Medincell announced in April 2024 a strategic collaboration with AbbVie to co-develop and commercialize up to six therapeutic products across multiple therapeutic areas and indications. Medincell will use its commercial-stage long-acting injectable technology platform to formulate innovative therapies. Medincell will conduct formulation activities and preclinical studies, including supportive CMC work to advance candidates into clinical trials.
AbbVie will finance and conduct the clinical development for each program and will be responsible for regulatory approval, manufacturing, and commercialization. Under the terms of the co-development and licensing agreement covering up to 6 programs, Medincell has received a $35 million upfront payment and is eligible to receive up to $1.9 billion in development and commercial milestones ($315 million for each program). Medincell is also eligible to receive mid-single to low-double-digit royalties on net sales.
UZEDY is the first product based on Medincell long-acting injection technology, BEPO®?, that reached commercial stage. US marketing authorization obtained from the U.S. FDA on April 28, 2023, immediately followed by commercial launch by Teva in May 2023. EUR1.7 million of royalties already received by Medincell, calculated on Teva's net sales from mid-May 2023 to end of March 2024.
The second innovative product developed with Teva is an investigational once-monthly subcutaneous long-acting injection of the atypical antipsychotic olanzapine (mdc-TJK). It has the potential to be the first long-acting injection with a favorable safety profile as other LAIs of olanzapine have been associated with an FDA black box warning for PDSS that limits their use. For both partnered programs, Teva is fully responsible for leading the development and commercialization.
Medincell may receive up to $105 million in commercial milestones for UZEDY®? and up to $117 million in development and commercial milestones for mdc-TJK over the coming years, in addition to royalties on all net sales of both products. 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 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??).
The company collaborate with leading leading pharmaceutical ingredients with leading pharmaceutical ingredients with leading pharmaceutical ingredient to the company's proprietary BEPO®?®? technology which controls the delivered of a drug at a therapeutic levels for several days, weeks and months from the subcutaneous and local injection of a simple deposit the few millimeters, entirely bioreorbable. The first treatmentbased on BEPO®?technology, intended for the treatment of patients, was approved by the FDA In April 2023, and is currently distributed in the United States byTeva under the name Steady Teq??).