Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a commercial
biotechnology company, today announced that the National Medical
Products Administration (NMPA) approved the marketing application
for LINZESS® (linaclotide) for adults with irritable bowel syndrome
with constipation (IBS-C) in China. Ironwood anticipates that it
will launch the drug with its partner in China, AstraZeneca, in the
second half of 2019.
Linaclotide is a guanylate cyclase-C (GC-C) receptor agonist
currently approved and available for the treatment of adults with
IBS-C or chronic idiopathic constipation (CIC) in the United States
and more than 30 other countries.
Tom McCourt, who will become president of Ironwood following
completion of its planned separation into two companies, commented,
“Today’s regulatory approval in China represents another important
step in bringing linaclotide to millions of adult patients
suffering from IBS-C in many countries around the world. With
approximately 14 million adult patients suffering from IBS-C in
China, this approval is incredibly important as it brings a new
option to treat some of the bothersome recurring abdominal and
constipation symptoms associated with IBS-C.”
Data from the Phase III trial in China indicated that patients
treated with linaclotide showed a statistically significant
improvement compared to placebo-treated patients for both
co-primary endpoints. Regarding the first primary endpoint, 60.0%
of linaclotide-treated patients were Abdominal Pain/Discomfort
Responders, compared to 48.8% of placebo-treated patients
(p=0.001).
Regarding the second primary endpoint, 31.7% of
linaclotide-treated patients were IBS Degree of Relief Responders,
compared to 15.4% of placebo-treated patients (p < 0.0001).
Statistically significant improvements were achieved in all
pre-specified secondary endpoints in this trial, including
abdominal pain, abdominal discomfort, bloating, straining,
frequency of complete spontaneous bowel movements, frequency of
spontaneous bowel movements and stool consistency.
The most common adverse event reported in linaclotide-treated
patients was diarrhea (9.4% for linaclotide vs. 1.2% for placebo).
Discontinuation due to diarrhea was 0.7% for linaclotide vs. 0.2%
for placebo. Overall rates of discontinuation due to adverse events
were 1.7% for linaclotide vs. 1.4% for placebo.
The randomized, double-blind, placebo-controlled Phase III
clinical trial randomized 839 adults with IBS-C in China,
Australia, Canada, New Zealand and the United States. Patients were
randomized 1:1 to receive either 290mcg of linaclotide, or placebo,
for 12 weeks. The co-primary endpoints of the trial were (i)
12-Week Abdominal Pain/Discomfort Responder, which is defined as a
patient who has at least a 30% improvement in his/her abdominal
pain or abdominal discomfort level for at least half of the weeks
in the 12-week treatment period, and (ii) 12-Week IBS Degree of
Relief Responder, which is defined as a patient who rates their IBS
symptoms as being "considerably relieved" or "completely relieved"
for at least half of the weeks in the 12-week treatment period.
AstraZeneca and Ironwood are jointly responsible for the
development and commercialization of linaclotide in China, with
AstraZeneca primarily responsible for local operational
execution.
About linaclotide
Linaclotide is a guanylate cyclase-C (GC-C) agonist that is
thought to work in two ways based on nonclinical studies.
Linaclotide binds to the GC-C receptor locally, within the
intestinal epithelium. Activation of GC-C results in increased
intestinal fluid secretion and accelerated transit and a decrease
in the activity of pain-sensing nerves in the intestine. The
clinical relevance of the effect on pain fibers, which is based on
nonclinical studies, has not been established. Linaclotide is
marketed by Ironwood and Allergan plc in the United States as
LINZESS® and is indicated for the treatment of adults with
irritable bowel syndrome with constipation (IBS-C) or chronic
idiopathic constipation (CIC). Linaclotide is marketed by Allergan
for the treatment of adults with moderate to severe IBS-C in Europe
under the brand name CONSTELLA®. Ironwood is partnered with
AstraZeneca for development and commercialization of linaclotide in
China, Hong Kong and Macau. Astellas also has the exclusive rights
to develop and commercialize linaclotide in Japan.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a commercial
biotechnology company focused on creating medicines that make a
difference for patients, building value for our fellow
shareholders, and empowering our passionate team. We discovered,
developed and are commercializing linaclotide, the U.S. branded
prescription market leader for adults with irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation (CIC).
Our pipeline priorities for linaclotide include a Phase IIIb trial
evaluating its efficacy and safety on multiple abdominal symptoms,
including abdominal bloating, pain, and discomfort in adult
patients with IBS-C, as well as research into a formulation of
linaclotide designed to relieve abdominal pain associated with
IBS.
We are also advancing a pipeline of innovative product
candidates in areas of significant unmet need, including persistent
gastroesophageal reflux disease, diabetic nephropathy, heart
failure with preserved ejection fraction and sickle cell disease.
Ironwood was founded in 1998 and is headquartered in Cambridge,
Mass. For more information, please visit www.ironwoodpharma.com or
www.twitter.com/ironwoodpharma; information that may be important
to investors will be routinely posted in both these locations.
LINZESS® and CONSTELLA® are registered trademarks of Ironwood
Pharmaceuticals, Inc. Any other trademarks referred to in this
press release are the property of their respective owners. All
rights reserved.
Forward-Looking Statements
This press release contains forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements, including statements about Ironwood's
business, leadership team, business strategy, pipeline advancement,
productivity and the potential of its products and product
candidates and their impact; and the completion and timing of
the planned separation of Ironwood. Each forward-looking statement
is subject to risks and uncertainties that could cause actual
results to differ materially from those expressed or implied in
such statement. Applicable risks and uncertainties include those
related to the possibility that we may not complete the separation
of our business on the terms or timeline currently contemplated, if
at all, achieve the expected benefits of the separation, and that
the separation could harm our business, results of operations and
financial condition; the risk that the transaction might not be
tax-free; the risk that we may be unable to make, on a timely or
cost-effective basis, the changes necessary to operate as
independent companies; Cyclerion’s lack of independent operating
history and the risk that its accounting and other management
systems may not be prepared to meet the financial reporting and
other requirements of operating as an independent public company;
the risk that a separation may adversely impact our ability to
attract or retain key personnel; the effectiveness of development
and commercialization efforts by us and our partners; preclinical
and clinical development, manufacturing and formulation
development; the risk that findings from our completed nonclinical
and clinical studies may not be replicated in later studies;
efficacy, safety and tolerability of our products and product
candidates; decisions by regulatory authorities; the risk that we
may never get sufficient patent protection for our products and our
product candidates or that we are not able to successfully protect
such patents; the outcomes in legal proceedings to protect or
enforce the patents relating to our products and product
candidates, including ANDA litigation; developments in the
intellectual property landscape; challenges from and rights of
competitors or potential competitors; the risk that we are unable
to manage our operating expenses or cash use for operations, or are
unable to commercialize our products, within the guided ranges or
otherwise as expected and those risks listed under the heading
"Risk Factors" and elsewhere in Ironwood's Quarterly Report on Form
10-Q for the quarter ended September 30, 2018, and in our
subsequent SEC filings. These forward-looking statements
(except as otherwise noted) speak only as of the date of this press
release, and Ironwood undertakes no obligation to update these
forward-looking statements.
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version on businesswire.com: https://www.businesswire.com/news/home/20190115005422/en/
Investors & MediaMeredith Kaya, 617-374-5082Vice
President, Investor Relations and Corporate
Communicationsmkaya@ironwoodpharma.com
MediaMaryann Quinn, 617-374-3952Director, Corporate
Communicationsmquinn@ironwoodpharma.com
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