Medincell: European Filing Planned for Olanzapine LAI in Q2 2026
Medincell, through its partner Teva Pharmaceuticals, announces that the submission of a Marketing Authorization Application (MAA) for Olanzapine LAI in Europe is scheduled for the second quarter of 2026. This move aligns with the company's strategy to access key therapeutic markets.
Teva Pharmaceuticals has announced its plan to submit an MAA for Olanzapine LAI, aimed at treating adult schizophrenia, to the European Medicines Agency (EMA) in the second quarter of 2026. This long-acting injection provides a monthly subcutaneous formulation. Christophe Douat, CEO of Medincell, describes this step as 'key' and emphasizes that Europe is a strategic market where olanzapine is widely prescribed for schizophrenia treatment. Following the submission, the regulatory process includes a two-week validation phase, followed by a standard evaluation typically lasting between 9 and 15 months. The opinion of the Committee for Medicinal Products for Human Use (CHMP), usually issued two months before the European Commission's final decision, is a crucial part of this process.
Partnership Benefits and Regulatory Progress
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Medincell benefits from a partnership with Teva Pharmaceuticals for the development of Olanzapine LAI. Teva submitted a New Drug Application (NDA) to the U.S. FDA on December 9, 2025. Medincell is entitled to receive royalties on net sales as well as milestone payments and commercial milestones related to the achievement of annual sales thresholds. Olanzapine LAI is part of Medincell's strategy to develop long-acting injectable treatments using its proprietary BEPO® technology, which controls the release of the active ingredient from a bioresorbable depot administered through subcutaneous injection.
SectorSanté · Biotechnologies · Vaccins et laboratoires de recherche›Biotechnologie
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Contexte
Period
Period: 9M 2025
Guidance from the release
We are pleased with the company’s growth and momentum.
Total income €14,1 million; Revenues €11,6 million (+35 %); UZEDY® royalties €4,2 million; Operating result €(6,6) million (improved 13 % year-over-year); Net result €(16 078) thousand; Cash and low-risk financial investments €53,5 million (incl. €49,8 million cash and €3,7 million low-risk investments); Net financial debt €17 629 thousand; NDA for Olanzapine LAI submitted to FDA on December 9, 2025; AbbVie partnership advancing with regulatory package expected in 2026.
Risks mentioned
Foreign exchange risk: weakness of USD vs EUR impacted revenues and generated ~€1 million FX losses
Dependency on partner commercialization (Teva) for UZEDY® royalties and sales forecasts
Regulatory risk: approvals (e.g., Olanzapine LAI) and acceptance for review uncertain
Financial volatility linked to fair value revaluation of EIB BSA warrants (non-cash €6,8 million impact)
Opportunities identified
Olanzapine LAI: NDA submitted and potential launch could be a major growth catalyst
UZEDY®: upward revision of 2025 net sales forecast by Teva (from $160 million to $190-200 million)
AbbVie partnership: first program advancing toward first-in-human trials (regulatory package expected 2026)
Gates Foundation financing: new $3 million envelope to advance mdc-STM malaria program
Expanded geographic approvals (Canada, South Korea) supporting broader commercialization
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