BioNxt Solutions Inc.
15.7.2024 13:34:47 CEST | ACCESS Newswire | Press release
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
Lithium Measurement MR-Technology Provider NanoNord Expands Business with DLE Leader ElectraLith, Following Danish State Visit to Australia25.3.2026 13:30:00 CET | Press release
Danish company expands collaboration with Australian deeptech rising star during the Royal State Visit to Melbourne AALBORG, DENMARK AND MELBOURNE, AU / ACCESS Newswire / March 25, 2026 / The North Jutland technology company NanoNord has, in connection with the Royal Couple's state visit to Australia, secured an order for additional measurement equipment valued at between 160k - 240k AUD from the Australian deeptech pioneer ElectraLith. The order underscores the growing international potential for Danish measurement technology in the green transition. NanoNord was part of the business delegation during the state visit and seized the opportunity to strengthen its business with both existing and new customers in Australia. It is not the first time the Danish Royal Family has been close to NanoNord - the company was originally officially inaugurated by a then-young Crown Prince Frederik. Danish Technology Measures Lithium in Real Time NanoNord's flagship technology, Tveskaeg, is an MR-bas
Rancho BioSciences Appoints Chris O'Brien as CEO to Deliver AI-Ready Data Solutions for Faster, More Reliable R&D25.3.2026 13:00:00 CET | Press release
Veteran life sciences leader to drive enterprise growth and expand adoption of AI-ready data solutions across pharma and biotech SAN DIEGO, CA / ACCESS Newswire / March 25, 2026 / Rancho BioSciences today announced the appointment of Chris O'Brien as Chief Executive Officer. O'Brien will lead the company's next phase of growth as Rancho expands adoption of its AI-ready data solutions across pharmaceutical, biotechnology, and research organizations. Rancho BioSciences delivers AI-ready data solutions that transform fragmented biomedical data into standardized, reusable assets for AI, analytics, and machine learning. As life sciences organizations continue investing in AI and advanced analytics, preparing inconsistent and siloed data remains a major bottleneck-often slowing analysis and limiting reuse across programs. Rancho addresses this by standardizing and harmonizing complex data so it can be used immediately and consistently across the R&D lifecycle. O'Brien brings more than 20 yea
Datavault AI Partners with Rising British Heavyweight Moses Itauma25.3.2026 13:00:00 CET | Press release
21-Year-Old Boxing Phenom to Showcase Datavault AI Brand in Manchester Showdown Against Jermaine Franklin PHILADELPHIA, PA / ACCESS Newswire / March 25, 2026 / Datavault AI Inc. ("Datavault AI" or the "Company") (NASDAQ:DVLT), a provider of data monetization, credentialing, digital engagement, and real-world asset ("RWA") tokenization technologies, today announced that it has entered into a partnership agreement with undefeated British heavyweight boxing sensation Moses Itauma. The 21-year-old Commonwealth champion's highly anticipated bout against Jermaine Franklin will be on March 28, 2026, at the Co-op Live Arena in Manchester, England, and will be broadcast globally on DAZN. The partnership reflects Datavault AI's strategic focus on elite combat sports talent as the Company builds out its athlete name, image, and likeness ("NIL") digital asset exchange platform, being developed in exploratory collaboration with Sports Illustrated. Itauma (13-0, 11 KOs) is widely regarded as one of
GA-ASI's UK and Japan MQ-9B Programs Are Honored With Excellence Awards from Aviation Week24.3.2026 20:00:00 CET | Press release
GA-ASI Wins 2 of the 9 Awards Presented SAN DIEGO, CA / ACCESS Newswire / March 24, 2026 / General Atomics Aeronautical Systems, Inc. (GA-ASI) was named the winner of two awards during Aviation Week's 21st annual Program Excellence Awards last week. GA-ASI's United Kingdom (UK) Protector Program was given the Special Projects Award, while its Japan COCO (Company-Owned, Company-Operated) Program won in the category of OEM System Sustainment. "We're excited that these two important MQ-9B international programs have been recognized by Aviation Week," said GA-ASI CEO Linden Blue. "We're fortunate to have an incredible team of employees whose dedication and commitment to our customers is truly remarkable." MQ-9B is GA-ASI's most advanced Remotely Piloted Aircraft (RPA) system and includes the SkyGuardian® and SeaGuardian® models, as well as the UK's Protector RG Mk1. In 2025, GA-ASI achieved the first-ever Military Type Certificate (MTC) for the Royal Air Force's (RAF) Protector RG Mk1, pas
Professional Services Firms Bet Big on AI but Skills Gaps Are Holding Them Back, General Assembly Survey Finds24.3.2026 14:00:00 CET | Press release
Most firms have had to abandon at least one AI initiative due to a lack of skills in the past year NEW YORK, NY / ACCESS Newswire / March 24, 2026 / Most professional services firms (61%) have had to abandon at least one AI initiative in the past year due to a lack of internal skills, with more than a third (35%) abandoning multiple initiatives, according to new research from General Assembly, the global leader in practical AI skills training and an LHH company. "Professional services firms face a capability paradox," said Ash Khanna, Head of Professional Services at General Assembly. "AI can accelerate output, but it can't replace the judgment that comes from doing the hard work. We're seeing junior talent generate recommendations faster than ever, but struggle to defend the reasoning behind them. Firms must invest in the durable human skills that make AI output credible and defensible. Upskilling can't be an afterthought; it has to be as central to a firm's AI strategy as the technol
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