Second Quarter 2012 and Recent Highlights
In April, the
U.S. Food and Drug Administration(FDA) notified Ironwoodand 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). FDAaction 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 Diegofrom 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 Administrationfor 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.
Ironwood ended the second quarter of 2012 with approximately
$158 millionof cash, cash equivalents, and available-for-sale securities. Ironwood used approximately $93 millionof cash for operations during the six months ended June 30, 2012.
Conference Call Information
Ironwood will host a conference call and webcast at
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
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.
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
|Condensed Consolidated Balance Sheets|
|Cash, cash equivalents and available-for-sale securities||$||157,653||$||164,016|
|Accounts receivable, net||2,466||652|
|Prepaid expenses and other assets||5,964||2,899|
|Total current assets||166,083||167,567|
|Property and equipment, net||34,859||33,625|
|Liabilities and Stockholders' Equity|
|Accounts payable, net and accrued expenses||$||30,749||$||24,568|
|Current portion of capital lease obligations||277||233|
|Current portion of deferred rent||4,517||4,042|
|Current portion of deferred revenue||13,578||36,291|
|Total current liabilities||49,121||65,134|
|Capital lease obligations||364||422|
|Total stockholders' equity||128,781||109,856|
|Total liabilities and stockholders' equity||$||208,663||$||208,977|
|Condensed Consolidated Statements of Operations|
|(in thousands, except share and per share amounts)|
Three Months Ended
Six Months Ended
|Research and development||32,238||19,409||61,748||38,964|
|General and administrative||23,200||10,805||41,574||20,029|
|Total operating expenses||55,438||30,214||103,322||58,993|
|Loss from operations||(40,834||)||(18,952||)||(76,470||)||(37,494||)|
|Other income (expense), net||31||108||66||249|
|Net loss per share—basic and diluted||$||(0.38||)||$||(0.19||)||$||(0.73||)||$||(0.37||)|
Weighted average number of common shares used in net loss per share - basic and diluted
Vice President, Corporate Communications
Associate Director, Investor Relations
News Provided by Acquire Media