Bionxt obtains European patent for MS drug tech

Executive Summary

• Bionxt Solutions Inc. received a decision from the European Patent Office (EPO) to grant European patent No. 4539857 for its proprietary sublingual cladribine oral thin film (ODF) drug delivery technology.
• The patent grant provides enforceable intellectual property protection in up to 39 European Patent Convention (EPC) contracting states, with the patent term extending through at least June 14, 2043.
• This milestone supports Bionxt’s global commercialization strategy for its lead candidate, BNT23001, intended for the treatment of multiple sclerosis (MS) and other autoimmune/neurodegenerative conditions, while the company prepares for planned human bioequivalence studies.

Key Details

• Patent Specifics: European Patent No. 4539857 covering Bionxt’s proprietary sublingual cladribine oral thin film (ODF) drug delivery technology.
• Effective Date: The grant takes effect upon publication in the European patent bulletin on March 11, 2026 (Bulletin 26/11).
• Geographic Scope: Protection extends to up to 39 EPC contracting states upon assignment in designated jurisdictions.
• Patent Term: Extends through at least June 14, 2043, subject to validation requirements, renewal fees, and national procedures.
• Technology Description: The patent covers a sublingual oral thin film formulation designed for transmucosal absorption of cladribine, offering a swallow-free, needle-free dosage format to improve patient convenience and adherence, particularly for MS patients with dysphagia.
• Indication Coverage: The patent is not limited to Multiple Sclerosis; it encompasses the sublingual delivery of cladribine for additional autoimmune and neurodegenerative indications, including Myasthenia Gravis.
• Global IP Strategy Context:
  • Follows a previously announced "intention to grant" from the EPO.
  • Builds on a final patent grant from the Eurasian Patent Organization (EAPO) covering eight member states.
  • Includes a fast-track United States Track One patent filing completed in October 2025 for prioritized examination by the USPTO.
  • Nationalization efforts are ongoing in Canada and other strategic pharmaceutical markets.
• Clinical Development Status: The company is preparing for planned human bioequivalence studies for BNT23001. As cladribine is an approved active pharmaceutical ingredient, development focuses on demonstrating bioavailability and comparability relative to existing oral formulations.
• Preclinical Data: Previously reported preclinical pharmacokinetic data in a large-mass animal model demonstrated increased systemic exposure relative to a reference oral tablet formulation.

Notable Quotes

• "The European patent decision represents an important milestone for Bionxt... Securing patent protection in this region strengthens our global intellectual property position and supports our ongoing licensing and partnership discussions." — Hugh Rogers, CEO
• "This development builds on our recent Eurasian patent grant and aligns with the progress of our cladribine program as we prepare for planned human bioequivalence studies. With intellectual property protection advancing across multiple jurisdictions, Bionxt continues to establish a globally defensible platform around our sublingual cladribine technology." — Hugh Rogers, CEO