Cara signs $540M deal with Fresenius and Vifor Pharma to commercialize Korsuva

Dialysis machine
A joint venture of Vifor Pharma Group and Fresenius Medical Care signed a potential $540 million deal after Cara's January launch of a phase 3 trial of Korsuva, following a 2016 clinical hold and a missed phase 2b trial for an oral formulation. (Getty/porpeller)

A joint venture of Vifor Pharma Group and Fresenius Medical Care acquired an international license to Cara Therapeutics’ investigational Korsuva injection, an alternative opioid analgesic with a somewhat-rocky development history, for treating the severe itching associated with chronic kidney disease in hemodialysis patients.

The combined company, Vifor Fresenius Medical Care Renal Pharma Ltd., paid Cara $50 million in upfront cash alongside an investment of $20 million in common stock, for global commercialization rights outside of the U.S., Japan and South Korea.

Cara is also eligible for up to $470 million in milestone payments, plus tiered sales royalties, and retains the rights to the drug in other indications. Cara also holds on to full development and commercialization rights in the U.S.—except in Fresenius dialysis clinics, where VFMCRP and Cara will co-promote the drug under a profit-sharing agreement.

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“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, president and CEO of Cara Therapeutics.

CKD-aP is a stubborn, systemic itch that occurs with high frequency and intensity in patients undergoing dialysis. There are currently no approved therapies in the U.S. or the E.U., Cara said, and the FDA has previously granted Korsuva a breakthrough therapy designation in the indication.

Vifor Pharma COO Stefan Schulze described the injection as a potentially first-in-class medicine for a highly debilitating disease, and a “natural fit” for the company’s nephrology portfolio.

“Sixty to 70% of dialysis patients experience CKD-aP. Nearly 20% suffer from a very severe form, which is associated with much lower survival,” said Schulze, adding that the drug does not penetrate the brain and bypasses unwanted side effects, such as the addiction associated with other opioid painkillers.

The Stamford, Connecticut-based Cara launched a phase 3 trial of Korsuva in January, comparing it to placebo in 350 U.S. hemodialysis patients with the goal of lowering daily itch intensity and improving quality-of-life. Cara also plans to expand development this year to other renal, hepatic and dermatological patient populations, Chalmers said at the time.

The FDA previously put a clinical hold on a 2016 phase 3 trial of Korsuva, also known as CR845 or difelikefalin, following spikes in four post-operative patients’ sodium levels. Cara said all four patients returned to normal levels within 24 hours, and that none presented symptoms of hypernatremia.

Meanwhile, an oral formulation of CR845 missed its primary endpoint in a phase 2b trial last year, failing to beat placebo in osteoarthritis pain and causing the company’s stock to drop 28%. Patients who took the highest doses experienced a 35% reduction in mean joint pain score, but the findings were not statistically significant.

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