CAMBRIDGE, Mass. & NEW YORK--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest
Laboratories, Inc. (NYSE: FRX) announced today they will present
linaclotide-related data during Digestive Disease Week® 2013 in Orlando,
Fla., May 18 through May 21, 2013. Among the data highlighted will be
two oral presentations: one providing insight into the GC-C/cGMP pathway
in patients with IBS-C and another describing the effects of linaclotide
on inhibiting visceral pain, both based on nonclinical studies.
The oral presentation titled "Mechanisms Underlying Linaclotide
Induced Inhibition of Colonic Nociception" (abstract #1602418) will
be presented at 2:45 p.m. ET on Monday, May 20, 2013, in room 104A by
Stuart Brierley, Ph.D., NHMRC Career Development Fellow and Head of the
Visceral Pain Research Group, Nerve-Gut Research Laboratory, Discipline
of Medicine at the University of Adelaide.
The oral presentation titled "Alterations in the Guanylate Cyclase-C
Receptor/cGMP Pathway in Patients with Constipation Predominant
Irritable Bowel Syndrome" (abstract #1602470) will also be presented
by Dr. Brierley at 8:45 a.m. ET on Sunday, May 19, 2013 in room 314A.
Also being presented are the following poster presentations:
Clinical Posters
Assessing Abdominal and Bowel Symptoms Using Adequate Relief Based
Thresholds: Results from 2 Phase 3 Trials of Linaclotide in Patients
with Irritable Bowel Syndrome with Constipation (abstract #1598133)
on Monday, May 20, 2013, 8 a.m. — 5 p.m. in Hall WA1, presented by
Michael Camilleri, M.D., Professor of Pharmacology, Physiology, and
Medicine, Department of Gastroenterology and Hepatology, Mayo Clinic
Determining the Minimum Duration for Initial Treatment with
Linaclotide in IBS-C Patients: Results from Pooled Phase 3 Trials
(abstract #1596597) on Sunday, May 19, 2013, 8 a.m. — 5 p.m. in Hall
WA1, presented by William Chey, M.D., Professor of Medicine, Director of
the Gastrointestinal Physiology Laboratory and Co-Director of the
Michigan Bowel Control Program at the University of Michigan
The Effect of Linaclotide on IBS-QOL Sexual Subscale Scores in
Patients with Irritable Bowel Syndrome with Constipation: Results from a
Post hoc Analysis of 2 Phase 3 Trials of Linaclotide (abstract
#1598793), on Tuesday, May 21, 2013, 8 a.m. — 5 p.m. in Hall WA1,
presented by Mark Currie, Ph.D., Senior Vice President, Chief Scientific
Officer and President of R&D, Ironwood Pharmaceuticals Inc.
Health Economic & Outcomes Research Poster
Longitudinal Direct Medical Costs Associated with Irritable Bowel
Syndrome-Constipation and Chronic Idiopathic Constipation in a
Population-Based Sample over a 10-Year Period (abstract #1581789),
on Sunday, May 19, 2013, 8 a.m. — 5 p.m. in Hall WA1, presented by Linda
Herrick, Ph.D., Associate Dean of Undergraduate Nursing, South Dakota
State University
All data are embargoed until the time of presentation.
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 transit and a
reduction in visceral pain, which is thought to be mediated by decreased
activity of pain-sensing nerves. The clinical relevance of the effect on
pain fibers in nonclinical studies has not been established. Linaclotide
is marketed by Ironwood and Forest 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 was also approved by the European Commission for the
treatment of adults in the European Union with IBS-C and is marketed
under the brand name Constella® through a license agreement between
Ironwood and Almirall, S.A. Ironwood also has partnered with Astellas
Pharma Inc. for development and commercialization of linaclotide in
Japan, and with AstraZeneca for development and commercialization of
linaclotide in China.
Important Safety Information
|
WARNING: PEDIATRIC RISK
|
LINZESS is contraindicated in pediatric patients up to 6 years
of age. Use should be avoided in pediatric patients 6 through 17
years of age. In nonclinical studies, administration of a single,
clinically relevant adult oral dose of linaclotide caused deaths
in young juvenile mice.
|
Contraindications
-
LINZESS is contraindicated in pediatric patients up to 6 years of age.
-
LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
-
LINZESS is contraindicated in pediatric patients up to 6 years of age.
In nonclinical studies, deaths occurred within 24 hours in young
juvenile mice (1 to 3 week-old mice; approximately equivalent to human
pediatric patients less than 2 years of age) following administration
of one or two daily oral doses of linaclotide.
-
Use of LINZESS should be avoided in pediatric patients 6 through 17
years of age. Linaclotide did not cause deaths in older juvenile mice
(approximately equivalent to humans age 12 to 17 years). Although
there were no deaths in older juvenile mice, given the deaths in young
juvenile mice and the lack of clinical safety and efficacy data in
pediatric patients, use of LINZESS should be avoided in pediatric
patients 6 through 17 years of age.
Diarrhea
-
Diarrhea was the most common adverse reaction of LINZESS-treated
patients in the pooled IBS-C and CIC double-blind placebo-controlled
trials. Severe diarrhea was reported in 2% of LINZESS-treated
patients. The incidence of diarrhea was similar in the IBS-C and CIC
populations.
-
Patients should be instructed to stop LINZESS if severe diarrhea
occurs and to contact their healthcare provider, who should consider
dose suspension.
Adverse Reactions
-
In IBS-C clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence
(4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and
abdominal distension (2% vs 1%).
-
In CIC clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence
(6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis
(3% vs 2%) and abdominal distension (3% vs 2%).
Please see full Prescribing Information including Boxed Warning: http://www.frx.com/pi/linzess_pi.pdf.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is committed to the art and
science of making medicines, from discovery through commercialization.
We're focused on three goals: transforming knowledge into medicines that
make a difference for patients, creating value that will inspire the
continued support of our fellow shareholders, and building a team that
passionately pursues excellence. Our first product, linaclotide, is
approved in the United States and Europe. Our pipeline priorities
include exploring further opportunities for linaclotide, leveraging our
deep expertise in functional gastrointestinal disorders, and advancing
programs in other areas such as allergic conditions, cardiovascular
disease, central nervous system disorders and other conditions defined
by patient symptoms. 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
to learn more about Ironwood. Information that may be important to
investors will be routinely posted in both these locations.
About Forest Laboratories, Inc.
Forest Laboratories' (NYSE: FRX) longstanding global partnerships and
track record developing and marketing pharmaceutical products in the
United States have yielded its well-established central nervous system
and cardiovascular franchises and innovations in anti-infective and
respiratory, gastrointestinal, and pain management medicine. The
Company's pipeline, the most robust in its history, includes product
candidates in all stages of development across a wide range of
therapeutic areas. The Company is headquartered in New York, NY. To
learn more, visit www.FRX.com.
About Digestive Disease Week (DDW)
Digestive Disease Week® (DDW®) is the largest international gathering of
physicians, researchers and academics in the fields of gastroenterology,
hepatology, endoscopy and gastrointestinal surgery. Jointly sponsored by
the American Association for the Study of Liver Diseases (AASLD), the
American Gastroenterological Association (AGA) Institute, the American
Society for Gastrointestinal Endoscopy (ASGE) and the Society for
Surgery of the Alimentary Tract (SSAT), DDW takes place May 18 — 21,
2013, at the Orange County Convention Center, FL. The meeting showcases
more than 5,000 abstracts and hundreds of lectures on the latest
advances in GI research, medicine and technology. More information can
be found at www.ddw.org.
Except for the historical information contained herein, this release
contains forward‐looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995. These statements involve a
number of risks and uncertainties, including the potential that the
presentations identified above are not given at all or at the times or
locations specified, in addition to the risk factors listed from time to
time in each of Forest's and Ironwood's Annual Reports on Form 10‐K,
Quarterly Reports on Form 10‐Q, and other SEC filings. Neither Forest
nor Ironwood 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.

Forest Laboratories, Inc.
Frank J. Murdolo, 212-224-6714
Vice
President - Investor Relations
media.relations@frx.com
or
Ironwood
Pharmaceuticals, Inc.
Media Relations:
Lisa Buffington,
617-374-5103
lbuffington@ironwoodpharma.com
or
Investor
Relations:
Meredith Kaya, 617-374-5082
mkaya@ironwoodpharma.com
Source: Forest Laboratories, Inc. & Ironwood Pharmaceuticals, Inc.
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