FREMONT, Calif. and
WALTHAM, Mass., Nov. 30, 2021 /PRNewswire/ -- Ardelyx, Inc.
(Nasdaq: ARDX), a specialty biopharmaceutical company founded with
a mission to discover, develop and commercialize innovative
first-in-class medicines that meet significant unmet medical needs,
today announced plans to launch IBSRELA, the company's approved
treatment for irritable bowel syndrome with constipation (IBS-C) in
adults, in the second quarter of 2022.
Mike Raab, president and chief
executive officer of Ardelyx, stated, "Over the last five
years, the IBS-C market has grown to be sizeable and concentrated,
with 9,000 high-writing physicians accounting for approximately 50%
of the almost five million prescriptions written annually for drugs
indicated for the treatment of IBS-C. This market is ripe for the
entry of a novel therapeutic option like IBSRELA, as existing
therapies do not adequately address all patient treatment needs.
Our market research has clearly shown that treating physicians
recognize the need for new therapeutic alternatives to address the
unmet medical needs of patients currently managed for IBS-C. That
same research demonstrates high interest in, and intent to
prescribe, IBSRELA for a subset of patients. By capturing even a
modest share, in the mid to high single-digit of this large market,
IBSRELA has the potential to generate at least $500 million in peak annual net revenue. We will
use the next few months to build commercial inventory and prepare
the market for a second-quarter 2022 launch. We believe we have a
clear line of sight to breakeven and ultimate profitability for the
product, which we expect will create significant shareholder
value."
William Chey, M.D.,
Nostrant Professor of Medicine at the University of Michigan School of Medicine, added,
"It is now widely recognized that while people with IBS-C present
with similar symptoms, it is a disorder of heterogeneous
pathogenesis. Therefore, while there has been much improvement in
our treatment of patients with IBS-C over the last two decades with
the introduction and broad adoption of GC-C agonists, it should be
no surprise that many patients continue to suffer. There is a need
for innovation. The launch of IBSRELA, as a first-in-class
NHE3 inhibitor, is exciting, as it offers a unique mechanism of
action with compelling clinical data, providing physicians with an
important new tool to advance the care of patients with IBS-C."
"IBSRELA, with its first-in-class mechanism and strong clinical
data package, is an important new addition to the IBS-C treatment
armamentarium," said Laura A.
Williams, M.D., M.P.H., chief medical officer of Ardelyx.
"The approval of IBSRELA was based on two successful Phase 3 trials
involving over 1,200 patients with IBS-C. Both trials met their
primary and most secondary endpoints. Additionally, in both trials,
improvements from baseline in average weekly bowel movements and
abdominal pain were observed by Week 1, with improvement sustained
through the end of treatment. IBSRELA can play a meaningful role in
the treatment of patients suffering from IBS-C."
"As we work to bring IBSRELA to patients, we remain intent on
pursuing approval of tenapanor for hyperphosphatemia through the
formal dispute resolution process with the FDA, and as a commercial
facing organization, if approved, we will be well-positioned to
bring this novel therapy to patients," said Mike Raab, president and chief executive officer
of Ardelyx.
Conference Call Information
The company will host a conference call today, November 30, 2021 at 8:00
AM ET to discuss the plans to launch IBSRELA for the
treatment of IBS-C. To participate in the conference call, please
call (855) 296-9612 (toll-free) or (920) 663-6277 (toll) and
reference call ID number 2977157. A webcast of the call can also be
accessed by visiting the Investor page of the company's website
www.ardelyx.com and will be available on the website for 30 days
following the call.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF
SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
IBSRELA is contraindicated in patients less than 6 years of age; in
nonclinical studies in young juvenile rats administration of
tenapanor caused deaths presumed to be due to dehydration. Avoid
use of IBSRELA in patients 6 years to less than 12 years of age.
The safety and effectiveness of IBSRELA have not been established
in patients less than 18 years of age.
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CONTRAINDICATIONS
- IBSRELA is contraindicated in patients less than 6 years of age
due to the risk of serious dehydration.
- IBSRELA is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
WARNINGS AND PRECAUTIONS
Risk of Serious Dehydration in Pediatric Patients
- IBSRELA is contraindicated in patients below 6 years of age.
The safety and effectiveness of IBSRELA in patients less than 18
years of age have not been established. In young juvenile rats
(less than 1 week old; approximate human age equivalent of less
than 2 years of age), decreased body weight and deaths occurred,
presumed to be due to dehydration, following oral administration of
tenapanor. There are no data available in older juvenile rats
(human age equivalent 2 years to less than 12 years).
- Avoid the use of IBSRELA in patients 6 years to less than 12
years of age. Although there are no data in older juvenile rats,
given the deaths in younger rats and the lack of clinical safety
and efficacy data in pediatric patients, avoid the use of IBSRELA
in patients 6 years to less than 12 years of age.
Diarrhea
Diarrhea was the most common adverse reaction in two randomized,
double-blind, placebo-controlled trials of IBS-C. Severe diarrhea
was reported in 2.5% of IBSRELA-treated patients. If severe
diarrhea occurs, suspend dosing and rehydrate patient.
MOST COMMON ADVERSE REACTIONS
The most common adverse reactions in IBSRELA-treated patients
(incidence ≥2% and greater than placebo) were: diarrhea (16% vs 4%
placebo), abdominal distention (3% vs <1%), flatulence (3% vs
1%) and dizziness (2% vs <1%).
INDICATION
IBSRELA (tenapanor) is indicated for the treatment of Irritable
Bowel Syndrome with Constipation (IBS-C) in adults.
Please see full Prescribing
Information, including Boxed Warning, for additional
risk information.
About Irritable Bowel Syndrome with Constipation
(IBS-C)
Irritable bowel syndrome with constipation (IBS-C) is a
gastrointestinal disorder characterized by both abdominal pain and
altered bowel movements, estimated to affect 11 million people in
the US. IBS-C is associated with significantly impaired quality of
life, reduced productivity, and substantial economic burden.
About IBSRELA for IBS-C
IBSRELA (tenapanor) is a locally acting inhibitor of the
sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the
apical surface of the small intestine and colon primarily
responsible for the absorption of dietary sodium. By inhibiting
NHE3 on the apical surface of the enterocytes, tenapanor reduces
absorption of sodium from the small intestine and colon, resulting
in an increase in luminal water concentration, which accelerates
intestinal transit time and results in a softer stool consistency.
IBSRELA has also been shown to reduce abdominal pain by decreasing
visceral hypersensitivity and by decreasing intestinal permeability
in animal models. In rat model of colonic hypersensitivity,
tenapanor reduced visceral hyperalgesia and normalized colonic
sensory neuronal excitability.
About Ardelyx, Inc.
Ardelyx is focused on discovering, developing and
commercializing innovative first-in-class medicines to meet
significant unmet medical needs. Ardelyx received approval for
IBSRELA (tenapanor) with plans to launch in the second quarter of
2022. Ardelyx is developing 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 is
also advancing RDX013, a potassium secretagogue, for the potential
treatment of elevated serum potassium, or hyperkalemia, a problem
among certain patients with kidney and/or heart disease and has 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 Ardelyx's plans to
launch IBSRELA in the second quarter 2022; Ardelyx's expectations
regarding peak annual net revenue for IBSRELA; Ardelyx's
expectations regarding the percentage of the market that Ardelyx
expects to capture with IBSRELA; Ardelyx's expectations regarding
its ability to generate revenue sufficient to achieve breakeven and
to potentially reach profitability with sales of IBSRELA, and
Ardelyx's plans to continue to seek approval for tenapanor for the
control of serum phosphorus in patients with chronic kidney disease
on dialysis. 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 commercialization of drugs, and 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 12,
2021, and its future current and periodic reports to be
filed with the Securities and Exchange Commission.
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SOURCE Ardelyx