Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest
Laboratories, Inc. (NYSE: FRX) announced today they will present
linaclotide-related data during Digestive Disease Week® 2013 in
Orlando, Fla., May 18 through May 21, 2013. Among the data
highlighted will be two oral presentations: one providing insight
into the GC-C/cGMP pathway in patients with IBS-C and another
describing the effects of linaclotide on inhibiting visceral pain,
both based on nonclinical studies.
The oral presentation titled “Mechanisms Underlying Linaclotide
Induced Inhibition of Colonic Nociception” (abstract #1602418) will
be presented at 2:45 p.m. ET on Monday, May 20, 2013, in room 104A
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.
The oral presentation titled “Alterations in the Guanylate
Cyclase-C Receptor/cGMP Pathway in Patients with Constipation
Predominant Irritable Bowel Syndrome” (abstract #1602470) will also
be presented by Dr. Brierley at 8:45 a.m. ET on Sunday, May 19,
2013 in room 314A.
Also being presented are the following poster presentations:
Clinical Posters
Assessing Abdominal and Bowel Symptoms Using Adequate Relief
Based Thresholds: Results from 2 Phase 3 Trials of Linaclotide in
Patients with Irritable Bowel Syndrome with Constipation (abstract
#1598133) on Monday, May 20, 2013, 8 a.m. – 5 p.m. in Hall WA1,
presented by Michael Camilleri, M.D., Professor of Pharmacology,
Physiology, and Medicine, Department of Gastroenterology and
Hepatology, Mayo Clinic
Determining the Minimum Duration for Initial Treatment with
Linaclotide in IBS-C Patients: Results from Pooled Phase 3 Trials
(abstract #1596597) on Sunday, May 19, 2013, 8 a.m. – 5 p.m. in
Hall WA1, presented by William Chey, M.D., Professor of Medicine,
Director of the Gastrointestinal Physiology Laboratory and
Co-Director of the Michigan Bowel Control Program at the University
of Michigan
The Effect of Linaclotide on IBS-QOL Sexual Subscale Scores in
Patients with Irritable Bowel Syndrome with Constipation: Results
from a Post hoc Analysis of 2 Phase 3 Trials of Linaclotide
(abstract #1598793), on Tuesday, May 21, 2013, 8 a.m. – 5 p.m. in
Hall WA1, presented by Mark Currie, Ph.D., Senior Vice President,
Chief Scientific Officer and President of R&D, Ironwood
Pharmaceuticals Inc.
Health Economic & Outcomes Research
Poster
Longitudinal Direct Medical Costs Associated with Irritable
Bowel Syndrome-Constipation and Chronic Idiopathic Constipation in
a Population-Based Sample over a 10-Year Period (abstract
#1581789), on Sunday, May 19, 2013, 8 a.m. – 5 p.m. in Hall WA1,
presented by Linda Herrick, Ph.D., Associate Dean of Undergraduate
Nursing, South Dakota State University
All data are embargoed until the time of presentation.
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 transit and a reduction in visceral
pain, which is thought to be mediated by decreased activity of
pain-sensing nerves. The clinical relevance of the effect on pain
fibers in 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 was also approved by the European
Commission for the treatment of adults in the European Union with
IBS-C and is marketed under the brand name Constella® through a
license agreement between Ironwood and Almirall, S.A. Ironwood also
has partnered with Astellas Pharma Inc. for development and
commercialization of linaclotide in Japan, and with AstraZeneca for
development and commercialization of linaclotide in China.
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 Precautions
Pediatric 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 Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is committed to the art
and science of making medicines, from discovery through
commercialization. We’re focused on three goals: transforming
knowledge into medicines that make a difference for patients,
creating value that will inspire the continued support of our
fellow shareholders, and building a team that passionately pursues
excellence. Our first product, linaclotide, is approved in the
United States and Europe. Our pipeline priorities include exploring
further opportunities for linaclotide, leveraging our deep
expertise in functional gastrointestinal disorders, and advancing
programs in other areas such as allergic conditions, cardiovascular
disease, central nervous system disorders and other conditions
defined by patient symptoms. 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 to learn more about Ironwood.
Information that may be important to investors will be routinely
posted in both these locations.
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 and respiratory,
gastrointestinal, and pain management medicine. The Company’s
pipeline, the most robust in its history, includes product
candidates in all stages of development across a wide range of
therapeutic areas. The Company is headquartered in New York, NY. To
learn more, visit www.FRX.com.
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 18 – 21, 2013, at
the Orange County Convention Center, FL. 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.
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