— Received FDA Approval of LINZESS™ (linaclotide) for Treatment of
Adult Patients with IBS-C or CIC; Prepared for Commercial Launch in
December —
— Received Positive Opinion from CHMP Recommending Approval of
linaclotide for Treatment of Adults with IBS-C in E.U. —
— Peer-Reviewed Publications of LINZESS Phase 3 IBS-C Data in
American Journal of Gastroenterology —
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its
third quarter 2012 and recent business activities.
Third Quarter 2012 and Recent Highlights
Linaclotide
-
The U.S. Food and Drug Administration (FDA) approved LINZESS as a
once-daily treatment for adult men and women suffering from irritable
bowel syndrome with constipation (IBS-C) or chronic idiopathic
constipation (CIC). LINZESS can help to relieve abdominal pain and
constipation associated with IBS-C, and constipation and hard stools
associated with CIC. Ironwood and Forest Laboratories, Inc. expect
LINZESS to be available to U.S. patients in December 2012.
-
Ironwood and Almirall, S.A. received a positive opinion from the
European Committee for Medicinal Products for Human Use (CHMP),
recommending approval of linaclotide for the symptomatic treatment of
moderate to severe IBS-C in adults in the E.U. A decision by the
European Commission is expected in 2012. If approved, the product will
be marketed under the brand name Constella®.
-
Astellas, Ironwood's linaclotide partner in Japan, initiated a
double-blind, placebo-controlled, dose-ranging Phase 2 clinical trial
of linaclotide in more than 500 Japanese adult patients with IBS-C.
-
Results from the two Phase 3 trials of linaclotide for the treatment
of IBS-C in adults were published in the October 2012 issue of the
American Journal of Gastroenterology (AJG).
-
Ironwood and Forest will present 10 abstracts at the American College
of Gastroenterology (ACG) 2012 Annual Scientific Meeting being held in
Las Vegas from October 19-24, 2012. Data being presented include
analyses of abdominal and bowel symptoms from Phase 3 trials of
linaclotide in IBS-C and CIC, as well as data about the economic
burden of IBS-C and CIC and data on the use of patient-reported
outcomes to assess the symptoms of these conditions.
-
Ironwood and Almirall will present six abstracts and two oral
presentations at the 20th United European Gastroenterology
Week being held in Amsterdam from October 20-24, 2012. Data being
presented include analyses of abdominal and bowel symptoms from Phase
3 trials of linaclotide in IBS-C.
Research & Development
-
In addition to the company's ongoing efforts to evaluate linaclotide's
pharmacological potential in a variety of patient populations,
Ironwood continues to pioneer the guanylate cyclase-C (GC-C) agonist
space through the advancement of a second GC-C agonist, IW-9179.
IW-9179 is currently being investigated in a Phase 2a clinical trial
designed to evaluate its safety in approximately 80 patients with
functional dyspepsia.
-
Ironwood continues to advance its broader pipeline, which includes
early development candidates and discovery research efforts focused on
gastrointestinal disease, central nervous system disorders,
respiratory disease, and cardiovascular disease.
Corporate
-
Ironwood received an $85 million milestone payment from Forest for FDA
approval of LINZESS.
-
Including the $85 million milestone payment, Ironwood ended the third
quarter of 2012 with approximately $193 million of cash, cash
equivalents, and available-for-sale securities and used approximately
$47 million of net cash for operations during the nine months ended
September 30, 2012.
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m. Eastern
Time, on Tuesday, October 16, to discuss its third quarter 2012 and
recent business activities. Individuals interested in participating in
the call should dial (877) 643-7155 (U.S. and Canada) or (914)
495-8552 (international) using conference ID number 37414107. To access
the webcast, please visit the Investors section of Ironwood's website at www.ironwoodpharma.com
at least 15 minutes prior to the start of the call to ensure adequate
time for any software downloads that may be required. The call will be
available for replay via telephone starting today at approximately 11:30
a.m. Eastern Time, running through 11:59 p.m. Eastern Time on October
23, 2012. To listen to the replay, dial (855) 859-2056 (U.S. and Canada)
or (404) 537-3406 (international) using conference ID number 37414107.
The archived webcast will be available on Ironwood's website for 14 days
beginning approximately one hour after the call.
About LINZESS (linaclotide)
LINZESS is the first and only guanylate cyclase-C (GC-C) agonist
approved by the FDA 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 chronic
abdominal pain and constipation associated with IBS-C and constipation
and hard stools associated with CIC. The recommended dose is 290 mcg for
IBS-C patients and 145 mcg for CIC patients.
LINZESS binds to the GC-C receptor locally in the intestine, with no
measurable blood plasma concentrations, resulting in an increase in both
intracellular and extracellular concentrations of cyclic guanosine
monophosphate (cGMP). Elevations in intracellular cGMP are believed to
stimulate secretion of intestinal fluid and accelerate gastrointestinal
transit resulting in increased frequency of bowel movements. Elevations
in extracellular cGMP are believed to decrease activity of pain-sensing
nerves, which is thought to be responsible for a reduction in intestinal
pain, according to nonclinical models.
Ironwood and Forest will co-promote LINZESS in the United States.
Ironwood has outlicensed linaclotide to Almirall, S.A. for European
development and commercialization and to Astellas Pharma Inc. for
development and commercialization in Japan, Indonesia, Korea, the
Philippines, Taiwan, and Thailand.
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome with constipation (IBS-C) is a chronic
functional gastrointestinal disorder that affects as many as 13 million
people in the United States and over 20 million people in Europe. IBS-C
can have a negative impact on daily living; patients often experience
recurring abdominal pain or discomfort, constipation, and bowel symptoms
including hard or lumpy stools in more than 25% of bowel movements, and
soft or watery stools in less than 25% of bowel movements. There are
currently few available therapies to treat this disorder.
About Chronic Idiopathic Constipation (CIC)
Chronic idiopathic constipation (CIC) is a functional gastrointestinal
disorder in which individuals experience infrequent bowel movements
(less than three times per week) for at least three months. Patients who
suffer from CIC may also experience a sensation of incomplete evacuation
and hard stools. As many as 35 million Americans may suffer from
symptoms associated with CIC.
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%).
Drug Interactions
No drug-drug interaction studies have been conducted with LINZESS.
Linaclotide and its active metabolite are not measurable in plasma
following administration of the recommended clinical doses; hence, no
systemic drug-drug interactions or drug interactions mediated by plasma
protein binding of linaclotide or its metabolite are anticipated
Linaclotide does not interact with the cytochrome P450 enzyme system
based on the results of in vitro studies. In addition, linaclotide is
neither a substrate nor an inhibitor of the efflux transporter
P-glycoprotein (P-gp).
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial
pharmaceutical company dedicated to the art and science of great
drugmaking. LINZESS (linaclotide), Ironwood's guanylate cyclase-C (GC-C)
agonist, is an FDA-approved drug for the treatment of adults with
irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic
constipation (CIC). Ironwood also has a growing pipeline of additional
drug candidates in earlier stages of development. Ironwood is located in
Cambridge, Mass. To learn more, visit www.ironwoodpharma.com.
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, the anticipated time period
in which LINZESS will be available for IBS-C and CIC patients,
linaclotide's potential as a treatment for IBS-C or CIC, the potential
approval of linaclotide in the E.U. as a result of the positive CHMP
opinion, Astellas's development plans for linaclotide in Japan, and our
development plans for IW-9179 and our other pipeline programs . 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
the risks that we are unable to launch LINZESS in the U.S. as
anticipated, we or our partners are unable to manufacture or distribute
a sufficient commercial supply of LINZESS to enable a successful
commercial launch, adoption of LINZESS by physicians or patients is not
as rapid as anticipated, serious adverse events arise in patients that
are deemed to be definitely or probably related to linaclotide
treatment, the incidence or severity of diarrhea in patients treated
with linaclotide is higher than expected, the European Commission does
not agree with the CHMP recommendation for approval of linaclotide in
the E.U., or advancements in our development pipeline do not proceed as
expected, as well as risks related to the difficulty of predicting
regulatory approvals and the acceptance of and demand for new
pharmaceutical products. Applicable risks also include those that are
listed in our Quarterly Report on Form 10-Q for the quarter ended June
30, 2012, in addition to the risk factors that are listed from time to
time in our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q
and any subsequent SEC filings. We undertake no 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.
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
|
|
|
|
September 30,
2012
|
|
December 31,
2011
|
Assets
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities
|
|
$
|
193,323
|
|
$
|
164,016
|
Accounts receivable, net
|
|
|
182
|
|
|
652
|
Inventory
|
|
|
965
|
|
|
—
|
Prepaid expenses and other assets
|
|
|
7,877
|
|
|
2,899
|
Total current assets
|
|
|
202,347
|
|
|
167,567
|
Property and equipment, net
|
|
|
36,470
|
|
|
33,625
|
Other assets
|
|
|
7,701
|
|
|
7,785
|
Total assets
|
|
$
|
246,518
|
|
$
|
208,977
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
Accounts payable, net and accrued expenses
|
|
$
|
27,636
|
|
$
|
24,568
|
Current portion of capital lease obligations
|
|
|
280
|
|
|
233
|
Current portion of deferred rent
|
|
|
4,531
|
|
|
4,042
|
Current portion of deferred revenue
|
|
|
3,130
|
|
|
36,291
|
Total current liabilities
|
|
|
35,577
|
|
|
65,134
|
Capital lease obligations
|
|
|
361
|
|
|
422
|
Deferred rent
|
|
|
9,690
|
|
|
12,435
|
Deferred revenue
|
|
|
18,782
|
|
|
21,130
|
Total stockholders' equity
|
|
|
182,108
|
|
|
109,856
|
Total liabilities and stockholders' equity
|
|
$
|
246,518
|
|
$
|
208,977
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
(unaudited)
|
|
|
|
Three Months Ended
September 30,
|
|
Nine Months Ended
September 30,
|
|
|
2012
|
2011
|
2012
|
2011
|
Revenue
|
|
$
|
96,413
|
|
$
|
12,218
|
|
$
|
123,265
|
|
$
|
33,717
|
|
Operating expenses:
|
|
|
|
|
|
|
Research and development
|
|
|
23,453
|
|
|
22,905
|
|
|
85,201
|
|
|
61,869
|
|
General and administrative
|
|
|
25,352
|
|
|
10,929
|
|
|
66,926
|
|
|
30,958
|
|
Total operating expenses
|
|
|
48,805
|
|
|
33,834
|
|
|
152,127
|
|
|
92,827
|
|
Income (loss) from operations
|
|
|
47,608
|
|
|
(21,616
|
)
|
|
(28,862
|
)
|
|
(59,110
|
)
|
Other income (expense), net
|
|
|
27
|
|
|
986
|
|
|
93
|
|
|
1,235
|
|
Net Income (loss) before income tax expense
|
|
|
47,635
|
|
|
(20,630
|
)
|
|
(28,769
|
)
|
|
(57,875
|
)
|
Income tax expense
|
|
|
—
|
|
|
3
|
|
|
—
|
|
|
3
|
|
Net income (loss)
|
|
$
|
47,635
|
|
$
|
(20,633
|
)
|
$
|
(28,769
|
)
|
$
|
(57,878
|
)
|
|
|
|
|
|
|
|
Net income (loss) per share—basic
|
|
$
|
0.44
|
|
$
|
(0.21
|
)
|
$
|
(0.27
|
)
|
$
|
(0.58
|
)
|
Net income (loss) per share—diluted
|
|
$
|
0.42
|
|
$
|
(0.21
|
)
|
$
|
(0.27
|
)
|
$
|
(0.58
|
)
|
|
|
|
|
|
|
|
Weighted average number of common shares used in net income (loss)
per share —basic
|
|
|
107,266,823
|
|
|
100,174,100
|
|
|
106,036,522
|
|
|
99,699,545
|
|
Weighted average number of common shares used in net income (loss)
per share —diluted
|
|
|
114,337,327
|
|
|
100,174,100
|
|
|
|
106,036,522
|
|
|
99,699,545
|
|
Ironwood Pharmaceuticals, Inc.
Media Relations
Lisa
Buffington, 617-374-5103
Vice President, Corporate Communications
[email protected]
or
Investor
Relations
Meredith Kaya, 617-374-5082
Associate Director,
Investor Relations
[email protected]
Source: Ironwood Pharmaceuticals, Inc.
News Provided by Acquire Media