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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.

BioNxt Solutions Inc. (CSE:BNXT, OTC PINK:BNXTF, FSE:BXT) ha ricevuto un rapporto internazionale di esame positivo dall'Ufficio europeo dei brevetti per la sua domanda di brevetto riguardante la somministrazione sublinguale di farmaci anticancro per il trattamento delle malattie neurodegenerative autoimmuni. L'azienda si aspetta di ricevere il brevetto dell'UE entro otto settimane e prevede di entrare nella fase nazionale del processo PCT in più giurisdizioni.

Il programma principale di BioNxt si concentra sullo sviluppo di una formulazione di dosaggio di Cladribina in film disciogliibile per via orale (ODF) per il mercato della sclerosi multipla (SM). L'azienda sta anche espandendo la propria attività nel trattamento della Miastenia Grave (MG) utilizzando composti anticancro in sistemi di somministrazione ODF. I pazienti affetti da SM e MG spesso sperimentano disfagia, il che potrebbe dare ai prodotti farmaceutici ODF un vantaggio rispetto alle compresse convenzionali.

Il mercato globale dei farmaci per la SM è previsto raggiungere 41 miliardi di dollari entro il 2033, mentre si prevede che il mercato della MG tocchi 6.7 miliardi di dollari entro il 2032. Si anticipa che il mercato più ampio per i trattamenti delle malattie del SNC crescerà fino a 238.8 miliardi di dollari entro il 2032.

BioNxt Solutions Inc. (CSE:BNXT, OTC PINK:BNXTF, FSE:BXT) ha recibido un informe internacional de examen positivo de la Oficina Europea de Patentes para su solicitud de patente sobre la administración sublingual de fármacos anticancerígenos para el tratamiento de enfermedades neurodegenerativas autoinmunes. La empresa espera recibir la concesión de la patente de la UE en un plazo de ocho semanas y planea ingresar a la fase nacional del proceso PCT en múltiples jurisdicciones.

El programa principal de BioNxt se centra en el desarrollo de una forma de dosificación de Cladribina en película dispersable por vía oral (ODF) para el mercado de la esclerosis múltiple (EM). La empresa también está ampliando su actividad en el tratamiento de Miastenia Gravis (MG) utilizando compuestos anticancerígenos en sistemas de administración ODF. Los pacientes con EM y MG a menudo experimentan disfagia, lo que podría dar a los productos medicamentosos ODF una ventaja sobre las tabletas convencionales.

Se proyecta que el mercado global de medicamentos para la EM alcanzará 41 mil millones de dólares para 2033, mientras que se espera que el mercado de la MG llegue a 6.7 mil millones de dólares para 2032. Se anticipa que el mercado más amplio para tratamientos de enfermedades del SNC crecerá hasta 238.8 mil millones de dólares para 2032.

BioNxt Solutions Inc. (CSE:BNXT, OTC PINK:BNXTF, FSE:BXT)는 긍정적인 국제 심사 보고서를 유럽특허청으로부터 받았으며, 이는 자가면역 신경퇴행성 질환 치료를 위한 항암제의 설하 전달 방법에 관한 특허 출원과 관련이 있습니다. 이 회사는 8주 내에 EU 특허 승인을 기대하고 있으며, 여러 관할권에서 PCT 절차의 국가 단계에 들어갈 계획입니다.

BioNxt의 주요 프로그램은 다발성 경화증(MS) 시장을 위한 경구용 분산 필름(ODF) 클라드리빈 제형 개발에 주력하고 있습니다. 이 회사는 ODF 전달 시스템을 이용하여 중증 근무력증(MG) 치료로 사업을 확장하고 있습니다. MS 및 MG 환자들은 종종 삼킴 장애를 겪는 경우가 많아, ODF 약물 제품이 기존의 정제보다 이점을 가질 수 있습니다.

전 세계 MS 약물 시장은 2033년까지 410억 달러에 이를 것으로 예상되며, MG 시장은 2032년까지 67억 달러에 이를 것으로 보입니다. 중추신경계(CNS) 질환 치료를 위한 더 넓은 시장은 2032년까지 2388억 달러로 성장할 것으로 예상됩니다.

BioNxt Solutions Inc. (CSE:BNXT, OTC PINK:BNXTF, FSE:BXT) a reçu un rapport international d'examen positif de l'Office européen des brevets pour sa demande de brevet concernant la libération sublinguale de médicaments anticancéreux pour le traitement des maladies neurodégénératives auto-immunes. L'entreprise s'attend à obtenir le brevet de l'UE dans un délai de huit semaines et prévoit d'entrer dans la phase nationale du processus PCT dans plusieurs juridictions.

Le programme phare de BioNxt se concentre sur le développement d'une forme de dosage de Cladribine sous forme de film dispersible par voie orale (ODF) pour le marché de la sclérose en plaques (SEP). L'entreprise s'étend également au traitement de la Mysténie grave (MG) en utilisant des composés anticancéreux dans des systèmes de libération ODF. Les patients atteints de SEP et de MG éprouvent souvent des difficultés à avaler, ce qui pourrait donner aux produits médicamenteux ODF un avantage par rapport aux comprimés conventionnels.

Le marché mondial des médicaments pour la SEP devrait atteindre 41 milliards de dollars d'ici 2033, tandis que le marché de la MG devrait atteindre 6,7 milliards de dollars d'ici 2032. Le marché plus large des traitements des maladies du SNC devrait croître jusqu'à 238,8 milliards de dollars d'ici 2032.

BioNxt Solutions Inc. (CSE:BNXT, OTC PINK:BNXTF, FSE:BXT) hat einen positiven internationalen Prüfungsbericht vom Europäischen Patentamt für seinen Patentantrag zur sublingualen Verabreichung von Antikrebsmedikamenten zur Behandlung von autoimmunen neurodegenerativen Erkrankungen erhalten. Das Unternehmen erwartet die Erteilung des EU-Patents innerhalb von acht Wochen und plant, in mehreren Gerichtsbarkeiten in die nationale Phase des PCT-Verfahrens einzutreten.

Das Hauptprogramm von BioNxt konzentriert sich auf die Entwicklung einer oral dispersiblen Film (ODF) Cladribin-Dosierungsform für den Markt der Multiplen Sklerose (MS). Das Unternehmen erweitert auch seine Aktivitäten in der Behandlung von Myasthenia Gravis (MG) mit antikanzerogenen Verbindungen in ODF-Verabreichungssystemen. Sowohl MS- als auch MG-Patienten leiden häufig unter Schluckbeschwerden, was den ODF-Arzneimitteln einen Vorteil gegenüber herkömmlichen Tabletten verschaffen könnte.

Der globale Markt für MS-Medikamente wird voraussichtlich bis 2033 41 Milliarden Dollar erreichen, während der MG-Markt voraussichtlich bis 2032 6,7 Milliarden Dollar erreichen wird. Es wird erwartet, dass der breitere Markt für CNS-Erkrankungen bis 2032 auf 238,8 Milliarden Dollar anwachsen wird.

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.

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.



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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.

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