EMA Accepts Submission of Olanzapine LAI by Teva in Partnership with Medincell
The European Medicines Agency has accepted the marketing authorization application for Olanzapine LAI, a long-acting subcutaneous injection of olanzapine for the treatment of schizophrenia in adults. Teva and Medincell make a significant step forward in the development of this therapeutic candidate designed to improve treatment adherence in managing this chronic neuropsychiatric condition.
A Monthly Treatment to Enhance Therapeutic Adherence
Olanzapine LAI (TEV-749) delivers the effectiveness of oral olanzapine in the form of a monthly subcutaneous injection. This formulation employs SteadyTeq technology, a proprietary copolymer from Medincell that ensures controlled and sustained release of the active ingredient. According to the partners, the treatment addresses a major medical need: the lack of a viable long-acting olanzapine formulation currently limits therapeutic options. Adherence to therapy remains a central challenge for individuals with schizophrenia, particularly those dependent on daily oral forms.
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The application submitted to the EMA is based on a robust clinical development program, including the phase 3 SOLARIS study. During its development, Olanzapine LAI demonstrated an efficacy and safety profile consistent with that of currently available oral olanzapine formulations. Schizophrenia affects between 0.3% and 1.5% of the European population. Approximately 80% of patients experience multiple relapses within the first five years of treatment. Long-acting injectable treatments are already widely used in Europe in the management of psychiatric disorders, which identifies a market for this new option.
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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