– Ironwood capitalizing on GI leadership and
expertise in an effort to bring innovative therapies to patients
–
– Strategy centered on accelerating LINZESS®
(linaclotide) growth and advancing late-stage programs IW-3718 and
MD-7246 –
– Business poised to drive revenue growth and
begin generating profits –
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused
healthcare company, today announced that it has completed the
tax-free spin-off of its soluble guanylate cyclase (sGC) business,
Cyclerion Therapeutics, Inc. (Cyclerion).
Ironwood is executing on its strategy to drive growth as a
GI-focused company, building upon its commercial success with
LINZESS and advancing its late-stage, first-in-category development
candidates including IW-3718 for the potential treatment of
persistent gastroesophageal reflux disease (GERD) and MD-7246 for
the potential treatment of abdominal pain associated with irritable
bowel syndrome with diarrhea (IBS-D). In 2018, Ironwood grew
revenue 16% year-over-year to $347 million, driven primarily by
U.S. LINZESS collaboration revenue of $264 million and linaclotide
API sales of $70 million. In 2019, Ironwood expects revenue to be
in the range of $370 to $390 million. The company also expects to
provide guidance on 2019 non-GAAP profitability from continuing
operations on its first quarter 2019 investor update.
Mark Mallon, chief executive officer of Ironwood, stated, “Today
marks the beginning of a new chapter for Ironwood, one that
combines a strong drug development and commercial foundation with a
sharpened focus on our core objective – creating medicines that
make a difference for people living with GI diseases. We are well
positioned to deliver on our strategic initiatives, which include
accelerating growth of LINZESS, advancing our GI development
portfolio, and generating profits from continuing operations on a
non-GAAP basis. I am honored and excited to lead a spectacular team
in this next phase of Ironwood’s growth and development, and to
drive further innovation within the GI market in order to deliver
differentiated therapies to patients.”
Cyclerion common stock will begin regular way trading on the
Nasdaq Global Select Market under the symbol “CYCN” on April 2,
2019. Ironwood will continue to trade on Nasdaq under the ticker
symbol "IRWD."
As previously announced, the separation was completed through
today’s distribution to Ironwood shareholders of one share of
Cyclerion common stock for every 10 shares of Ironwood common stock
held as of the close of business on March 19, 2019, the record date
for the distribution. Ironwood shareholders of record will also
receive cash in lieu of any fractional shares of Cyclerion common
stock that those holders would have received after application of
the above ratio.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused
healthcare company focused on creating medicines that make a
difference for patients living with GI diseases. We discovered,
developed and are commercializing linaclotide, the U.S. branded
prescription market leader for adults with irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation (CIC).
We are currently advancing a Phase IIIb trial evaluating the
efficacy and safety of linaclotide on multiple abdominal symptoms,
including bloating, pain, and discomfort, in adult patients with
IBS-C.
We are also advancing two late-stage, first-in-category GI
product candidates: IW-3718 is a gastric retentive formulation of a
bile acid sequestrant being developed for the potential treatment
of persistent gastroesophageal reflux disease, and MD-7246 is a
delayed-release formulation of linaclotide that is being evaluated
as an oral, intestinal, non-opioid, pain-relieving agent for
patients suffering from abdominal pain associated with IBS with
diarrhea.
Ironwood was founded in 1998 and is headquartered in Cambridge,
Mass. For more information, please visit our newly launched website
at www.ironwoodpharma.com or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely
posted in both these locations.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand for the treatment of adult
patients with irritable bowel syndrome with constipation (IBS-C)
and chronic idiopathic constipation (CIC), based on IQVIA data.
Since its FDA approval in August of 2012 and subsequent launch in
December 2012, greater than 2.5 million unique patients have filled
approximately 12.2 million prescriptions for LINZESS, according to
IQVIA.
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, straining, and
incomplete evacuation associated with CIC. The recommended dose is
290 mcg for IBS-C patients and 145 mcg for CIC patients, with a
72-mcg dose approved for use in CIC depending on individual patient
presentation or tolerability. LINZESS should be taken at least 30
minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 6
years of age. The safety and effectiveness of LINZESS in pediatric
patients less than 18 years of age have not been established. In
neonatal mice, linaclotide increased fluid secretion as a
consequence of GC-C agonism resulting in mortality within the first
24 hours due to dehydration. Due to increased intestinal expression
of GC-C, patients less than 6 years of age may be more likely than
patients 6 years of age and older to develop severe diarrhea and
its potentially serious consequences. In adults with IBS-C or CIC
treated with LINZESS, the most commonly reported adverse event was
diarrhea.
LINZESS is not a laxative; it is the first medicine approved by
the FDA in a class called guanylate cyclase-C (GC-C) agonists.
LINZESS contains a peptide called linaclotide that activates the
GC-C receptor in the intestine. Activation of GC-C is thought to
result 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 the United States, Ironwood and Allergan plc co-develop and
co-commercialize LINZESS for the treatment of adults with IBS-C or
CIC. In Europe, Allergan markets linaclotide under the brand name
CONSTELLA® for the treatment of adults with moderate to severe
IBS-C. In Japan, Ironwood's partner Astellas markets linaclotide
under the brand name LINZESS for the treatment of adults with IBS-C
or CIC. Ironwood also has partnered with AstraZeneca for
development and commercialization of LINZESS in China, and with
Allergan for development and commercialization of linaclotide in
all other territories worldwide.
About IW-3718
IW-3718 is a novel, gastric retentive formulation of
colesevelam, a bile acid sequestrant, developed by Ironwood using
the proprietary Acuform® drug delivery formulation technology
licensed from Assertio Therapeutics, Inc. IW-3718 is designed to
deliver the bile acid sequestrant to the stomach over an extended
period of time where it is positioned to intercept bile before it
reaches the esophagus. Data from non-clinical and clinical studies
collectively support the extended release and gastric-retentive
profile of IW-3718. Ironwood has issued patents and pending patent
applications for IW-3718 that are expected to provide patent
coverage into the mid-2030s.
About MD-7246
MD-7246 is a delayed release formulation of linaclotide being
evaluated by Ironwood and its partner Allergan as an oral,
non-opioid, pain-relieving agent for patients in the U.S. suffering
from abdominal pain associated with IBS with diarrhea (IBS-D).
Linaclotide 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. MD-7246 is designed
to provide targeted delivery of linaclotide to the colon, where the
majority of the abdominal pain associated with IBS is believed to
originate, with minimal effect on fluid secretion thereby reducing
its impact on bowel function. Ironwood and Allergan have issued
patents and pending patent applications for MD-7246 that are
expected to provide patent coverage into the mid-2030s.
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment
of both irritable bowel syndrome with constipation (IBS-C) and
chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN
PEDIATRIC PATIENTS
LINZESS is contraindicated in patients
less than 6 years of age. In nonclinical studies in neonatal mice,
administration of a single, clinically relevant adult oral dose of
linaclotide caused deaths due to dehydration. Use of LINZESS should
be avoided in patients 6 years to less than 18 years of age. The
safety and effectiveness of LINZESS have not been established in
patients less than 18 years of age.
Contraindications
- LINZESS is contraindicated in patients
less than 6 years of age due to the risk of serious
dehydration.
- LINZESS is contraindicated in patients
with known or suspected mechanical gastrointestinal
obstruction.
Warnings and Precautions
Pediatric Risk
- LINZESS is contraindicated in patients
less than 6 years of age. The safety and effectiveness of LINZESS
in patients less than 18 years of age have not been established. In
neonatal mice, linaclotide increased fluid secretion as a
consequence of GC-C agonism resulting in mortality within the first
24 hours due to dehydration. Due to increased intestinal expression
of GC-C, patients less than 6 years of age may be more likely than
patients 6 years of age and older to develop severe diarrhea and
its potentially serious consequences.
- Use of LINZESS should be avoided in
pediatric patients 6 years to less than 18 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 years to less than 18 years of age.
Diarrhea
- Diarrhea was the most common adverse
reaction in LINZESS-treated patients in the pooled IBS-C and CIC
double-blind placebo-controlled trials. The incidence of diarrhea
was similar in the IBS-C and CIC populations. Severe diarrhea was
reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and
in <1% of 72 mcg LINZESS-treated CIC patients. If severe
diarrhea occurs, dosing should be suspended and the patient
rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than
placebo)
- In IBS-C clinical trials: 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 trials of a 145 mcg dose:
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%). In a CIC trial of a
72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension
(2% vs <1%).
Please see full Prescribing Information including Boxed Warning:
http://www.allergan.com/assets/pdf/linzess_pi
IRONWOOD®, the three-leaf logo, LINZESS® and CONSTELLA® are
registered trademarks of Ironwood Pharmaceuticals, Inc. Any other
trademarks referred to in this press release are the property of
their respective owners. All rights reserved.
Forward-Looking Statements
This press release contains forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements, including statements about Ironwood’s
ability to achieve profitability and its competitiveness and
strategic positioning; the development, launch, commercial
availability and commercial potential of our products, product
candidates and the other products that we promote and the drivers,
timing, impact and results thereof; the potential indications for,
and benefits of, our products and product candidates; patent
coverage for IW-3718 and MD-7246; and our financial performance and
results, and guidance and expectations related thereto (including
the drivers and timing thereof), including expectations related to
revenue. 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 those related to the possibility that we
may not achieve the expected benefits of the separation and that
the separation could harm our business, results of operations and
financial condition; the risk that the costs of the separation
outweigh the benefits of the separation; the effectiveness of
development and commercialization efforts by us and our partners;
preclinical 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;
efficacy, safety and tolerability of our products and product
candidates; decisions by regulatory and judicial authorities; the
risk that we may never get sufficient patent protection for our
products and product candidates or that we are not able to
successfully protect such patents; the outcomes in legal
proceedings to protect or enforce the patents relating to our
products and product candidates, including ANDA litigation;
developments in the intellectual property landscape; challenges
from and rights of competitors or potential competitors; the risk
that our planned investments do not have the anticipated effect on
our company revenues, our products or product candidates; the risk
that we are unable to manage our operating expenses or cash use for
operations, or are unable to commercialize our products, within the
guided ranges or otherwise as expected; the risk that Ironwood may
not achieve profitability; the risk that a separation may adversely
impact our ability to attract or retain key personnel; and the
risks listed under the heading “Risk Factors” and elsewhere in
Ironwood’s Annual Report on Form 10-K for the year ended December
31, 2018, and in our subsequent SEC filings. These forward-looking
statements (except as otherwise noted) speak only as of the date of
this press release, and Ironwood undertakes no obligation to update
these forward-looking statements.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190401005676/en/
Media and Investors:Meredith Kaya, 617-374-5082Vice
President, Investor Relations and Corporate
Communicationsmkaya@ironwoodpharma.comMedia:Maryann Quinn,
617-374-3952Director, Corporate
Communicationsmquinn@ironwoodpharma.com
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