Ironwood and Forest to Present 17 Linaclotide-Related Abstracts at Digestive Disease Week® 2012
CAMBRIDGE, Mass. & NEW YORK--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest
Laboratories, Inc. (NYSE: FRX) today announced they will present
linaclotide-related data in one oral presentation and 16 poster
presentations during Digestive Disease Week (DDW) 2012 being held in San
Diego, May 19 through May 22, 2012. Linaclotide is an investigational
guanylate cyclase type-C agonist (GCCA) for the treatment of irritable
bowel syndrome with constipation (IBS-C) and chronic constipation.
The oral presentation titled "Efficacy of Linaclotide in Improving
Abdominal Symptoms Rated as Most Severe by Patients with Irritable Bowel
Syndrome with Constipation (IBS-C)" will be presented by Satish Rao,
M.D., Professor of Medicine and Chief, Section of Gastroenterology and
Hepatology, Georgia Health Sciences University in Augusta, Ga., in Room
24abc at 4:34 p.m. PDT on Monday, May 21, 2012. This presentation will
report the results from an analysis on the effect of linaclotide in
improving the abdominal symptoms that IBS-C patients reported as most
severe.
Also being presented are the following poster presentations:
Clinical Posters
Saturday, May 19, 2012 (available 8:00 a.m. PDT):
-
Mediation Analysis Supports a Direct Effect of Linaclotide on
Relief of Abdominal Pain Independent of Constipation Improvement
(Sa1098), authored by James E. MacDougall, Ph.D.
-
Developing Benchmarks for Clinically Meaningful Change for IBS-C
Symptoms Using Data from Two Phase 3 Trials of Linaclotide
(Sa1094), authored by Brennan M. Spiegel, M.D.
-
The Effect of Co-morbid Psychological Distress on Baseline
Irritable Bowel Syndrome with Constipation Symptoms and Response to
Linaclotide Treatment (Sa1421), authored by William D. Chey, M.D.
Monday, May 21, 2012 (available 8:00 a.m. PDT):
-
Linaclotide Significantly Improved Abdominal Pain Compared with
Placebo in Patients with Irritable Bowel Syndrome Regardless of
Baseline Pain Severity in Two Phase 3 Trials (Mo1856), authored by
Phillip Schoenfeld, M.D.
-
Characterization and Association of Abdominal Pain With Anxiety or
Depression in Patients with Irritable Bowel Syndrome with Constipation
(Mo1858), authored by Eamonn M. Quigley, M.D.
Tuesday, May 22, 2012 (available 8:00 a.m. PDT):
-
Assessing the Percent of Days Linaclotide Improved Abdominal
Symptoms and Stool Frequency in Patients with IBS-C: A Pooled Analysis
of Two Phase 3 Trials (Tu1380), authored by Satish Rao, M.D.
-
Effects of 26 Weeks of Linaclotide Treatment on Adequate Relief and
IBS Severity in Patients with Irritable Bowel Syndrome with
Constipation (Tu1381), authored by William Chey, M.D.
-
Comparison of Responder Rates and Degree of Agreement for
Symptom-Specific and Global-Relief Endpoints in Two Phase 3 Trials of
Linaclotide in IBS-C (Tu1065), authored by G. Richard Locke, M.D.
-
Effects of Linaclotide Treatment on Patient-Reported Ratings of
Change for Symptoms of Irritable Bowel Syndrome with
Constipation: Pooled 12-Week Findings From Two Phase 3 Trials
(Tu1068), authored by G. Richard Locke, M.D.
-
Do Baseline Factors Contribute to Treatment Satisfaction in
Patients with Chronic Constipation Treated With Linaclotide vs Placebo?
(Tu1069), authored by Phillip S. Schoenfeld, M.D.
-
Factors Contributing to Treatment Satisfaction in Patients with
Irritable Bowel Syndrome with Constipation Treated with Linaclotide vs
Placebo (Tu1401), authored by Anthony Lembo, M.D.
-
Effects of Linaclotide on Straining Associated with Bowel Movements
in Patients with Irritable Bowel Syndrome with Constipation (IBS-C): a
Post Hoc Analysis of Pool Data From Two Phase 3 Trials (Tu1423),
authored by Anthony Lembo, M.D.
Health Economics & Outcomes Research Posters
Sunday, May 20, 2012 (available 8:00 a.m. PDT):
-
Treatment Patterns and Indicators of Unmet Needs in Medicaid
Patients with Irritable Bowel Syndrome with Constipation and Chronic
Constipation (Su1194), authored by Robyn Carson, M.P.H.
Tuesday, May 22, 2012 (available 8:00 a.m. PDT):
-
Impact of Linaclotide Treatment on Work Productivity and Activity
Impairment in Adults with Irritable Bowel Syndrome with
Constipation: Pooled Results from Two Randomized, Double-Blind,
Placebo-Controlled Phase 3 Trials (Tu1402), authored by Jessica L.
Buono, M.P.H.
Preclinical Posters
Monday, May 21, 2012 (available 8:00 a.m. PDT):
-
Mechanism of Action for Linaclotide Induced Abdominal Pain Relief (Mo1849),
authored by Joel Castro
-
Cyclic Guanylate Monophosphate (cGMP) Attenuates Responses and
Sensitization of Mouse Colorectal Afferents (Mo1846), authored by
Bin Feng
About Linaclotide
Linaclotide, an investigational drug, is a guanylate cyclase type-C
agonist (GCCA). In preclinical models, linaclotide reduced visceral
hypersensitivity, increased fluid secretion, and accelerated intestinal
transit. The effects on secretion and transit are mediated through
cyclic guanosine monophosphate (cGMP), which is also believed to
modulate the activity of local nerves to reduce pain. Linaclotide is an
orally delivered peptide that acts locally in the gut with no measurable
systemic exposure at therapeutic doses and is intended for once-daily
administration. An issued composition of matter patent for linaclotide
provides protection to 2025 in the United States. Ironwood and Forest
plan to co-promote linaclotide in the U.S. pending U.S. Food and Drug
Administration approval. Ironwood has out-licensed linaclotide to
Almirall, S.A. for European development and commercialization, and to
Astellas Pharma Inc. for development and commercialization in Japan,
Indonesia, Korea, the Philippines, Taiwan, and Thailand.
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS-C is a chronic functional gastrointestinal disorder characterized by
abdominal pain, abdominal discomfort, and bloating associated with
altered bowel habits, and as many as 11 million people in the U.S.
suffer from it. IBS-C can have a negative impact on daily living. There
are currently few available therapies to treat this disorder.
About Chronic Constipation (CC)
As many as 34 million Americans suffer from symptoms associated with CC
and 8.5 million patients have sought treatment. Patients with CC often
experience hard and lumpy stools, straining during defecation, a
sensation of incomplete evacuation, and fewer than three bowel movements
per week, as well as abdominal discomfort and bloating. There is a high
rate of dissatisfaction with currently available treatments for CC.
About Digestive Disease Week (DDW)
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, the American
Gastroenterological Association (AGA) Institute, the American Society
for Gastrointestinal Endoscopy and the Society for Surgery of the
Alimentary Tract, DDW takes place May 19—22, 2012, at the San Diego
Convention Center. The meeting showcases more than 5,000 abstracts and
hundreds of lectures on the latest advances in GI research, medicine and
technology. For more information, visit www.ddw.org.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial
pharmaceutical company dedicated to the art and science of great
drugmaking. Linaclotide, Ironwood's guanylate cyclase type-C agonist, is
an investigational drug for the treatment of irritable bowel syndrome
with constipation (IBS-C) and chronic constipation (CC). Linaclotide's
development program has been completed and supports the submitted NDA
for both indications, as well as the MAA submission in Europe for the
IBS-C indication. Ironwood also has a growing pipeline of additional
drug candidates in earlier stages of development. Ironwood is located in
Cambridge, Mass. To learn more, visit www.ironwoodpharma.com.
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,
respiratory, gastrointestinal, and pain management medicine. Forest's
pipeline, the most robust in its history, includes product candidates in
all stages of development across a wide range of therapeutic areas.
Forest is headquartered in New York, NY. To learn more, visit www.FRX.com.
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 Murdolo, 212-224-6714
Vice
President - Investor Relations
media.relations@frx.com
or
Ironwood
Pharmaceuticals, Inc.
Susan Brady, 617-621-8304
Corporate
Communications
sbrady@ironwoodpharma.com
Source: Forest Laboratories, Inc. & Ironwood Pharmaceuticals, Inc.
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