Biotech
Wednesday, July 17th, 2024 3:39 pm EDT
Key Points
- BioNxt Solutions Inc. has signed a statement of work with a German-based international CRDMO for the development of its Cladribine oral dissolvable film (ODF) program, which includes technology transfer, evaluation batch production, stability testing, and cGMP manufacturing of clinical study samples.
- The Cladribine ODF is targeted at the multiple sclerosis (MS) market, with Cladribine tablets already approved in over 75 countries for highly active forms of relapsing-remitting MS and certain leukemias, and annual sales exceeding one billion USD.
- BioNxt has filed provisional patent applications for Cladribine ODF, with expectations to have three to four patents filed internationally by late 2024 to early 2025, potentially extending patent protection to 2044.
VANCOUVER, BC / ACCESSWIRE / July 17, 2024 / BioNxt Solutions Inc. (“BioNxt” or the “Company“) (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) 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.
About BioNxt Solutions Inc.
BioNxt Solutions Inc. is a bioscience accelerator focused on next-generation drug formulations and delivery systems, diagnostic screening tests, and new active pharmaceutical production and evaluation, including: precision transdermal and oral dissolvable drug formulations; rapid, low-cost infectious disease and oral health screening tests; and standardization and clinical evaluation of emerging active pharmaceutical ingredients for neurological applications. The Company has research and development operations in North America and Europe, with an operational focus in Germany, and is currently focused on regulatory approval and commercialization of medical products for European markets.
BioNxt Solutions Inc.
Wolfgang Probst, CEO and Director
Email: info@bionxt.com
Phone: +1 780-818-6422
Cautionary Statement Regarding “Forward-Looking” Information
Some of the statements contained in this news release are forward-looking statements and information within the meaning of applicable securities laws. Forward-looking statements and information can be identified by the use of words such as “expects”, “intends”, “is expected”, “potential”, “suggests” or variations of such words or phrases, or statements that certain actions, events or results “may”, “could”, “should”, “would”, “might” or “will” be taken, occur or be achieved. Forward-looking statements and information are not historical facts and are subject to a number of risks and uncertainties beyond the Company’s control. Actual results and developments are likely to differ, and may differ materially, from those expressed or implied by the forward-looking statements contained in this news release. Accordingly, readers should not place undue reliance on forward-looking statements. The Company undertakes no obligation to update publicly or otherwise revise any forward-looking statements, except as may be required by law.
SOURCE: BioNxt Solutions Inc.
