Cara Therapeutics (NASDAQ:CARA) licensed worldwide rights, except in the U.S., Japan and South Korea, to commercialize KORSUVA injection for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in dialysis patients to Vifor Fresenius Medical Care Renal Pharma, a joint venture of Vifor Pharma Group (SIX:VIFN) and Fresenius Medical Care (NYSE:FMS) that specializes in treatments for CKD.
The FDA previously granted breakthrough therapy designation to KORSUVA injection for this indication, for which there are currently no approved therapies in the U.S. or EU.
Under the accord, Cara will receive an upfront payment of $50-million and an equity investment of $20-million to acquire Cara common stock at a price of approximately $17 a share. Cara also will be eligible to receive additional payments of up to $470-million, which includes $30-million in regulatory and up to $440-million in tiered commercial milestones. Cara is also eligible to receive tiered royalties based on net sales of KORSUVA injection in the licensed territories.
Cara retains full development and commercialization rights for KORSUVA injection for the treatment of CKD-aP in the U.S., except in the dialysis clinics of Fresenius Medical Care North America, where Vifor Fresenius and Cara will promote KORSUVA injection under a profit-sharing arrangement.
Fresenius Medical is the largest kidney dialysis provider in the U.S. and treated approximately 38% of U.S. dialysis patients in 2017. Cara will solely promote KORSUVA injection in all non-Fresenius clinics in the U.S.
In a statement, Vifor Pharma COO, Stefan Schulze, said 60% to 70% of dialysis patients experience CKD-aP. “Nearly 20% suffer from a very severe form, which is associated with much lower survival,” he said, adding that the drug does not penetrate the brain and bypasses unwanted side effects, such as the addiction associated with other opioid painkillers.
