BioNxt Signs Master Services Agreement with International Contract Research, Development, and Manufacturing Organization

Vancouver, BC - BioNxt Solutions Inc. ("BioNxt" or the "Company") has signed a master services agreement (MSA) with a German-based international contract research, development, and manufacturing organization (CRDMO). This partnership is pivotal for BioNxt's future product development, particularly its oral dissolvable (ODF) drug formulations pipeline.

The CRDMO, headquartered in Munich, Germany, has facilities in five countries and over 500 employees. They offer GCP/GLP/GMP/ISO/IEC-certified services and specialize in clinical trial supplies, including solids, semi-solids, liquids, oral films, and transdermal patches. They also provide integrated lab analytical services during development and GMP manufacturing.

Wolfgang Probst, Interim CEO of BioNxt, stated that this agreement is crucial for advancing the company's Cladribine ODF program to the next stage, focusing on human comparative bioequivalence studies. Cladribine tablets, used for multiple sclerosis (MS) and certain leukemia forms, are approved in over 75 countries and generate over one billion USD in annual sales.

BioNxt has filed provisional patent applications for Cladribine ODF, with several filings expected in major international jurisdictions by late 2024 to early 2025. Patent protection could extend to 2044.