FREMONT, Calif. and
TOKYO, Nov.
28, 2017 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ: ARDX) and
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, "Kyowa Hakko Kirin"), today
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."
About Tenapanor for Hyperphosphatemia
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.
About Ardelyx, Inc.
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. The company has
established unique cardiorenal and GI business portfolios aimed at
bringing new, effective medicines with distinct safety and dosing
advantages to underserved patients. Ardelyx's portfolio includes
the Phase 3 development of tenapanor for the treatment of
hyperphosphatemia in people with end-stage renal disease who are on
dialysis and RDX013, a potassium secretagogue program. The
company's GI portfolio includes tenapanor for the treatment of
people with irritable bowel syndrome with constipation (IBS-C), for
which the company anticipates submitting a New Drug Application in
the second half of 2018, and RDX8940, a TGR5 agonist. For more
information, please visit http://www.ardelyx.com/ and connect with
us on Twitter @Ardelyx.
About Kyowa Hakko Kirin Co., Ltd.
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. In this
way, the company is working to realize its vision of becoming a
Japan-based global specialty
pharmaceutical company that contributes to the health and wellbeing
of people around the world.
You can learn more about the business at:
www.kyowa-kirin.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
Ardelyx's product candidates in treating the diseases and
conditions for which they are being developed; the potential for
Ardelyx to receive upfront, milestone and royalty payments from
Kyowa Hakko Kirin; Ardelyx's expected timing for the filing of its
NDA for tenapanor for the treatment of IBS-C, and Ardelyx's ability
to establish collaborations in the future. 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 7,
2017, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
Contacts for Ardelyx Inc.:
Monique Allaire, THRUST IR (For
Ardelyx Inc.)
781-631-0759
monique@thrustir.com
OR
Alicia Davis, THRUST IR (For
Ardelyx Inc.)
910-620-3302
alicia@thrustir.com
Contacts for Kyowa Hakko Kirin Co. Ltd.:
Hiroki Nakamura
+81-3-5205-7205
media@kyowa-kirin.co.jp
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SOURCE Ardelyx