Medincell and AbbVie will co-develop up to six LAI therapeutic products whereas AbbVie will provide funding, manage the clinical development, handle regulatory approval, manufacturing and commercialisation
Medincell and AbbVie ink injectable therapy development agreement. (Credit: AbbVie Inc.)
Medincell has entered into a co-development and licensing agreement worth up to nearly $2bn with AbbVie to develop next-generation long-acting injectable (LAI) therapies.
The France-based commercial-stage biopharmaceutical licensing company and AbbVie will co-develop up to six LAI therapeutic products in multiple indications and therapeutic areas. The therapies will be formulated using Medincell’s commercial-stage LAI technology platform.
For every programme, AbbVie will provide funding, manage the clinical development, and handle regulatory approval, manufacturing, and commercialisation.
The first candidate for the LAI programme has been chosen, and the formulation process has begun.
According to the terms of the agreement, Medincell will get an upfront payment of $35m and is entitled to possible development and commercial milestones worth up to $1.9bn.
Both firms have agreed on $315m for each programme as well as royalties on global net sales.
Medincell CEO Christophe Douat said: “This will be an exciting partnership with one of the most innovative and successful pharmaceutical companies.
“Medincell has entered a new period of growth following the FDA approval of the first product using our technology in April 2023. The full potential of long-acting injectable therapies is getting increasingly recognised.”
The partnership combines Medincell’s development know-how and its LAI technology with AbbVie’s clinical development and commercialisation experience.
In addition to preclinical research and formulation activities, Medincell will carry out supportive chemistry, manufacturing, and controls (CMC) work to move candidates closer to clinical trials.
Medincell develops LAI drugs in several therapeutic areas by combining active pharmaceutical components with its proprietary BEPO technology.
BEPO controls the delivery of a medication at a therapeutic level from a subcutaneous or local injection of a small, completely bioresorbable deposit that lasts for several days, weeks, or months.
The US Food and Drug Administration (FDA) authorised the first BEPO-based medicine for schizophrenia in April 2023. Israel-based Teva is currently selling the drug in the US under the brand name UZEDY (risperidone).