Berliner Tageszeitung - BioNxt Secures Unitary European Patent for Sublingual Cladribine ODF Platform Across 18 Countries

The European Patent Office registered the patent's unitary effect on March 31, 2026, with effect from March 11, 2026. The Unitary Patent provides centralized protection across 18 participating European countries, including major pharmaceutical markets such as Germany, France, Italy, the Netherlands, Sweden, and Portugal.

Core Patent Covers Sublingual Cladribine Film Technology

The patent relates to a sublingual pharmaceutical composition containing cladribine, preferably formulated as a cladribine-cyclodextrin complex and embedded in a hydrophilic polymer-based oral thin film matrix.

The patent protected technology is designed for transmucosal delivery and is applicable to multiple sclerosis as well as additional autoimmune indications, including myasthenia gravis and neuromyelitis optica spectrum disorders.

With a priority date of June 15, 2022, the patent establishes long-term intellectual property protection for BioNxt's lead drug delivery platform.

Unitary Patent Unlocks Scalable European Commercialization

The Unitary Patent system allows BioNxt to secure and enforce patent protection across 18 EU member states under a single legal framework, significantly reducing administrative complexity compared to traditional national validation routes.

This milestone enhances BioNxt's ability to pursue regional licensing agreements, strategic co-development partnerships, and efficient market access across Europe, and represents a key step in the Company's transition toward commercialization of its lead product candidate, BNT23001 (sublingual cladribine ODF).

ODF Platform Demonstrates Strong Preclinical and Clinical Progress

BioNxt's ODF platform consists of a thin, fast-dissolving film administered sublingually, enabling drug absorption through the oral mucosa while bypassing the gastrointestinal tract. This approach is designed to improve bioavailability, reduce variability in drug absorption, and enhance patient compliance, particularly in populations with swallowing difficulties.

Preclinical studies supporting the cladribine ODF program have demonstrated comparable systemic exposure to the reference oral product Mavenclad^®, supporting bioequivalence potential and favorable tolerability with no treatment-related adverse effects observed following repeated sublingual administration.

BioNxt is also advancing a human bioavailability study comparing its ODF formulation with the marketed tablet, representing a key step toward regulatory approval.

Management Highlights Strategic Importance of European Patent

"The registration of unitary effect for EP4539857 marks an important milestone in our European IP strategy," said Hugh Rogers, CEO of BioNxt. "By securing protection across 18 key markets under a single framework, we are strengthening our foundation for commercialization and future partnership opportunities."

About BioNxt Solutions Inc.

BioNxt Solutions Inc. is a bioscience innovator focused on next-generation drug delivery platforms, diagnostic screening systems, and active pharmaceutical ingredient development. Its proprietary platforms include sublingual thin films, transdermal patches, oral tablets, and a new targeted chemotherapy platform designed to deliver cancer drugs directly to tumors while reducing side effects.

With research and development operations in North America and Europe, BioNxt is advancing regulatory approvals and commercialization efforts, primarily focused on European markets. BioNxt is committed to improving healthcare by delivering precise, patient-centric solutions that enhance treatment outcomes worldwide.

BioNxt is listed on the Canadian Securities Exchange: BNXT, OTC Markets:BNXTF and trades in Germany under WKN: A3D1K3. To learn more about BioNxt, please visit www.bionxt.com.

Investor Relations & Media Contact

Hugh Rogers, Co-Founder, CEO and Director
Email: [email protected]
Phone: +1 780-818-6422

Web: www.bionxt.com
LinkedIn: https://www.linkedin.com/company/bionxt-solutions
Instagram: https://www.instagram.com/bionxt

Cautionary Statement Regarding "Forward-Looking" Information

This news release contains forward-looking statements within the meaning of applicable securities laws. Forward-looking statements are based on management's current expectations, estimates, projections, beliefs, and assumptions as of the date of this release.

Forward-looking statements in this release include, but are not limited to, statements regarding: the development and advancement of the Company's cladribine oral thin-film (ODF) program; the potential benefits and performance of the Company's ODF drug delivery platform; the applicability of the platform to multiple sclerosis, myasthenia gravis, and other autoimmune indications; the scope, strength, and enforceability of the Company's intellectual property portfolio; the strategic value of the Unitary Patent and broader patent estate; the Company's ability to secure and maintain patent protection in key jurisdictions; the anticipated timing, scope, and outcomes of ongoing and future research and development activities; potential regulatory pathways, including bioavailability and bioequivalence studies; and potential commercialization, licensing, or partnering opportunities.

Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause actual results, performance, or achievements to differ materially from those expressed or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks associated with research and development activities; scientific, formulation, and technical challenges; the possibility that preclinical or early-stage results may not be predictive of future outcomes; uncertainties relating to regulatory review and approval; risks related to intellectual property protection, enforcement, and potential challenges; patent validity and scope risks; manufacturing and scale-up risks; reliance on third-party partners and service providers; competitive developments in the pharmaceutical and drug delivery markets; and general economic, market, and capital market conditions.

Readers are cautioned not to place undue reliance on forward-looking statements. Except as required by applicable securities laws, BioNxt undertakes no obligation to update or revise any forward-looking statements to reflect new information, future events, or otherwise.

Mavenclad^® is a registered trademark that is not owned by, affiliated with, sponsored by, or associated with BioNxt Solutions Inc.

SOURCE: BioNxt Solutions Inc.

View the original press release on ACCESS Newswire

A. Lefebvre--BTZ