The High Court has allowed Brepco Biopharma Limited to end Piramal Critical Care B.V.’s exclusive rights to commercialise the paediatric drug Neoatricon in 25 European markets, while preserving Piramal’s position in Germany, the UK and Italy pending a full trial.
Neoatricon, developed by Irish company Brepco after 15 years of research and trials, is a ready-to-use formulation of dopamine hydrochloride for seriously ill children. Brepco received EU marketing authorisation in May 2024 and appointed Piramal to commercialise the product across 29 countries.
Their licence required launches within 12 months in Germany, the Netherlands and Sweden, and within 18 months elsewhere. Piramal launched in Germany, the UK and Italy, but missed the relevant deadlines across the 25 countries covered by a March 2026 termination notice.
Piramal argued that the parties had agreed a phased strategy prioritising the largest European markets and that supply difficulties contributed to delays. Brepco denied agreeing to any extension beyond the written contractual deadlines.
Ms Justice Eileen Roberts held that Piramal had some arguments to make at trial but that its challenge to the March termination was comparatively weak. The balance of justice favoured allowing Brepco to seek other commercial partners in countries where the product remained unlaunched, particularly because its ten-year EU exclusivity period was continuing to run down.
A different conclusion applied to Brepco’s April notice, which sought to terminate the entire relationship on the basis that Piramal had “become insolvent”. The court found no evidence at this stage that Piramal could not pay debts as they fell due. Its financial statements also recorded continuing support from its parent company.
The court therefore restrained Brepco from acting on the April notice in Germany, the UK and Italy.
The ruling is interlocutory only. It does not finally decide whether either termination notice was legally valid. Those issues remain for trial.