Cara Therapeutics, Inc. (CARA) and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) Enter into Ex-U.S. Licensing Agreement

“As a global leader in providing treatment for chronic kidney disease patients, VFMCRP is an ideal partner to bring KORSUVA injection to dialysis patients across Europe and other licensed territories,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “Additionally, we believe the ability to leverage VFMCRP’s nephrology-focused commercial expertise in our co-promotion partnership for U.S. Fresenius Medical Care dialysis facilities will provide significant momentum for adoption of KORSUVA injection, if approved in the U.S. Importantly, we continue to retain all rights to KORSUVA/CR845 in other indications.”

“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 U.S. CR845 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- induced itching and post-operative pain.”

Summary of License Agreement

Under the terms of the Agreement, Cara will receive an upfront payment in the amount of $50 million in cash and an equity investment of $20 million to acquire Cara common stock at a price of approximately $17/share. Cara will also 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 that are all sales related. Cara is also eligible to receive tiered royalties based on net sales of KORSUVA injection in the licensed territories. VFMCRP will have the exclusive rights to commercialize KORSUVA injection for the treatment of CKD-aP in dialysis patients ex-U.S. except in Japan and South Korea. 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 (FMCNA), where VFMCRP and Cara will promote KORSUVA injection under a profit-sharing arrangement based on net FMCNA clinic sales recorded by Cara. FMCNA 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-FMC clinics in the U.S. and retain all profits from those sales.