CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 15, 2019--
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190115005422/en/
Source: Ironwood Pharmaceuticals, Inc.
Investors & Media
Meredith Kaya, 617-374-5082
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President, Investor Relations and Corporate Communications
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