Bionxt receives EU patent grant notice for oral MS film

Executive Summary

• Bionxt Solutions Inc. received an "Intention to Grant" notification from the European Patent Office (EPO) for its oral cladribine sublingual thin-film formulation (BNT23001) for the treatment of multiple sclerosis (MS).
• This notification complements a previously announced readiness to grant from the Eurasian Patent Organization (EAPO), collectively securing potential patent protection across up to 54 jurisdictions, including all EPO contracting, validation, and extension states, plus eight EAPO member countries.
• The company is advancing BNT23001 through development, currently completing a large-mass animal bioequivalence study to establish dosing parameters for an upcoming human bioequivalence trial, while actively pursuing co-development and out-licensing partnerships.

Key Details

• Patent Notification: Received "Intention to Grant" from the European Patent Office (EPO) for European patent application No. 23 729 446.7.
• Patent Scope: Covers a sublingual, orally dispersible thin-film formulation of cladribine for the treatment of MS and related neurodegenerative diseases.
• Geographic Coverage: Potential protection across up to 54 jurisdictions (all EPO contracting, validation, and extension states, plus eight EAPO member countries), covering an addressable population of nearly one billion people across Europe, Eurasia, and associated validation states.
• Complementary IP: Complements the company's previously announced readiness to grant from the Eurasian Patent Organization (EAPO) for Eurasian patent application No. 202590051.
• Formulation Details: The patents protect a proprietary transmucosal cladribine delivery composition in the form of a sublingual thin film comprising a cladribine-cyclodextrin complex and hydrophilic polymers (starch and pullulan), designed for rapid absorption through the oral mucosa.
• Market Context: The European MS treatment market was valued at approximately $7.95 billion (U.S.) in 2024 and is projected to reach $13.56 billion (U.S.) by 2032 (CAGR ~6.9%). Oral therapies are projected to maintain a leading share of approximately 49% by 2025.
• Competitive Landscape: MAVENCLAD (cladribine tablets) serves as a benchmark, approved by the European Medicines Agency and used by more than 100,000 patients globally. Bionxt's formulation is swallow-free and water-free.
• Development Status: Bionxt is completing a large-mass animal bioequivalence study to establish dosing parameters for an upcoming human bioequivalence trial.
• Strategic Actions: The company is actively pursuing co-development and out-licensing partnerships with innovator and generic manufacturers. Additional IP filings are underway, including a United States fast-track application and filings in North America and Japan.

Notable Quotes

• "Securing patent protection in both Europe and Eurasia marks a major step forward in our global IP and commercialization strategy. These patents strengthen our position as a leader in advanced oral drug delivery and support the continued development and partnering of BNT23001." — Hugh Rogers, Chief Executive Officer