Bionxt signs LOI for cladribine commercialization

Executive Summary

• Bionxt Solutions Inc. signed a non-binding Letter of Intent (LOI) establishing an exclusive negotiation framework for the potential commercialization of its sublingual cladribine oral thin film (ODF) product in Eurasian Patent Organization (EAPO) member states.
• The company secured significant intellectual property victories, receiving patent grants from the Eurasian Patent Organization (EAPO) and the European Patent Office (EPO) for its proprietary cladribine ODF technology, valid through at least 2043.
• The agreement outlines a pathway for regional licensing with financial terms including upfront payments, royalties, and revenue sharing, while the company advances bioequivalence studies for its needle-free drug delivery platform.

Key Details

• Strategic Agreement: Bionxt signed a non-binding LOI for an exclusive negotiation period of 60 days to finalize a definitive licensing agreement for cladribine ODF in EAPO member states.
• Commercial Terms: The framework includes potential regional licensing rights, exclusivity during negotiations, and financial structures comprising upfront payments, royalties, and revenue sharing.
• Eurasian Patent Grant: Patent No. 051510 issued by the EAPO on Nov. 14, 2025, covers sublingual delivery of therapeutic compounds (including BNT23001). It provides protection in eight EAPO member states (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan), covering a population of over 200 million, valid through June 14, 2043.
• European Patent Grant: European Patent No. 4539857 granted by the EPO, effective March 11, 2026. Upon national validation, it covers up to 39 EPC contracting states, valid through at least June 14, 2043.
• Product Development: The cladribine ODF is a needle-free and swallow-free alternative to conventional tablets, designed to improve patient convenience and adherence.
• Clinical Status: Preparations for a human bioequivalence study are underway following successful preclinical pharmacokinetic studies in animal models.
• Market Context: The global needle-free drug delivery market was valued at ~$14.39 billion in 2024, projected to reach ~$30.73 billion by 2032. The global oral thin films market is projected to grow at an 8.6% CAGR through 2032.
• Target Indications: The product targets multiple sclerosis (MS), which affects ~2.9 million people globally, and other autoimmune neuromuscular disorders like myasthenia gravis (MG).

Notable Quotes

• "We believe this strategic agreement marks an important milestone in the commercialization of our cladribine ODF program," said Hugh Rogers, chief executive officer and director of Bionxt Solutions.
• "Securing long-term patent protection in both the Eurasian region and Europe strengthens our global IP position and underscores the commercial relevance of our platform. We look forward to engaging with potential partners in Europe and Eurasia to pursue licensing and commercialization opportunities that bring patient-centric therapies to market."