MADISON, Wis., & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Exact
Sciences Corp. (NASDAQ: EXAS) and Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today an agreement to
co-promote Exact Sciences' Cologuard®, the first and only FDA-approved
noninvasive stool DNA screening test for colorectal cancer. The
agreement provides for the near-term expansion of Cologuard promotional
efforts through the use of Ironwood's clinical sales specialists to more
than double the number of physicians reached in the United States. The
non-exclusive co-promotion agreement covers an initial one-year term
with the opportunity for extension.
Ironwood's clinical sales specialists are expected to begin Cologuard
promotional efforts in the second quarter of 2015, educating health care
practitioners to whom they currently detail LINZESS® (linaclotide).
LINZESS is the first and only approved therapy in a class of drugs that
works differently to treat irritable bowel syndrome with constipation
(IBS-C) and chronic idiopathic constipation (CIC) in adults. The
agreement augments Exact Sciences' 140 sales representatives with
Ironwood's team of approximately 160 sales representatives.
"As we continue growing the Cologuard business and providing world-class
service, this agreement offers an opportunity to broaden our reach among
primary care physicians and gastroenterologists by engaging with them
through sales calls and medical education," said Maneesh Arora, chief
operating officer of Exact Sciences. "Ironwood's brand and the expertise
of their proven sales force complement the early success of our sales
team and strong physician interest in Cologuard."
"We at Ironwood are committed to innovation in gastrointestinal health,
and we look forward to expanding our conversations with health care
providers to include the importance of colon cancer screening," said Tom
McCourt, chief commercial officer of Ironwood. "Primary care
physicians and gastroenterologists place a high priority on cancer
screening and diagnostics. We have built strong relationships with many
of these physicians through our discussions about LINZESS for the
treatment of adult IBS-C or CIC patients, and we believe introducing
Cologuard to these physicians has the potential to enable millions of
average risk patients unwilling to undergo a screening colonoscopy to be
screened for colon cancer."
Under the terms of the deal, Ironwood will be compensated from the net
sales generated from the physicians on whom they call. LINZESS will
remain the first-position product for the Ironwood sales team. Exact
Sciences will maintain responsibility for all other aspects of
commercialization of Cologuard. The companies will also collaborate on
medical education initiatives to support more in-depth understanding of
Cologuard and the importance of colorectal cancer screening.
About Cologuard
Cologuard is the first and only FDA approved noninvasive stool DNA
screening test for colorectal cancer. Cologuard offers people 50 years
and older who are at average risk for colorectal cancer an easy-to-use
screening test. Cologuard is intended for the qualitative detection of
colorectal neoplasia associated DNA markers and for the presence of
occult hemoglobin in human stool. Cologuard found 92 percent of
colorectal cancers with 87 percent specificity in a cross-sectional
study that included 10,000 average risk patients. Cologuard does not
require medication, dietary restrictions or bowel preparation prior to
taking the test. Both false positives and false negatives do occur. Any
positive result should be followed by a diagnostic colonoscopy. A
negative Cologuard test result does not guarantee absence of cancer or
advanced adenoma. Following a negative result, patients should continue
participating in a screening program at an interval and with a method
appropriate for the individual patient. Cologuard performance when used
for repeat testing has not been evaluated or established. Available by
prescription only, Cologuard is not right for everyone. Ask your doctor
or visit www.CologuardTest.com
for more information.
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 under 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 due to dehydration in young juvenile mice.
The safety and efficacy of LINZESS in pediatric patients under 18 years
of age have not been established. In adults with IBS-C or CIC treated
with LINZESS, the most commonly reported adverse event was diarrhea.
Ironwood and Actavis plc 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 AB
for development and commercialization in China.
LINZESS 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 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 Exact Sciences
Exact Sciences Corp. (NASDAQ: EXAS) is a molecular diagnostics company
focused on the early detection and prevention of colorectal cancer. The
company has exclusive intellectual property protecting its noninvasive,
molecular screening technology for the detection of colorectal cancer.
Cologuard is included in the colorectal cancer screening guidelines of
the American Cancer Society and stool DNA is included in the U.S.
Multi-Society Task Force on Colorectal Cancer. For more information,
please visit the company's website at www.exactsciences.com,
follow us on Twitter @ExactSciences
or find us on Facebook.
LINZESS® and CONSTELLA® are trademarks owned by Ironwood
Pharmaceuticals, Inc. COLOGUARD® is a trademark of Exact Sciences, Corp.
Any other trademarks referred to in this press release are the property
of their respective owners. All rights reserved.
This press release contains forward-looking statements. Investors of
Ironwood Pharmaceuticals, Inc. or Exact Sciences Corp. are cautioned not
to place undue reliance on these forward-looking statements, including,
but not limited to, the promotional efforts and success of Ironwood's
clinical sales specialists with respect to Cologuard and LINZESS. 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,
but are not limited to, the potential that Ironwood may not effectively
promote Cologuard. Applicable risks also include those that are listed
under the heading "Risk Factors" and elsewhere in each of Exact
Sciences' and Ironwood's Annual Report on Form 10-K for the year ended
December 31, 2014, in addition to the risk factors that are listed from
time to time in each of Exact Sciences' and Ironwood's Annual Reports on
Form 10‐K, Quarterly Reports on Form 10‐Q and any other subsequent SEC
filings. Neither Exact Sciences nor Ironwood undertakes any obligation
to update these forward-looking statements to reflect events or
circumstances occurring after this press release. Except as otherwise
noted, 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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Ironwood Pharmaceuticals, Inc.
Media Relations:
Trista
Morrison, 617-374-5095
tmorrison@ironwoodpharma.com
or
Investor
Relations:
Meredith Kaya, 617-374-5082
mkaya@ironwoodpharma.com
or
Exact
Sciences Corp.
Media and Investor Relations:
J.P.
Fielder, 202-746-6352
jfielder@exactsciences.com
Source: Ironwood Pharmaceuticals, Inc. and Exact Sciences Corp.
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