CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its
recent and fourth quarter 2010 business activities.
Fourth Quarter 2010 and Recent Highlights
Linaclotide
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In November, Ironwood and its U.S. partner, Forest Laboratories, Inc.,
completed the clinical efficacy portion of the linaclotide development
program to support upcoming regulatory submissions in both the U.S.
and the E.U. Linaclotide met 66 out of 66 U.S. and E.U. primary and
secondary endpoints in the four Phase 3 trials assessing its efficacy
and safety in patients with irritable bowel syndrome with constipation
(IBS-C) or chronic constipation (CC). Diarrhea was the most common
adverse event in linaclotide‐treated patients in these trials.
In
the 26-week Phase 3 IBS-C trial, improvements in both abdominal pain
and complete spontaneous bowel movements were achieved for
linaclotide-treated patients in the first week of treatment, and these
improvements were sustained throughout the entire period. Of
particular note, at the 26th week of treatment,
linaclotide-treated patients had a mean reduction in abdominal pain of
50 percent compared to 27 percent for placebo-treated patients
(p
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Ironwood and Forest are on track to submit a New Drug Application
(NDA) for linaclotide with the U.S. Food and Drug Administration for
both the IBS-C and CC indications in the third quarter of 2011.
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Ironwood's European partner, Almirall, S.A., is on track to submit a
Market Authorization Application (MAA) for linaclotide with the
European Medicines Agency for the IBS‐C indication in the second half
of 2011.
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Ironwood and Forest were recently informed that all six
linaclotide-related abstracts submitted for presentation at the 2011
Digestive Disease Week (DDW) annual meeting have been accepted. Four
abstracts will be discussed in oral presentations and two will be made
available through poster presentations. These presentations will be
the first time that Ironwood and Forest discuss the full results of
the two Phase 3 IBS-C clinical trials. These presentations will be
made May 7—9, 2011 at the DDW annual meeting in Chicago.
Pipeline and Corporate
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Ironwood continues to advance its pipeline, which includes product
candidates and research efforts focused on gastrointestinal disease,
pain and inflammation, respiratory and allergic disease, and
cardiovascular disease. To augment its internal discovery
capabilities, Ironwood recently initiated a collaboration with
Protagonist Therapeutics, Inc. through which Protagonist will use its
proprietary disulfide rich peptide technology platform to discover
peptides against targets identified by Ironwood. Ironwood has the
right to advance such peptides through preclinical and clinical
development, and if such development is successful, commercialization.
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Ironwood ended fiscal year 2010 with $248 million of cash, cash
equivalents, and available-for-sale securities. Based on its current
operating plan, Ironwood targets ending fiscal year 2011 with greater
than $150 million of cash, cash equivalents, and available-for-sale
securities.
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m. Eastern
Time today to discuss its business activities. Individuals interested in
participating in the call should dial (888) 206‐4836 (U.S. and Canada)
or (913) 312‐0679 (international) using conference ID number 9353790. 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 March 17,
2011. To listen to the replay, dial (888) 203‐1112 (U.S. and Canada) or
(719) 457‐0820 (international) using conference ID number 9353790. 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 an agonist of the guanylate
cyclase type-C (GC-C) receptor located on the luminal surface of the
intestine. In preclinical models, linaclotide has been shown to reduce
visceral pain, increase fluid secretion, and accelerate 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. Linaclotide is in Phase 3 clinical development for the
treatment of irritable bowel syndrome with constipation (IBS-C) and
chronic constipation. The efficacy portion of linaclotide's development
program has been completed and will support the NDA submission for both
indications, as well as the MAA submission for the IBS-C indication. An
issued composition of matter patent for linaclotide provides protection
to 2025. Ironwood and Forest are co-developing and, if it is approved,
will 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, discomfort, and bloating associated with altered bowel
habits, and as many as 11 million people in the U.S. suffer from it.
There are currently few available therapies to treat this disorder and
there is a high rate of dissatisfaction with available therapies.
Patients suffering from IBS-C can be affected physically,
psychologically, socially, and economically.
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 discomfort and bloating. This condition
significantly affects patients' quality of life by impairing their
ability to work and participate in typical daily activities. There is a
high rate of dissatisfaction with currently available treatments.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial
pharmaceutical company dedicated to the art and science of great
drugmaking. Linaclotide, Ironwood's GC-C agonist, is in Phase 3 clinical
development for the treatment of irritable bowel syndrome with
constipation (IBS-C) and chronic constipation. The efficacy portion of
linaclotide's development program has been completed and will support
the NDA submission for both indications, as well as the MAA submission
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 timing of the filing of a
New Drug Application or a Marketing Authorization Application for
linaclotide, linaclotide's potential as a treatment for IBS-C or chronic
constipation, our potential presentations at DDW, the potential size of
linaclotide's target patient population, and our targeted cash-on-hand
for 2011. 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 our linaclotide development
activities do not progress as expected, 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, we are unable to
produce an adequate commercial supply of linaclotide, as well as risks
related to the difficulty of predicting regulatory approvals, the
acceptance of and demand for new pharmaceutical products, the impact of
competitive products and pricing, and whether linaclotide will ever be
commercialized successfully. Applicable risks also include those that
are listed in our Quarterly Report on Form 10-Q for the three months
ended September 30, 2010, 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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|
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December 31,
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December 31,
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2010
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2009
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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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248,027
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$
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122,306
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Accounts receivable, net
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2,895
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5,219
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Prepaid expenses and other assets
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8,153
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2,673
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Current assets of discontinued operations
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—
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1,250
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Total current assets
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259,075
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131,448
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Property and equipment, net
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34,369
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21,754
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Other assets
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7,921
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8,153
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Long-term assets of discontinued operations
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—
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1,096
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Total assets
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$
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301,365
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$
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162,451
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Liabilities and Stockholders' Equity (Deficit)
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Accounts payable and accrued expenses
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$
|
21,380
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$
|
21,454
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Current portion of long-term debt and capital lease obligations
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197
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1,079
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Current portion of deferred rent
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2,799
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|
180
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|
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Current portion of deferred revenue
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40,050
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|
32,360
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Current liabilities of discontinued operations
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|
—
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1,364
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Total current liabilities
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64,426
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56,437
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Long-term debt and capital lease obligations
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|
393
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|
|
939
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|
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Deferred rent
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|
14,612
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|
|
10,486
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Deferred revenue
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|
62,383
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|
93,642
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Long-term liabilities of discontinued operations
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—
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|
937
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Convertible preferred stock
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—
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298,350
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Total stockholders' equity (deficit)
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159,551
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(298,340
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)
|
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Total liabilities and stockholders' equity (deficit)
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$
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301,365
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$
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162,451
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|
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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
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Year Ended
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December 31,
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December 31,
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2010
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2009
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2010
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2009
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Revenue
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$
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16,772
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$
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8,404
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$
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43,857
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$
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34,321
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Operating expenses:
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Research and development
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21,266
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24,182
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77,454
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76,100
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General and administrative
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8,301
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5,589
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27,169
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19,037
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Total operating expenses
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29,567
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29,771
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104,623
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95,137
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Loss from operations
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(12,795
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)
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(21,367
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)
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(60,766
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)
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(60,816
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)
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Other income (expense), net
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1,144
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|
666
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1,411
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|
522
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Net loss from continuing operations before income tax benefit
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(11,651
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)
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(20,701
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)
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(59,355
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)
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(60,294
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)
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Income tax benefit(1) |
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(143
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)
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(2,944
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)
|
|
|
(296
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)
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Net loss from continuing operations
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(11,651
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)
|
|
|
(20,558
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)
|
|
|
(56,411
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)
|
|
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(59,998
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)
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Net income (loss) from discontinued operations(1) |
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|
-
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|
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(4,016
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)
|
|
|
4,551
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|
|
(13,314
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)
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Net loss
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|
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(11,651
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)
|
|
|
(24,574
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)
|
|
|
(51,860
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)
|
|
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(73,312
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)
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Net (income) loss from discontinued operations
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|
|
|
|
|
|
|
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|
|
|
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attributable to noncontrolling interest
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-
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|
644
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(1,121
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)
|
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2,127
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Net loss attributable to Ironwood Pharmaceuticals, Inc.
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$
|
(11,651
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)
|
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$
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(23,930
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)
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$
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(52,981
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)
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$
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(71,185
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)
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Net income (loss) per share attributable to
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|
|
|
|
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Ironwood Pharmaceuticals, Inc.-basic and diluted:
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|
|
|
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Continuing operations
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$
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(0.12
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)
|
|
$
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(2.83
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)
|
|
$
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(0.63
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)
|
|
$
|
(8.43
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)
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Discontinued operations
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|
-
|
|
|
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(0.47
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)
|
|
|
0.04
|
|
|
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(1.57
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)
|
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Net loss per share
|
|
$
|
(0.12
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)
|
|
$
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(3.30
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)
|
|
$
|
(0.59
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)
|
|
$
|
(10.00
|
)
|
|
Weighted average number of common shares used in
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|
|
|
|
|
|
|
|
|
|
net income (loss) per share attributable to
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ironwood Pharmaceuticals, Inc.-basic and diluted
|
|
|
98,615,754
|
|
|
|
7,249,416
|
|
|
|
89,653,364
|
|
|
|
7,116,774
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(1)
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The results of operations for the year ended December 31, 2010
include a $2.9 million income tax benefit associated with the sale
of the company's subsidiary, Microbia, Inc. The company has recorded
this income tax benefit from continuing operations in the quarter
ended September 30, 2010 and has offset this benefit by an identical
and corresponding income tax provision from discontinued operations
in that same period.
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Ironwood Pharmaceuticals
Susan Brady, 617-621-8304
[email protected]
Source: Ironwood Pharmaceuticals, Inc.
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