CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its
second quarter 2012 and recent business activities.
Second Quarter 2012 and Recent Highlights
Linaclotide
-
In April, the U.S. Food and Drug Administration (FDA) notified
Ironwood and Forest Laboratories, Inc. that it will require a
three-month extension to complete its review of the data supporting
the New Drug Application (NDA) for linaclotide for the treatment of
irritable bowel syndrome with constipation (IBS-C) and chronic
constipation (CC). FDA action has been extended to September 2012.
Ironwood and Forest continue to plan for a 2012 launch.
-
Ironwood and Forest presented linaclotide-related data in one oral
presentation and sixteen poster presentations at the 2012 Digestive
Disease Week (DDW) annual meeting held in San Diego from May 19-22,
2012. Included in these presentations were data about the effect of
linaclotide on abdominal pain and other symptoms in Phase 3 clinical
trials involving patients with IBS- C.
-
Ironwood submitted a Clinical Trial Application (CTA) to China's State
Food and Drug Administration for a Phase 3 trial of linaclotide in
patients with IBS-C. The CTA has been accepted for review.
-
As part of the strategy to maximize the utility of linaclotide over
time, Ironwood and Forest have initiated a Phase 3b clinical trial to
further characterize the effect of linaclotide on abdominal symptoms
in patients with chronic constipation.
Research & Development
-
Ironwood continues to advance its 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 ended the second quarter of 2012 with approximately $158
million of cash, cash equivalents, and available-for-sale securities.
Ironwood used approximately $93 million of cash for operations during
the six months ended June 30, 2012.
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m. Eastern
Time, July 17, to discuss its second 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 98056073. 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 July 31,
2012. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or
(404) 537-3406 (international) using conference ID number 98056073. The
archived webcast will be available on Ironwood's website for 14 days
beginning approximately one hour after the call.
About Linaclotide
Linaclotide, an investigational drug, is a guanylate cyclase-C agonist
(GCCA). In preclinical models, linaclotide reduced visceral
hypersensitivity, increased fluid secretion, and accelerated intestinal
transit. The effects on secretion and transit are mediated through
cyclic guanosine monophosphate (cGMP), which is also believed to
modulate the activity of local nerves to reduce pain. Linaclotide is an
orally delivered peptide that acts locally in the gut with no measurable
systemic exposure at therapeutic doses and is intended for once-daily
administration. An issued composition of matter patent for linaclotide
provides protection to 2025 in the United States. Ironwood and Forest
plan to co-promote linaclotide in the United States. Ironwood has
out-licensed linaclotide to Almirall 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)
IBS-C is a chronic functional gastrointestinal disorder characterized by
abdominal pain, abdominal discomfort, and bloating associated with
altered bowel habits, and as many as 11 million people in the U.S.
suffer from it. IBS-C can have a negative impact on daily living. There
are currently few available therapies to treat this disorder.
About Chronic Constipation (CC)
As many as 34 million Americans suffer from symptoms associated with CC
and 8.5 million patients have sought treatment. Patients with CC often
experience hard and lumpy stools, straining during defecation, a
sensation of incomplete evacuation, and fewer than three bowel movements
per week, as well as abdominal discomfort and bloating. There is a high
rate of dissatisfaction with currently available treatments for CC.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial
pharmaceutical company dedicated to the art and science of great
drugmaking. Linaclotide, Ironwood's guanylate cyclase-C agonist (GCCA),
is an investigational drug for the treatment of irritable bowel syndrome
with constipation (IBS-C) and chronic constipation (CC). The efficacy
portion of linaclotide's development program has been completed and
supports the submitted NDA for both indications, as well as the MAA
submission in Europe for the IBS-C indication. 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 FDA's target action date,
our development plans for linaclotide in China, and linaclotide's
potential as a treatment for IBS-C or CC. 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 the FDA
further extends its review of the linaclotide NDA, 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 FDA
issues a complete response letter for linaclotide, China's State Food
and Drug Administration does not grant our request for a Phase 3
clinical trial or we choose not to perform a clinical trial in China,
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
Ironwood Pharmaceuticals' Quarterly Report on Form 10-Q for the quarter
ended March 31, 2012, in addition to the risk factors that are listed
from time to time in Ironwood Pharmaceuticals' 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.
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Condensed Consolidated Balance Sheets
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(in thousands)
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(unaudited)
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June 30,
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December 31,
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2012
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2011
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Assets
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Cash, cash equivalents and available-for-sale securities
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$
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157,653
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$
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164,016
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Accounts receivable, net
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2,466
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|
|
652
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Prepaid expenses and other assets
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5,964
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|
|
2,899
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Total current assets
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166,083
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|
|
167,567
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Property and equipment, net
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|
|
34,859
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|
|
33,625
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Other assets
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|
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7,721
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|
|
7,785
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Total assets
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$
|
208,663
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|
$
|
208,977
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|
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Liabilities and Stockholders' Equity
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Accounts payable, net and accrued expenses
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$
|
30,749
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$
|
24,568
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Current portion of capital lease obligations
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|
|
277
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|
|
233
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|
Current portion of deferred rent
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|
|
4,517
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|
|
4,042
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Current portion of deferred revenue
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13,578
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|
|
36,291
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Total current liabilities
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|
49,121
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|
|
65,134
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Capital lease obligations
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|
|
364
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|
|
422
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Deferred rent
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|
10,832
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|
|
12,435
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Deferred revenue
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|
|
19,565
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|
|
21,130
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Total stockholders' equity
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|
|
128,781
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|
|
109,856
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Total liabilities and stockholders' equity
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$
|
208,663
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|
$
|
208,977
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Condensed Consolidated Statements of Operations
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(in thousands, except share and per share amounts)
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(unaudited)
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Three Months Ended
June 30,
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Six Months Ended
June 30,
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2012
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2011
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2012
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2011
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Revenue
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$
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14,604
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|
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$
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11,262
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$
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26,852
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$
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21,499
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Operating expenses:
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Research and development
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32,238
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19,409
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61,748
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38,964
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General and administrative
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23,200
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10,805
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41,574
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20,029
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Total operating expenses
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55,438
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30,214
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103,322
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58,993
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Loss from operations
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(40,834
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)
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|
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(18,952
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)
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(76,470
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)
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|
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(37,494
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)
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Other income (expense), net
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31
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|
|
|
108
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|
|
66
|
|
|
|
249
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Net loss
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|
$
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(40,803
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)
|
|
$
|
(18,844
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)
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$
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(76,404
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)
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$
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(37,245
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)
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Net loss per share—basic and diluted
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$
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(0.38
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)
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$
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(0.19
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)
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$
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(0.73
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)
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$
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(0.37
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)
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Weighted average number of common shares used in net loss per
share - basic and diluted
|
|
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107,078,150
|
|
|
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99,674,969
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105,414,607
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|
|
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99,458,336
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Ironwood Pharmaceuticals, Inc.
Media Relations
Lisa
Buffington, 617-374-5103
Vice President, Corporate Communications
lbuffington@ironwoodpharma.com
or
Investor
Relations
Meredith Kaya, 617-374-5082
Associate Director,
Investor Relations
mkaya@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
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