XPhyto has outlined plans to move its rotigotine transdermal patch into a pivotal clinical trial. The Canadian company committed to further development of the rival to UCB’s Neupro after completing a bioavailability pilot study of the Parkinson’s patch.
Schwarz Pharma won FDA approval for rotigotine transdermal patch Neupro in 2007, shortly after UCB moved to buy the German drugmaker. The patch generated sales of €311 million ($378 million) last year. Revenues have plateaued in recent years, peaking at €321 million in 2018, and UCB faces the loss of patents in the U.S. and the EU this year.
XPhyto is trying to muscle in on the market. The company, which calls itself a bioscience accelerator, is working with its wholly owned German subsidiary Vektor Pharma TF to rise to the challenge of creating a transdermal patch capable of delivering the dopamine agonist rotigotine.
The patch moved into a human bioavailability pilot study early this year. Based on the data, XPhyto now plans to start a pivotal clinical trial of its rotigotine transdermal patch that could set it up to fight UCB for the market.
Vektor is scaling up to support XPhyto’s ambitions. The subsidiary has signed a purchase and sale agreement for a property in Germany, moving it a step closer to the establishment of commercial manufacturing capacity. Vektor can establish a laboratory and manufacturing space of up to 32,000 square feet on the site.
“The company is reviewing scalable construction options to synchronize its manufacturing capacity with demand from in-house and contract manufacturing opportunities,” XPhyto said in a statement.