FREMONT, Calif., Dec. 11, 2017 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX) today announced that the company has entered into a
license agreement with Shanghai Fosun Pharmaceutical
Industrial Development Company Limited (Fosun Pharma) providing
Fosun Pharma with the exclusive rights to develop and
commercialize Ardelyx's lead product, tenapanor, in China for the treatment of patients with
irritable bowel syndrome with constipation (IBS-C) and for the
treatment of hyperphosphatemia related to chronic kidney disease.
The agreement also provides Fosun Pharma the rights to
commercialize tenapanor for other indications for which it is
approved in the United States.
Tenapanor is an investigational oral, minimally systemic NHE3
inhibitor discovered and developed by Ardelyx.
Under the terms of the agreement, Ardelyx will receive an
upfront payment of $12 million and is
eligible to receive additional milestones of up to $113 million, as well as tiered royalty payments
on net sales ranging from the mid-teens to 20 percent. Fosun
Pharma will have the exclusive rights to market and sell
tenapanor in China.
"As one of the leading healthcare companies in China, Fosun Pharma is an ideal partner
to commercialize tenapanor in the Chinese market. Their strong
focus on and track record of successfully marketing cardiorenal
medicines in China, as well as
their experience in GI, were critical decision-making factors in
this collaboration," said Mike Raab,
president and chief executive officer of Ardelyx. "Now, with our
recent collaboration with Kyowa Hakko Kirin for tenapanor in
hyperphosphatemia in Japan,
together with this second regional collaboration with Fosun
Pharma for both indications in China, we are successfully executing our
strategy to bring tenapanor to patients and physicians as
efficiently as possible, while also enhancing our cash runway. We
look forward to working with the Fosun Pharma team to bring
tenapanor to the many patients in China who suffer from IBS-C and
hyperphosphatemia."
"We are pleased to partner with Ardelyx to bring a potential
first-in-class treatment option to patients suffering from IBS-C
and cardiorenal diseases, including hyperphosphatemia," said
Yifang Wu, president and chief
executive officer of Shanghai Fosun Pharmaceutical (Group) Co.,
Ltd., the parent company of Shanghai Fosun Industrial Development
Company Limited. "Tenapanor's potential as a differentiated
treatment for both cardiorenal and GI diseases is impressive. The
data generated by Ardelyx to-date gives us confidence that
tenapanor could be a leading treatment option for both therapeutic
areas, offering unique advantages to patients. We look forward to
Ardelyx's regulatory approval of tenapanor in the U.S., so we can
ultimately bring this treatment to patients in China."
About Tenapanor
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 IBS-C, acts by inhibiting, or
blocking, the NHE3 transporter in the gastrointestinal (GI) tract
to reduce the absorption of dietary sodium, which leads to an
increased amount of sodium within the gut. This increased sodium
increases water in the gut, which loosens stool, helping to
alleviate constipation. Preclinical studies have shown that
tenapanor may work to reduce abdominal pain caused by IBS-C through
the inhibition of TRPV-1 dependent signaling. Ardelyx has also seen
a desired benefit in the abdominal pain component of IBS-C in its
clinical studies to-date. Two Phase 3 clinical trials for tenapanor
in IBS-C have been completed by Ardelyx, each demonstrating
statistical significance for the primary endpoint, the combined
responder rate for six of 12 weeks, defined as a 30 percent
reduction in abdominal pain and an increase of one or more complete
spontaneous bowel movements (CSBM) in the same week, compared to
baseline, for at least six of the 12 weeks of the treatment period.
Tenapanor was well-tolerated in both trials. In the second half of
2018, Ardelyx plans to submit a New Drug Application requesting
marketing authorization from the U.S. Food and Drug Administration
(FDA) for tenapanor to treat IBS-C.
Tenapanor is also in Phase 3 development for the treatment of
hyperphosphatemia in patients with end-stage renal disease who are
on dialysis. In hyperphosphatemia, tenapanor blocks 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
meaningful changes in other ions, other than sodium, in preclinical
or clinical studies. Ardelyx completed its first Phase 3 clinical
trial for tenapanor in hyperphosphatemia, which demonstrated a
statistically significant primary endpoint, the difference in
change in serum phosphorus between the pooled tenapanor-treated
patients and placebo-treated patients from the end of the
eight-week treatment period to the end of the four-week randomized
withdrawal period, in the responder population. Tenapanor was
well-tolerated in the trial. Ardelyx has designed a second Phase 3
clinical trial with input from FDA and is currently updating the
protocol and preparing to begin enrollment.
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.
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
Shanghai Fosun Pharmaceutical Industrial Development; Ardelyx's
expected timing for the filings 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.
SOURCE Ardelyx