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No PDSS* observed after approximately 99% of injections scheduled for an approval application
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Confirmation that full Phase 3 safety data is expected in H2 2024
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Positive Phase 3 efficacy results have already been published in May 2024 (read the full press release)
MONTPELLIER, France, September 05, 2024–(BUSINESS WIRE)–Regulatory News:
Medincell (Paris:MEDCL):
Teva Pharmaceuticals, the U.S. subsidiary of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), announced yesterday at the 22th Morgan Stanley’s annual Global Healthcare conference that approximately 99% of the injections planned for an approval application have been completed to date (presentation available here). Teva also reaffirmed that the full safety data required for an approval application are expected to be available in the second half of 2024.
The drug candidate mdc-TJK is a once-monthly, long-acting subcutaneous injection of Olanzapine – an atypical antipsychotic – for the treatment of schizophrenia. It has the potential to become the first long-acting Olanzapine treatment with a favorable safety profile, as other Olanzapine LAIs have a “black box” warning from the FDA for the risk of post-injection sedation syndrome (PDSS) that limits their use.
Teva is solely responsible for the development and commercialization of Olanzapine LAI. Medincell could receive up to $117 million in development and commercialization milestones for this program over the next several years, in addition to royalties on all net sales.
*PDDS = Post injection Delirium/Sedation Syndrome
About Medincell
Medincell is a company of licensing clinical and commercial-stage biopharmaceutical company developing long-acting injectable drugs in a variety of therapeutic areas. Our innovative treatments aim to ensure compliance with medical prescriptions, improve the efficacy and accessibility of drugs, and reduce their environmental footprint. They combine active ingredients with our proprietary BEPO technology® which controls the release 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. Headquartered in Montpellier, Medincell currently employs over 140 people representing more than 25 different nationalities.
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UZEDY® and SteadyTeq™ are registered trademarks of Teva Pharmaceuticals
medincell.com
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Contacts
David Heuzé
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[email protected] / +33 (0)6 83 25 21 86
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Head of US Financial Strategy & IR
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Nicolas Merigeau/Arthur Rouillé
Media Relations
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Investor Relations France
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