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Ironwood and Forest to Present Additional Phase 2b Data for Novel Gastrointestinal Agent Linaclotide
Date:5/12/2009

- 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.

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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 Inc. and Its Products

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.


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SOURCE Forest Laboratories, Inc.; Ironwood Pharmaceuticals, Inc.
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