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:

- Assessing Treatment Response in Chronic Constipation Clinical Trials: Concepts Elicited Through Qualitative Interviews With Patients, a poster presentation presented by Sheri Fehnel, Ph.D. on Monday, May 3 from 12:00 p.m. - 2:00 p.m. (CDT)

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 1-5, 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 http://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 http://www.ironwoodpharma.com.

Source
Forest Laboratories, Inc.