Bionxt receives EAPO readiness-to-grant notification

Executive Summary

• Bionxt Solutions Inc. received a "Readiness to Grant" notification from the Eurasian Patent Organization (EAPO) for its patent application regarding the sublingual delivery of anti-cancer drugs for autoimmune neurodegenerative diseases.
• The patent covers Bionxt's lead product, BNT23001, a sublingual thin-film formulation of cladribine for treating multiple sclerosis (MS).
• The EAPO patent, valid in eight member states with a combined population of over 200 million, is expected to be granted upon payment of a publication fee this week.

Key Details

• Patent Notification: The Eurasian Patent Organization (EAPO) issued a readiness-to-grant notification for Bionxt's comprehensive patent application.
• Patent Scope: The patent family covers sublingual delivery of anti-cancer drugs for autoimmune neurodegenerative diseases, specifically highlighting BNT23001 (cladribine thin-film for Multiple Sclerosis).
• Geographic Coverage: The EAPO patent is valid in Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, and Turkmenistan.
• Next Steps: The company intends to pay the publication fee to the EAPO this week to finalize the grant.
• Global IP Strategy: Nationalization is underway in key markets including the European Union, Canada, Australia, New Zealand, and Japan. A Track 1 priority filing is active in the United States.
• Regulatory Status: Both the European Patent Office and the Eurasian Patent Office have issued favorable communications, formally accepting novelty, inventive step, and industrial applicability.
• Clinical Context: The CEO noted the company is days away from commencing a two-week large-mass animal bioequivalence study to determine dosing parameters for an upcoming human bioequivalence study.

Notable Quotes

• "Solidifying patent protection is a critical part of our commercialization strategy," said Hugh Rogers, chief executive officer of Bionxt. "The timing is excellent as the company is days away from commencing a two-week-long large-mass animal bioequivalence study to determine dosing parameters for our upcoming human bioequivalence study. The coming months are expected to be very exciting for Bionxt as multiple clinical programs advance and our intellectual property portfolio gains international recognition and protection."