In collaboration with AbbVie, initiation of preclinical and
supportive CMC* work to advance a first Long-Acting Injectable
candidate into clinical development
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
- Reaffirming revenue guidance for 2024 by Teva: c.$80
million
- Exploring an additional indication for the treatment of Bipolar
I Disorder in adults
- 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.
www.medincell.com
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particularly concerning the progress of the Company's clinical
trials. Although the Company considers that its forecasts are based
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version on businesswire.com: https://www.businesswire.com/news/home/20240903817726/en/
David Heuzé - Head of Corporate and Financial Communications,
and ESG david.heuze@medincell.com / +33 (0)6 83 25 21 86
Grace Kim - Head of US Financial Strategy and IR
grace.kim@medincell.com / +1 (646) 991-4023
Investors Relations France Louis-Victor
Delouvrier/Alban Dufumier medincell@newcap.eu / +33 (0)1 44 71
94 94
Media Relations Nicolas Mérigeau
medincell@newcap.eu / +33 (0)1 44 71 94 94
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