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BioNxt Announces National Level Patent Filings for Sublingual Anticancer Drugs for the Treatment of Autoimmune Neurodegenerative Diseases

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BioNxt Solutions has initiated national patent filings for sublingual anticancer drugs treating autoimmune neurodegenerative diseases. Following a positive International Preliminary Report on Patentability from the European Patent Office, the company is advancing patent protection across multiple jurisdictions including independent filing nations and European/Eurasian Patent Organizations. The patents, valid until 2045, cover multiple drug products.

The company's lead program focuses on a sublingual Cladribine product for Multiple Sclerosis, a market expected to reach $41 billion by 2033. A second program targets Myasthenia Gravis, with a market potential of $6.7 billion by 2032. Both products aim to benefit patients with dysphagia, a common symptom in these conditions.

BioNxt Solutions ha avviato le procedure per la registrazione di brevetti nazionali per farmaci antitumorali sublinguali che trattano malattie neurodegenerative autoimmuni. Dopo un report preliminare internazionale positivo sulla brevettabilità da parte dell'Ufficio Europeo dei Brevetti, l'azienda sta avanzando nella protezione dei brevetti in più giurisdizioni, comprese le nazioni con deposito indipendente e le organizzazioni dei brevetti europei ed euroasiatici. I brevetti, validi fino al 2045, coprono diversi prodotti farmaceutici.

Il programma principale dell'azienda si concentra su un prodotto sublinguale di Cladribina per la Sclerosi Multipla, un mercato che si prevede raggiungerà i 41 miliardi di dollari entro il 2033. Un secondo programma è rivolto alla Miastenia Grave, con un potenziale di mercato di 6.7 miliardi di dollari entro il 2032. Entrambi i prodotti mirano a beneficiare i pazienti con disfagia, un sintomo comune in queste condizioni.

BioNxt Solutions ha iniciado la presentación de solicitudes de patentes nacionales para medicamentos anticancerígenos sublinguales que tratan enfermedades neurodegenerativas autoinmunes. Tras un informe preliminar internacional positivo sobre la patentabilidad de la Oficina Europea de Patentes, la empresa está avanzando en la protección de patentes en múltiples jurisdicciones, incluyendo países de presentación independiente y organizaciones de patentes europeas y euroasiáticas. Las patentes, válidas hasta 2045, cubren múltiples productos farmacéuticos.

El programa principal de la empresa se centra en un producto sublingual de Cladribina para la Esclerosis Múltiple, un mercado que se espera alcance los 41 mil millones de dólares para 2033. Un segundo programa está dirigido a Miastenia Gravis, con un potencial de mercado de 6.7 mil millones de dólares para 2032. Ambos productos tienen como objetivo beneficiar a los pacientes con disfagia, un síntoma común en estas condiciones.

BioNxt Solutions는 자가 면역 신경퇴행성 질환 치료를 위한 설하 항암제의 국내 특허 출원을 시작했습니다. 유럽 특허청의 긍정적인 국제 예비 보고서에 이어 해당 회사는 독립적인 특허 출원 국가 및 유럽/유라시아 특허기구를 포함한 여러 관할권에서 특허 보호를 진행하고 있습니다. 이 특허들은 2045년까지 유효하며, 여러 의약품 제품을 포함합니다.

회사의 주요 프로그램은 다발성 경화증을 위한 클라드리빈 제품에 집중하고 있으며, 이 시장은 2033년까지 410억 달러에 이를 것으로 예상됩니다. 두 번째 프로그램은 중증 근무력증을 목표로 하며, 이 시장의 잠재력은 2032년까지 67억 달러에 이를 것으로 보입니다. 두 제품 모두 이러한 질환에서 일반적인 증상인 연하곤란이 있는 환자에게 도움이 되는 것을 목표로 하고 있습니다.

BioNxt Solutions a lancé des dépôts de brevets nationaux pour des médicaments anticancéreux sublinguaux traitant des maladies neurodégénératives auto-immunes. Suite à un rapport préliminaire international positif sur la brevetabilité de l'Office Européen des Brevets, la société avance dans la protection de ses brevets à travers plusieurs juridictions, y compris les pays de dépôt indépendant et les organisations de brevets européennes/eurasiennes. Les brevets, valables jusqu'en 2045, couvrent plusieurs produits pharmaceutiques.

Le programme principal de la société se concentre sur un produit sublingual de Cladribine pour la Sclérose en Plaques, un marché qui devrait atteindre 41 milliards de dollars d'ici 2033. Un deuxième programme vise la Myasthénie Grave, avec un potentiel de marché de 6,7 milliards de dollars d'ici 2032. Ces deux produits ont pour but de bénéficier aux patients souffrant de dysphagie, un symptôme commun à ces conditions.

BioNxt Solutions hat nationale Patentanmeldungen für sublinguale Antikrebsmedikamente gestartet, die autoimmun-neurodegenerative Krankheiten behandeln. Nach einem positiven internationalen vorläufigen Prüfbericht zur Patentierbarkeit vom Europäischen Patentamt schreitet das Unternehmen voran, um Patentschutz in mehreren Jurisdiktionen zu erlangen, einschließlich der unabhängigen Anmeldeländer und der europäischen/eurasischen Patentorganisationen. Die Patente sind bis 2045 gültig und decken mehrere Arzneimittelprodukte ab.

Das Hauptprogramm des Unternehmens konzentriert sich auf ein sublinguales Cladribin-Produkt für Multiple Sklerose, dessen Markt voraussichtlich bis 2033 41 Milliarden Dollar erreichen wird. Ein zweites Programm zielt auf Myasthenia Gravis, dessen Marktpotential bis 2032 bei 6,7 Milliarden Dollar liegen könnte. Beide Produkte zielen darauf ab, Patienten mit Dysphagie, einem häufigen Symptom dieser Erkrankungen, zu helfen.

Positive
  • Patents expected to provide protection until 2045
  • Targeting Multiple Sclerosis market worth $41 billion by 2033
  • Addressing Myasthenia Gravis market projected at $6.7 billion by 2032
  • Product offers advantage for patients with dysphagia
  • Cladribine tablets currently generate over $1 billion in annual sales
Negative
  • None.

VANCOUVER, BC / ACCESSWIRE / October 29, 2024 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC PINK:BNXTF)(FSE:BXT) is pleased to announce that it has initiated the nationalization process for the filing of a family of patents for the sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases. The patents are 100% owned by BioNxt.

Subject to the international Patent Cooperation Treaty ("PCT"), the European Patent Office ("EPO") issued a positive International Preliminary Report on Patentability ("IPRP"), announced by the Company on September 9, 2024. The EPO accepted the Company's claim that the patent family was new, useful, and non-obvious, satisfying the requirements for patentability.

Based on the report's findings, BioNxt is advancing its patent protection process to national level filings in the following international jurisdictions:

  • Independent filing nations: Australia (AU), Canada (CA), New Zealand (NZ), USA (US), Japan (JP);

  • European Patent Office: Albania, Austria, Belgium, Bulgaria, Switzerland/Liechtenstein, Cyprus, Czech Republic, Germany, Denmark, Estonia, Spain, Finland, France, Great Britain, Greece, Croatia, Hungary, Ireland, Iceland, Italy, Lihuania, Luxembourg, Latvia, North Macedonia, Monaco, Malta, Netherlands, Norway, Poland, Portugal, Romania, Serbia, Sweden, Slovenia, Slovak Republic, San Marino, Turkey; and

  • Eurasian Patent Organization ("EAPO"): Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Russian Federation.

Regarding national level patent recognition, most PCT member countries will accept EPO recognized patents based on the IPRP, subject to required translation and administrative filings in the given jurisdiction. Some countries, namely the US and Japan, may undertake an individual patent review; however, the IPRP is expected to guide the review process, which is typically positive.

The Company's family of patents for sublingual delivery of anticancer drugs for the treatment of autoimmune neurodegenerative diseases is expected to provide patent protection for multiple drug products out to 2045.

BioNxt's lead drug development program in its autoimmune neurodegenerative disease portfolio is a 100% owned and proprietary sublingual Cladribine product for the treatment of Multiple Sclerosis ("MS"). 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 anticipated to top USD 41 billion by 2033 according to Market.us. BioNxt's sublingual Cladribine product is expected to yield a significant advantage over the tablet form for patients suffering from Dysphagia (difficulty swallowing), which is a common symptom among MS patients.

BioNxt's second drug development program in its autoimmune neurodegenerative portfolio is a 100% owned and proprietary sublingual Cladribine product for the treatment of Myasthenia Gravis ("MG"). MG is an autoimmune and neuromuscular disease characterised by muscle weakness and fatigue. MG patients also commonly experience Dysphagia whereby a sublingual product is expected to yield a significant advantage over conventional tablet forms. The global MG market is expected to reach USD 6.7 billion by 2032 according to Clinical Trials Arena.

The expectation of the growing incidence of Central Nervous System ("CNS") pathologies will drive investment into new drugs and new drug delivery systems capable of targeting these diseases. According to Precedence Research, the drug delivery market is expected to grow to USD 3.18 trillion by 2034 and according to GMI Market Insights the market size for drugs to treat CNS diseases is expected to grow to USD 238.8 billion by 2032.

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

When will BioNxt's (BNXTF) patent protection for sublingual anticancer drugs expire?

BioNxt's patent protection for sublingual anticancer drugs is expected to last until 2045.

What are the two main diseases targeted by BioNxt's (BNXTF) sublingual Cladribine products?

BioNxt's sublingual Cladribine products target Multiple Sclerosis (MS) and Myasthenia Gravis (MG).

What is the projected market size for Multiple Sclerosis drugs that BioNxt (BNXTF) is targeting?

The global Multiple Sclerosis drug market is anticipated to reach USD 41 billion by 2033.

How many countries have approved Cladribine tablets that BioNxt (BNXTF) is developing in sublingual form?

Cladribine tablets are currently approved for use in over 75 countries, including by the FDA and EMA.

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