Cara Therapeutics Announces Approval of KORSUVA IV Injection Syringe in Japan for the Treatment of Pruritus in Hemodialysis Patients

Approval triggers $1.5 million milestone payment to Cara

STAMFORD, Conn., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that its licensing partner Maruishi Pharmaceutical Co., Ltd. received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare for KORSUVA IV Injection Syringe for the treatment of pruritus in hemodialysis patients. Cara earned a $1.5 million milestone payment upon approval, per the terms of the licensing agreement.

“We are pleased that our first-in-class therapy KORSUVA injection will be available to hemodialysis patients in Japan who are suffering from pruritus,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “As we work toward establishing Cara Therapeutics as the leader in the treatment of chronic pruritus, we will continue to collaborate with our partners to address the significant unmet need for an effective antipruritic treatment for chronic kidney disease patients undergoing hemodialysis worldwide.”

The approval is based on positive results of a Phase 3 clinical trial in Japan, which was jointly conducted by Maruishi and its sublicensee Kissei Pharmaceutical Co., Ltd. In the trial, 178 patients were administered KORSUVA or placebo for 6 weeks followed by an open-label extension period of KORSUVA administration for 52 weeks. The primary endpoint, change in itch Numerical Rating Scale score, and the secondary endpoint, change in itching scores of Shiratori severity criteria, were significantly improved from baseline compared to the placebo group and KORSUVA was well-tolerated.

KORSUVA is approved by the U.S. Food and Drug Administration for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. It is approved by the European Commission under the brand name Kapruvia. The product is also approved in additional countries. Cara’s partner CSL Vifor has commercialization rights in all territories except Japan and South Korea.

About Cara Therapeutics & Maruishi Pharmaceutical Co., Ltd. License Agreement

In April 2013, the companies entered into a license agreement under which Cara granted Maruishi an exclusive license to develop, manufacture, and commercialize drug products containing difelikefalin for acute pain and/or uremic pruritus in Japan. Maruishi has the right to grant sub-licenses in Japan, which entitles Cara to receive sub-license fees, net of prior payments made by Maruishi to Cara.