Apr 4, 2022 in Drug Delivery, Press Releases

XPhyto reports market and product developments on platform-based Rotigotine transdermal patch for Parkinson’s disease

Vancouver, Canada, and Uttenweiler, Germany (April 4, 2022) – XPhyto Therapeutics Corp. (CSE:XPHY / OTC:XPHYF / FSE:4XT) (“XPhyto” or the “Company”) is pleased to provide a market and product development report on its Rotigotine transdermal (“TDS”) patch. The Company’s Rotigotine patch is based on the TDS platform technology developed by its wholly owned German subsidiary, Vektor Pharma TF GmbH (“Vektor”).

Rotigotine is a non-ergoline dopamine agonist approved for the treatment of Parkinson’s disease (PD) 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 R&D market for new formulations is competitive; however, there appears to be little success beyond the name brand product launched by the originator in 2007. According to Wissen Market Research, global sales for Rotigotine patches were approximately US$518 million in 2021 with the market expected to surpass US$766 million by 2030.

On May 13, 2021, XPhyto announced successful completion of a European-based human bioavailability study for its Rotigotine TDS product. The comparative study was carried out over an approximately two-week period as an open label, randomized, crossover, two-period, two-sequence, single dose pilot study to assess the relative bioavailability of its product compared to the name brand product. Based on the results of this study, the Company is advancing the product toward a final pivotal study in Q4 2022 and pending positive results of that study, to an application for regulatory approval.

As an interim step to evaluate optimization opportunities prior to the pivotal study, the Company has completed a human cadaver skin permeation study at Vektor’s EU GMP laboratory and manufacturing facility in Baden-Württemberg, Germany, to compare Rotigotine absorption between two additional derivative formulas and the name brand product. Analytical results of this study are expected to be finalized and announced in the coming weeks.

XPhyto’s Rotigotine transdermal product is a single product based on Vektor’s 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 KuickResearch, Pharmaceutical and Healthcare, estimate the market will reach approximately US$20 billion by 2028.

Vektor 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 Reseach, 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.

Executive management of XPhyto’s drug formulation business is led by Prof. Dr. Beckert, managing director of Vektor Pharma TF GmbH.

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