Bionxt Solutions Gains Key European Patent for Innovative MS Therapy

Bionxt Solutions has achieved a significant regulatory milestone that advances the commercial prospects for its multiple sclerosis treatment. The European Patent Office has issued an "Intention to Grant" notification to the company's German subsidiary, Vektor Pharma TF GmbH, for a novel drug delivery technology. This development positions the company to potentially disrupt the European MS therapy market with its innovative approach.

At the core of this advancement is patent application 23 729 446.7, covering a thin-film formulation of Cladribin, an established therapeutic agent for multiple sclerosis and neurodegenerative conditions. Unlike conventional tablets or injections, this innovative delivery system administers the medication through absorption via the oral mucosa. The film dissolves beneath the tongue without requiring water or swallowing, offering potential benefits including enhanced bioavailability and improved patient experience. These advantages could prove valuable in a healthcare landscape increasingly focused on self-administration and treatment convenience.

"This European and Eurasian patent protection strengthens our position as a leading provider of advanced oral drug formulations," stated CEO Hugh Rogers. The company anticipates receiving intellectual property protection across up to 54 jurisdictions with a combined population approaching one billion people, particularly when considering the complementary "Readiness to Grant" notice already received from the Eurasian Patent Organization.

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Positioning in a Expanding Therapeutic Market

The commercial potential is substantial, with Europe's multiple sclerosis treatment market valued at $7.95 billion in 2024 and projected to reach $13.56 billion by 2032. Approximately 1.2 million Europeans live with MS, and oral therapies are expected to capture roughly 49% of market share by 2025. Bionxt's swallow-free, water-free film technology aims to establish a competitive position as a patient-friendly alternative within this expanding treatment category.

The development pathway continues with a major animal-based bioequivalence study nearing completion. Results from this research will determine appropriate dosing for human bioequivalence trials scheduled to commence in early 2026. Concurrently, Bionxt is pursuing fast-track patent applications in the United States, Japan, and additional markets. The company is also actively seeking partnerships with pharmaceutical manufacturers to accelerate the commercialization timeline for its formulation.