- At least $1 billion in LINZESS® (linaclotide) annual net sales
expected by 2020; greater than $2 billion linaclotide U.S. peak sales
- At least three additional blockbuster opportunities expected to be
in later-stage development by 2017/2018 -
- Financial strength to manage core business without raising
additional capital -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 11, 2016--
Pharmaceuticals, Inc. (NASDAQ:IRWD) today detailed its strategy to
build a top-performing commercial biotechnology company generating
rapid, sustainable, high-margin growth. As part of this strategy, the
Company outlined three- and five-year operational and financial goals,
which include bringing new medicines to market, advancing several
blockbuster opportunities into later-stage clinical development, and
generating growing cash flows. These goals do not include the potential
upside impact of any acquisitions, licensing or other corporate
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“Ironwood is one of the few companies in the biopharmaceutical industry
to have successfully discovered, developed and commercialized a product
that has become the branded prescription market leader in its category,”
said Peter Hecht, chief executive officer of Ironwood. “Our flagship
product LINZESS is well on its way to becoming our first blockbuster: in
just its third year on the market, it generated
approximately $450 million in 2015 U.S. net sales, annual growth of more
than 50%, and is delivering rapidly expanding commercial margins. We are
advancing potential blockbuster products for IBS-C/CIC,
vascular/fibrotic diseases, and refractory GERD, and we believe the
growing contribution from our commercial business and cash on hand are
sufficient to fully fund our core business without the need to raise
2015 Accomplishments and Updates:
Ironwood is advancing internally-developed programs in at least three
important franchises: irritable bowel syndrome with constipation
(IBS-C)/chronic idiopathic constipation (CIC), where LINZESS and
linaclotide colonic release may represent a peak U.S. sales
opportunity exceeding $2 billion (shared 50/50 with Allergan plc),
with additional global potential; vascular and fibrotic disease, where
multiple sGC stimulators may each represent a peak sales opportunity
exceeding $1 billion; and refractory gastroesophageal reflux disease
(GERD), where IW-3718 may represent a peak sales opportunity exceeding
LINZESS U.S. net sales, based on estimates provided by Allergan, are
expected to be approximately $450 million for the full year 2015, an
increase of more than 50% compared to the full year 2014. LINZESS U.S.
net sales are reported by Allergan, and final numbers will be provided
during Ironwood’s Fourth Quarter 2015 Investor Update.
Nearly 1 million unique patients have filled a LINZESS prescription
since its launch in December 2012, according to IMS Health.
2017/2018 Operational and Financial Goals:
Ironwood expects its current business to become cash flow positive
during this period.
At least three clinical programs targeting major opportunities are
expected to be in later-stage clinical development by the end of 2018.
These may include linaclotide colonic release for the treatment of
IBS-C, IW-3718 for the treatment of refractory GERD, at least one sGC
stimulator in an indication to be determined based on early-stage
clinical data, a second formulation of linaclotide colonic release
intended for the treatment of IBS-mixed and IW-9179 for the treatment
of diabetic gastroparesis.
At least two additional linaclotide launches are anticipated by the
end of 2018, beginning with the 72 mcg dose of linaclotide in the U.S.
in the first half of 2017.
By the end of 2020, Ironwood expects:
To be generating rapidly growing cash flows.
LINZESS annual net sales to be at least $1 billion.
At least two additional product launches from Ironwood’s internal
At least five Phase III clinical programs ongoing.
“Ironwood’s proven expertise in R&D innovation, commercial performance
and strategic partnering, performed by an incredibly talented team
committed to financial discipline, have allowed us to build the bedrock
of a successful commercial biotechnology company,” said Hecht. “We
created a treatment for a significant unmet medical need in which
patients are motivated to seek relief, and we are now pushing hard to
repeat this success with the product candidates in our pipeline as we
work to deliver on our commitment to sustainable, high-margin growth as
one of the industry’s top-performing commercial biotechnology companies.”
Ironwood will provide further details on this strategy during its
presentation at the 34th Annual J.P. Morgan Healthcare Conference on
Monday, January 11, 2016 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern
Time at the Westin St. Francis Hotel in San Francisco. The presentation
will be followed by a question and answer session that will begin at
2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time.
A live webcast of Ironwood’s presentation and the question and answer
session will be accessible through the Investors section of the
company’s website at www.ironwoodpharma.com.
To access the webcast, please log on to the Ironwood website
approximately 15 minutes prior to the start time to ensure adequate time
for any software downloads that may be required. A replay of the webcast
will be available on Ironwood’s website for 14 days following the
About Linaclotide Colonic Release
Results derived from responses to a web based survey commissioned by
Forest Pharmaceuticals and Ironwood Pharmaceuticals suggest that up to
40 million adults in the U.S. may suffer from irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation (CIC).
Linaclotide is indicated for the treatment of these conditions in adults
and is the first and only FDA-approved guanylate cyclase‐C (GC‐C)
agonist. It binds to the GC-C receptor in the intestine and is thought
to work in two ways, based on non-clinical studies: by decreasing the
activity of pain-sensing nerves and by increasing fluid secretion into
the intestine. The investigational linaclotide colonic release
formulations are second generation GC-C agonists designed to provide
targeted delivery of linaclotide to the distal small intestine and
colon. This may further decrease the activity of key pain-sensing nerves
in the colon with a smaller increase in fluid secretion. Ironwood
believes a linaclotide colonic relief formulation designed to improve
abdominal pain relief could offer the opportunity to drive growth and
expand the IBS-C/CIC market.
About Ironwood’s sGC Platform
Dysregulation of the enzyme soluble guanylate cyclase (sGC) may play a
role in multiple vascular and fibrotic diseases with high unmet need
such as pulmonary arterial hypertension, congestive heart failure,
Duchenne muscular dystrophy, diabetic nephropathy, achalasia, and other
disorders. Found throughout the body, sGC is part of a signaling pathway
that regulates blood flow, inflammation and fibrosis and, its impairment
can lead to end organ failure and death. Ironwood established its
expertise in this signaling pathway through the discovery and
development of linaclotide, a guanylate cyclase C (GC-C) agonist.
Stimulation of sGC is a clinically validated approach, and Ironwood
leveraged its GC-C expertise to discover a broad library of sGC
stimulators. Ironwood’s investigational sGC stimulators IW-1973 and
IW-1701 have demonstrated high tissue penetration in non-clinical models
and are in Phase I studies with data expected in 2016.
About IW-3718 and Refractory Gastroesophageal Reflux Disease (GERD)
Greater than 45 million Americans are estimated to suffer from
refractory gastroesophageal reflux disease (GERD), and of those an
estimated 10 million experience continued symptoms such as heartburn and
regurgitation despite receiving the current standard of care treatment
with a proton pump inhibitor (PPI) to suppress stomach acid production.
There are a limited number of FDA-approved treatment options for these
patients. Research suggests reflux of bile from the intestine into the
stomach and esophagus may play a role in the ongoing symptoms of
refractory GERD patients. IW-3718 is a novel, gastric retentive
formulation of a bile acid sequestrant designed to reduce bile exposure
in the esophagus. Data from an exploratory Phase IIa clinical study
indicated IW-3718 improved heartburn and certain other symptoms
associated with refractory GERD, and a Phase IIb trial is expected to
initiate in early 2016.
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
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 Allergan plc are co-promoting LINZESS in the United States.
Linaclotide is marketed by Allergan 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 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.
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
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 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
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.
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.
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.
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.
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including, but not limited to, statements about development,
launch and commercialization plans for linaclotide and our product
candidates and our corporate goals; commercial efforts for linaclotide
and the other products that we promote and the drivers, timing, impact
and results thereof; market size, growth and opportunity, including peak
sales, and potential demand for linaclotide, our product candidates and
the other products that we promote, as well as their potential impact on
applicable markets; the potential indications for, and benefits of,
linaclotide and our product candidates; the anticipated timing of
pre-clinical, clinical and regulatory developments; the design, timing
and results of clinical and preclinical studies; the timing of filings
with regulatory authorities; expected periods of patent exclusivity; the
strength of the intellectual property protection for our product and
product candidates; potential business development activity and the
timing and impact thereof; profitability of the U.S. LINZESS brand
collaboration with Allergan plc; and our company's financial performance
and results, and guidance and expectations related thereto, including
our projected cash needs and expectations regarding the need for future
financings, cash flows, operating expenses, revenue growth, operating
leverage, commercial margin, and LINZESS net sales and marketing and
sales expense. 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, those related to
pre-clinical and clinical development, manufacturing, and formulation
development; the risk that findings from our completed nonclinical and
clinical studies may not be replicated in later studies; decisions made
by U.S. regulatory authorities, the U.S. Patent and Trademark Office and
their foreign counterparts; the risk that we may never get sufficient
patent protection for linaclotide and our product candidates;
intellectual property rights of competitors or potential competitors;
efficacy, safety and tolerability of linaclotide and our product
candidates; competition in disease states; the commercial potential of
linaclotide, our product candidates and the other products that we
promote; the risk that our planned investments do not have the
anticipated effect on our company revenues, linaclotide or our product
candidates; the risk that we are unable to identify and execute on
business development opportunities in a cost-effective and timely manner
or that such opportunities do not have the impact expected; the risk
that we are unable to manage our operating expenses and capital
expenditures due to foreseeable or unforeseeable events or occurrences;
and the risk that we and Allergan are unable to commercialize LINZESS
effectively or within the guided range of expenses. Applicable risks
also include those that are listed under the heading "Risk Factors" and
elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter
ended September 30, 2015, in addition to the risk factors that are
listed from time to time in Ironwood's Annual Reports on Form 10‐K,
Quarterly Reports on Form 10‐Q and any other subsequent SEC filings.
Ironwood undertakes no 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.
Further, the 2015 LINZESS U.S. net sales information included in this
press release is preliminary and based on estimates; it may change as we
receive final 2015 data from Allergan and as we and Allergan complete
the preparation of our respective 2015 financial statements. LINZESS
U.S. net sales are reported by Allergan.
View source version on businesswire.com: http://www.businesswire.com/news/home/20160111005571/en/
Source: Ironwood Pharmaceuticals, Inc.
Ironwood Pharmaceuticals, Inc.
Meredith Kaya, 617-374-5082