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.
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