Ardelyx Announces Acceptance of New Drug Application for Tenapanor for Hyperphosphatemia in China
13 Juli 2023 - 2:00PM
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 a New Drug Application (NDA) for tenapanor has
been accepted for review by China’s Center for Drug Evaluation of
the National Medical Products Administration (NMPA) for the control
of serum phosphorus in adult patients with chronic kidney disease
on hemodialysis. This acceptance triggers a $2 million milestone
payment to Ardelyx under the terms of the license agreement between
Ardelyx and its collaboration partner in China, Shanghai Fosun
Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). A
potential approval of the NDA submission in China is expected by
the end of 2024.
“The NDA acceptance for tenapanor for hyperphosphatemia in China
marks a significant step forward in Ardelyx’s commitment to
bringing our novel therapies to patients with unmet medical needs
and our desire to expand internationally alongside best-in-class
partners who complement our capabilities and share our mission,”
said Mike Raab, president and chief executive officer of Ardelyx.
“I commend our collaboration partner, Fosun Pharma, on the
impressive clinical results they generated which demonstrate the
important role that tenapanor can play in offering a new treatment
option for patients with hyperphosphatemia. We look forward to
further collaboration as Fosun Pharma brings this treatment to
patients.”
Under the terms of its agreement with Fosun Pharma, Ardelyx
received an upfront payment of $12 million and is eligible to
receive additional developmental and commercialization milestones
of up to $110 million and tiered royalty payments on net sales
ranging from the mid-teens to 20 percent. Fosun Pharma has the
exclusive rights to market and sell tenapanor in China, Hong Kong
and Macau.
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, 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. For more information,
please visit https://ardelyx.com/ and connect with us on Twitter,
LinkedIn and Facebook.
About Fosun PharmaFounded in 1994, Shanghai
Fosun Pharmaceutical (Group) Co., Ltd.* ("Fosun Pharma"; stock
code: 600196. SH, 02196. HK) is a global innovation-driven
pharmaceutical and healthcare industry group. Fosun Pharma directly
operates businesses including pharmaceuticals, medical devices,
medical diagnosis, and healthcare services. As a shareholder of
Sinopharm Co., Ltd., Fosun Pharma expands its areas in the
pharmaceutical distribution and retail business.
Fosun Pharma is patient-centered and clinical needs-oriented.
The company continuously enriches its innovative product pipeline
through independent research and development, cooperative
development, license-in, and in-depth incubation. Fosun Pharma
improves the research and clinical development capabilities of FIC
(First-in-class) and BIC (Best-in-class) new drugs as well as
accelerates the R&D and launch of innovative technologies and
products.
Guided by the 4IN strategy (Innovation, Internationalization,
Intelligentization, and Integration), Fosun Pharma will uphold the
development model of “Innovation Transformation, Integrated
Operation and Steady Growth”, with the mission of creating
shareholder values through strengthening its independent R&D
and external cooperation and enriching its product pipelines, as
well as promoting the global networks and enhancing operational
efficiency. Fosun Pharma will actively promote the digital and
physical business layout in the pharmaceutical and healthcare
industry and is committed to becoming a first-class enterprise in
the global medical and health market.
For more information, please visit our official website:
www.fosunpharma.com
Forward Looking StatementsTo 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 role that
tenapanor can play in offering new treatment options for patients
with hyperphosphatemia; the current expectation for potential
review timelines for the NDA for tenapanor for hyperphosphatemia in
China; and the potential for Ardelyx to receive additional
developmental and commercialization milestone and royalty payments
under its license agreements with Fosun Pharma. 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 process for drug development, regulatory approval and
commercialization. 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 Annual Report on Form 10-K filed with the
Securities and Exchange Commission on March 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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