BIONXT REPORTS UPDATE ON COMMERCIALIZATION OF ROTIGOTINE PATCH FOR TREATMENT OF PARKINSON’S DISEASE
VANCOUVER, BC – 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 resultsin 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 patchesin 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 ingredientsforthe 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.