TOKYO & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Astellas
Pharma Inc. (TSE: 4503) and Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that the Phase
III clinical trial of linaclotide conducted in Japan in adults with
irritable bowel syndrome with constipation (IBS-C) met its primary
endpoints. Astellas expects to submit a new drug application to the
Ministry of Health, Labor and Welfare in Japan in 2016.
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist currently approved
in the United States for the treatment of adults with IBS-C and chronic
idiopathic constipation (CIC). It is also approved for adults with IBS-C
or CIC in more than 30 other countries.
"I am really pleased to receive the positive top-line data from the
Phase III IBS-C trial. Astellas expects linaclotide to provide a new
therapeutic option for patients suffering from IBS-C," said Bernhardt G.
Zeiher, M.D., President, Development at Astellas Group.
"Linaclotide has now met all primary endpoints in all eight of its Phase
III/IIIb clinical trials, spanning two indications, three doses and
multiple countries," said Mark Currie, Ph.D., Chief Scientific Officer
and President of Research and Development at Ironwood. "Our recent
positive Phase III data in China and now in Japan represent important
achievements by Ironwood and our global partners toward bringing
linaclotide to appropriate patients around the world, and we continue to
innovate with linaclotide as part of our mission to address a broad
spectrum of patient needs."
Top-line data from the Phase III trial in Japan indicate
linaclotide-treated patients showed statistically significant
improvement compared to placebo-treated patients for both of the two
co-primary endpoints. Regarding the first primary endpoint, 34% of
linaclotide-treated patients were Global Assessment of Relief of IBS
Symptoms Responders, compared to 18% of placebo-treated patients
(p < 0.001). Regarding the second primary endpoint, 35% of
linaclotide-treated patients were Complete Spontaneous Bowel Movement
(CSBM) Overall Responders, compared to 19% of placebo-treated patients
(p < 0.001). Additionally, improvements were achieved in pre-specified
secondary endpoints in this trial covering abdominal and constipation
symptoms, including bloating and abdominal pain/discomfort. Diarrhea
rates in this trial were 9.6% for linaclotide vs. 0.4% for placebo; all
cases were characterized as mild or moderate in severity.
The double-blind, placebo-controlled Phase III clinical trial randomized
500 adults with IBS-C in Japan. Patients were randomized 1:1 to receive
either 500 mcg of linaclotide or placebo for 12 weeks. The co-primary
endpoints of the trial were (i) Global Assessment of Relief of IBS
Symptoms Responder Rate, in which patients rated their improvement in
IBS symptoms over each week compared to the baseline period and achieved
significant or moderate relief for at least six out of 12 weeks, and
(ii) CSBM Overall Responder Rate, in which patients reported
experiencing at least three CSBMs per week and an increase of at least
one CSBM from baseline in the same week, and achieved both of these
measures for at least six out of 12 weeks. The trial also includes an
additional 40-week, open-label follow-on study period, which is ongoing.
It is estimated that 2.9% of adults in Japan suffer from IBS-C, and
there are no prescription products currently approved in Japan for the
treatment of this condition. Ironwood and Astellas entered into a
licensing agreement in 2009 to develop and commercialize linaclotide in
Japan.
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), with more than 825,000 unique patients in the U.S. having filled
more than 3.5 million linaclotide prescriptions since launch, according
to IMS Health. Linaclotide is marketed by Allergan for the treatment of
adults with moderate to severe IBS-C in Europe under the brand name
CONSTELLA®. Ironwood also has partnered with Astellas for
development and commercialization of linaclotide in Japan and with
AstraZeneca for development and commercialization in China.
About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to
improving the health of people around the world through the provision of
innovative and reliable pharmaceutical products. We focus on Urology,
Oncology, Immunology, Nephrology and Neuroscience as prioritized
therapeutic areas while advancing new therapeutic areas and discovery
research leveraging new technologies/modalities. We are also creating
new value by combining internal capabilities and external expertise in
the medical/healthcare business. Astellas is on the forefront of
healthcare change to turn innovative science into value for patients.
For more information, please visit our website at www.astellas.com/en.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is focused on creating medicines
that make a difference for patients, building value to earn the
continued support of our fellow shareholders, and empowering our team to
passionately pursue excellence. We discovered, developed and are
commercializing linaclotide, which is approved in the United States and
a number of other countries. Our pipeline priorities include exploring
further opportunities for linaclotide, as well as leveraging our
therapeutic expertise in gastrointestinal disorders and our
pharmacologic expertise in guanylate cyclases to address patient needs.
Ironwood was founded in 1998 and is headquartered in Cambridge, Mass.
Connect with us at www.ironwoodpharma.com
or on Twitter at www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
LINZESS and CONSTELLA are trademarks owned by Ironwood Pharmaceuticals,
Inc. Any other trademarks referred to in this press release are the
property of their respective owners. All rights reserved.
This press release contains forward looking statements. Investors are
cautioned not to place undue reliance on these forward‐looking
statements, which include, among other things, statements about the
top-line assessment of the data from the Phase III clinical trial of
linaclotide in adults with IBS-C; the development and regulatory plans
for linaclotide in Japan, and the timing thereof, including the expected
submission of a new drug application in Japan; the design of the Phase
III trial and its impact on the results thereof; the design and possible
benefits of linaclotide and its potential as a treatment for adult men
and women IBS-C patients in Japan, as well as the ability of Ironwood
and its partners to bring linaclotide to appropriate patients around the
world; IBS-C prevalence and unmet need; and market size, growth and
opportunity, and potential demand for linaclotide in Japan. 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,
but are not limited to, the risk that Astellas is unable to effectively
or timely execute on the development and regulatory plan for linaclotide
in Japan; the risk that findings from the completed linaclotide clinical
trials may not be predictive of the product's performance, if it is
commercialized; the risk that unfavorable findings may arise from new
clinical data or additional analyses of existing clinical data; those
related to the efficacy, safety and tolerability of linaclotide; those
related to decisions made by regulatory authorities and the timing of
those decisions; the commercial potential of linaclotide in Japan; the
risk that Ironwood and Astellas may never get sufficient patent
protection for linaclotide in Japan; those related to intellectual
property rights of competitors or potential competitors; the risk that
the patient population is not as presently estimated; and the risks
presented by future business decisions made by Ironwood, Astellas and
their competitors or potential competitors. Applicable risks also
include those that are listed in Ironwood's Quarterly Report on Form
10‐Q for the quarter ended September 30, 2015, in addition to the risk
factors that are listed from time to time in Ironwood's Annual Reports
on Form 10‐K, Quarterly Reports on Form 10‐Q and any
subsequent SEC filings. Neither Ironwood nor Astellas undertakes any
obligation to update these forward‐looking statements to reflect events
or circumstances occurring after this press release. These
forward‐looking statements speak only as of the date of this press
release. All forward‐looking statements are qualified in their entirety
by this cautionary statement.
View source version on businesswire.com: http://www.businesswire.com/news/home/20151130006090/en/
Ironwood Pharmaceuticals, Inc.
Media Relations:
Trista
Morrison, 617-374-5095
[email protected]
or
Investor
Relations:
Meredith Kaya, 617-374-5082
[email protected]
or
Astellas
Media
Relations:
So Shimada, +81- 3-3244-3201
[email protected]
Source: Ironwood Pharmaceuticals, Inc. and Astellas Pharma Inc.
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