MedinCell’s Partner Teva Announces Successful Launch of UZEDY™

MONTPELLIER, France--(BUSINESS WIRE)--MedinCell (Paris:MEDCL):

Access here the complete press release

During today’s Q2 earnings call, Richard Francis, President and CEO of Teva, and Eric Hughes, Executive Vice President, Global R&D & Chief Medical Officer, commented the US launch of UZEDY since May 2023 and the olanzapine Long-Acting Injectable (LAI).

About UZEDY

Richard Francis said¹:

“We are actually right on plan or slightly ahead of our market access strategy targets and we are very happy with the launch.”

“The newest member of our innovative family is said risperidone, our long-acting treatment for schizophrenia. Now, to remind everybody, this is a $4 billion market and we've only just launched UZEDY, but we're very pleased with the feedback we're getting from healthcare professionals. And they're confirming that the product profile that we have is unique and advantageous. Now we're seeing this in the fact that our NBRX² is 40%, so already we're getting 40% of the risperidone long-acting market. We're also seeing hospitals look to use our free samples and free trial requests, and we're having good discussions with our payers. So once again, I think excitement around UZEDY early days, but initial feedback is very positive.”

UZEDY, a long-acting injectable (LAI) risperidone for the treatment of schizophrenia in adults, is the first FDA-approved product based on MedinCell’s BEPO technology. MedinCell is eligible for up to $105m commercial milestones and for royalties on net sales.

About LAI olanzapine (mdc-TJK), initiated in January 2023

Eric Hughes said¹:

“Our Olanzapine Phase 3 study is actually enrolling very quickly.”

“Olanzapine as an oral agent account for 20% of the patients being treated today, but only less than 1% of patients on the long-acting form are being using that product. And that's primarily because of the safety profile³.”

Richard Francis, said¹:

“With olanzapine, I've already highlighted the fact that it's a $4 billion market. But if we do manage to bring this to the market with a favorable safety profile, I think we have a real opportunity to have a significant product on our hands here.”

mdc-TJK is an investigational long-acting injectable olanzapine also based on BEPO technology. If approved, it could be the first olanzapine LAI with a favorable safety profile offering a valued treatment option as a complement to UZEDY for severe schizophrenia patients. MedinCell is eligible for $12m left out of $17m of development milestones, for up to $105m commercial milestones and for royalties on net sales.

Other programs

Teva and MedinCell also announce the initiation of preliminary formulation activities for a new program in an undisclosed indication, along with the decision to terminate the mdc-ANG program at preclinical stage for strategic reasons.

¹ Extracts from the Teva’s Q2 2023 earnings call, August 2, 2023. Full webcast, transcript and presentation are available on ir.tevapharm.com
² NBRx = new-to-brand prescriptions: new prescriptions, as in the first time a patient is being prescribed a particular drug
³ The only existing LAI of Olanzapine has a FDA black box warning from for PDSS (Post injection Delirium/Sedation Syndrome) that limits its use