- 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.”
CR845 injection is a potent itch and inflammation suppressant without the undesirable side-effects typical of an opioid medicine such as hallucination or opioid addiction. This investigational medicine was designated a breakthrough therapy for CKD-aP in haemodialysis patients by the FDA in June 2017 and shows compelling phase-II data on safety and efficacy. If approved, CR845 injection will be the first medicine for this indication outside of Japan.
VFMCRP has also secured the first right of negotiation for using CR845 injection to treat post-operative pain outside of the US, Japan and South Korea, for which a phase-III development programme began in September 2015.
Under the terms of the agreement, Cara will receive an upfront payment of USD 50 million in cash and equity investment of USD 20 million to acquire Cara common stock. Cara will also be eligible to receive additional payments upon achievement of certain regulatory and commercial milestones, as well as tiered royalties on net sales of CR845 injection for CKD-aP in the licensed territories.
Cara retains development and commercialisation rights for CR845 injection for the treatment of CKD-aP in the US. Cara will solely promote the product in all non-FMC clinics in the US. VFMCRP and Cara will promote the investigational medicine to FMCNA (Fresenius Medical Care North America) dialysis clinics under a profit-sharing arrangement.