Cara Therapeutics, Inc. (CARA), a commercial-stage biopharmaceutical company focused on pruritus, announced Monday the Approval of KORSUVA IV Injection Syringe in Japan to treat pruritus in hemodialysis patients. The company now would receive $1.5 million milestone payment from its licensing partner Maruishi Pharmaceutical Co., Ltd under the deal.<\/p>\n
In pre-market activity on Nasdaq, Cara shares were gaining around 3.6 percent to trade at $1.73.<\/p>\n
Maruishi Pharmaceutical received manufacturing and marketing approval from Japan’s Ministry of Health, Labour and Welfare.<\/p>\n
It was in April 2013 that the companies entered into a license deal, 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.<\/p>\n
Under the deal terms, Cara is eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered, double-digit royalties related to any sales of the licensed product sold in Japan by Maruishi, if any, and share in any sub-license fees.<\/p>\n
The approval is based on positive results of a Phase 3 clinical trial in Japan, jointly conducted by Maruishi and its sublicensee Kissei Pharmaceutical Co., Ltd. In the trial, 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. KORSUVA was well-tolerated.<\/p>\n
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. The European Commission also has approved it under the brand name Kapruvia.<\/p>\n
The product is also approved in additional countries. Cara’s partner CSL Vifor has commercialization rights in all territories except Japan and South Korea.<\/p>\n
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