FREMONT, Calif., June 3, 2015 /PRNewswire/ -- Ardelyx, Inc.
(NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused
on cardio-renal, gastrointestinal and metabolic
diseases, today announced that it has entered into a
termination agreement with AstraZeneca (LSE: AZN, SSE: AZN, NYSE:
AZN), such that all the rights to Ardelyx's portfolio of NHE3
inhibitors, including Ardelyx's lead product candidate, tenapanor,
are returned to Ardelyx. Ardelyx has agreed to pay AstraZeneca
$15 million upfront along with other
future contingent payments. Concurrently, Ardelyx will pay an
additional $10 million in R&D costs and for
the acceleration of the transfer of the program back to
Ardelyx. Ardelyx formed a partnership with AstraZeneca in
October 2012 to develop and
commercialize Ardelyx's internally discovered portfolio of NHE3
inhibitors including tenapanor.
![Ardelyx logo Ardelyx logo](http://photos.prnewswire.com/prnvar/20140619/119451)
With the acquisition of worldwide rights from AstraZeneca,
Ardelyx plans to accelerate the clinical development path for
tenapanor in constipation-predominant irritable bowel syndrome
(IBS-C) by initiating a Phase 3 clinical program in IBS-C patients
in the fourth quarter of this year. Additionally Ardelyx is
planning to begin a Phase 2b clinical trial in the fourth quarter
of this year to evaluate the optimal dosing regimen for tenapanor
for the treatment of hyperphosphatemia in dialysis patients.
"By regaining the worldwide rights to tenapanor, we now have a
late-stage clinical asset that has demonstrated significant promise
for the treatment of IBS-C and hyperphosphatemia, both of which are
conditions where we believe tenapanor could potentially transform
the treatment paradigm," said Mike
Raab, President and Chief Executive Officer.
"Ardelyx can now accelerate the clinical development of
tenapanor to meet the needs of two underserved patient populations.
We are grateful for the substantial investment that AstraZeneca has
made in the NHE3 program, and we have been fortunate to have them
as a partner," Mr. Raab added.
In a separate press release, Ardelyx announced today a new
product candidate, RDX022, for which it will be pursuing a 505b(2)
regulatory pathway in the United
States. Ardelyx is developing RDX022 for the treatment of
elevated potassium, or hyperkalemia. Ardelyx expects to initiate
clinical trials with RDX022 in mid-2015. Ardelyx also announced
today that it has entered into an agreement to sell shares of
common stock and warrants to purchase common stock for the
aggregate gross proceeds of approximately $77.8 million in a private placement.
Proceeds from the private placement will be used to develop both
tenapanor and RDX022, two wholly-owned programs that are targeted
to begin Phase 3 clinical trials in the fourth quarter 2015 and
second half of 2016, respectively.
About the Termination Agreement
Ardelyx and AstraZeneca have executed a termination agreement
under which Ardelyx regained all rights for all NHE3 inhibitors
previously licensed to AstraZeneca, including tenapanor.
Under the terms of the termination agreement, Ardelyx has agreed
to pay AstraZeneca certain amounts for the return of the rights,
including $15 million up front,
royalties equal to 10% of net sales of tenapanor by Ardelyx or a
licensee, and 20% of non-royalty payments that Ardelyx receives
from a new partner should it elect to license, or otherwise provide
rights to develop and commercialize tenapanor, with all such
amounts not to exceed $90 million.
Ardelyx has also agreed to pay AstraZeneca $10 million in R&D costs and in consideration
of the acceleration of the transfer of information, data and
materials to Ardelyx. In addition, AstraZeneca is obligated to
complete the manufacture of clinical trial material necessary for
the Phase 3 clinical program in IBS-C patients, and Ardelyx has
agreed to purchase the Phase 3 clinical trial material and other
drug product inventory from AstraZeneca for up to $10 million.
Tenapanor's Clinical Development
Tenapanor is a minimally-absorbed small molecule inhibitor of
NHE3, a transporter of sodium in the gastrointestinal tract. Orally
administered tenapanor has been shown in clinical trials to reduce
the intestinal absorption of both dietary sodium and phosphorus. A
total of 14 clinical trials of tenapanor have been completed, and
over 1,000 subjects have been administered tenapanor to date.
In October 2014, Ardelyx reported
positive Phase 2b data for the use of tenapanor in treating
patients with IBS-C. At the twice-daily 50mg dose of tenapanor, the
study met its primary efficacy endpoint of an increase in the
complete spontaneous bowel movement (CSBM) responder rate
(p<0.001). Most secondary endpoints, including abdominal pain,
the overall responder rate and other abdominal and IBS-C symptoms,
demonstrated statistically significant and clinically meaningful
improvements. Ardelyx plans to initiate a Phase 3 clinical
program to further evaluate tenapanor in IBS-C patients in the
fourth quarter of 2015, assuming the successful transfer of
clinical trial material from AstraZeneca. In February 2015, Ardelyx announced results from a
Phase 2b clinical study in hyperphosphatemic patients on dialysis
with end stage renal disease, or CKD-5D. In the study, there was a
statistically significant dose-related decrease in serum phosphate
levels for tenapanor-treated patients compared to patients
receiving placebo (p=0.012). It was noted, however, that the rate
of diarrhea and the rate of discontinuations due to diarrhea were
higher than expected based on previous clinical trials. Higher
discontinuations rates due to diarrhea were observed primarily in
the 30mg once daily and 30mg twice daily dose groups. Ardelyx plans
to begin a second Phase 2b dose-ranging clinical program for
tenapanor in hyperphosphatemia in dialysis patients during the
fourth quarter of 2015 assuming successful transfer of clinical
trial material from AstraZeneca.
Additional details on tenapanor and Ardelyx's research and
development programs will be presented at Ardelyx's upcoming
R&D Investor Day, planned for July 14,
2015, in New York, NY.
Conference Call & Webcast Information
Ardelyx will host a live conference call and webcast today at
8:30am Eastern Time. The live webcast
and a replay may be accessed by visiting Ardelyx's website on the
investor page of the Company's website at
http://ir.ardelyx.com/
Please connect to the Company's website at least 15 minutes
prior to the live webcast to ensure adequate time for any software
download that may be needed to access the webcast. Alternatively,
please call 1-855-296-9612 (US) or 920-663-6277 (International) to
listen to the live conference call. The conference ID number for
the live call is 59352386. Please dial in approximately 10 minutes
prior to the call. An archived webcast replay will be available on
the Company's website for two weeks.
About Ardelyx
Ardelyx is a clinical-stage biopharmaceutical company focused on
the discovery, development and commercialization of innovative,
minimally-systemic, small molecule therapeutics that work
exclusively in the gastrointestinal tract to treat cardio-renal,
gastrointestinal and metabolic diseases. Ardelyx has developed a
proprietary drug discovery and design platform enabling it, in a
rapid and cost-efficient manner, to discover and design novel drug
candidates. Utilizing this platform, the Company has discovered and
designed tenapanor. In addition to tenapanor, Ardelyx is developing
RDX022, a non-absorbed polymer for the treatment of hyperkalemia,
or high potassium, in kidney and heart disease patients, and has
discovered small molecule NaP2b inhibitors for the treatment of
hyperphosphatemia in CKD-5D, a program licensed to Sanofi.
Ardelyx is also independently advancing several research programs
focused in cardio-renal, gastrointestinal and metabolic diseases.
Ardelyx is located in Fremont,
California. For more information, please visit Ardelyx's
website at www.ardelyx.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
tenapanor in treating IBS-C patients, the potential for tenapanor
in treating hyperphosphatemia in patients with end stage renal
disease on dialysis, Ardelyx's future development plans for
tenapanor and the timing thereof, the potential for RDX022 in
treating hyperkalemia, Ardelyx's future development plans for
RDX022 and the timing thereof, and the potential of Ardelyx's drug
discovery and design platform. Such forward-looking statements
involve substantial risks and uncertainties that could cause the
development of tenapanor, 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
the clinical development process, Ardelyx's reliance upon
AstraZeneca for the timely delivery of clinical trial material
required for the initiation of the Phase 3 clinical program in
IBS-C and the Phase 2b clinical trial in hyperphosphatemia, and
Ardelyx's reliance upon AstraZeneca to facilitate a complete and
timely transition of the tenapanor program from AstraZeneca to
Ardelyx. 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 filed on Form 10-Q with the
Securities and Exchange Commission on May
12, 2015, and its future periodic reports to be filed with
the Securities and Exchange Commission.
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