BioNxt Signs Letter of Intent with Gen-Plus GmbH & Co KG for Potential Business Collaborations

Rhea-AI Summary

BioNxt Solutions Inc. (CSE:BNXT, OTCQB:BNXTF, FSE:BXT) has signed a non-binding letter of intent (LOI) with Gen-Plus GmbH & Co KG, a German-based international contract research, development, and manufacturing company. The LOI outlines potential collaborations in areas such as intellectual property development, clinical trial planning, and thin film commercial manufacturing.

BioNxt is developing a proprietary oral dissolving film (ODF) Cladribine dosage form for the multiple sclerosis (MS) market. Cladribine tablets are currently approved in over 75 countries, with annual sales exceeding $1 billion USD. The global MS drug market is projected to reach $41 billion by 2033. BioNxt has filed provisional patent applications for its Cladribine ODF, with potential patent protection extending to 2044.

Positive

• Potential collaboration with Gen-Plus in key pharmaceutical development areas
• Development of proprietary ODF Cladribine for the billion-dollar MS market
• Filed provisional patent applications with potential protection until 2044
• Targeting a global MS drug market projected to reach $41 billion by 2033

Negative

• Non-binding nature of the letter of intent with Gen-Plus
• Lack of specific details on cooperation programs

VANCOUVER, BC / ACCESSWIRE / August 15, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTCQB:BNXTF)(FSE:BXT) is pleased to report that it has signed a non-binding letter of intent (the "LOI") with German-based international contract research, development, and manufacturing company Gen-Plus GmbH & Co KG ("Gen-Plus"), a part of Conscio Group.

Further to the Master Service Agreement and Cladribine Statement of Work signed by BioNxt and Gen-Plus announced on July 9, 2024, and July 17, 2024, respectively, the LOI recognizes a number of important areas of potential cooperation between the parties, including but not limited to intellectual property and prototype development for new pharmaceutical products, clinical trial planning and batch manufacturing, laboratory, equipment, and office collaboration, business development, and thin film commercial manufacturing. The Company will provide further details on specific cooperation programs as they progress.

Gen-Plus, a part of Conscio Group, has a head office in Munich, Germany, and through the Conscio Group operates within 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.

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

FAQ

What is the potential market size for BioNxt's Cladribine ODF product?

BioNxt is targeting the multiple sclerosis (MS) drug market, which is expected to reach $41 billion globally by 2033, according to Market.us. Currently, Cladribine tablets have annual sales exceeding $1 billion USD.

What is the current status of BioNxt's (BNXTF) patent applications for Cladribine ODF?

BioNxt has filed provisional patent applications for its Cladribine ODF. The company expects to have three to four patent applications filed in major international jurisdictions by late 2024 to early 2025, with potential patent protection extending to 2044.

What are the key areas of collaboration outlined in the LOI between BioNxt (BNXTF) and Gen-Plus?

The LOI outlines potential collaborations in areas including intellectual property and prototype development for new pharmaceutical products, clinical trial planning and batch manufacturing, laboratory and equipment collaboration, business development, and thin film commercial manufacturing.

How many countries have approved Cladribine tablets for use as of August 2024?

As of August 2024, Cladribine tablets are approved for use in over 75 countries, including approvals from the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA).