BioNxt Receives European Patent Notification for Cladribine Thin-Film

BioNxt Solutions Inc. announced that its German subsidiary, Vektor Pharma TF GmbH, received an "Intention to Grant" notification from the European Patent Office for its sublingual cladribine thin-film formulation. This innovation targets multiple sclerosis (MS) and related neurodegenerative diseases, providing potential access across significant pharmaceutical markets in Europe and Eurasia.

This patent, alongside the Eurasian Patent Organization’s "Readiness to Grant," could secure protection across up to 54 jurisdictions. The sublingual thin-film enables rapid absorption, potentially enhancing bioavailability and patient compliance compared to traditional tablets or injectables.

The European MS market, valued at US$7.95 billion in 2024, is expected to reach US$13.56 billion by 2032. Oral therapies, anticipated to hold a 49% market share by 2025, are gaining popularity due to ease of use and improved patient adherence.

BioNxt's strategy includes a large-mass animal bioequivalence study and pursuit of co-development and out-licensing partnerships. These developments signify a step forward in BioNxt's global IP and commercialization approach, aimed at enhancing treatment outcomes through innovative drug delivery.