Second Quarter 2011 and Recent Highlights
Linaclotide
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Ironwood and its U.S. partner,
Forest Laboratories, Inc. , recently submitted a New Drug Application (NDA) for linaclotide to theU.S. Food and Drug Administration (FDA) for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). The submission includes efficacy and safety data from a Phase 3 program that comprised four double-blind placebo-controlled clinical trials and two open-label long term safety studies. A total of more than 2,800 patients received a once-daily dose of either linaclotide or placebo across the four placebo-controlled clinical trials: two trials in patients with IBS-C and two trials in patients with CC. Over 3,200 patients have enrolled in the long term safety studies, and more than 1,100 of those patients have received linaclotide for at least 12 months. -
Ironwood's European partner, Almirall, S.A., is on track to submit a
Market Authorization Application (MAA) for linaclotide to the
European Medicines Agency for IBS‐C in the second half of 2011. -
The results of the two Phase 3 clinical trials in patients with CC are
published in this week's
New England Journal of Medicine . The published data show that in clinical trials, treatment with once-daily dosing of linaclotide over 12 weeks achieved statistical significance for the primary endpoint of 12-week complete spontaneous bowel movement (CSBM) overall responder. In both trials, statistical significance was achieved for all pre-specified secondary endpoints, which included measures of bloating, abdominal discomfort, and average weekly CSBMs. In these two Phase 3 clinical trials, the most commonly reported adverse event was diarrhea. Most events of diarrhea were reported as mild to moderate. The topline data were first presented at the Digestive Disease Week annual meeting inMay 2010 . -
Ironwood entered into commercial supply agreements with
PolyPeptide Laboratories, Inc. and Polypeptide Laboratories (Sweden ) AB and withRoche Colorado Corporation , each for the manufacture of the linaclotide drug substance that will be incorporated into the finished product for commercialization. Ironwood also entered into an agreement withAlmac Pharma Services Limited to complete the manufacturing process of linaclotide in the parts of the world outside of the partnered territories ofNorth America ,Europe ,Japan , and certain other Asian countries and to introduce redundancy into the supply chain within these partnered territories.
Pipeline
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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 disease, and cardiovascular
disease. In
July 2011 , Ironwood entered into a collaboration with Depomed, Inc. to utilize Depomed's Acuform™ gastric retentive drug delivery technology to enable an Ironwood early stage, non-GC-C development program directed at a gastrointestinal disorder.
Corporate
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Ironwood ended the second quarter of 2011 with approximately
$201 million of cash, cash equivalents, and available-for-sale securities. Ironwood used approximately$42 million of cash for operations for the six months endedJune 30, 2011 . Based on its current operating plan, Ironwood continues to target 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
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 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. The efficacy portion of linaclotide's development
program has been completed and supports the recently submitted NDA for
linaclotide for the treatment of irritable bowel syndrome with
constipation (IBS-C) and chronic constipation, 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
Based on improved methods used to measure linaclotide content, the numbers that define the linaclotide dose are being adjusted from 133 mcg to 145 mcg and from 266 mcg to 290 mcg. These methods are based on current industry best practices. The adjustment does not reflect a change in the actual amount of linaclotide used in clinical trials. These 145 mcg and 290 mcg designations are utilized in the recently published NEJM article and the recently submitted NDA.
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 an 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
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
Marketing Authorization Application for linaclotide, linaclotide's
potential as a treatment for IBS-C or chronic constipation, our recent
collaboration with Depomed and its potential benefit to our development
pipeline, 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
Almirall's MAA submission does 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, and
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
Condensed Consolidated Balance Sheets (in thousands) (unaudited) |
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June 30,
2011 |
December 31,
2010 |
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Assets | |||||
Cash, cash equivalents and available-for-sale securities | $ | 201,097 | $ | 248,027 | |
Accounts receivable, net | 2,627 | 2,895 | |||
Prepaid expenses and other assets | 4,658 | 8,153 | |||
Total current assets | 208,382 | 259,075 | |||
Property and equipment, net | 33,484 | 34,369 | |||
Other assets | 7,861 | 7,921 | |||
Total assets | $ | 249,727 | $ | 301,365 | |
Liabilities and Stockholders' Equity | |||||
Accounts payable, accrued expenses and other current liabilities | $ | 18,778 | $ | 21,380 | |
Current portion of capital lease obligations | 229 | 197 | |||
Current portion of deferred rent | 3,282 | 2,799 | |||
Current portion of deferred revenue | 48,555 | 40,050 | |||
Total current liabilities | 70,844 | 64,426 | |||
Capital lease obligations | 540 | 393 | |||
Deferred rent | 14,379 | 14,612 | |||
Deferred revenue | 33,144 | 62,383 | |||
Other liabilities | 703 | — | |||
Total stockholders' equity | 130,117 | 159,551 | |||
Total liabilities and stockholders' equity | $ | 249,727 | $ | 301,365 |
Condensed Consolidated Statements of Operations (in thousands, except share and per share amounts) (unaudited) |
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Three Months Ended
June 30, |
Six Months Ended
June 30, |
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2011 | 2010 | 2011 | 2010 | |||||||||||||
Revenue | $ | 11,262 | $ | 9,188 | $ | 21,499 | $ | 18,026 | ||||||||
Operating expenses: | ||||||||||||||||
Research and development | 19,409 | 19,897 | 38,964 | 37,446 | ||||||||||||
General and administrative | 10,805 | 6,601 | 20,029 | 12,386 | ||||||||||||
Total operating expenses | 30,214 | 26,498 | 58,993 | 49,832 | ||||||||||||
Loss from operations | (18,952 | ) | (17,310 | ) | (37,494 | ) | (31,806 | ) | ||||||||
Other income (expense), net | 108 | 145 | 249 | 160 | ||||||||||||
Net loss from continuing operations | (18,844 | ) | (17,165 | ) | (37,245 | ) | (31,646 | ) | ||||||||
Net loss from discontinued operations | — | (44 | ) | — | (1,816 | ) | ||||||||||
Net loss | (18,844 | ) | (17,209 | ) | (37,245 | ) | (33,462 | ) | ||||||||
Net loss from discontinued operations |
— | 73 | — | 402 | ||||||||||||
Net loss attributable to Ironwood |
$ | (18,844 | ) | $ | (17,136 | ) | $ | (37,245 | ) | $ | (33,060 | ) | ||||
Net loss per share attributable to Ironwood |
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Continuing operations | $ | (0.19 | ) | $ | (0.18 | ) | $ | (0.37 | ) | $ | (0.39 | ) | ||||
Discontinued operations | — | — | — | (0.02 | ) | |||||||||||
Net loss per share | $ | (0.19 | ) | $ | (0.18 | ) | $ | (0.37 | ) | $ | (0.41 | ) | ||||
Weighted average number of common shares |
99,674,969 | 97,642,330 | 99,458,336 | 80,893,200 |
sbrady@ironwoodpharma.com
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