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VANCOUVER, BC / ACCESSWIRE / October 29, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) is pleased to announce that it has initiated the nationalization process for the filing of a family of patents for the sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases. The patents are 100% owned by BioNxt.
Subject to the international Patent Cooperation Treaty ("PCT"), the European Patent Office ("EPO") issued a positive International Preliminary Report on Patentability ("IPRP"), announced by the Company on September 9, 2024. The EPO accepted the patent and confirmed the novelty, industrial applicability, and inventive step of all its claims, satisfying the requirements for patentability.
Based on the report's findings, BioNxt is advancing its patent protection process to the nationalization phase in the following international jurisdictions:
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Independent filing nations: Australia (AU), Canada (CA), New Zealand (NZ), USA (US), Japan (JP);
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European Patent Office: Albania, Austria, Belgium, Bulgaria, Switzerland/Liechtenstein, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lihuania, Luxembourg, Latvia, North Macedonia, Monaco, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovak Republic, San Marino, Turkey; and
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Eurasian Patent Organization ("EAPO"): Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Russian Federation.
Regarding national level patent recognition, most PCT member-states will accept EPO opinions on patentability based on the IPRP, and only a translation and administrative filings are required in the given jurisdiction. Some states, namely the US and Japan, may undertake an individual patent review; however, the IPRP is expected to guide the review process, which is typically positive.
The Company's patent family for sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases is expected to provide patent protection for multiple drug products out to 2045.
BioNxt's lead drug development program in its autoimmune neurodegenerative disease portfolio is a 100% owned and proprietary sublingual Cladribine product for the treatment of Multiple Sclerosis ("MS"). Cladribine tablets are currently approved for use in over 75 countries, including by the United States Food and Drug Administration ("FDA") and the European Medicines Agency ("EMA"), with 2023 annual sales in excess of one billion USD according to Merck KGaA. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS. MS represents the largest market segment for the sale of Cladribine with approximately 2.3 million people living with MS worldwide, with the highest prevalence in North America and Europe, noted by Atlas of MS. The global Multiple Sclerosis drug market is anticipated to top USD 41 billion by 2033 according to Market.us. BioNxt's sublingual Cladribine product is expected to yield a significant advantage over the tablet form for patients suffering from Dysphagia (difficulty swallowing), which is a common symptom among MS patients.