BioNxt Signs Strategic Agreement for Eurasian Commercialization Following Cladribine ODF Patent Grant in Eurasia and Europe

Executive Summary

• BioNxt Solutions Inc. signed a non‑binding letter of intent (LOI) establishing an exclusive 60‑day negotiation period for a potential regional licensing arrangement to commercialize its sublingual cladribine oral thin film (ODF) in Eurasian Patent Organization (EAPO) member states.
• The company secured formal patent protection for the cladribine ODF technology in both the Eurasian region (EAPO Patent No. 051510) and Europe (European Patent No. 4539857), covering a combined population of over 200 million people and extending through at least June 2043.
• BioNxt is preparing a human bio‑equivalence study and actively evaluating licensing partners, positioning the firm for accelerated market entry in Europe and Eurasia with significant addressable markets for multiple sclerosis and other autoimmune neuromuscular disorders.

Key Details

• LOI Terms
• Exclusive negotiation period: 60 days.
• Framework includes potential regional licensing rights, exclusivity during negotiations, upfront payments, royalties, and revenue sharing.

• Collaboration to cover regulatory strategy, manufacturing coordination, quality control, and commercialization planning.

• Patent Protection

• EAPO Patent No. 051510 issued 14 Nov 2025 – covers sublingual delivery of therapeutic compounds (including lead candidate BNT23001) in all eight EAPO member states (Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Russia, Tajikistan, Turkmenistan).

• European Patent No. 4539857 published 11 Mar 2026 – pending national validation for up to 39 EPC contracting states; protection through at least June 2043.

• Market Opportunity

• Combined Eurasian population >200 million; additional coverage across major European markets upon patent validation.

• Multiple sclerosis affects ~2.9 million globally, with substantial patient bases in Europe/Eurasia; cladribine is an approved therapy for relapsing MS.

• Development Status

• Preclinical PK studies completed; human bio‑equivalence study preparations underway.

• Development pathway focuses on demonstrating bio‑equivalence to existing tablet formulation of cladribine.

• Industry Context

• Global needle‑free drug delivery market valued at ~US$14.39 bn in 2024, projected to reach ~US$30.73 bn by 2032.

• Oral thin film market expected CAGR of ~8.6 % through 2032.

• Management Quote

• “We believe this strategic agreement marks an important milestone in the commercialization of our cladribine ODF program,” said Hugh Rogers, CEO and Director.

Notable Quotes

“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.” – Hugh Rogers, CEO & Director, BioNxt Solutions Inc.