BioNxt Signs Master Services Agreement with International Contract Research, Development, and Manufacturing Organization
BioNxt Solutions has signed a master services agreement (MSA) with a German international contract research, development, and manufacturing organization (CRDMO) to advance its pipeline of oral dissolvable (ODF) drug formulations.
The CRDMO, based in Munich, Germany, offers certified services and manufacturing capabilities across five countries. BioNxt aims to leverage this agreement to progress its proprietary ODF Cladribine dosage form for the multiple sclerosis (MS) market.
Cladribine tablets, already approved in over 75 countries, including by the FDA and EMA, have annual sales exceeding $1 billion. BioNxt plans to file additional patent applications for Cladribine ODF by early 2025, potentially extending patent protection to 2044.
This agreement facilitates BioNxt's regulatory, technical, and laboratory needs, setting the stage for a human comparative bioequivalence study.
- BioNxt signed an MSA with an international CRDMO, enhancing its product development capabilities.
- The agreement supports BioNxt's pipeline, especially its proprietary ODF Cladribine dosage for the MS market.
- Cladribine tablets generate annual sales over $1 billion, indicating a lucrative market.
- BioNxt plans additional patent applications for Cladribine ODF by 2025, with potential protection until 2044.
- None.
VANCOUVER, BC / ACCESSWIRE / July 9, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report that it has signed a master services agreement ("MSA") with a German-based international contract research, development, and manufacturing organization (the "CRDMO"). The MSA will serve as the foundation for BioNxt's future product development, particularly its pipeline of oral dissolvable ("ODF") drug formulations.
With a head office in Munich, Germany, the CRDMO is 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. The CRDMO also offers integrated lab analytical services during development & GMP manufacturing, including API characterization, method development, optimization, validation, permeation studies, stabilities studies, etc.
"This is a very important step for our company," stated Wolfgang Probst, Interim CEO and Director of BioNxt. "With the recent success of our Cladribine ODF toxicity and comparative PK study, we are eager to advance the program to the next stage, namely the human comparative bioequivalence study. The MSA we just signed puts BioNxt in a position to satisfy all the necessary laboratory, technical, and regulatory steps toward clinical studies and product commercialization."
BioNxt is developing a
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.
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FAQ
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