Ardelyx Says Japan Approves Tenapanor For Hyperphosphatemia

(RTTNews) - Biopharmaceutical company Ardelyx, Inc. (ARDX) announced Monday 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 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.