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.
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SOURCE Ardelyx