Vifor Pharma and Cara Expand Licensing Deal for Late-Stage Kidney Disease Drug

 

Shares of Cara Therapeutics were up more than 18% in premarket trading after the company struck a licensing agreement worth up to $290 million with Switzerland’s Vifor Pharma for the commercialization of a treatment for severe itching associated with chronic kidney disease.

Vifor Pharma secured U.S. commercial rights to Korsuva (difelikefalin) Injection for the treatment of chronic kidney disease-associated pruritus (CKD-aP) in the U.S. dialysis market for non-Fresenius Medical Care clinics. In its announcement this morning, Vifor said this will address about 66% of the market in the United States. The two companies have a 60%/40% profit sharing agreement for sales of the intravenous medication in the United States.

The new agreement builds on a relationship Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma signed in 2018 for global rights to intravenous Korsuva, excluding the U.S., Japan and South Korea. Vifor specializes in treatments for chronic kidney disease. Under that agreement, Cara had sole responsibility to promote IV Korsuva in the US in non-Fresenius Medical Care clinics.

In April, Korsuva hit the mark in a Phase III study for treatment of hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritus. The drug demonstrated efficacy in reducing the irritating itch and was well-tolerated. Korsuva is designed to alleviate pain and pruritus, the severe itching associated with 40% of dialysis patients by selectively targeting peripheral kappa opioid receptors. Data from the ITCH National Registry Study showed that among those with pruritus, approximately 59% experienced symptoms daily or nearly daily for more than a year. There is little relief for these symptoms beyond antihistamines and steroid treatment. Korsuva does not penetrate the brain, which means it bypasses unwanted side-effects such as opioid addiction.

Cara Chief Executive Officer Derek Chalmers called Vifor the ideal commercial partner. If Korsuva is approved by the U.S. Food and Drug Administration, Chalmers said Vifor’s established sales force will be able to hit the ground running with the treatment and that will allow Cara to focus on the development of Oral Korsuva in atopic dermatitis, pre-dialysis CKD and additional pruritic conditions. Cara is expected to submit a New Drug Application to the FDA in the fourth quarter of this year. Korsuva earned Breakthrough Therapy designation from the FDA in 2017.

Stefan Schulze, CEO of Vifor Pharma Group, touted the importance of the deal for his company. He said Vifor Pharma has both a strong market position as well as “deep expertise in the nephrology space.” He said the deal further strengthens the company’s presence in the U.S. nephrology market.

“Moderate to severe hemodialysis-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,” Schulze said in a statement.

Under terms of the deal, Connecticut-based Cara Therapeutics will receive $100 million in an upfront payment, as well as an equity investment of $50 million. Additional milestone payments could bring the total of the deal to about $290 million.