Ardelyx, Inc. and Kyowa Hakko Kirin Co., Ltd. announced that they have entered into a license agreement that provides Kyowa Hakko Kirin with exclusive rights to develop and commercialize Ardelyx's lead investigational product, tenapanor, for the treatment of cardiorenal diseases, including hyperphosphatemia, in Japan.
Tenapanor is an oral, minimally systemic NHE3 inhibitor discovered and developed by Ardelyx that is in phase 3 development in the United States for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis.
Under the terms of the license agreement, Ardelyx will receive a $30 million upfront payment and is eligible to receive additional development and commercialization milestones worth up to $130 million. Ardelyx is also eligible to receive high-teen royalties throughout the term of the agreement. Kyowa Hakko Kirin will have the exclusive rights to develop, market and commercialize tenapanor for cardiorenal diseases and conditions associated with them, including hyperphosphatemia, in Japan.
"Kyowa Hakko Kirin is an established leader in the development of cardiorenal products and an ideal partner to develop tenapanor for such diseases in the Japanese market," said Mike Raab, president and chief executive officer of Ardelyx. "This agreement represents the first collaboration under our strategy of evaluating collaborative opportunities to bring tenapanor to patients and physicians across all potential indications as efficiently as possible. We look forward to working with the experienced Kyowa Hakko Kirin team to bring this first-ever, non-binder treatment to the many patients with hyperphosphatemia who need an effective and easy-to-take treatment."
"Developing medicines for renal disease and conditions associated with it is an important aspect of Kyowa Hakko Kirin's strategic focus," said Masashi Miyamoto, Ph.D., director of the board, managing executive officer, director of corporate strategy and planning department. "We are excited to collaborate with Ardelyx, who has deep experience in developing cardiorenal medicines, and for the potential of tenapanor to be a game-changing, first-in-class treatment for patients with hyperphosphatemia. We are looking forward to the opportunity to bring this important product to patients in Japan."
Tenapanor, discovered and developed by Ardelyx, is a first-in-class, proprietary, minimally absorbed, oral, experimental medication in late-stage clinical development. It has a unique mechanism of action that, in hyperphosphatemia, acts by blocking the NHE3 sodium transporter in the GI tract, reducing the absorption of dietary sodium and resulting in increased protons within the cells. The increase in protons causes a reduction in phosphate uptake by tightening junctions or pores that regulate phosphate absorption in the GI tract. Overall, this mechanism appears to be preferential to phosphate absorption given that Ardelyx has not observed any changes in other ions in preclinical or clinical studies.
Ardelyx is focused on enhancing the way patients with cardiorenal and gastrointestinal (GI) diseases are treated by using the gut as the gateway to delivering medicines that matter.
Kyowa Hakko Kirin Co., Ltd. is a research-based life sciences company, with special strengths in biotechnologies. In the core therapeutic areas of oncology, nephrology and immunology/allergy, Kyowa Hakko Kirin leverages leading-edge biotechnologies centered on antibody technologies, to continually discover innovative new drugs and to develop and market those drugs world-wide.