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October 28, 2019
Ironwood Pharmaceuticals to Highlight New Data at the American College of Gastroenterology 2019 Annual Scientific Meeting

– Linaclotide abstract recognized as a Presidential Poster Recipient –

BOSTON--(BUSINESS WIRE)-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced the presentation of clinical data for linaclotide and MD-7246, as well as results from a survey for patients with persistent gastroesophageal reflux disease (GERD), from Ironwood and its collaborators during the American College of Gastroenterology (ACG) 2019 Annual Scientific Meeting being held in San Antonio, TX, October 25 through October 30, 2019.

A linaclotide poster at the meeting was recognized by the ACG as a Presidential Poster Award recipient. Every year less than 5% of accepted abstracts receive this distinction for high quality, novel, unique, and interesting research. The abstract features safety and efficacy data from a Phase II trial of linaclotide in pediatric patients aged six to 17 with functional constipation. Linaclotide, a guanylate cyclase‐C (GC‐C) agonist, is activated by a mechanism pioneered by Ironwood scientists.

Phase I data demonstrating the limited effect of MD-7246 on bowel frequency and stool consistency in healthy volunteers will be presented in a poster session. MD-7246, an investigational product, is being evaluated as an oral, intestinal, non-opioid, pain-relieving agent for patients suffering from abdominal pain associated with certain GI diseases, including IBS with diarrhea (IBS-D). MD-7246 is a delayed-release formulation of linaclotide designed to provide targeted delivery of linaclotide to the colon, where the majority of the abdominal pain associated with IBS-D is believed to originate, and to limit fluid secretion in the small intestine resulting in minimal impact on bowel function.

Survey results highlighting the prevalence of persistent GERD and characteristics of patients living with the condition will also be presented at the meeting. Persistent GERD affects patients who continue to experience symptoms such as heartburn and regurgitation despite receiving treatment with a proton pump inhibitor (PPI). Ironwood’s IW-3718, a gastric retentive formulation of the bile acid sequestrant colesevelam, is being evaluated in Phase III clinical trials for the treatment of persistent GERD.

The data will be presented as follows:

Prevalence and Patient Experience in Persistent GERD

  • Persistent GERD Symptoms Despite PPI Treatment – Prevalence and Patient Characteristics: Results from a Cross-Sectional Patient Survey (poster session P0274), by Douglas Taylor, Ironwood Pharmaceuticals, Inc., Cambridge, MA, was presented on Sunday, October 27, 3:30 to 7:00 p.m., in Exhibit Halls 3 and 4 of the Henry B. Gonzalez Convention Center.

Phase II Data on Linaclotide in Pediatric Functional Constipation (Presidential Poster Award)

  • Linaclotide Safety and Efficacy in Children Aged 6 to 17 Years With Functional Constipation (Presidential Poster P1689), by Carlo Di Lorenzo, MD, Nationwide Children's Hospital, Columbus, OH, will be presented on Monday, October 28, 10:30 a.m. to 4:15 p.m., in Exhibit Halls 3 and 4 of the Henry B. Gonzalez Convention Center.

Phase I Data on MD-7246 in Healthy Volunteers

  • MD-7246, a Delayed-Release Formulation of Linaclotide Targeting Visceral Pain Associated With IBS-D, Does Not Impact Bowel Frequency or Stool Consistency in Healthy Volunteers: Results From Phase I Trial (poster session P1259), by Braden Kuo, MD, MSc, Massachusetts General Hospital, Boston, MA, will be presented on Monday, October 28, 10:30 a.m. to 4:15 p.m., in Exhibit Halls 3 and 4 of the Henry B. Gonzalez Convention Center.

About Linaclotide

Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in two ways based on nonclinical studies. Linaclotide binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established. Linaclotide is available for the treatment of adults with IBS-C or CIC in the U.S. and more than 30 other countries. Linaclotide is marketed by Ironwood and Allergan plc in the United States as LINZESS® and is indicated for the treatment of adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Linaclotide is marketed by Allergan for the treatment of adults with moderate to severe IBS-C in Europe under the brand name CONSTELLA®. AstraZeneca has the exclusive rights to develop and commercialize linaclotide in China (including Hong Kong and Macau). Astellas Pharma Inc. has exclusive rights to develop and commercialize linaclotide in Japan. Allergan has exclusive rights to develop and market in the rest of the world countries.

About MD-7246

MD-7246 is a delayed release formulation of linaclotide being evaluated by Ironwood and its partner Allergan plc as an oral, non-opioid, pain-relieving agent for adult patients in the U.S. suffering from abdominal pain associated with GI diseases, including irritable bowel syndrome with diarrhea. MD-7246 is designed to provide targeted delivery of linaclotide to the colon, where the majority of the abdominal pain associated with IBS-D is believed to originate, and to limit fluid secretion in the small intestine resulting in minimal impact on bowel function. Ironwood and Allergan have issued patents and pending patent applications covering MD-7246 that are expected to provide patent coverage into the mid-2030s.

About Persistent Gastroesophageal Reflux Disease (GERD)

An estimated 10 million adult Americans and more than 60 million adult patients globally suffer from persistent gastroesophageal reflux disease (GERD), meaning they continue to experience symptoms such as heartburn and regurgitation despite receiving treatment with a proton pump inhibitor (PPI). While PPIs suppress production of stomach acid, Ironwood’s clinical research demonstrates that reflux of bile from the intestine into the stomach and esophagus may play a key role in the ongoing symptoms of persistent GERD. FDA-approved treatment options for these patients are limited.

About LINZESS (linaclotide)

LINZESS® is the #1 prescribed brand for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC), based on IQVIA data.

LINZESS is a once-daily capsule that helps relieve the abdominal pain and constipation associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72-mcg dose approved for use in CIC depending on individual patient presentation or tolerability. LINZESS should be taken at least 30 minutes before the first meal of the day.

LINZESS is contraindicated in pediatric patients less than 6 years of age. The safety and effectiveness of LINZESS in pediatric patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences. In adults with IBS-C or CIC treated with LINZESS, the most commonly reported adverse event was diarrhea.

LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called guanylate cyclase-C (GC-C) agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.

In the United States, Ironwood and Allergan plc co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, Allergan markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization of LINZESS in China, and with Allergan for development and commercialization of linaclotide in all other territories worldwide.

LINZESS Important Safety Information

INDICATIONS AND USAGE

LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

IMPORTANT SAFETY INFORMATION

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS

LINZESS is contraindicated in patients less than 6 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have not been established in patients less than 18 years of age.

Contraindications

  • LINZESS is contraindicated in patients less than 6 years of age due to the risk of serious dehydration.
  • LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Warnings and Precautions

Pediatric Risk

  • LINZESS is contraindicated in patients less than 6 years of age. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
  • Use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.

Diarrhea

  • Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in <1% of 72 mcg LINZESS-treated CIC patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.

Common Adverse Reactions (incidence ≥2% and greater than placebo)

  • In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
  • In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).

Please see full Prescribing Information including Boxed Warning: http://www.allergan.com/assets/pdf/linzess_pi

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused healthcare company dedicated to creating medicines that make a difference for patients living with GI diseases. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).

We are also advancing two late-stage, first-in-category GI product candidates: IW-3718 is a gastric retentive formulation of a bile acid sequestrant being developed for the potential treatment of persistent gastroesophageal reflux disease, and MD-7246 is a delayed-release formulation of linaclotide that is being evaluated as an oral, intestinal, non-opioid, pain-relieving agent for patients suffering from abdominal pain associated with IBS with diarrhea.

Ironwood was founded in 1998 and is headquartered in Boston, Mass. For more information, please visit our website at www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.

Forward-Looking Statements

This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about the safety and efficacy, and potential of linaclotide to treat, pediatric patients aged six to 17 with functional constipation; the mechanisms of action and effects of linaclotide, MD-7246 and IW-3718; the potential of MD-7246 to treat patients suffering from abdominal pain associated with certain GI diseases, including IBS-D; the prevalence of, and characteristics of patients with, persistent GERD; and the potential of IW-3718 to treat persistent GERD. Each forward‐looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to preclinical and clinical development, manufacturing and formulation development; the risk that future clinical studies need to be discontinued for any reason, including safety, tolerability, enrollment, manufacturing or economic reasons; the risk that findings from our completed non-clinical and clinical studies may not be replicated in later studies; efficacy, safety and tolerability of our products and product candidates; the risk that the therapeutic opportunities for linaclotide, MD-7246 and IW-3718 are not as we expect; decisions by regulatory and judicial authorities; the risk that we are unable to successfully commercialize our products and product candidates, if approved; the risk that we may never get sufficient patent protection for our products and product candidates or that we are not able to successfully protect such patents; the outcomes in legal proceedings to protect or enforce the patents relating to our products and product candidates, including ANDA litigation; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues, products or product candidates; the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and the risks listed under the heading "Risk Factors" and elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, and in our subsequent SEC filings. These forward-looking statements (except as otherwise noted) speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements.

Media and Investors:
Meredith Kaya, 617-374-5082
Vice President, Strategy, Investor Relations and Corporate Communications
mkaya@ironwoodpharma.com

Source: Ironwood Pharmaceuticals, Inc.

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