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BioNxt Receives Positive International Examination Report From the European Patent Office for Broad Patent Application for Sublingual Delivery of Anticancer Drugs for the Treatment of Autoimmune Neurodegenerative Diseases

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BioNxt Solutions Inc. (CSE:BNXT, OTC PINK:BNXTF, FSE:BXT) has received a positive international examination report from the European Patent Office for its patent application on sublingual delivery of anticancer drugs for treating autoimmune neurodegenerative diseases. The company expects EU patent grant within eight weeks and plans to enter the national phase of the PCT process in multiple jurisdictions.

BioNxt's lead program focuses on developing a proprietary orally dispersible film (ODF) Cladribine dosage form for the multiple sclerosis (MS) market. The company is also expanding into Myasthenia Gravis (MG) treatment using anticancer compounds in ODF delivery systems. Both MS and MG patients often experience dysphagia, potentially giving ODF drug products an advantage over conventional tablets.

The global MS drug market is projected to reach $41 billion by 2033, while the MG market is expected to hit $6.7 billion by 2032. The broader market for CNS disease treatments is anticipated to grow to $238.8 billion by 2032.

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Positive

  • Received positive international examination report from European Patent Office
  • EU patent expected to be granted within eight weeks
  • Plans to file patents in multiple major international jurisdictions
  • Potential patent protection extending to 2045
  • Lead program targets MS market with $41 billion potential by 2033
  • Expanding into Myasthenia Gravis market, expected to reach $6.7 billion by 2032
  • ODF drug delivery system may have advantages for patients with dysphagia

Negative

  • None.

News Market Reaction

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-18.82% News Effect

On the day this news was published, BNXTF declined 18.82%, reflecting a significant negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

VANCOUVER, BC / ACCESSWIRE / September 9, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) is pleased to report that the European Patent Office ("EPO") has issued a positive international examination report for the Company's comprehensive patent application for sublingual delivery of anticancer drug for the treatment of autoimmune neurodegenerative diseases. The Company expects the EU patent to be granted within eight weeks and to rapidly enter the national phase of the Patent Cooperation Treaty ("PCT") patent process with submissions planned for the US, Canada, China, Japan, Australia, and other jurisdictions.

BioNxt plans to continue development of and extend its patent portfolio regarding orally dispersible films ("ODFs") containing highly potent anticancer compounds for neurodegenerative diseases. The Company intends to file several related provisional patent applications in the EU with three to four patents expected to be on file in multiple major international jurisdictions by late 2025 to early 2026 with potential patent protection extending to 2045.

BioNxt's lead program is the development of 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 2023 annual sales in excess of one billion USD according to Merck KGaA. Cladribine tablets are approved for several indications, namely highly active forms of relapsing-remitting MS. 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.

Further to the Company's MS program, BioNxt is pleased to announce that its second clinical indication using anticancer compounds in an ODF delivery system will be Myasthenia Gravis ("MG"). MG is an autoimmune and neuromuscular disease characterised by muscle weakness and fatigue. Similar to MS patients, MG patients commonly experience Dysphagia (difficulty swallowing), which is expected to yield a significant advantage to ODF drug products over conventional tablet forms. The global MG market is expected to reach USD 6.7 billion by 2032.

In general, the expectation of continued increasing prevalence of Central Nervous System ("CNS") pathologies will drive investment into new drugs and new drug delivery systems capable of targeting these diseases. The market size for drugs to treat CNS diseases is growing and expected to reach USD 238.8 billion by 2032 according to GMI Market Insights.

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 BioNxt's stock symbol on the OTC Pink market?

BioNxt's stock symbol on the OTC Pink market is BNXTF.

What is BioNxt's lead program focusing on?

BioNxt's lead program is developing a proprietary orally dispersible film (ODF) Cladribine dosage form for the multiple sclerosis (MS) market.

What is the projected value of the global Multiple Sclerosis drug market by 2033?

The global Multiple Sclerosis drug market is expected to reach $41 billion by 2033, according to Market.us.

What is BioNxt's second clinical indication using anticancer compounds in an ODF delivery system?

BioNxt's second clinical indication using anticancer compounds in an ODF delivery system is Myasthenia Gravis (MG).

How long could BioNxt's potential patent protection extend to?

BioNxt's potential patent protection could extend to 2045.
BioNxt Solutions Inc

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