Benzinga | Oct 20, 2020 05:51AM EDT

Vifor Pharma and Cara Therapeutics Signed US License Agreement for IV Korsuva to Treat Dialysis Patients with Pruritus; Cara to Receive Upfront Payment of $100M in Cash and an Equity Investment of $50M

Vifor Pharma and Cara Therapeutics, Inc. (NASDAQ:CARA) today announced that both companies have signed a license agreement for commercialization of Korsuva (difelikefalin) Injection ("IV Korsuva") 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.

"With an established fully dedicated nephrology sales force in the US, Vifor Pharma is an ideal commercialization partner to bring IV Korsuva to dialysis patients across the country," said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. "In addition, we believe Vifor Pharma's existing relationships with US dialysis providers will provide significant momentum for the launch and adoption of IV Korsuva, if approved. As a result of this agreement, we expect to focus Cara's internal resources on our clinical programs for Oral Korsuva in atopic dermatitis, pre-dialysis CKD and additional pruritic conditions."

"Vifor Pharma has a strong market position and deep expertise in the nephrology space. This agreement further strengthens our US nephrology presence. The Vifor Pharma Group now has the commercialization rights for IV Korsuva in the full dialysis segment by adding all non-FMC dialysis clinics, representing approximately 66% of the US market," said Stefan Schulze, CEO of Vifor Pharma Group. "Moderate to severe haemodialysis-associated pruritus is a debilitating condition that impacts up to 40% of dialysis patients around the world and for which there is currently no approved treatment in the US or Europe. IV Korsuva is an important, innovative new therapeutic that has the potential to address this significant unmet need. We remain committed to making IV Korsuva available next year to dialysis patients, who urgently need an effective therapy."

Under the terms of the agreement, Cara will receive an upfront payment of USD 100 million in cash and an equity investment of USD 50 million. In addition, Cara will be eligible to receive an additional equity investment upon US regulatory approval of IV Korsuva, as well as milestone payments dependent on achieving commercial targets, which together could total up to USD 290 million. Additional information regarding the terms of the agreements between Cara and Vifor announced today will be set forth in a Current Report on Form 8-K to be filed by Cara with the U.S. Securities and Exchange Commission on October 20, 2020.

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 IV 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 IV 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 IV Korsuva under a profit-sharing arrangement based on net FMCNA clinic sales recorded by Cara. Under the agreement, Cara had sole responsibility to promote IV Korsuva in the US in non-Fresenius Medical Care clinics.