Bionxt's European patent applications accepted

Executive Summary

• Bionxt Solutions Inc. has received formal communications from the European Patent Office (EPO) and the Eurasian Patent Organization (EAPO) confirming that the core claims of its patent application for its proprietary sublingual cladribine thin-film formulation have been accepted.
• Full patent grants are anticipated in the near future for both jurisdictions, with only minor formal amendments or language modifications required and already addressed by the company.
• The patents cover the composition of the sublingual film, methods of administration, dosage, use for treating autoimmune diseases, and scalable manufacturing processes for chemotherapy drugs in oral-dissolvable delivery systems.

Key Details

• European Patent Office (EPO): Issued an office action with the intention to grant for Bionxt's key patent application. All core claims met requirements for novelty, inventive step, and industrial applicability. The next office action is expected within the coming weeks.
• Eurasian Patent Organization (EAPO): Issued a formal notice that the patent application has been accepted, covering eight member countries across Eastern Europe and Central Asia. Minor language modifications were submitted promptly. Full patent grant across all member states is anticipated in the near term.
• Patent Scope: The protected technology includes Bionxt's sublingual cladribine thin-film formulation for relapsing-remitting multiple sclerosis (RRMS). It also covers applications of chemotherapy drugs in oral-dissolvable delivery systems for autoimmune neurological diseases.
• Global Strategy: The company previously filed an international PCT application and has entered the national phase in the United States, Canada, Japan, Australia, and New Zealand. These applications are currently progressing through local examination procedures.
• Next Milestones: Bionxt expects formal grant notices and publication from the EPO and EAPO shortly. The company is simultaneously preparing for GMP manufacturing and a human bioequivalence clinical study in Europe to support regulatory filings and commercialization.

Notable Quotes

• "Securing intellectual property rights in both Europe and Eurasia marks a critical step forward for our cladribine program and sublingual delivery platform. These patents represent significant commercial value by protecting a high-potential product, enabling regional exclusivity, and enhancing our ability to generate future licensing and partnership revenue." — Hugh Rogers, Chief Executive Officer