VFMCRP AND CARA THERAPEUTICS TO DEVELOP AND COMMERCIALISE CR845 INJECTION FOR CHRONIC KIDNEY DISEASE-ASSOCIATED PRURITUS

Vifor Pharma Ltd. / VFMCRP AND CARA THERAPEUTICS TO DEVELOP AND COMMERCIALISE CR845 INJECTION FOR CHRONIC KIDNEY DISEASE-ASSOCIATED PRURITUS . Processed and transmitted by Nasdaq Corporate Solutions. The issuer is solely responsible for the content of this announcement.

• Vifor Fresenius Medical Care Renal Pharma (VFMCRP) to develop and commercialise CR845/difelikefalin injection worldwide except in the US, Japan and South Korea for the treatment of chronic kidney disease-associated pruritus (CKD-aP)
• Significant unmet medical need for a highly debilitating disease: 60-70% of dialysis patients affected by CKD-aP (20% severely), but no approved treatment in Europe and the US
• CR845 is a potent kappa opioid agonist that is itch and inflammation suppressant with FDA breakthrough therapy status and an excellent efficacy and safety profile (phase-II proof-of-concept), but without typical undesirable side-effects such as opioid addiction
• Further potential of CR845 injection in post-operative pain (in phase III), for which VFMCRP has first right of negotiation

VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA (VFMCRP), A JOINT COMPANY OF VIFOR PHARMA GROUP AND FRESENIUS MEDICAL CARE, ANNOUNCED TODAY THAT IT ENTERED INTO A DEVELOPMENT AND LICENCING AGREEMENT WITH US BIOPHARMACEUTICAL, CARA THERAPEUTICS, INC, TO COMMERCIALISE CR845 (DIFELIKEFALIN) INJECTION FOR THE TREATMENT OF CHRONIC KIDNEY DISEASE-ASSOCIATED PRURITUS (CKD-AP) IN HEMODYALISIS PATIENTS WORLDWIDE, EXCLUDING THE US, JAPAN AND SOUTH KOREA.

"CR845 injection is a first-in-class, innovative investigational medicine for treating a highly debilitating disease. It 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," said Stefan Schulze, Vifor Pharma President of the Executive Committee and COO. "Sixty to 70% of dialysis patients experience CKD-aP. Nearly 20% suffer from a very 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 US. 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 post-operative pain."