BioNxt Signs Statement of Work with International CRDMO for Cladribine ODF Development

VANCOUVER, BC / ACCESSWIRE / July 17, 2024 / BioNxt Solutions Inc. has signed a statement of work (SOW) with a German-based international contract research, development, and manufacturing organization (CRDMO). The agreement focuses on BioNxt's Cladribine oral dissolvable film (ODF) development program.

The SOW outlines key deliverables, including technology transfer, evaluation batch production under GMP conditions, stability testing, cGMP manufacturing of clinical study samples, and preparation of the PK study dossier for EU submission.

BioNxt is developing a proprietary ODF Cladribine dosage form for the multiple sclerosis (MS) market. Cladribine tablets are approved in over 75 countries and generate over one billion USD annually. MS represents the largest market for Cladribine, with around 2.3 million people affected globally.

The CRDMO, headquartered in Munich, Germany, has facilities in five countries and employs over 500 people. They provide certified services and manufacturing for clinical trials, specializing in solids, semi-solids, liquids, oral films, and transdermal patches.

BioNxt has filed provisional patent applications related to Cladribine ODF, with several patent applications expected in major jurisdictions by late 2024 to early 2025, potentially extending patent protection to 2044.