Medincell and Teva Progress in the Development of Olanzapine LAI
Medincell announces, through its partner Teva Pharmaceuticals, significant advancements in the development of a monthly subcutaneous olanzapine injection for the treatment of schizophrenia, according to a press release.
According to a press release from Teva Pharmaceuticals, sales of UZEDY, a subcutaneous risperidone injection for schizophrenia marketed in the United States since May 2023, reached $43 million in the third quarter of 2025, marking a 24% increase from the same period in 2024. Furthermore, year-to-date sales have risen to $136 million, an 82% increase from the previous year. Teva maintains its sales forecast for 2025 in the range of $190 to $200 million.
Successful Completion of Phase 3 Trial for Olanzapine LAI
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Medincell's partner, Teva Pharmaceuticals, announced the completion of the pivotal phase 3 trial for Olanzapine LAI in January 2025, with positive efficacy results and no incidents of post-injection delirium/sedation syndrome (PDSS). Medincell is expected to receive $7 million in development milestones and, according to the group, could benefit from mid- to high-single digit royalties on net sales post-approval.
Significant Market Potential for Olanzapine LAI in the US
Olanzapine LAI shows significant market potential in the United States, where 20% to 30% of patients on oral olanzapine could be candidates for this extended-release injectable form. The absence of a post-injection monitoring requirement is seen as a factor facilitating its adoption. The application for market entry in the US is scheduled for the fourth quarter of 2025, with potential approval expected by the end of 2026, according to the company.
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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