Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) and Forest
Laboratories, Inc. (NYSE:FRX) announced today they will present
linaclotide-related data during Digestive Disease Week® 2014 in
Chicago, May 3 through May 6, 2014. The data will be presented
through the following poster presentations:
Clinical Posters
Efficacy and Safety of Linaclotide in Chronic Idiopathic
Constipation Patients With Abdominal Bloating: Phase 3b Trial
Results (abstract #Sa2008) on Saturday, May 3, 2014, 8 a.m. – 5
p.m. in the South Hall, presented by Brian Lacy, M.D., Ph.D.,
Section Chief, Gastroenterology and Hepatology, Associate Professor
of Medicine, Geisel School of Medicine, Dartmouth-Hitchcock Medical
Center.
The Relationship Between Chronic Constipation Symptoms and
Health-Related Quality of Life: Results From 2 Phase 3 Trials
(abstract #Sa1076) on Saturday, May 3, 2014, 8 a.m. – 5 p.m. in the
South Hall, presented by Doug Taylor, Director, Health Economics
& Outcomes Research, Ironwood Pharmaceuticals, Inc.
Preclinical Posters
Extracellular Cyclic GMP (cGMP), the Downstream Mediator
Released in Response to Linaclotide-Induced Activation of Guanylate
Cyclase-C (GC-C), Reduces Excitability of Murine and Human Dorsal
Root Ganglion (DRG) Neurons (abstract #Mo2029) on Monday, May 5,
2014, 8 a.m. – 5 p.m. in the South Hall, presented by Stuart
Brierley, Ph.D., NHMRC Career Development Fellow and Head of the
Visceral Pain Research Group, Nerve-Gut Research Laboratory,
Discipline of Medicine at the University of Adelaide.
Distinct Alterations in the Guanylate Cyclase-C (GC-C)/cyclic
GMP (cGMP) Pathway Are Evident Across Different Subtypes of
Irritable Bowel Syndrome (IBS) Patients (abstract #Su2066) on
Sunday, May 4, 2014, 8 a.m. – 5 p.m. in the South Hall, also
presented by Dr. Brierley.
Linaclotide Induces Endocytosis of the Sodium/Hydrogen Exchanger
3 (NHE3) and Inhibits Sodium Absorption (abstract #Mo1752) on
Monday, May 5, 2014, 8 a.m. – 5 p.m. in the South Hall, presented
by Nadia Ameen, MBBS, Associate Professor of Pediatrics
(Gastroenterology) and of Cellular and Molecular Physiology at Yale
School of Medicine.
Health Economic & Outcomes Research Poster
Irritable Bowel Syndrome With Constipation (IBS-C), Chronic
Idiopathic Constipation (CIC), Functional Dyspepsia (FD), and
Gastroesophageal Reflux Disease (GERD) Commonly Overlap: Results of
a Cross-Sectional Population-Based Survey (abstract #Sa1065) on
Saturday, May 3, 2014, 8 a.m. – 5 p.m. in the South Hall, presented
by Nimish Vakil, M.D., Clinical Professor of Medicine at the
University of Wisconsin School of Medicine and Public Health.
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 Forest 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 up to 6 years of age. Use should be avoided in pediatric
patients 6 through 17 years of age.
In nonclinical studies, administration
of a single, clinically relevant adult oral dose of linaclotide
caused deaths in young juvenile mice.
Contraindications
- LINZESS is contraindicated in pediatric
patients up to 6 years of age.
- LINZESS is contraindicated in patients
with known or suspected mechanical gastrointestinal
obstruction.
Warnings and PrecautionsPediatric Risk
- LINZESS is contraindicated in pediatric
patients up to 6 years of age. In nonclinical studies, deaths
occurred within 24 hours in young juvenile mice (1 to 3 week-old
mice; approximately equivalent to human pediatric patients less
than 2 years of age) following administration of one or two daily
oral doses of linaclotide.
- Use of LINZESS should be avoided in
pediatric patients 6 through 17 years of age. Linaclotide did not
cause deaths in older juvenile mice (approximately equivalent to
humans age 12 to 17 years). 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, who should consider dose suspension.
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 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 Forest Laboratories, Inc.
Forest Laboratories (NYSE:FRX) is a leading, fully integrated,
specialty pharmaceutical company largely focused on the United
States market. Forest markets a portfolio of branded drug products
and develops new medicines to treat patients suffering from
diseases principally in five therapeutic areas: central nervous
system, cardiovascular, gastrointestinal, respiratory, and
anti-infective. Forest’s strategy of acquiring product rights for
development and commercialization through licensing, collaborative
partnerships and targeted mergers and acquisitions allows Forest to
take advantage of attractive late-stage development and commercial
opportunities, thereby managing the risks inherent in drug
development. In January 2014, Forest acquired Aptalis
Pharmaceuticals for $2.9 billion in cash in order to gain access to
its GI and Cystic Fibrosis products, including treatments for
Ulcerative Proctitis, Duodenal Ulcers, H. Pylori, Anal Fissures,
and Pancreatic Insufficiency. In February 2014, Forest and Actavis
plc announced an agreement where Forest would be acquired for about
$25 billion in cash and stock. The acquisition of Forest by Actavis
is contingent upon regulatory and shareholder approvals.
Forest is headquartered in New York, NY.
About Digestive Disease Week (DDW)
Digestive Disease Week® (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 (AASLD), the American Gastroenterological
Association (AGA) Institute, the American Society for
Gastrointestinal Endoscopy (ASGE) and the Society for Surgery of
the Alimentary Tract (SSAT), DDW takes place May 3 – 6, 2014, at
McCormick Place, Chicago, IL. The meeting showcases more than 5,000
abstracts and hundreds of lectures on the latest advances in GI
research, medicine and technology. More information can be found at
www.ddw.org.
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.Media Relations:Amanda Kaufman,
646-231-7316amanda.kaufman@frx.comorInvestor Relations:Frank J.
Murdolo, 212-224-6714media.relations@frx.com-or-Ironwood
Pharmaceuticals, Inc.Media Relations:Trista Morrison,
617-374-5095tmorrison@ironwoodpharma.comorInvestor Relations:Mary
Conway, 617-621-8308mconway@ironwoodpharma.com
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