Regulatory News:
Medincell (Paris:MEDCL):
Teva Canada Limited, a subsidiary of Medincell's partner Teva Pharmaceutical Industries Ltd., has received regulatory approval for risperidone LAI (Long-Acting Injectable) from Health Canada for the treatment of schizophrenia in adults1
Risperidone LAI formulated with Medincell's proprietary technology is now approved in the United States, South Korea, and Canada.
About Medincell
Medincell is a clinical- and commercial-stage biopharmaceutical licensing company developing long-acting injectable treatments across multiple therapeutic areas. Our innovative treatments are designed to ensure adherence to medical prescriptions, enhance the effectiveness and accessibility of medicines, and reduce their environmental impact.
These treatments combine active pharmaceutical ingredients with our proprietary BEPO technology, which enables controlled drug delivery at therapeutic levels for several days, weeks, or months following a subcutaneous or local injection of a small, fully bioresorbable deposit.
The first treatment based on BEPO technology was approved for schizophrenia by the FDA in April 2023 and is now marketed in the United States by Teva under the name UZEDY (BEPO technology is licensed to Teva under the name SteadyTeq).
Our investigational pipeline includes numerous innovative therapeutic candidates in various stages of development, from formulation to Phase 3 clinical trials. We collaborate with leading pharmaceutical companies and foundations to advance global health through new treatment options.
Headquartered in Montpellier, France, Medincell employs over 140 people representing more than 25 nationalities.
medincell.com
UZEDY, LONGAVO and SteadyTeq are trademarks of Teva Pharmaceuticals.
www.medincell.com
This press release may contain forward-looking statements, particularly concerning the progress of the Company's clinical trials. Although the Company considers that its forecasts are based on reasonable assumptions, any statements other than statements of historical fact that may be contained in this press release relating to future events are subject to change without notice, to factors beyond the Company's control and to the Company's financial capabilities.
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A list and description of such risks, hazards and uncertainties can be found in the documents filed by the Company with the Autorité des Marchés Financiers (AMF) pursuant to its regulatory obligations, including in the Company's document de base, registered with the AMF on September 4, 2018 under number I. 18-062, as well as in documents and reports to be published subsequently by the Company. Furthermore, these forward-looking statements only apply as of the date of this press release. Readers are cautioned not to place undue reliance on these forward-looking statements. Except as required by law, the Company undertakes no obligation to publicly update these forward-looking statements, nor to update the reasons why actual results may differ materially from those anticipated in the forward-looking statements, even if new information becomes available. The Company's updating of one or more forward-looking statements does not imply that it will or will not update these or any other forward-looking statements.
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1 https://pdf.hres.ca/dpd_pm/00080831.PDF
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Contacts:
David Heuzé
Head of Corporate and Financial Communications, and ESG
david.heuze@Medincell.com +33 (0)6 83 25 21 86
Grace Kim
Chief Strategy Officer, U.S. Finance
grace.kim@medincell.com +1 (646) 991-4023
Nicolas Mérigeau Arthur Rouillé
Media Relations
Medincell@newcap.eu +33 (0)1 44 71 94 94
Louis-Victor Delouvrier Alban Dufumier
Investor Relations France
Medincell@newcap.eu +33 (0)1 44 71 94 94
