Benzinga | Apr 14, 2021 08:05AM EDT

Ardelyx Reports Its Collab Partner, Kyowa Kirin, Initiated Phase 3 Studies Of Tenapanor For Hyperphosphatemia In Japan

Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa Kirin), has initiated four Phase 3 clinical studies in Japan evaluating tenapanor for hyperphosphatemia. The achievement of this development milestone triggers a $5 million payment to Ardelyx.



The Phase 3 clinical trials consist of a multi-center, randomized, double-blind, placebo-controlled, parallel-group comparative study; a phosphate binder-combination parallel-group comparative study; an open-label, single-arm study evaluating hyperphosphatemia patients on peritoneal dialysis; and a long-term study evaluating serum phosphorus in patients who switch from one or more phosphate binders to tenapanor for hyperphosphatemia in Japan.

"As we approach our April 29 PDUFA date for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis and prepare for potential commercialization in the U.S., we are pleased to see the significant progress made by our partner Kyowa Kirin," said Mike Raab, president and chief executive officer of Ardelyx. "We are thrilled to have key strategic partners like Kyowa Kirin, along with our partners in Canada and China, to support development of, and once approved, patient access to, tenapanor globally."

Under the terms of the license agreement for tenapanor with Kyowa Kirin, which was signed in 2017 Ardelyx received a $30 million upfront payment and is eligible to receive up to $55.0 million in total development milestones and 8.5 billion yen in commercialization milestones. Ardelyx is also eligible to receive high-teen royalties on sales throughout the term of the agreement. Kyowa Kirin has been granted the exclusive rights to develop, market and commercialize tenapanor for cardiorenal diseases and conditions associated with them, including hyperphosphatemia, in Japan.