BioNxt Reports "Intention to Grant" Patent Notification from the European Patent Office for Its Oral Cladribine Sublingual Thin-Film as the Multiple Sclerosis Market Shifts Toward Patient-Friendly Therapies

Executive Summary

• BioNxt’s German subsidiary received an “Intention to Grant” notification from the European Patent Office for a sublingual thin‑film cladribine formulation (European patent No. 23 729 446.7).
• The EPO notice complements a prior “Readiness to Grant” from the Eurasian Patent Organization, together covering up to 54 jurisdictions and an addressable population of nearly 1 billion people across Europe and Eurasia.
• The expanded IP portfolio underpins BioNxt’s commercialization strategy for its lead multiple‑sclerosis candidate BNT23001 and supports ongoing preclinical studies and partnership efforts.

Key Details

• Patent Notification: “Intention to Grant” from the EPO for European patent application No. 23 729 446.7 covering a sublingual, orally dispersible thin‑film formulation of cladribine.
• Geographic Coverage: Potential protection in all EPO contracting, validation and extension states plus eight Eurasian Patent Organization member countries – up to 54 jurisdictions pending national validation.
• Addressable Market: Nearly 1 billion people across Europe, Eurasia, and associated validation states; European MS market valued at US$7.95 bn in 2024, projected US$13.56 bn by 2032 (CAGR ~6.9%).
• Formulation Details: Sublingual thin film containing a cladribine‑cyclodextrin complex with hydrophilic polymers (starch, pullulan) designed for rapid oral mucosal absorption, potentially improving bioavailability and patient adherence versus tablets/injectables.
• Strategic Significance: Strengthens BioNxt’s global leadership in oral/transmucosal drug delivery; supports commercialization of BNT23001 and facilitates co‑development/out‑licensing partnerships.
• Development Progress: Large‑mass animal bioequivalence study underway to define dosing for upcoming human bioequivalence trial.
• Additional IP Filings: U.S. fast‑track application pending; further filings planned in North America, Japan, and other regions to broaden global coverage.
• CEO Quote: “Securing patent protection in both Europe and Eurasia marks a major step forward in our global IP and commercialization strategy,” said Hugh Rogers, CEO.

Notable Quotes

“These patents strengthen our position as a leader in advanced oral drug delivery and support the continued development and partnering of BNT23001.” – Hugh Rogers, CEO, BioNxt Solutions Inc.