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May 14, 2012
Ironwood and Forest to Present 17 Linaclotide-Related Abstracts at Digestive Disease Week® 2012

CAMBRIDGE, Mass. & NEW YORK--(BUSINESS WIRE)-- 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.

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

Source: Forest Laboratories, Inc. & Ironwood Pharmaceuticals, Inc.

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