Ardelyx and Kyowa Kirin Expand Partnership with Two Additional Agreements

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Ardelyx and Kyowa Kirin Expand Partnership with Two Additional Agreements
- Companies establish a research collaboration with associated options to license any resulting development candidates with the potential for up to $500 million in development and sales milestones for Ardelyx
- In addition, Kyowa Kirin makes $20 million equity investment in Ardelyx

FREMONT, Calif. and TOKYO, Nov. 25, 2019 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases and Kyowa Kirin Co., Ltd., (TSE:4151, President and CEO: Masashi Miyamoto, Kyowa Kirin), 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.

About Ardelyx, Inc.
Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) who are on dialysis, and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

About Kyowa Kirin
Kyowa Kirin commits to innovative drug discovery driven by state-of-the-art technologies. The company focuses on creating new values in the four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa Kirin brand, the employees from 36 group companies across North America, EMEA and Asia/Oceania unite to champion the interests of patients and their caregivers in discovering solutions wherever there are unmet medical needs.

You can learn more about the business of Kyowa Kirin at www.kyowakirin.com 

Forward Looking Statements
To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the potential for Kyowa Kirin to exercise one or more of the options granted under the research collaboration agreement with Ardelyx, and the potential for Ardelyx to receive upfront or sales or development milestone payments from Kyowa Kirin should Kyowa Kirin exercise one or more of the options arising from the research collaboration.  Such forward-looking statements involve substantial risks and uncertainties that could cause the development of Ardelyx's product candidates or Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in research, and the clinical development process, including the regulatory approval process. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on November 6, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

Ardelyx logo (PRNewsFoto/Ardelyx)

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SOURCE Ardelyx

Investor and Media Contacts to Ardelyx, Kimia Keshtbod, 510-745-1751, kkeshtbod@ardelyx.com; Sylvia Wheeler, Wheelhouse Life Science Advisors, swheeler@wheelhouselsa.com; Alex Santos, Wheelhouse Life Science Advisors, asantos@wheelhouselsa.com; Media Contact to Kyowa Kirin, Hiroki Nakamura, +81-3-5205-7205, Email: media@kyowakirin.com