Aug 25, 2020 in Drug Delivery, Press Releases
XPhyto Provides Update On Parkinsons’ Transdermal Patch
Vancouver, Canada (August 25, 2020) – XPhyto Therapeutics Corp. (CSE:XPHY / OTCQB:XPHYF / FSE:4XT) (“XPhyto” or the “Company”), a next generation bioscience company, is pleased to announce an update on its transdermal delivery system (“TDS”) for the neurologic drug Rotigotine.
Further to the Company’s press release dated, June 8, 2020, regarding formula finalization, Vektor Pharma TF GmbH (“Vektor”), a wholly owned German subsidiary of XPhyto, has now completed process implementation for the manufacture of its Rotigotine patches. With process implementation complete, clinical sample manufacturing and analytical work will commence in Vektor’s EU GMP laboratory and manufacturing facility based in Baden-Württemberg, Germany. Human bioavailability studies in Europe are scheduled for Q3 2020 with results expected in Q4 2020. Updates to the Rotigotine drug delivery program will be provided periodically as it proceeds.
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. Rotigotine, the active pharmaceutical ingredient, is a generic “off-patent” drug that is typically formulated as a oncedaily transdermal patch which provides a slow and constant supply of the drug over the course of 24 hours. Global and European sales of Rotigotine patches in 2019 were approximately $500MM and $250MM CAD respectively.
“Our goal is the commercialization of a low-cost Rotigotine patch with superior bioavailability and adhesion properties,” said Hugh Rogers, XPhyto’s CEO. “Incorporating Rotigotine into Vektor’s novel transdermal drug delivery system platform is a major accomplishment. With the formula locked and manufacturing soon to commence, we look forward to the upcoming clinical studies.”