Ardelyx to receive an aggregate of
$35 million in milestone payments and
payments associated with the recent amendment of the license
agreement
WALTHAM,
Mass., Oct. 31, 2022 /PRNewswire/ -- Ardelyx,
Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a
mission to discover, develop and commercialize innovative
first-in-class medicines that meet significant unmet medical needs,
today announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd. (TSE: 4151, Kyowa
Kirin), has submitted a New Drug Application (NDA) to the Japanese
Ministry of Health, Labour and Welfare (MHLW) for tenapanor for the
improvement of hyperphosphatemia in adult patients with chronic
kidney disease (CKD) on dialysis. This submission triggers an
aggregate of $35 million to Ardelyx
in milestone payments and payments under the recent amendment to
the license agreement between Ardelyx and Kyowa Kirin. Kyowa Kirin
made a public announcement, which is available here: Kyowa Kirin
Announces NDA Submission of Tenapanor Hydrochloride (KHK7791) for
Improvement of Hyperphosphatemia in Chronic Kidney Disease Patients
on Dialysis in Japan
![Ardelyx logo (PRNewsFoto/Ardelyx) (PRNewsfoto/Ardelyx) Ardelyx logo (PRNewsFoto/Ardelyx) (PRNewsfoto/Ardelyx)](https://mma.prnewswire.com/media/1309911/Ardelyx_Logo.jpg)
"The NDA submission represents important progress toward making
tenapanor available in Japan to
treat hyperphosphatemia in patients with CKD on dialysis," said
Mike Raab, president and chief
executive officer of Ardelyx. "The data generated by Kyowa Kirin in
Japan further supports our
extensive clinical results demonstrating the importance of having
tenapanor in the armamentarium of treatment options for
nephrologists. We congratulate our partners on their work, and we
would like to express our gratitude to them, the hundreds of
patients that participated in their clinical studies in
Japan, and the medical staff that
supported these patients. Together, we share a common vision for
the betterment of patients with kidney disease."
The NDA is supported by data from four Phase 3 clinical trials,
conducted by Kyowa Kirin in Japan
in patients with hyperphosphatemia on maintenance dialysis. Across
Kyowa Kirin's clinical program, tenapanor demonstrated
statistically significant reductions in serum phosphorus levels,
with tenapanor both as monotherapy and when added to phosphate
binders for patients whose serum phosphorus levels were poorly
controlled on phosphate binders alone. The results of the studies
undertaken by Kyowa Kirin suggest that tenapanor may also reduce
the medication burden of phosphorus management utilizing marketed
phosphate binders for treating hyperphosphatemia. In these studies,
the safety and tolerability profile for tenapanor was consistent
with prior studies in Japan, with
no new safety signals identified.
In the U.S., Ardelyx is pursuing approval of tenapanor for the
treatment of hyperphosphatemia in adult patients with CKD on
dialysis, with the brand name XPHOZAH, and has an appeal underway
in response to the Complete Response Letter it received from the
FDA for its NDA. As part of the appeal process, the FDA will
convene an Advisory Committee Meeting to review XPHOZAH on
November 16, 2022. For more details
please visit:
https://www.govinfo.gov/app/details/FR-2022-09-19/2022-20198
About Tenapanor for
Hyperphosphatemia
Tenapanor, discovered and developed by Ardelyx, in an
investigational first-in-class phosphate absorption inhibitor
(PAI). With its unique blocking mechanism of action, tenapanor acts
locally in the gut to inhibit the sodium hydrogen exchanger 3
(NHE3), reducing phosphate absorption through the paracellular
pathway, the primary pathway of phosphate absorption. This novel
blocking mechanism enables a one 30 mg tablet BID dosing regimen.
The most common side effect with tenapanor in clinical trials was
diarrhea.
About Hyperphosphatemia
Hyperphosphatemia is a serious condition resulting in an
abnormally elevated level of phosphorus in the blood that is
estimated to affect more than 745,000 dialysis patients in major
developed countries. The kidney is the organ responsible for
regulating phosphorus levels, but when kidney function is
significantly impaired, phosphorus is not adequately eliminated
from the body. As a result, hyperphosphatemia is a nearly universal
condition among people with CKD on dialysis with internationally
recognized KDIGO treatment guidelines that recommend lowering
elevated phosphate levels toward the normal range
(2.5-4.5mg/dL).
About Ardelyx, Inc.
Ardelyx was founded with a mission to discover, develop and
commercialize innovative first-in-class medicines that meet
significant unmet medical needs. Ardelyx's first approved product,
IBSRELA® (tenapanor) is available in the United States and Canada. Ardelyx is developing
XPHOZAH® (tenapanor), a novel product candidate to
control serum phosphorus in adult patients with CKD on dialysis,
which has completed three successful Phase 3 trials. Ardelyx has a
Phase 2 potassium lowering compound, RDX013, for the potential
treatment of elevated serum potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease and an
early-stage program in metabolic acidosis, a serious electrolyte
disorder in patients with CKD. Ardelyx has established agreements
with Kyowa Kirin in Japan, Fosun
Pharma in China and Knight
Therapeutics in Canada for the
development and commercialization of tenapanor in their respective
territories.
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
tenapanor, if approved, to reduce the medication burden of
phosphorus management utilizing marketed phosphate binders for
treating hyperphosphatemia. Such forward-looking statements involve
substantial risks and uncertainties that could cause 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, uncertainties
associated with the clinical development and regulatory processes.
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 August 4,
2022, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
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