Pharma Focus Asia

Ardelyx and Kyowa Kirin Expand Partnership with Two Additional Agreements

Tuesday, November 26, 2019

Ardelyx, Inc., a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases and Kyowa Kirin Co., Ltd.,, a Japan-based Global Specialty Pharmaceutical Company, today announced the expansion of their partnership with two new agreements.

In the first agreement, the companies have established a two-year research collaboration, whereby Ardelyx will execute a research plan, in which Kyowa Kirin will also join, to advance two of Ardelyx's ongoing research programs focused on the identification and design of compounds to two undisclosed targets. In return, Kyowa Kirin will pay Ardelyx $10 million ($5 million a year for two years) to support the ongoing research. Following the end of the research period, Kyowa Kirin will have the option to license any candidates nominated by the companies for further development and commercialization in certain specified territories, with additional commitments payable to Ardelyx of up to $10.5 million in upfronts and up to $500 million in development and sales milestones. The research collaboration will be governed by a joint research committee. Additional terms were not disclosed.

Under the second agreement, Kyowa Kirin has made a $20 million equity investment in Ardelyx at $6.96 for 2,873,563 shares.

"Kyowa Kirin is a leader in the development and commercialization of medicines for patients with cardiorenal disease and an important and highly collaborative partner for Ardelyx and we're thrilled to expand our relationship with them," said Mike Raab, president and chief executive officer of Ardelyx.  "The research collaboration will leverage our successful drug discovery platform, which includes tools and techniques for selectively modulating the exposure of drug leads, our human stem cell-based translational technology, and our extensive experience in developing disease models, expertise that has proven successful in our development and approval of tenapanor. Funding from this agreement and the equity investment serve as an important source of capital as we prepare for the potential launch and commercialization of tenapanor in hyperphosphatemia."

Takeyoshi Yamashita, Ph.D., Executive officer, Director of Corporate Strategy & Planning Department of Kyowa Kirin added, "We view Ardelyx's ability selectively targeting key molecule to be well validated with the successful discovery and development of tenapanor, a novel, ground-breaking inhibitor of the sodium hydrogen exchanger 3 (NHE3).  Through our newly established research and equity agreements, we look forward to a deeper, expanded collaboration with the Ardelyx team."   

Ardelyx and Kyowa Kirin initially established a collaboration partnership in November 2017 through a license agreement that provided Kyowa Kirin with exclusive rights to develop and commercialize Ardelyx's lead investigational product, tenapanor, for the treatment of cardiorenal diseases, including hyperphosphatemia, in Japan. Kyowa Kirin will have the exclusive rights to develop, market and commercialize tenapanor for cardiorenal diseases and conditions associated with them, including hyperphosphatemia, in Japan.

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