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

2023-09-25

临床3期引进/卖出上市批准临床结果

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.

Under the terms of the agreement, Cara is eligible to receive milestone payments upon the achievement of defined clinical and regulatory events as well as tiered, double-digit royalties with respect to any sales of the licensed product sold in Japan by Maruishi, if any, and share in any sub-license fees.

About Cara Therapeutics

Cara Therapeutics is a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus. The Company’s KORSUVA® (difelikefalin) injection is the first and only FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. The Company is developing an oral formulation of difelikefalin and has Phase 3 programs ongoing for the treatment of pruritus in patients with advanced chronic kidney disease and atopic dermatitis. In addition, the Company has initiated a Phase 2/3 program of oral difelikefalin for the treatment of moderate-to-severe pruritus in patients with notalgia paresthetica. For more information, visit www.CaraTherapeutics.com and follow the company on X (Twitter), LinkedIn and Instagram.

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the potential of difelikefalin solution for injection to be a therapeutic option for CKD-aP in dialysis dependent patients in Japan. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara's filings with the Securities and Exchange Commission, including the "Risk Factors" section of Cara's Annual Report on Form 10-K for the year ended December 31, 2022 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission, including its Form 10-Q for the quarter ended June 30, 2023. All forward-looking statements contained in this press release speak only as of the date on which they were made. Except to the extent required by law, Cara undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

MEDIA CONTACT:

Annie Spinetta

6 Degrees

973-768-2170

aspinetta@6degreespr.com

INVESTOR CONTACT:

Iris Francesconi, Ph.D.

Cara Therapeutics

203-406-3700

investor@caratherapeutics.com