Nov 15, 2023 in Press Releases
BIONXT REPORTS ON NEW CLADRABINE ODF PRODUCT DEVELOPMENT AND COMMERCIALIZATION PROGRAM
VANCOUVER, BC – November 15, 2023 ‐ BioNxt Solutions Inc. (“BioNxt” or the “Company”) (CSE: BNXT / OTCQB: BNXTF / FSE: BXT) is pleased to provide further development details on its recently announced 100% Cladribine IP acquisition and related development program. BioNxt has commenced the development and commercialization of a proprietary oral dissolvable film (“ODF”) based Cladribine product for the treatment of neurodegenerative diseases, namely Multiple Sclerosis (“MS”).
After ten years of use as a niche oncology therapeutic for the treatment of certain forms of leukemia, Cladribine was re-discovered as a powerful agent for the treatment of MS. Launched by a major drug company in 2017 in Europe and 2019 in the US as a proprietary tablet formulation for the treatment of MS, Cladribine tablets reached over one billion in global sales in 2022 with a three-year CAGR of 18%. 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. The global Multiple Sclerosis drug market is expected to top US$ 41 Billion by 2033 according to Market.us.
BioNxt’s new proprietary Cladribine ODF formulation is designed to provide several advantages over conventional tablet formulations. The primary expected advantage is instant dissolution in the oral cavity and absorption into the bloodstream thereby bypassing the stomach and upper intestine where absorption may be limited. As a result there is potential for greater dosing precision and efficiency which may permit a reduced daily and course dose for patients. The Company also recognizes the potential for greater application of ODF versus tablet formulations, particularly with dysphagic patients who cannot swallow or have difficulty swallowing, which represents over 40% of MS patients.
BioNxt is planning human bioequivalence studies for 2024 with preclinical work already underway. The Company will provide greater details on its clinical strategy in due course.
The Company has filed Cladribine ODF-related preliminary patent applications with three to four patent applications expected to be on file in major international jurisdictions by late 2024 to early 2025 with potential patent protection extending to 2044.