Kyowa Kirin Announces Approval of PHOZEVEL® for Improvement of Hyperphosphatemia in Chronic Kidney Disease Patients on Dialysis in Japan

Kyowa Kirin Co Ltd. announced today that it has received an approval for manufacturing   and   marketing   PHOZEVEL®     (Generic   name:   tenapanor   hydrochloride, Development  code:  KHK7791)*1,  a  small  molecule  compound  licensed  from  Ardelyx,  Inc  for the improvement of hyperphosphatemia in chronic kidney disease patients on dialysis as of today. We are excited to announce the manufacturing and marketing approval of PHOZEVEL® for the improvement  of  hyperphosphatemia  in  chronic  kidney  disease  patients  on  dialysis,”  said Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division at Kyowa Kirin. “We expect that PHOZEVEL®, with its novel mechanism of action as a phosphate absorption inhibitor, will provide a new treatment option for the improvement of hyperphosphatemia in chronic  kidney  disease  patients  on  dialysis  and  significantly  improve  the  quality  of  life  for patients. We appreciate Ardelyx’s continued support to bringing this drug to market. Under the continued strong partnership, we will work closely to provide appropriate product information for PHOXEVEL®  to patients and healthcare professionals in Japan who are in need of a new option to manage their hyperphosphatemia” “The approval of PHOZEVEL®  in Japan marks the very first regulatory approval of tenapanor for hyperphosphatemia. I thank our partners at Kyowa Kirin for their long-standing collaboration and congratulate them for their tireless efforts to get PHOZEVEL®  approved,” said Mike Raab, President and CEO at Ardelyx. “Together with Kyowa Kirin, we believe PHOZEVEL® can provide a  meaningful  benefit  for  chronic  kidney  disease  patients  on  dialysis.  With  this  approval, nephrologists in Japan will now have an important novel treatment option for the management of elevated serum phosphorus levels. We look forward to continuing this important relationship and supporting Kyowa Kirin as they bring this novel product to patients and the entire Japanese kidney community.”  This approval is based on the results of four Phase 3 clinical trials conducted by Kyowa Kirin inJapan, in patients with hyperphosphatemia on maintenance dialysis. These data demonstrated a  statistically  significant  reduction  in  serum  phosphorus  levels,  with  PHOZEVEL®,  both  as monotherapy and when added to phosphate binders for patients whose serum phosphorus levels  were  poorly  controlled  on  conventional  phosphate  binders  alone.  The  results  of  the studies undertaken by Kyowa Kirin suggest that PHOZEVEL®  may also reduce the medication burden  of  phosphorus  management  utilizing  conventional  phosphate  binders  for  treating hyperphosphatemia  and  the  long-term  management  of  serum  phosphorus  levels  can  be maintained. In these studies, the safety and tolerability profile for PHOZEVEL®  was consistent with prior studies in Japan, with no new safety signals identified. PHOZEVEL®   discovered  and  developed  by  Ardelyx  in  the  United  States,  is  a  first-in-class phosphate absorption inhibitor. Kyowa Kirin entered into an exclusive license agreement with Ardelyx in November 2017 for the development and commercialization rights for this product in Japan, targeting cardiorenal diseases, including hyperphosphatemia. The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

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