Cara Therapeutics Inc (Nasdaq: CARA) has entered into a licensing agreement for KORSUVA (CR845/difelikefalin) injection for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in dialysis patients, the US biopharmaceutical company disclosed on Wednesday.
The US Food and Drug Administration (FDA) granted Breakthrough Therapy Designation to KORSUVA injection for this indication, for which there are currently no approved therapies in the United States or the European Union.
Vifor Fresenius Medical Care Renal Pharma Ltd (VFMCRP), a joint company of Vifor Pharma Group (SIX: VIFN) and Fresenius Medical Care (NYSE: FMS) that specialises in treatments for CKD, has licensed worldwide rights, except in the US, Japan and South Korea, to commercialise KORSUVA injection in dialysis patients with pruritus.
Under the terms of the deal, Cara will receive an upfront payment of USD50m in cash and an equity investment of USD20m. The company will also be eligible to receive additional payments of up to USD470m in regulatory and commercial milestones.
Cara retains full development and commercialisation rights for KORSUVA injection for the treatment of CKD-aP in the US, except in the dialysis clinics of Fresenius Medical Care North America (FMCNA), where VFMCRP and Cara will promote KORSUVA injection under a profit-sharing arrangement.
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