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On October 20th Vifor Pharma and Cara Therapeutics announced that they had signed a commercial license agreement to commercialize Cara's Korsuva (difelikefalin), an injectable drug for chronic kidney disease-related itching (CKD-aP).
the agreement, Cara will receive a 60 percent profit share of the product in the U.S. dialysis market (not covered by the Faisanus Healthcare Clinic), with Vifor accounting for 40 percent.
decision sent Cara shares up more than 18 percent in pre-market trading.
, Cara will receive $100 million in cash advances and $50 million in equity investments.
addition, once Korsuva is approved by the FDA, Cara will be eligible for additional equity investments, as well as milestone payments depending on the achievement of business objectives, which could total up to $290 million.
the latest agreement, Vifor will have about 66 percent of the U.S. market share in total dialysis.
understands that Vifor has a strong market position in the U.S. kidney industry and is working with Fresenius Medical Care, a U.S.-owned company affiliated with the German Fessenius Group, which is also a global giant in the field of kidney disease and dialysis.
May 2018, Cara signed an initial agreement with Vifor and Fessenjus' kidney division authorizing the development and commercialization of Korsuva for the treatment of CKD-aP in patients with global hemodialysis and peritiopathy, excluding Japan, South Korea and most U.S. markets.
at the time, Cara reserved all development and commercial rights to Korsuva in the U.S. market for the treatment of CKD-aP, with the exception of the dialysis clinic at FMCNA in North America, where Cara was fully responsible for marketing Korsuva in the U.S. non-Faisenjus medical clinic.
Korsuva™ is a "first-in-class" Kappa opioid-subject (KOR) agonist for the peripheral nervous system and certain immune cells to relieve pain and itching.
the drug relieves severe itching by selectively targeting the outer blood Kappa opioids.
Korsuva doesn't penetrate the brain barrier, which means it bypasses adverse side effects such as opioid addiction.
April 2020, a phase 3 study of hemodialysis patients with moderate to severe CKD-aP, KALM-2, showed that Korsuva reduced the average worst itching intensity NRS score by three points or more for 54% of patients compared to the placebo group (42%). More, there was a statistically significant improvement (p s 0.02) to reach the primary endpoint, while the proportion of patients with an average worst itching intensity NRS score of 4 points or more was statistically significantly improved (p s 0.01), reaching a secondary endpoint, and good tolerance.
in another phase 3 study of CKD-aP hemodialysis patients, Korsuva's symptoms improved compared to the control group (28%).
studies have shown that the drug can significantly reduce itching intensity and improve quality of life.
Korsuva was named the FDA's breakthrough treatment in 2017.
cara said the drug is expected to file a new drug application with the FDA in the fourth quarter of this year.
: 1.VFMCRP and Cara Therapeutics announce positive results from global KALM-2 pivotal phase-III trial of KORSUVA™ injection in haemodialysis patients with Pruritus 2.Cara lines up a $440M deal for US rights to its late-stage drug for severe it, With $150M cash on the table 3.Vifor Pharma and Cara Expand Licensing Deal for Late-Stage Kidney Disease Drug.