In a joint venture, Vifor Pharma Group and Fresenius Medical Care have bought the international commercialization rights to market a new opioid analgesic for treating pruritus, the itching commonly associated with chronic kidney disease in patients on hemodialysis.
Vifor Fresenius Medical Care Renal Pharma Ltd. has paid Cara Therapeutics $50 million in advance and will invest an additional $20 million in Cara stock to market the investigational drug, called Korsuva (CR845), in countries outside of the United States, Japan and South Korea. Cara retains development and commercialization rights for the CR845 injection in the United States. Cara will solely promote the product in all non-FMC clinics in the United States. Vifor Fresenius Medical Care Renal Pharma Ltd. and Cara will promote the investigational medicine to Fresenius Medical Care North America dialysis clinics under a profit-sharing arrangement. Cara is also eligible for up to $470 million in milestone payments, plus tiered sales royalties, and retains the rights to the drug in other indications.
CR845 is “a natural fit to our leading product portfolio in nephrology, and we look forward to making it available to patients who urgently need better therapy,” Vifor Pharma Chief Operating Officer Stefan Schulze, said in the release. “Sixty to 70% of dialysis patients experience [chronic kidney disease-associated pruritus] CKD-aP. Nearly 20% suffer from a severe form, which is associated with much lower survival. And despite this clear unmet medical need, there is no approved treatment for CKD-aP in Europe or the U.S. CR845 injection does not penetrate the brain and so bypasses unwanted side-effects like opioid addiction. It has significant potential for setting new standards in providing relief, both from CKD-aP-induced itching and postoperative pain.”
CR845 was designated a breakthrough therapy for CKD-aP in patients on hemodialysis by the FDA in June 2017, according to the release and, if approved, CR845 injection will be the first medicine for this indication outside of Japan.