BioNxt Solutions Inc.
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 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 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.
View the original press release on accesswire.com
To view this piece of content from www.accesswire.com, please give your consent at the top of this page.
About ACCESS Newswire
Subscribe to releases from ACCESS Newswire
Subscribe to all the latest releases from ACCESS Newswire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from ACCESS Newswire
BioNxt Solutions Unveils Accelerated 90-Day Plan: Global Patent Advancements, MS Clinical Trial, and Anti-Aging Expansion19.2.2025 03:05:00 CET | Press release
VANCOUVER, BC / ACCESS Newswire / February 19, 2025 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT), a bioscience innovator specializing in advanced drug delivery systems, is pleased to report on several major milestones for the next 90 days, including the registration of national-level patents, the completion of a human bioequivalence study for its lead Multiple Sclerosis (MS) treatment, and the development of its longevity and anti-aging product. Global Patent Filings: Accelerating Commercial Pathways for BioNxt's Pipeline BioNxt confirm that all national-level filings pursuant to the Patent Cooperation Treaty (PCT) are complete in key jurisdictions of interest, including the United States, Canada, Australia, Europe, and Japan. The Company's national-level filings are based on the positive international examination report issued by the European Patent Office (EPO) in Q3 2024 for the Company's comprehensive patent application for sublingual deli
GA-ASI and CAE Sign Long-Term Agreement to Develop the Next Generation MQ-9B SkyGuardian(R) Mission Trainer18.2.2025 20:00:00 CET | Press release
SAN DIEGO, CALIFORNIA / ACCESS Newswire / February 18, 2025 / General Atomics Aeronautical Systems, Inc. and CAE are pleased to announce a long-term agreement for the development and production of the next-generation mission trainer for GA-ASI's MQ-9B SkyGuardian® remotely piloted aircraft system (RPAS). The contract with GA-ASI includes a firm order for 11 mission trainers, with the opportunity to deliver up to 50 devices over the next five years. The agreement brings together two industry leaders to enhance the training capabilities for operators of MQ-9B and builds on the long-standing business relationship between GA-ASI and CAE. Recognized globally as the reference in synthetic training for RPAS, CAE leverages the latest visualization technology in the development of the next-generation MQ-9B SkyGuardian Mission Trainers. The trainers will employ the CAE Prodigy Image Generator to provide a highly realistic training environment to replicate flight operations. Powered by a state-of
Sama Launches Agentic Capture, a Robust Data Capture Framework for Multi-Modal Agentic AI18.2.2025 08:00:00 CET | Press release
SAN FRANCISCO, CA / ACCESS Newswire / February 18, 2025 / Sama, the leader in purpose-built, responsible enterprise AI with agile data labeling for model development and supervised fine-tuning, today announced the launch of Agentic Capture, a feedback framework for multi-modal agentic AI. Built on Sama's configurable capture platform, this new framework is capable of managing the types of multi-modal, complex use cases necessary for agentic AI across a variety of industries. Agentic Capture, built on Sama's extensible data labeling platform, ensures consistent, accurate annotation through the use of high-quality rubrics and instructions. The framework's precision insights and transparent reporting provide a deeper understanding of the AI agent's behaviors and its impact on model goals, and offers the human in the loop (HITL) validation necessary to effectively iterate on model performance. AI agents are models that can act autonomously to make decisions, take actions and learn from int
General Atomics and EDGE Establish Partnership to Manufacture, Test and Repair Electromechanical Systems17.2.2025 10:00:00 CET | Press release
SAN DIEGO, CALIFORNIA / ACCESS Newswire / February 17, 2025 / EPI, an entity of EDGE Group and the cornerstone of precision engineering in the UAE's aerospace, oil and gas, and defence industries, has signed a Memorandum of Understanding (MoU) with General Atomics-Systems Integration, an affiliate of General Atomics.General Atomics signs an MOU with EPI on February 17, 2025 during IDEX. The signing ceremony was held on February 17, 2025, at the Abu Dhabi National Exhibition Centre during the International Defence Exhibition and Conference (IDEX) 2025. "Through this collaboration, EPI will significantly expand its capabilities. This will include the establishment of a state-of-the-art facility to support the production of electromechanical systems," said Michael Deshaies, CEO of EPI. "Working with EPI will mark a leap forward in the development and manufacturing of this advanced aviation technology," said General Atomics-Systems Integration Vice President Scott Sappenfield. "We expect t
Graid Technology Announces SupremeRAID SE Support for the NVIDIA GeForce RTX 5000 Series, Expanding High-Performance RAID for Workstations13.2.2025 11:00:00 CET | Press release
With Support for the NVIDIA® GeForce RTX™ 5090, 5080, 5070 Ti, 5070 and 5060, SupremeRAID™ SE Continues to Push the Boundaries of High-Performance Workstation Storage SANTA CLARA, CALIFORNIA / ACCESS Newswire / February 13, 2025 / Graid Technology, the leader in GPU-based RAID solutions, today announced that SupremeRAID™ SE now supports the entire NVIDIA® GeForce RTX™ 5000 series, delivering unparalleled RAID performance to high-end workstation users. With support for the GeForce RTX 5090, 5080, 5070 Ti, 5070, and 5060, professionals can leverage NVIDIA's most powerful GPUs to maximize NVMe SSD performance with exceptional efficiency and resilience.Graid Technology Announces SupremeRAID™ SE Support for the NVIDIA® GeForce RTX™ 5000 Series SupremeRAID™ SE is Graid Technology's bring-your-own-GPU RAID solution, designed for workstation users who demand high-speed data access, reliability, and flexibility. With support for the GeForce RTX 5000 series, users can take advantage of NVIDIA's
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom