- Data to be presented at Digestive Disease Week 2009 -
CAMBRIDGE, Mass. and NEW YORK, May 12, 2009 /PRNewswire-FirstCall/ --
Ironwood Pharmaceuticals, Inc. and Forest Laboratories, Inc. (NYSE: FRX) today
announced they will be reporting additional clinical data from their Phase 2b
studies for linaclotide, a first-in-class investigational compound for the
treatment of irritable bowel syndrome with constipation (IBS-C) and chronic
constipation (CC), during the 2009 Digestive Disease Week (DDW) annual meeting
being held in Chicago, IL from May 30 through June 4, 2009. The presentations
will include three oral and one poster presentation. Ironwood and Forest
presented the initial analyses from both the IBS-C and CC studies last year.
(Logo: http://www.newscom.com/cgi-bin/prnh/20001011/FORESTLOGO )
The scheduled times and titles of the presentations are:
-- Effect of Linaclotide on IBS-C Symptoms in the First Week of
Treatment: Results from a Phase 2b Study, an oral presentation by
Anthony Lembo, M.D. on Sunday, May 31 at 10:45 a.m.
-- Global Endpoints in IBS Clinical Trials: Results from a Phase 2b Study
of Linaclotide, an oral presentation by Jeffrey Johnston, M.D.,
F.A.C.P., F.A.C.G. on Sunday, May 31 at 2:30 p.m.
-- Effect of Linaclotide on Quality of Life in Adults with Chronic
Constipation: Results from a Phase 2b Study, an oral presentation by
Bernard Lavins, M.D. on Monday, June 1 at 2:15 p.m.
-- Time to Onset of Linaclotide Effect on the Bowel Habits in Patients
with Chronic Constipation: Results from a Phase 2b Study, a poster
presentation by Jeffrey Johnston, M.D., F.A.C.P., F.A.C.G. on Tuesday,
June 2 from 8:00 a.m. to 5:00 p.m.
About Linaclotide
Linaclotide is a first-in-class compound in Phase 3 clinical development
for the treatment of IBS-C and CC. Linaclotide demonstrated proof of concept
in a comprehensive Phase 2b program, comprised of two clinical studies in over
700 patients with either IBS-C or CC. In patients with IBS-C, linaclotide
significantly reduced abdominal pain and bloating and improved bowel function
throughout the 12-week treatment period. In patients with CC, linaclotide
reduced constipation throughout the 4-week treatment period. Across both
studies, the most common adverse event in the linaclotide-treated groups was
diarrhea. The discontinuation rate due to any adverse event was 4.7 percent.
Linaclotide is a once daily, orally delivered peptide that acts locally in the
gut with no detectable systemic exposure at therapeutic doses. Linaclotide is
an agonist of guanylate cyclase type-C, a receptor found on the lining of the
intestine. 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 United States.
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS-C is a chronic functional gastrointestinal disorder characterized by
abdominal pain and discomfort associated with altered bowel habits. There are
currently few available therapies to treat this disorder. Nine million U.S.
patients have been diagnosed with IBS-C, and as many as 15 million people in
the U.S. suffer from it. Patients suffering from IBS-C can be affected
physically, psychologically, socially, and economically.
About Chronic Constipation (CC)
As many as 23 million Americans suffer from CC and 12 million patients
have sought treatment and been diagnosed. 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. The discomfort of
CC significantly affects patients' quality of life by impairing their ability
to work and participate in typical daily activities.
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 30 - June 4,
2009, at McCormick Place, Chicago, IL. 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 (www.ironwoodpharma.com) is an entrepreneurial
pharmaceutical company dedicated to the science and art of great drugmaking.
Linaclotide, the Company's first-in-class compound, is being evaluated in a
comprehensive Phase 3 program for the treatment of irritable bowel syndrome
with constipation (IBS-C) and chronic constipation (CC). Ironwood also has a
growing pipeline of additional drug candidates in earlier stages of
development. Microbia, Inc. (formerly Microbia Precision Engineering), a
majority-owned subsidiary of Ironwood, is an industrial biotechnology company
developing and commercializing novel bioprocesses for the production of
specialty chemicals. Ironwood has raised $281 million in private equity
financing and is located in Cambridge, Massachusetts.
About Forest Laboratories
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.
SOURCE Forest Laboratories, Inc.;
Ironwood Pharmaceuticals, Inc.
CONTACT:
Frank J. Murdolo, Vice President, Investor Relations,
Forest
Laboratories, Inc., +1-212-224-6714,
Frank.Murdolo@frx.com;
or
Susan Brady,
Ironwood Pharmaceuticals,
Corporate Communications, +1-617-621-8304,
sbrady@ironwoodpharma.com
Web Site: http://www.frx.com
http://www.ironwoodpharma.com
(FRX FRX)