Policy & Regulation
Vifor Pharma, Cara Therapeutics Sign US license Agreement for i.v. Korsuva to Treat Dialysis Patients with Pruritus
22 October 2020 - - Switzerland-based pharmaceuticals company Vifor Pharma and US-based biopharmaceutical company Cara Therapeutics, Inc. (NASDAQ: CARA) have signed a license agreement for commercialization of Korsuva (difelikefalin) Injection for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in the US dialysis market for non-Fresenius Medical Care clinics under a Cara 60%, Vifor Pharma 40% profit-sharing arrangement, the companies said.

Under the terms of the agreement, Cara will receive an upfront payment of 100 m in cash and an equity investment of 50m.

In addition, Cara will be eligible to receive an additional equity investment upon US regulatory approval of i.v. Korsuva, as well as milestone payments dependent on achieving commercial targets, which together could total up to 290m.

In May 2018, Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma (VFMCRP) signed an initial agreement that granted the rights to develop and commercialize i.v. Korsuva for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis and peritoneal dialysis patients worldwide, excluding the US, Japan and South Korea.

At that time, Cara retained full development and commercialization rights for i.v. Korsuva for the treatment of CKD-aP in the US except in the dialysis clinics of Fresenius Medical Care North America (FMCNA), where VFMCRP and Cara were to promote i.v. Korsuva under a profit-sharing arrangement based on net FMCNA clinic sales recorded by Cara.

Under the agreement, Cara had sole responsibility to promote i.v. Korsuva in the US in non-Fresenius Medical Care clinics.

Vifor Pharma Group is a global pharmaceuticals company. It aims to become a leader in iron deficiency, nephrology and cardio-renal therapies.

The company develops, manufactures and markets pharmaceutical products for precision patient care. Vifor Pharma Group holds a leading position in all its core business activities and consists of the following companies: Vifor Pharma and Vifor Fresenius Medical Care Renal Pharma (a joint company with Fresenius Medical Care).

Vifor Pharma Group is headquartered in Switzerland, and listed on the Swiss Stock Exchange (SIX Swiss Exchange, VIFN, ISIN: CH0364749348).

Cara Therapeutics is a clinical-stage biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pruritus by selectively targeting peripheral kappa opioid receptors, or KORs.

Cara is developing a novel and proprietary class of product candidates, led by KORSUVA (difelikefalin), a first-in-class KOR agonist that targets the body's peripheral nervous system, as well as certain immune cells. In two Phase 3 trials, i.v. KORSUVA has demonstrated statistically significant reductions in itch intensity and concomitant improvement in quality of life measures in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus (CKD-aP).

Cara has successfully completed its Phase 2 trial of oral KORSUVA for the treatment of pruritus in patients with CKD and is currently conducting Phase 2 trials of oral KORSUVA in atopic dermatitis and primary biliary cholangitis patients with moderate-to-severe pruritus.
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