Regulatory News:

MedinCell (Paris:MEDCL) has recently reached the commercial stage with the market launch by Teva of UZEDY™ for the treatment of schizophrenia. UZEDY is the first innovative product based on MedinCell’s long-acting injectable (LAI) BEPO® technology approved by US FDA.

Teva recently provided the annual revenue guidance for UZEDY, projecting approximately $80 million for 2024. This revenue estimate is in line with MedinCell's anticipated earnings from UZEDY, as the company is set to receive royalties from sales and could earn up to $105 million in commercial milestones.

In parallel, MedinCell is developing a portfolio of innovative treatments also using the BEPO technology. This notably includes the following candidate treatments:

2 candidates in clinical Phase 3:

  • mdc-TJK (partnership with Teva): Potentially, the first long-acting injectable olanzapine with a favorable safety profile that could enable a large adoption for treatment of patients with more severe forms of schizophrenia
  • mdc-CWM (partnership with AIC): An innovative sustained-release formulation of a non-steroidal anti-inflammatory drug celecoxib aiming at facilitating patient recovery after total knee replacement and decreasing the need for potentially addictive opioids

Other programs are currently in the evaluation, formulation or preclinical stage, some as part of the internal program development strategy, others within the framework of partnerships.

About MedinCell

MedinCell is a clinical- and commercial-stage biopharmaceutical company developing long-acting injectable drugs in many therapeutic areas. Our innovative treatments aim to guarantee compliance with medical prescriptions, to improve the effectiveness and accessibility of medicines, and to reduce their environmental footprint. They combine active pharmaceutical ingredients with our proprietary BEPO® technology which controls the delivery of a drug at a therapeutic level for several days, weeks or months from the subcutaneous or local injection of a simple deposit of a few millimeters, entirely bioresorbable. The first treatment based on BEPO® technology, intended for the treatment of schizophrenia, was approved by the FDA in April 2023, and is now distributed in the United States by Teva under the name UZEDY™ (BEPO® technology is licensed to Teva under the name SteadyTeq™).

We collaborate with leading pharmaceutical companies and foundations to improve global health through new treatment options. Based in Montpellier, MedinCell currently employs more than 140 people representing more than 25 different nationalities.

UZEDY™ and SteadyTeq™ are trademarks of Teva Pharmaceuticals

www.medincell.com

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