Ironwood Pharmaceuticals, Inc. (NASDAQ:IRWD) and Forest
Laboratories, Inc. (NYSE:FRX) announced today that they have
commenced a new direct-to-consumer (DTC) patient awareness campaign
for LINZESS® (linaclotide), a once-daily treatment for adults with
irritable bowel syndrome with constipation (IBS-C) or chronic
idiopathic constipation (CIC). The campaign aims to help adults
suffering from IBS-C or CIC recognize the symptoms of these
disorders, describe their symptoms to their doctor, and ask their
doctor about LINZESS to help proactively manage their disease. The
television portion of the campaign premiered last night on ABC.
“Millions of adults suffer from IBS-C or CIC, but many have not
been diagnosed. They may not realize that long-lasting or recurrent
symptoms such as infrequent or difficult-to-pass stools, not
completely emptying the bowels, and – in IBS-C – belly pain, could
indicate the presence of a medical condition and warrant discussion
with a doctor,” said Tom McCourt, chief commercial officer at
Ironwood. “Even among patients who are diagnosed with IBS-C or CIC,
fewer than 10 percent are aware of LINZESS, so we see a significant
need to raise awareness of these disease states and of LINZESS as a
possible treatment option.”
The consumer awareness campaign is based on research that
revealed gaps in the dialogue when and if adult patients with IBS-C
or CIC describe their symptoms to their doctor. The comprehensive
campaign includes print advertisements in highly visible consumer
magazines such as People, Cooking Light and Better Homes &
Gardens; television advertising during several Top 10 programs
including Modern Family, The Voice and NCIS; online advertising; an
updated brand web site (www.linzess.com); and brochures available
in doctors’ offices and pharmacies.
“Forest has traditionally focused primarily on physician-facing
activities rather than DTC, but with LINZESS, we felt we had a
unique opportunity to reach patients who were having a difficult
time identifying and conveying the symptoms they were
experiencing,” said Bill Meury, executive vice president, sales and
marketing at Forest. “We were struck by market research showing
that many IBS-C and CIC sufferers don’t fully describe the
severity, frequency, and recurring nature of their symptoms to
their doctors, sometimes resulting in a misdiagnosis of common,
occasional constipation. This campaign is intended to facilitate a
more comprehensive conversation between adult patients and
physicians, and to raise consumer awareness about these diseases
and LINZESS as a treatment option.”
LINZESS is the first and only FDA-approved treatment in a new
class of medicines for IBS-C and CIC known as GC-C agonists. It
became available to adult IBS-C or CIC patients in December 2012,
and it has been shown in clinical trials to significantly reduce
abdominal pain in IBS-C patients and significantly increase bowel
movement frequency in both IBS-C patients and CIC patients. LINZESS
is contraindicated in pediatric patients up to 6 years of age. The
use of LINZESS in pediatric patients 6 through 17 years of age
should be avoided.
The most common side effect of LINZESS is diarrhea.
About LINZESS (linaclotide)
LINZESS is the first and only guanylate cyclase-C (GC-C) agonist
approved by the FDA and is indicated for the treatment of both
irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC) in adults. 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 and incomplete evacuation associated with CIC.
The recommended dose is 290 mcg for IBS-C patients and 145 mcg for
CIC patients. LINZESS should be taken at least 30 minutes before
the first meal of the day.
LINZESS is thought to work in two ways based on nonclinical
studies. LINZESS 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.
In placebo-controlled Phase III clinical trials of more than
2,800 adults, LINZESS was shown to reduce abdominal pain in IBS-C
patients and increase bowel movement frequency in both IBS-C
patients and CIC patients. Improvement in abdominal pain and
constipation occurred in the first week of treatment and was
maintained throughout the 12-week treatment period. Maximum effect
on abdominal pain was seen at weeks 6-9 and maximum effect on
constipation occurred during the first week. When a subset of
LINZESS-treated patients in the trials were switched to placebo,
they reported their symptoms returned toward pretreatment levels
within one week, while placebo-treated patients switched to LINZESS
reported symptom improvements. LINZESS is contraindicated in
pediatric patients up to 6 years of age. The use of LINZESS in
pediatric patients 6 through 17 years of age should be avoided. In
nonclinical studies, administration of a single, clinically
relevant adult oral dose of linaclotide caused deaths in young
juvenile mice. LINZESS has not been studied in pediatric patients.
In adults with IBS-C or CIC treated with LINZESS, the most commonly
reported adverse event was diarrhea.
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 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.
Ironwood and Forest Laboratories, Inc. are co-promoting LINZESS
in the United States. 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® is a trademark owned by Ironwood Pharmaceuticals,
Inc.
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, the European Union, 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. The Company markets a portfolio of branded drug
products and develops new medicines to treat patients suffering
from diseases principally in the following therapeutic areas:
central nervous system, cardiovascular, gastrointestinal,
respiratory, anti-infective, and cystic fibrosis. Our strategy of
acquiring product rights for development and commercialization
through licensing, collaborative partnerships, and targeted mergers
and acquisitions allows us to take advantage of attractive
late-stage development and commercial opportunities, thereby
managing the risks inherent in drug development. The Company 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, including
statements about the goals and components of the patient awareness
campaign. These statements involve a number of risks and
uncertainties, including the risks that the campaign is not as
successful as anticipated, components of the campaign need to be
either modified or canceled, Forest and Ironwood need to or choose
to spend more on the campaign than originally anticipated, or there
is less or no increased demand for LINZESS resulting from the
campaign, 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.
Photos/Multimedia Gallery Available:
http://www.businesswire.com/multimedia/home/20140410005260/en/
Forest Laboratories, Inc.Media Relations:Amanda Kaufman,
646-231-7316amanda.kaufman@frx.comorInvestor Relations:Frank J.
Murdolo, 212-224-6714,media.relations@frx.comorIronwood
Pharmaceuticals, Inc.Media Relations:Trista Morrison,
617-374-5095tmorrison@ironwoodpharma.comorInvestor Relations:Mary
Conway, 617-621-8308mconway@ironwoodpharma.com
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