Winhealth Pharma today announced that the company has signed a long-term exclusive licensing agreement with Vifor Fresenius Medical Care Renal Pharma (VFMCRP) for the co-development and commercialization of KORSUVA® (difelikefalin) Injection (“i.v. Korsuva”) for the treatment of moderate-to-severe pruritus in adult patients undergoing hemodialysis in China.
Summary of License Agreement
Under the terms of the Agreement, VFMCRP will receive an upfront payment and will also be eligible to receive additional regulatory and commercial milestone payments. VFMCRP is also eligible to receive double-digit royalties based on net sales of KORSUVA® injection in the licensed territory. WinHealth will have the exclusive rights to develop and commercialize KORSUVA® injection for the treatment of CKD-associated Pruritus in dialysis patients in the licensed territory. WinHealth also has the rights for an extension of the territory to Hong Kong, Macau and Taiwan.
KORSUVA®/ Kapruvia® (difelikefalin), developed by Cara Therapeutics, Inc., is the first and currently only therapy approved for the treatment of adult hemodialysis patients with CKD-associated Pruritus in the Unites States, the European Union (incl. Iceland, Norway and Liechtenstein), Great Britain, Canada, Switzerland, Singapore and Australia.
Difelikefalin, the active substance in KORSUVA®, is a kappa opioid receptor agonist that binds to receptors (targets) on nerves and immune cells involved in controlling itch and inflammation. By binding to the receptors (called kappa opioid receptors), difelikefalin activates them, inhibiting the signals that lead to the feeling of itchiness itself.1
The hydrophilic peptidic structure of difelikefalin limits its entry into the central nervous system (CNS), distinguishing it from centrally active kappa opioid agonist. In contrast with most opioid analgesics, difelikefalin does not induce respiratory depression and is not a controlled substance 2,3,4.
About Chronic Kidney Disease (CKD)-associated Pruritus
CKD-associated Pruritus is an intractable systemic itch condition that occurs with high frequency and intensity in patients with chronic kidney disease undergoing hemodialysis. Pruritus has also been reported in patients with stage III-V CKD who are not on dialysis. Aggregate, longitudinal, multi-country studies estimate the weighted prevalence of CKD-associated Pruritus to be approximately 40% in patients with end-stage renal disease (ESRD), with approximately 25% of patients reporting severe pruritus. The majority of hemodialysis patients (approximately 60 to 70%) report pruritus, with 30 to 40% reporting moderate or severe pruritus. 5,6,7 Recent 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. Given its association with CKD/ESRD, most afflicted patients will continue to have symptoms for months or years, with currently employed antipruritic treatments, such as antihistamines and corticosteroids which are unable to provide consistent and adequate relief. Moderate-to-severe chronic pruritus has repeatedly been shown to contribute to symptoms that impair quality of life (such as poor sleep quality), and is associated with depression. 8 CKD-associated Pruritus is also an independent predictor of mortality among hemodialysis patients.
About Vifor Fresenius Medical Care Renal Pharma and CSL Vifor
Vifor Fresenius Medical Care Renal Pharma (VFMCRP) is a joint company of CSL Vifor and Fresenius Medical Care. CSL Vifor is a global partner of choice for pharmaceuticals and innovative, leading therapies in iron deficiency, dialysis and nephrology & rare disease. We specialize in strategic global partnering, in-licensing and developing, manufacturing and marketing pharmaceutical products for precision healthcare, aiming to help patients around the world lead better, healthier lives. CSL Vifor is headquartered in St. Gallen, Switzerland.
The parent company, CSL (ASX:CSL; USOTC:CSLLY), headquartered in Melbourne, Australia, employs 30,000 people and delivers its lifesaving therapies to people in more than 100 countries.
For more information about CSL Vifor, visit www.cslvifor.com.
About Winhealth Pharma
Hong Kong Winhealth Pharma Group is a China-based, global innovative biomedical company founded in 2006, providing novel breakthrough therapies to patients with rare diseases and other unmet medical needs. The Group has established long-term strategic partnership with dozens of world-leading biotechnology companies. It has built a unique, balanced and diversified portfolio with numerous orphan drugs and specialty products at commercial and late clinical stages, and will continuously look to bring in more innovative therapies from the globe. For more information, please visit http://www.winhealth.hk, or follow "Winhealth Pharma" on WeChat.
Presented at the 8th World Congress on Itch; September 27-29, 2015; Nara, Japan
4.New England Journal of Medicine 2020; 382:222-232
5.Pisoni RL, et al. Pruritus in haemodialysis patients: international results from the Dialysis Outcomes and Practice Patterns Study. Nephrol Dial Transplant. 2006; 21:3495-3505.
6.Ramakrishnan K, et al. Clinical characteristics and outcomes of end-stage renal disease patients with self-reported pruritus symptoms. International Journal of Nephrology and Renovascular Disease. 2014; 7: 1-12.
7.Sukul et al. Self-reported Pruritus and Clinical, Dialysis-Related, and Patient-Reported Outcomes in Hemodialysis Patients. Kidney Med. 2020 Nov 21;3(1):42-53.
8.Mathur VS, et al. A longitudinal study of Uremic Pruritus in hemodialysis patients. Clin J Am Soc Nephrol. 2010; 5(8):1410-1419.