Shares of Cara Therapeutics are soaring this morning after the company announced it secured $70 million in cash as part of a licensing agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) for the company’s chronic kidney disease treatment Korsuva.
Shares of Cara Therapeutics are soaring this morning after the company announced it secured $70 million in cash as part of a licensing agreement with Vifor Fresenius Medical Care Renal Pharma Ltd. (VFMCRP) for the company’s chronic kidney disease treatment Korsuva.
The two companies struck a deal that allows Vifor, a Vifor Pharma Group company, to have global rights to the CKD treatment except in the United States, South Korea and Japan. Korsuva, which last year earned the U.S. Food and Drug Administration’s Breakthrough Therapy Designation, is currently in Phase III development for the treatment of chronic kidney disease-associated pruritus (severe itching) (CKD-aP) in dialysis patients. Vifor specializes in treatments for CKD. Korsuva, formerly known as CR845, is the trade name for Cara’s late-stage product, a difelikefalin injection. Cara’s treatment is designed to alleviate pain and pruritus by selectively targeting peripheral kappa opioid receptors. There are currently no approved treatments for the CKD-associated pruritus in the United States or Europe, the company said.
Stefan Schulze, chief operations officer for Vifor Pharma, said Korsuva is a first-in-class, innovative investigational medicine for treating a highly debilitating disease. Schulze called the late-stage drug a natural fit to the company’s product portfolio in nephrology. He added the company is looking forward to bringing it to patients who are in need of better therapy.
“Sixty to 70 percent of dialysis patients experience CKD-aP. Nearly 20 percent suffer from a very severe form, which is associated with much lower survival. And despite this clear unmet medical need, there is no approved treatment for CKD-aP in Europe or the U.S. CR845 does not penetrate the brain, and so bypasses unwanted side-effects like opioid addiction. It has significant potential for setting new standards in providing relief, both from CKD- induced itching and post-operative pain,” Schulze said.
Under terms of the deal, Vifor provided Connecticut-based Cara with $70 million in upfront money. Cara will be eligible for an additional $470 million in regulatory and commercial milestones. Cara will also be eligible to receive tiered royalties based on net sales of Korsuva in the licensed territories, the company said. The one spot in the United States that Cara will not have rights to Korsuva is in the dialysis clinics operated by Fresenius Medical Care North America. FMCNA is the largest kidney dialysis provider in the U.S. Last year its clinics treated approximately 38 percent of U.S. dialysis patients.
That news was pleasing to Cara’s investors who snapped up shares of the company in early trading today. Shares of Cara Therapeutics shot up to as high as $15.25 at 10:20 a.m., but has dropped back to $15.14 as of 11:01 a.m. The stock opened at $13.60 this morning.
Derek Chalmers, president and chief executive officer of Cara, called VFMCRP an ideal partner to bring Korsuva to patients in Europe and other territories.
“Additionally, we believe the ability to leverage VFMCRP’s nephrology-focused commercial expertise in our co-promotion partnership for U.S. Fresenius Medical Care dialysis facilities will provide significant momentum for adoption of Korsuva injection, if approved in the U.S. Importantly, we continue to retain all rights to Korsuva/CR845 in other indications,” Chalmers said in a statement.
Cara launched its Phase III trial in hemodialysis patients suffering from moderate-to-severe CKD-aP in January.
