Tenapanor for Hyperphosphatemia Approved in Japan
25 September 2023 - 10:15AM
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 received
approval from the Japanese Ministry of Health, Labour and Welfare
(MHLW) for the New Drug Application (NDA) for tenapanor for the
improvement of hyperphosphatemia in adult patients with chronic
kidney disease (CKD) on dialysis. Tenapanor will be marketed with
the brand name PHOZEVEL® in Japan.
This approval triggers an aggregate of $30 million from Kyowa
Kirin to Ardelyx in milestone payments and payments under the
recent amendment to the license agreement between Ardelyx and Kyowa
Kirin. As a result of this approval, Ardelyx will also receive a $5
million payment under the terms of its agreement with HealthCare
Royalty Partners. In addition, Ardelyx may also receive an
additional $5 million from Healthcare Royalty Partners in the event
net sales in Japan exceed a certain target by 2025.
“The approval of tenapanor for hyperphosphatemia in Japan is a
historic moment for Ardelyx and CKD patients on dialysis. The
Japanese approval marks the very first regulatory approval of
tenapanor for hyperphosphatemia, a drug discovered and developed by
Ardelyx, which we and Kyowa Kirin believe can have a meaningful
benefit for the patients we serve. We are hopeful that with our FDA
user goal review date of October 17th of this year, that U.S.
approval will quickly follow,” said Mike Raab, Ardelyx president
and CEO. “With this approval, nephrologists in Japan will now have
an important novel treatment option for the management of elevated
serum phosphorus levels in their CKD patients on dialysis. I thank
our partners at Kyowa Kirin for their long-standing collaboration
and congratulate them for their tireless efforts in getting this
approved. We look forward to continuing this important relationship
and supporting them as they bring this novel product to patients
and the entire Japanese kidney community.”
In the U.S., Ardelyx is pursuing approval of tenapanor for the
treatment of hyperphosphatemia in adult patients with CKD on
dialysis who have had an inadequate response or intolerance to
phosphate binder therapy, with the brand name XPHOZAH, and has user
fee goal date of October 17, 2023. Pending approval, Ardelyx
expects to launch XPHOZAH in the U.S. in the fourth quarter of
2023.
The NDA in Japan was supported by data from four Phase 3
clinical trials, conducted in Japan by Kyowa Kirin in patients with
hyperphosphatemia on maintenance dialysis. Across Kyowa Kirin's
clinical program, tenapanor demonstrated statistically significant
reductions in serum phosphorus levels, 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 suggested that
tenapanor may also reduce the medication burden of phosphorus
management utilizing marketed phosphate binders in combination with
tenapanor or tenapanor alone for treating hyperphosphatemia. In
these studies, the safety and tolerability profile for tenapanor
was consistent with prior studies in Japan.
Kyowa Kirin made a public announcement regarding the approval,
which is available
here: https://www.kyowakirin.com/media_center/news_releases/2023/pdf/e20230925_02.pdf
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 for the control of serum
phosphorus in adult patients with chronic kidney disease (CKD) on
dialysis who have an inadequate response or intolerance to a
phosphate binder therapy, which has completed three successful
Phase 3 trials and an additional two Phase 4 open label 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. For more information,
please visit https://ardelyx.com/ and connect with us on Twitter,
LinkedIn and Facebook.
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 to provide a meaningful benefit to patients and the
potential for U.S. regulatory approval for tenapanor for the
treatment of hyperphosphatemia in adult patients with CKD on
dialysis who have had an inadequate response or intolerance to
phosphate binder therapy to follow shortly from the regulatory
approval of tenapanor in Japan. 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 regulatory process
for, and the commercialization of drugs in the U.S. and
internationally. 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 2, 2023, and its
future current and periodic reports to be filed with the Securities
and Exchange Commission.
Investor and Media Contacts: Caitlin
Lowieclowie@ardelyx.com
Kimia Keshtbod kkeshtbod@ardelyx.com
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