva's net sales from mid-May to end of September 2023

About Olanzapine LAI (mdc-TJK)

Eric Hughes, Executive Vice President, Global R Chief Medical Officer, announced during the call that 62% of the targeted 3,600 injections have already been performed as part of the ongoing Phase 3 clinical trial and that no PDSS has been observed. Full clinical package on efficiency and safety is expected in the second half of 2024.

mdc-TJK is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine for the treatment of schizophrenia. It has the potential to be the first long-acting Olanzapine with a favorable safety profile as other LAIs of Olanzapine have a FDA black box warning for PDSS that limits their use.

Teva is fully responsible to lead the development and commercialization of olanzapine LAI globally.

MedinCell may receive up to $117 million in development and commercial milestones over the coming years for mdc-TJK, and is eligible for royalties on all net sales.

Christophe Douat, CEO of MedinCell, says: “The guidance on UZEDY is very positive. Teva’s ambition reaffirms its confidence in its potential. Olanzapine LAI Phase 3, potential First-in-Class product, is progressing impressively and is ahead of schedule with a major milestone this year. Both illustrate the ability of MedinCell technology to do breakthrough products. Based on these news, we confirm our objective to achieve operational profitability as soon as possible and to generate additional revenue with new partnerships to extend our cash visibility until this horizon.”

View source version on businesswire.com: https://www.businesswire.com/news/home/20240131431252/en/

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