MONTPELLIER, France--(BUSINESS WIRE)--Regulatory News:
Medincell (Paris:MEDCL):
Collaboration with AbbVie
- Initiation of preclinical and supportive CMC* work to advance LAI candidate into clinical development
Collaboration with Teva
- UZEDY® (risperidone LAI)
- Reaffirming revenue guidance for 2024 by Teva: c.$80 million
- Exploring an additional indication for the treatment of Bipolar I Disorder in adults
- Olanzapine LAI
- No PDSS** observed after completion of c.95% of the targeted injections for submission (July 31, 2024)
- Full phase 3 safety results on track for H2 2024
Other in-house and partnered assets
- mdc-CWM (post operative pain): ongoing review of completed phase 3 study by Medincell partner Arthritis Innovation Corporation (AIC) with plans to meet with FDA in Q4 2024 to discuss additional studies required for approval
- mdc-WWM (contraception): CMC activities ongoing for initiation of clinical phase 1 activities in 2025
- mdc-STM (malaria): CMC activities ongoing for initiation of clinical phase 1 activities in 2025
- Over 10 in-house or partnered active programs currently at formulation stage
About the collaboration with AbbVie
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.
About the collaboration with Teva
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
- €1.7 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 olanzapine 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.
*CMC (Chemistry, Manufacturing, and Controls) in the pharmaceutical industry refers to the essential documentation and processes related to the chemical composition, manufacturing methods, and quality control measures of a drug, ensuring it meets regulatory standards for safety, efficacy, and quality.
**PDSS = Post injection Delirium/Sedation Syndrome
About Medincell
Medincell is a clinical-and commercial-stage biopharmaceutical licensing 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 registered trademarks of Teva Pharmaceuticals.
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