Kyowa Kirin, Ardelyx Amend Tenapanor Pact In Cardiorenal Disorders

Ardelyx Inc ARDX has amended its license agreement, initially executed in 2017, granting Kyowa Kirin exclusive rights to develop and commercialize Ardelyx's tenapanor for cardiorenal diseases, including hyperphosphatemia, in Japan.

  • Under the agreement, considering a reduction in the royalty rate due Ardelyx upon net sales in Japan, Kyowa Kirin has agreed to pay Ardelyx up to an additional $40 million, payable in two tranches.
  • The first payment is due following Kyowa Kirin's filing with the Japanese regulatory authority of its application for tenapanor, and the second payment following approval to market tenapanor for hyperphosphatemia in Japan. 
  • Kyowa Kirin is finalizing its Phase 3 program for tenapanor for hyperphosphatemia and has disclosed its current expectation to file for approval with Kyowa Kirin in 2H of 2022.
  • Ardelyx expects to receive a decision from Kyowa Kirin regarding its application in 2H of 2023. 
  • The royalty rate at which Kyowa Kirin will make payments on net sales to Ardelyx will be reduced from the high teens to low double digits for two years and then to the mid-single digits.
  • Price Action: ARDX shares are down 6.44% at $0.90 during the market session on Monday's last check.
  • Editor's Note: The post has been updated to clarify the amendment of the agreement.
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