Jun 8, 2020 in Drug Delivery, Press Releases
Parkinson’s Generic Transdermal Drug Delivery System
Vancouver, Canada (June 8, 2020) – XPhyto Therapeutics Corp. (CSE:XPHY / FSE:4XT / OTC:XPHYF) (“XPhyto” or the “Company”) is pleased to announce that its wholly owned German subsidiary, Vektor Pharma TF GmbH (“Vektor”), has finalized the formula for its novel transdermal delivery system (“TDS”) for the neurologic drug Rotigotine. Vektor is now proceeding with process implementation for the manufacture of Rotigotine patches for human clinical studies.
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.
“We are extremely pleased with the TDS development results thus far. It appears that our goal of optimizing the dosage form efficiency, to reduce the amount of drug required in each patch, and improving overall patch adhesion to the patient’s skin has been achieved,” said Prof. Dr. Thomas Beckert, founder and managing director of Vektor.
Vektor is now focused on process implementation for the manufacture of Rotigotine TDS clinical samples for use in human pilot studies. The parameters for increased manufacturing capacity are currently being evaluated with a final decision expected to be made within 30 days. Once process implementation is complete, clinical sample manufacturing and analytical work will commence in Vektor’s EU GMP laboratory and manufacturing facility based in Baden-Württemberg, Germany. Human pilot studies in Europe are scheduled for Q3 2020 with results expected in Q4 2020.
“XPhyto’s Parkinson’s drug patch is an excellent example of the Company’s generic drug delivery strategy whereby approved generic drugs can be delivered using Vektor’s novel drug delivery platforms,” said Hugh Rogers, CEO of XPhyto. “For both our transdermal patches and oral dissolvable films, we see the generic drug delivery model as a major opportunity for scalable value creation through expedited clinical evaluation and product launch, particularly in Europe.”