BioNxt Signs Statement Of Work With International Contract Research, Development, And Manufacturing Organization For Cladribine ODF Development

BioNxt Solutions Inc. ("BioNxt" or the "Company") is pleased to report that it has signed a statement of work ("SOW") with a German-based international contract research, development, and manufacturing organization (the "CRDMO"). The SOW is focused on the Company's flagship Cladribine oral dissolvable film ("ODF") development program.

The SOW sets out a number of important deliverables, including but not limited to technology transfer and implementation, evaluation batch production (GMP material under GMP conditions), stability testing, cGMP manufacturing of clinical study samples, and preparation of the PK study Investigational Medical Product Dossier for EU submission.

BioNxt is developing a 100% owned and proprietary ODF Cladribine dosage form, directed at the multiple sclerosis ("MS") market. 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 annual sales in excess of one billion USD. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS and certain forms of leukemia. 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 expected to top USD 41 billion by 2033 according to Market.us.

The CRDMO has a head office in Munich, Germany, with an international network of pharmaceutical service providers with facilities in five countries and over 500 employees. They offer GCP/GLP/GMP/ISO/IEC-certified services and GMP certified manufacturing of clinical trial supplies (Phase I-III) with a specialization in solids, semi-solids, liquids, oral films, and transdermal patches as well as integrated lab analytical services during development & GMP manufacturing, including API characterization, method development, optimization, validation, permeation studies, stabilities studies, etc.

The Company has filed Cladribine ODF-related provisional 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.