Published: April 26, 2010
Ironwood and Forest to Present Linaclotide Phase 3 Chronic Constipation Data
CAMBRIDGE, Mass. & NEW YORK - (BUSINESS WIRE) - Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories,
Inc. (NYSE: FRX) today announced they will be presenting Phase 3 chronic
constipation clinical trial results for linaclotide, an investigational
guanylate cyclase type-C (GC-C) agonist for the treatment of irritable
bowel syndrome with constipation (IBS-C) and chronic constipation (CC),
during the 2010 Digestive Disease Week (DDW) annual meeting being held
in New Orleans from May 1 through May 5, 2010. Ironwood and Forest
released the top-line results from the CC trials late last year and
expect to have data from the Phase 3 IBS-C trials in the second half of
2010.
The linaclotide CC data will be reported in two oral presentations and
one poster presentation. The scheduled times and titles of the
presentations are:
-
Efficacy and Safety of Once Daily Linaclotide Administered Orally
for 12-Weeks in Patients with Chronic Constipation: Results from Two
Randomized, Double-blind, Placebo-controlled Phase 3 Trials, an
oral presentation by Anthony Lembo, M.D. on Monday, May 3 at 8:50 a.m.
(CDT)
-
Results from the Randomized Withdrawal Period of a Phase 3 Clinical
Trial of Linaclotide in Chronic Constipation, a poster of
distinction presented by Jeffrey Johnston, M.D., F.A.C.P., F.A.C.G. on
Tuesday, May 4 at 12:00 p.m. - 2:00 p.m. (CDT)
-
Effect of Linaclotide on Quality of Life in Adults with Chronic
Constipation: Results from Two Randomized, Double-Blind,
Placebo-Controlled Phase 3 Trials, a late-breaking, distinguished
oral presentation by Robyn Carson, M.P.H. on Tuesday, May 4 at 4:45
p.m. (CDT)
In addition, Ironwood and Forest will present qualitative research on
symptoms of chronic constipation most important to patients in a poster
session on May 3 at DDW:
About Linaclotide
Linaclotide, an investigational drug, is an agonist of guanylate cyclase
type-C (GC-C), a receptor found on epithelial cells lining the
intestine. Activation of GC-C leads to increases in intracellular and
extracellular cyclic guanosine monophosphate (cGMP). In animal models,
extracellular cGMP inhibited afferent nerve firing and positively
affected markers of abdominal pain, while intracellular cGMP led to
activation of anion channels which stimulated anion and fluid section
into the intestine, leading to accelerated intestinal transit.
Linaclotide is an orally delivered peptide that acts locally in the gut
with no detectable systemic exposure at therapeutic doses and is
intended for once-daily administration. Linaclotide is in Phase 3
clinical development for the treatment of IBS-C and CC. In a Phase 2b
study in patients with IBS-C, linaclotide statistically significantly
reduced abdominal pain, abdominal discomfort, severity of straining, and
bloating, and increased complete spontaneous bowel movement frequency,
throughout the 12-week treatment period versus placebo. In two Phase 3
trials in patients with CC, statistical significance versus placebo was
achieved for the primary endpoint-increasing complete spontaneous bowel
movements-and all secondary endpoints, which included measures of
straining severity, stool hardness, bloating, and abdominal discomfort.
In Phase 2 IBS-C and Phase 3 CC trials, diarrhea was the most common
adverse event, occurring at an incidence between 12 percent and 20
percent for linaclotide-treated patients (at the 133 to 266 mcg dose
range) and between 1 percent and 7 percent for patients receiving
placebo. Diarrhea was the most common cause for discontinuation,
although most events of diarrhea were reported as mild to moderate. Data
from the Phase 3 IBS-C trials are expected in the second half of 2010.
An issued composition of matter patent for linaclotide provides
protection to 2025. In September 2007, Ironwood and Forest entered into
a 50/50 collaboration to co-develop and co-promote linaclotide in the
United States. Ironwood has out-licensed linaclotide to Almirall for
European development and commercialization, and to Astellas Pharma for
development and commercialization in Japan and other Asian countries.
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 discomfort and bloating. This condition
significantly affects patients' quality of life by impairing their
ability to work and participate in typical daily activities. Half of
patients are not satisfied with currently available treatments.
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS-C is a chronic functional gastrointestinal disorder characterized by
abdominal pain, discomfort, and bloating associated with altered bowel
habits, and as many as 11 million people in the U.S. suffer from it.
There are currently few available therapies to treat this disorder and
there is a high rate of dissatisfaction with available therapies.
Patients suffering from IBS-C can be affected physically,
psychologically, socially, and economically.
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 1â5, 2010, at the Ernest N. Morial
Convention Center, New Orleans. The meeting showcases approximately
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 GC-C agonist, is being evaluated in a
confirmatory Phase 3 program for the treatment of irritable bowel
syndrome with constipation (IBS-C) and chronic constipation. Ironwood
also has a growing pipeline of additional drug candidates in earlier
stages of development. Ironwood is located in Cambridge, Mass. To learn
more about Ironwood Pharmaceuticals, visit www.ironwoodpharma.com.
About Forest Laboratories, Inc.
Forest Laboratories (NYSE: FRX) is a U.S.-based pharmaceutical company
with a long track record of building partnerships and developing and
marketing products that make a positive difference in people's lives. In
addition to its well-established franchises in therapeutic areas of the
central nervous and cardiovascular systems, Forest's current pipeline
includes product candidates in all stages of development and across a
wide range of therapeutic areas. The company is headquartered in New
York, NY. To learn more about Forest Laboratories, 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 difficulty of
predicting FDA approvals, the acceptance and demand for new
pharmaceutical products, the impact of competitive products and pricing,
the timely development and launch of new products, and the risk factors
listed from time to time in Forest Laboratories' Annual Report on Form
10-K, Quarterly Report on Form 10-Q, and any subsequent SEC filings.

Forest Laboratories, Inc.
Frank Murdolo, 212-224-6714
Vice
President, Investor Relations
frank.murdolo@frx.com
or
Ironwood
Pharmaceuticals, Inc.
Susan Brady, 617-621-8304
Corporate
Communications
sbrady@ironwoodpharma.com
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