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Ardelyx, Inc., a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd., has received approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for the New Drug Application (NDA) for tenapanor for the improvement of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis. Tenapanor will be marketed with the brand name Phozevel in Japan.
This approval triggers an aggregate of $30 million from Kyowa Kirin to Ardelyx in milestone payments and payments under the recent amendment to the license agreement between Ardelyx and Kyowa Kirin. As a result of this approval, Ardelyx will also receive a $5 million payment under the terms of its agreement with HealthCare Royalty Partners. In addition, Ardelyx may also receive an additional $5 million from Healthcare Royalty Partners in the event net sales in Japan exceed a certain target by 2025.
“The approval of tenapanor for hyperphosphatemia in Japan is a historic moment for Ardelyx and CKD patients on dialysis. The Japanese approval marks the very first regulatory approval of tenapanor for hyperphosphatemia, a drug discovered and developed by Ardelyx, which we and Kyowa Kirin believe can have a meaningful benefit for the patients we serve. We are hopeful that with our FDA user goal review date of October 17th of this year, that U.S. approval will quickly follow,” said Mike Raab, Ardelyx president and CEO. “With this approval, nephrologists in Japan will now have an important novel treatment option for the management of elevated serum phosphorus levels in their CKD patients on dialysis. I thank our partners at Kyowa Kirin for their long-standing collaboration and congratulate them for their tireless efforts in getting this approved. We look forward to continuing this important relationship and supporting them as they bring this novel product to patients and the entire Japanese kidney community.”
In the US, Ardelyx is pursuing approval of tenapanor for the treatment of hyperphosphatemia in adult patients with CKD on dialysis who have had an inadequate response or intolerance to phosphate binder therapy, with the brand name Xphozah, and has user fee goal date of October 17, 2023. Pending approval, Ardelyx expects to launch Xphozah in the US in the fourth quarter of 2023.
The NDA in Japan was supported by data from four phase 3 clinical trials, conducted in Japan by Kyowa Kirin in patients with hyperphosphatemia on maintenance dialysis. Across Kyowa Kirin's clinical program, tenapanor demonstrated statistically significant reductions in serum phosphorus levels, 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 the studies undertaken by Kyowa Kirin suggested that tenapanor may also reduce the medication burden of phosphorus management utilizing marketed phosphate binders in combination with tenapanor or tenapanor alone for treating hyperphosphatemia. In these studies, the safety and tolerability profile for tenapanor was consistent with prior studies in Japan.
Ardelyx was founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product, Ibsrela (tenapanor) is available in the United States and Canada.
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