Business
Ardelyx Collaboration Partner, Kyowa Kirin, Announces Submission of New Drug Application for Tenapanor for Hyperphosphatemia in Japan
Ardelyx to receive an aggregate of $35 million in milestone payments and payments associated with the recent amendment of the license agreement WALTHAM,
About this update from Ardelyx, Inc.
[{"type":"text","content":"Ardelyx to receive an aggregate of $35 million in milestone payments and payments associated with the recent amendment of the license agreement\nWALTHAM, Mass., Oct. 31, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin), has submitted a New Drug Application (NDA) to the Japanese Ministry of Health, Labour and Welfare (MHLW) for tenapanor for the improvement of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis. This submission triggers an aggregate of $35 million to Ardelyx in milestone payments and payments under the recent amendment to the license agreement between Ardelyx and Kyowa Kirin. Kyowa Kirin made a public announcement, which is available here: Kyowa Kirin Announces NDA Submission of Tenapanor Hydrochloride (KHK7791) for Improvement of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis in Japan\n\n \n \n \n \n \n \n\n \n\"The NDA submission represents important progress toward making tenapanor available in Japan to treat hyperphosphatemia in patients with CKD on dialysis,\" said Mike Raab, president and chief executive officer of Ardelyx. \"The data generated by Kyowa Kirin in Japan further supports our extensive clinical results demonstrating the importance of having tenapanor in the armamentarium of treatment options for nephrologists. We congratulate our partners on their work, and we would like to express our gratitude to them, the hundreds of patients that participated in their clinical studies in Japan, and the medical staff that supported these patients. Together, we share a common vision for the betterment of patients with kidney disease.\"\nThe NDA is supported by data from four Phase 3 clinical trials, conducted by Kyowa Kirin in Japan in patients with hyperphosphatemia on maintenance dialysis. Across Kyowa Kirin's clinical program, tenapanor demonstrated statistically significant reductions in serum phosphorus levels, with tenapanor both as monotherapy and when added to phosphate binders for patients whose serum phosphorus levels were poorly controlled on phosphate binders alone. The results of...