CAMBRIDGE, Mass., Aug 05, 2010 (BUSINESS WIRE) -- Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its
business activities for the second quarter of 2010.
Second Quarter 2010 Highlights
Linaclotide
-
Both confirmatory Phase 3 clinical trials being carried out by
Ironwood and its U.S. partner, Forest Laboratories, Inc., assessing
the efficacy and safety of linaclotide in patients with irritable
bowel syndrome with constipation (IBS-C), are fully enrolled. Ironwood
and Forest anticipate reporting top-line results from the two trials
separately in the fourth quarter of 2010. Subsequent to each top-line
data release, Ironwood and its European partner, Almirall, S.A., will
report top-line results on the same data measured against the E.U.
co-primary efficacy endpoints which evaluate abdominal pain/ abdominal
discomfort and IBS degree of relief. Ironwood and Forest are targeting
a New Drug Application submission to the U.S. Food and Drug
Administration (FDA) in the middle of 2011.
-
The FDA issued draft guidance earlier this year on the design of
clinical trials for IBS-C. Among other recommendations, the draft
guidance recommends primary efficacy endpoints assessing abdominal
pain (greater-than or equal to 30 percent average weekly reduction vs. baseline) and stool
frequency (increase of one or more complete spontaneous bowel
movements (CSBMs) per week vs. baseline). Ironwood and Forest are
amending the clinical trial protocols in both ongoing Phase 3 IBS-C
clinical trials and have proposed to the FDA to add an additional
primary efficacy endpoint that is consistent with the draft FDA
guidance. This additional endpoint is as follows:
-
Six out of 12-week abdominal pain and CSBM responder: a
patient who, for at least six of the 12 weeks of the treatment
period, (a) has at least a 30 percent average weekly reduction in
abdominal pain from baseline and (b) has an increase of one or
more CSBMs per week from baseline.
Adding this endpoint to the clinical trial protocols will ensure that
the studies include analyses that conform to the FDA's most current
thinking as reflected in the draft guidance. This endpoint is in
addition to the original primary efficacy endpoints, which are as
follows:
-
Nine out of 12-week abdominal pain and CSBM responder: a
patient who, for at least nine of the 12 weeks of the treatment
period, meets the both the abdominal pain and CSBM responder criteria
listed below;
-
Nine out of 12-week CSBM responder: a patient who, for at least
nine of the 12 weeks of the treatment period, has three or more CSBMs
per week and an increase of one or more CSBMs per week from baseline;
and
-
Nine out of 12-week abdominal pain responder: a patient who,
for at least nine of the 12 weeks of the treatment period, has at
least a 30 percent average weekly reduction in abdominal pain from
baseline.
Corporate
-
Based on its current operating plan, Ironwood anticipates ending
fiscal year 2010 with greater than $220 million of cash, cash
equivalents, and available-for-sale securities.
Conference Call Information
Ironwood will host a conference call and webcast at 5:30 p.m. Eastern
Time today to discuss its business activities. Individuals interested in
participating in the call should dial (877) 312-5420 (U.S. and Canada)
or (970) 315-0261 (international) using conference ID number 91630665.
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 8:30 p.m. Eastern
Time, running through 11:59 p.m. Eastern Time on August 19, 2010. To
listen to the replay, dial (800) 642-1687 (U.S. and Canada) or (706)
645-9291 (international) using conference ID number 91630665. An
archived version of the event 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, activation of GC-C leads to increases
in intracellular and extracellular cyclic guanosine monophosphate
(cGMP), resulting in anion secretion, fluid secretion, and accelerated
intestinal transit. In addition, both linaclotide and cGMP have reduced
visceral pain in several preclinical models. 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 IBS-C and chronic constipation. An issued composition of
matter patent for linaclotide provides protection to 2025. Ironwood and
Forest are co-developing and co-promoting linaclotide in the United
States. Ironwood has out-licensed 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)
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. Half of
patients are not satisfied 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 being evaluated in
a confirmatory Phase 3 program for the treatment of irritable bowel
syndrome with constipation (IBS-C) and chronic constipation. Ironwood
also has a growing pipeline of additional drug candidates in earlier
stages of development. Ironwood is located in Cambridge, Mass.
This press release includes forward-looking statements. You are
hereby cautioned not to place undue reliance on these forward-looking
statements, including, but not limited to, statements about the Phase 3
IBS-C clinical trials and the effects on such trials of adding a fourth
primary efficacy endpoint. 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, among others, the risks that our
clinical studies and other development activities do not progress, as
predicted, and that we fail to meet any or all of the endpoints in our
Phase 3 IBS-C clinical trials, as well as the risks that are identified
under the heading "Risk Factors" in our Quarterly Report on Form 10-Q
for the three months ended March 31, 2010. For further discussion of
risks and uncertainties, individuals should refer to our past and future
SEC filings. We undertake no obligation and do not intend 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 Sheet
|
(in thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
June 30, 2010
|
Assets
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities
|
|
|
|
$
|
271,605
|
Accounts receivable, net
|
|
|
|
|
6,352
|
Prepaid expenses and other assets
|
|
|
|
|
4,202
|
Total current assets
|
|
|
|
|
282,159
|
Property and equipment, net
|
|
|
|
|
29,117
|
Other assets
|
|
|
|
|
10,808
|
Total assets
|
|
|
|
$
|
322,084
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
Accounts payable and accrued expenses
|
|
|
|
$
|
19,298
|
Current portion of long-term debt and capital lease obligations
|
|
|
|
|
1,263
|
Current portion of deferred rent
|
|
|
|
|
1,150
|
Current portion of deferred revenue
|
|
|
|
|
35,490
|
Total current liabilities
|
|
|
|
|
57,201
|
Long-term debt and capital lease obligations
|
|
|
|
|
1,715
|
Deferred rent
|
|
|
|
|
16,330
|
Deferred revenue
|
|
|
|
|
73,288
|
Total stockholders' equity
|
|
|
|
|
173,550
|
Total liabilities and stockholders' equity
|
|
|
|
$
|
322,084
|
Condensed Consolidated Statements of Operations
|
(in thousands, except share and per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, 2010
|
|
|
Six Months Ended June 30, 2010
|
Revenue
|
|
|
|
$
|
10,959
|
|
|
|
$
|
20,011
|
|
Operating expenses:
|
|
|
|
|
|
|
|
Research and development
|
|
|
|
|
20,953
|
|
|
|
|
39,590
|
|
General and administrative
|
|
|
|
|
7,325
|
|
|
|
|
13,968
|
|
Total operating expenses
|
|
|
|
|
28,278
|
|
|
|
|
53,558
|
|
Loss from operations
|
|
|
|
|
(17,319
|
)
|
|
|
|
(33,547
|
)
|
Other income, net
|
|
|
|
|
110
|
|
|
|
|
85
|
|
Net loss
|
|
|
|
|
(17,209
|
)
|
|
|
|
(33,462
|
)
|
Net loss attributable to noncontrolling interest
|
|
|
|
|
73
|
|
|
|
|
402
|
|
Net loss attributable to Ironwood Pharmaceuticals, Inc.
|
|
|
|
$
|
(17,136
|
)
|
|
|
$
|
(33,060
|
)
|
Net loss per share attributable to Ironwood Pharmaceuticals, Inc.-- basic
and diluted
|
|
|
|
$
|
(0.18
|
)
|
|
|
$
|
(0.41
|
)
|
Weighted average number of common shares used in net loss per share attributable
to Ironwood Pharmaceuticals, Inc.--basic and diluted
|
|
|
|
|
97,642,330
|
|
|
|
|
80,893,200
|
|
SOURCE: Ironwood Pharmaceuticals, Inc.
Corporate Inquiries:
Ironwood Pharmaceuticals
Susan Brady, 617-621-8304
sbrady@ironwoodpharma.com
or
Investor Inquiries:
Stern Investor Relations
Stephanie Ascher, 212-362-1200
stephanie@sternir.com
Copyright Business Wire 2010