Irish pharmaceutical developer Brepco Biopharma has secured the right to market its paediatric hypotension treatment across most European countries following a High Court ruling on a dispute over the product's commercialisation agreement.

Breaking News Ireland reports that the Dublin-based company successfully defended an application by Netherlands-based Piramal Critical Care BV, which sought to prevent the termination of an exclusive licensing agreement covering 29 countries across the European Union, the UK and Norway.

Brepco developed Neoatricon over a 15-year research programme to treat hypotension in seriously ill neonates, infants and children up to the age of 18. Under the agreement signed in 2022, Piramal was granted exclusive rights to commercialise the medicine across the licensed territories.

The dispute arose after Brepco argued that Piramal had failed to meet contractual launch obligations, claiming the medicine had only been introduced in Germany, the UK and Italy while little or no progress had been made in most of the remaining markets.

Piramal maintained that its phased commercialisation strategy focused initially on Europe's largest pharmaceutical markets, describing the approach as commercially appropriate and consistent with industry practice.

Following a two-day hearing, the High Court granted an injunction allowing Piramal to retain exclusive commercialisation rights in the UK, Germany and Italy, where the product had already been launched. However, the court declined to extend the injunction to the remaining territories, enabling Brepco to pursue alternative commercial arrangements across most European markets.

The decision provides Brepco with an opportunity to accelerate the availability of its treatment in countries where commercial launches had not yet taken place, while highlighting the importance of clearly defined performance obligations within pharmaceutical licensing and market access agreements.

The ruling also underscores the commercial significance of licensing partnerships in the pharmaceutical industry, where successful product launches, regulatory milestones and contractual delivery remain critical to expanding patient access and maximising the value of innovative medicines.