Ironwood and Actavis to Present Linaclotide Data at the American College of Gastroenterology 2014 Annual Scientific Meeting

Ironwood and Actavis to Present Linaclotide Data at the American College of Gastroenterology 2014 Annual Scientific Meeting

CAMBRIDGE, Mass. & DUBLIN--(BUSINESS WIRE)--Oct. 9, 2014-- Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Actavis plc (NYSE: ACT) announced today that the following linaclotide-related data will be presented during the American College of Gastroenterology 2014 Annual Scientific Meeting in Philadelphia, October 17 through October 22, 2014. The data will be presented via oral and poster presentations as follows:

Assessment of Dyspepsia Symptoms in CIC (Oral Presentation):

Linaclotide Efficacy on Dyspepsia Symptoms Using Nepean Dyspepsia Index (NDI) in A Phase 3B Trial Of CIC Patients With Bloating will be presented during Plenary Session 1: Functional Bowel Disorder/Pediatrics on Monday, October 20, 2014, 2:15 p.m. - 3:00 p.m., by Anthony Lembo, M.D., Associate Professor of Medicine at Harvard Medical School and Director of the GI Motility Laboratory at the Beth Israel Deaconess Medical Center.

Assessment of Treatment Satisfaction (Poster Presentations):

Up to Two Years on Linaclotide: Tolerability and Treatment Satisfaction in IBS-C Patients With and Without Diarrhea AEs (abstract #P1111; 2014 ACG Presidential Poster Award) on Monday, October 20, 2014, 10:30 a.m. - 4:00 p.m., presented by William Chey, M.D., Professor of Medicine, Director of the GI Physiology Laboratory, and Co-Director of the Michigan Bowel Control Program at the University of Michigan.

Effect of Diarrhea Adverse Events on Health-Related Quality of Life and Treatment Satisfaction in Patients With Irritable Bowel Syndrome With Constipation (abstract #P392) on Sunday, October 19, 2014, 3:30 p.m. - 7:00 p.m., presented by William Spalding, Director of Health Economics and Outcomes Research at Ironwood Pharmaceuticals, Inc.

Effect of Diarrhea Adverse Events on Health-Related Quality of Life and Treatment Satisfaction in Patients With Chronic Idiopathic Constipation (abstract #P412) on Sunday, October 19, 2014, 3:30 p.m. - 7:00 p.m., presented by Jessica Buono, Manager of Health Economics and Outcomes Research at Forest Laboratories, a member of the Actavis Group plc.

Treatment Expectations and Drivers of Treatment Satisfaction Among Chronic Idiopathic Constipation (CIC) and Irritable Bowel Syndrome With Constipation (IBS-C) Patients (abstract #P1605) on Tuesday, October 21, 2014, 10:30 a.m. - 4:00 p.m., presented by Rob Arbuckle, Director of Endpoint Development and Outcomes Assessment at Adelphi Values Ltd.

Unmet Needs in IBS-C and CC (Poster Presentation):

Unmet Treatment Needs Among Commercially Insured Patients With Irritable Bowel Syndrome With Constipation (IBS-C) or Chronic Constipation (CC) in the United States (abstract #P413) on Sunday, October 19, 2014, 3:30 p.m. - 7:00 p.m., presented by Judith Stephenson, Director of Research Operations at HealthCore Inc.

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 marketed by Ironwood and Actavis 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 Almirall, S.A. for the treatment of adults with moderate to severe IBS-C in Europe under the brand name CONSTELLA®. Ironwood also has partnered with Astellas Pharma Inc. for development and commercialization of linaclotide in Japan and with AstraZeneca for development and commercialization in China.

LINZESS and CONSTELLA are trademarks owned by Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.

Important Safety Information


WARNING: PEDIATRIC RISK
LINZESS is contraindicated in pediatric patients under 6 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. Use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. The safety and efficacy of LINZESS has not been established in pediatric patients under 18 years of age.

Contraindications

LINZESS is contraindicated in pediatric patients under 6 years of age.
LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions

Pediatric Risk

LINZESS is contraindicated in children under 6 years of age. The safety and effectiveness of LINZESS in pediatric patients under 18 years of age have not been established. In neonatal mice, increased fluid secretion as a consequence of GC-C agonism resulted in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, children under 6 years of age may be more likely than older children and adults to develop significant diarrhea and its potentially serious consequences.
Use of LINZESS should be avoided in pediatric patients 6 through 17 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 through 17 years of age.
Diarrhea

Diarrhea was the most common adverse reaction of LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. Severe diarrhea was reported in 2% of LINZESS-treated patients. The incidence of diarrhea was similar in the IBS-C and CIC populations.
Patients should be instructed to stop LINZESS if severe diarrhea occurs and to contact their healthcare provider. The healthcare provider should consider dose suspension and rehydration.
Adverse Reactions

In IBS-C clinical trials, the most common adverse reactions in LINZESS-treated patients (incidence =2% and greater than placebo) were 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 clinical trials, the most common adverse reactions in LINZESS-treated patients (incidence =2% and greater than placebo) were 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%).
Please see full Prescribing Information including Boxed Warning: http://www.frx.com/pi/linzess_pi.pdf.

About IBS-C and CIC

While estimates vary, as many as 13 million adults in the U.S. may suffer from IBS-C, and as many as 35 million may suffer from CIC. Results derived from responses to a web based survey commissioned by Forest Pharmaceuticals, now a member of the Actavis Group plc, and Ironwood Pharmaceuticals suggest that only about half of adult IBS-C sufferers are medically diagnosed, and only 12 percent of adult CIC sufferers are medically diagnosed. Hallmark symptoms associated with IBS-C include abdominal pain and constipation. Symptoms associated with CIC may include constipation, hard or lumpy stools, infrequent stools, and incomplete evacuation (not completely emptying the bowels). There are few available prescription treatment options for these conditions.

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (NASDAQ: IRWD) is focused on creating medicines that make a difference for patients, building value to earn the continued support of our fellow shareholders, and empowering our team to passionately pursue excellence. We discovered, developed and are commercializing linaclotide, which is approved in the United States and a number of other countries. Our pipeline priorities include exploring further opportunities for linaclotide, as well as leveraging our therapeutic expertise in gastrointestinal disorders and our pharmacologic expertise in guanylate cyclases to address patient needs across the upper and lower gastrointestinal tract. Ironwood was founded in 1998 and is headquartered in Cambridge, Mass. Connect with us at www.ironwoodpharma.com or on Twitter at www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.

About Actavis plc

Actavis plc (NYSE: ACT), headquartered in Dublin, Ireland, is a unique specialty pharmaceutical company focused on developing, manufacturing and commercializing high quality affordable generic and innovative branded pharmaceutical products for patients around the world.

Actavis markets a broad portfolio of branded and generic pharmaceuticals and develops innovative medicines for patients suffering from diseases principally in the central nervous system, gastroenterology, women's health, urology, cardiovascular, respiratory and anti-infective therapeutic categories. The Company is an industry leader in product research and development, with one of the broadest brand development pipelines in the pharmaceutical industry, and a leading position in the submission of generic product applications. Actavis has commercial operations in more than 60 countries and operates more than 30 manufacturing and distribution facilities around the world.

For more information, visit Actavis' website at www.actavis.com.

 

Source: Actavis plc and Ironwood Pharmaceuticals, Inc.

Actavis plc
Media Relations:
Charlie Mayr, 862-261-8030
or
David Belian, 862-261-8141
or
Investor Relations:
Lisa DeFrancesco, 862-261-7152
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Ironwood Pharmaceuticals, Inc.
Media Relations:
Trista Morrison, 617-374-5095
[email protected]
or
Investor Relations:
Meredith Kaya, 617-374-5082
[email protected]

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