XPhyto Therapeutics Corp (CSE:XPHY) (OTCPINK:XPHYF) revealed Monday that its German subsidiary had now finalized its formula for its skin patch to help Parkinson's disease sufferers ahead of human pilot studies earmarked for the third quarter of this year.
Vektor Pharma TF GmbH is an expert in the design, testing and manufacture of thin-film drug delivery systems, particularly transdermal patches and oral strips.
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The patches are based on the neurological drug Rotigotine, which is approved for the treatment of Parkinson's disease (PD) and restless legs syndrome (RLS) in Europe and the United States.
"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," Hugh Rogers, CEO of XPhyto said in a statement.
"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."
Global and European sales of Rotigotine patches last year came in at around US$500 million and C$250 million respectively, XPhyto noted.
"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 Professor Dr. Thomas Beckert, the founder and managing director of Vektor.
Vector is now assessing what is needed to increase manufacturing capacity of the patches with a final decision expected to be made within 30 days.
Clinical sample manufacturing and analytical work will then begin in Vektor's EU GMP laboratory and manufacturing facility based in Baden-Württemberg, Germany.
Human pilot studies in Europe are scheduled for the third quarter this year with results expected in the fourth quarter, XPhyto said.
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