BioNxt Reports Update on Commercialization of Rotigotine Patch for Treatment of Parkinson's Disease

Rhea-AI Summary

BioNxt Solutions Inc. has reported progress on its commercialization plan for a transdermal Rotigotine patch aimed at treating Parkinson's disease. Following promising in-vitro/ex-vivo results announced in October 2022, the company is set to initiate a human clinical pilot study in Q2 2023. This study aims to compare BioNxt's formulation with an established brand's product, focusing on bioavailability and skin tolerance. Concurrently, BioNxt is enhancing its manufacturing capabilities in Germany to meet regulatory standards. The global market for Rotigotine patches was valued at approximately $518 million in 2021, with projections of surpassing $766 million by 2030.

Positive

• Initiation of a human clinical pilot study for Rotigotine patch in Q2 2023.
• Promising in-vitro/ex-vivo results enhancing confidence in product efficacy.
• Development of commercial manufacturing capabilities in Germany to support regulatory compliance.
• Significant market potential with global sales for Rotigotine patches expected to reach over $766 million by 2030.

Negative

• None.

VANCOUVER, BC / ACCESSWIRE / February 13, 2023 / BioNxt Solutions Inc. ("BioNxt" or the "Company") (CSE:BNXT)(OTC:BNXTF)(FSE:BXT) is pleased to report an update on its commercialization plan for its transdermal Rotigotine patch for the treatment of Parkinson's disease ("PD"). The Company's Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH ("Vektor").

On October 18, 2022, BioNxt announced excellent in-vitro/ex-vivo results for its PD treatment based on comparative drug absorption analysis between the Company's new optimized transdermal formulation and the global name brand Rotigotine product. With these results in hand, the Company is preparing for a human clinical pilot study in Q2 2023. The comparative study is designed as a randomized, crossover, two-period, single dose pilot study to assess the relative bioavailability, skin adhesion and skin tolerance of BioNxt's new formulation compared to the name brand product. The study will be carried out in Europe in accordance with Good Clinical Practice (GCP) and the European Medical Agency (EMA) Guideline on quality of transdermal patches.

In parallel to its clinical study, BioNxt is planning the development of commercial manufacturing capabilities at its German drug development facility. This will include EU GMP-approved manufacturing and packaging equipment as well as a modified manufacturing line capable of producing pivotal trial materials compliant with commercial regulatory approval applications and final commercial products (transdermal and oral dissolvable). The Company expects to make further announcements regarding its commercialization capabilities over the coming months.

Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson's disease and restless legs syndrome (RLS) in Europe and the United States. The active pharmaceutical ingredient is not well absorbed via oral delivery and is formulated as a once-daily TDS patch to increase bioavailability and provide a slow and steady supply of the drug over the course of 24 hours. The therapeutic market for Parkinson's disease is over 10 million people worldwide and growing. The top selling name brand product launched by the originator in 2007 independently sold over $375 million of its Rotigotine TDS patches in 2021. According to Wissen Market Research, total global sales for Rotigotine patches were approximately US$518 million in 2021 with the market expected to surpass US$766 million by 2030.

BioNxt's Rotigotine transdermal product is a single product based on its 100% owned platform technology which represents a scalable opportunity for additional TDS drug development and manufacturing programs. According to Research and Markets, the global transdermal skin patch market had a value of nearly US$6.5 billion in 2020 while Kuick Research, Pharmaceutical and Healthcare, estimates the market will reach approximately US$20 billion by 2028.

Vektor, a wholly owned BioNxt subsidiary, is a German narcotics manufacturer, developer, and researcher located in the district of Biberach, Baden-Württemberg, Germany. For over a decade, the company and its team have been leaders in the design, testing and manufacture of innovative, non-invasive drug delivery systems, particularly transdermal patches and sub-lingual strips for the delivery of active pharmaceutical ingredients for the treatment of pain and neurological conditions. According to Precedence Research, the global drug delivery market was valued at US$1,476 billion in 2021 and is expected to grow to US$2,047 billion by 2030.

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.

Hugh Rogers, 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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https://www.accesswire.com/739060/BioNxt-Reports-Update-on-Commercialization-of-Rotigotine-Patch-for-Treatment-of-Parkinsons-Disease

FAQ

What updates did BioNxt Solutions provide regarding its Rotigotine patch on February 13, 2023?

BioNxt Solutions announced plans to initiate a human clinical pilot study in Q2 2023 and updates on its commercialization plan for the transdermal Rotigotine patch for treating Parkinson's disease.

What are the key goals of the upcoming clinical study for BioNxt's Rotigotine patch?

The clinical study aims to assess the relative bioavailability, skin adhesion, and skin tolerance of BioNxt's new formulation compared to a leading brand.

How does the market outlook for Rotigotine patches look?

The global market for Rotigotine patches was approximately $518 million in 2021 and is projected to exceed $766 million by 2030.

What manufacturing capabilities is BioNxt developing for its transdermal patch?

BioNxt is enhancing its German drug development facility to include EU GMP-approved manufacturing and packaging equipment.