— Received FDA Approval of LINZESS™ (linaclotide) for Treatment of Adult Patients with IBS-C or CIC; Prepared for Commercial Launch in December —
— Received Positive Opinion from CHMP Recommending Approval of linaclotide for Treatment of Adults with IBS-C in E.U. —
Third Quarter 2012 and Recent Highlights
The U.S. Food and Drug Administration(FDA) approved LINZESS as a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS can help to relieve abdominal pain and constipation associated with IBS-C, and constipation and hard stools associated with CIC. Ironwoodand Forest Laboratories, Inc. expect LINZESS to be available to U.S. patients in December 2012.
Ironwoodand Almirall, S.A. received a positive opinion from the European Committee for Medicinal Productsfor Human Use (CHMP), recommending approval of linaclotide for the symptomatic treatment of moderate to severe IBS-C in adults in the E.U. A decision by the European Commissionis expected in 2012. If approved, the product will be marketed under the brand name Constella®.
Astellas, Ironwood's linaclotide partner in
Japan, initiated a double-blind, placebo-controlled, dose-ranging Phase 2 clinical trial of linaclotide in more than 500 Japanese adult patients with IBS-C.
Results from the two Phase 3 trials of linaclotide for the treatment
of IBS-C in adults were published in the
October 2012issue of the American Journal of Gastroenterology(AJG).
Ironwood and Forest will present 10 abstracts at the
American College of Gastroenterology(ACG) 2012 Annual Scientific Meeting being held in Las Vegasfrom October 19-24, 2012. Data being presented include analyses of abdominal and bowel symptoms from Phase 3 trials of linaclotide in IBS-C and CIC, as well as data about the economic burden of IBS-C and CIC and data on the use of patient-reported outcomes to assess the symptoms of these conditions.
Ironwood and Almirall will present six abstracts and two oral
presentations at the 20th United European Gastroenterology
Week being held in
Amsterdamfrom October 20-24, 2012. Data being presented include analyses of abdominal and bowel symptoms from Phase 3 trials of linaclotide in IBS-C.
Research & Development
- In addition to the company's ongoing efforts to evaluate linaclotide's pharmacological potential in a variety of patient populations, Ironwood continues to pioneer the guanylate cyclase-C (GC-C) agonist space through the advancement of a second GC-C agonist, IW-9179. IW-9179 is currently being investigated in a Phase 2a clinical trial designed to evaluate its safety in approximately 80 patients with functional dyspepsia.
- Ironwood continues to advance its broader pipeline, which includes early development candidates and discovery research efforts focused on gastrointestinal disease, central nervous system disorders, respiratory disease, and cardiovascular disease.
Ironwood received an
$85 millionmilestone payment from Forest for FDAapproval of LINZESS.
$85 millionmilestone payment, Ironwood ended the third quarter of 2012 with approximately $193 millionof cash, cash equivalents, and available-for-sale securities and used approximately $47 millionof net cash for operations during the nine months ended September 30, 2012.
Conference Call Information
Ironwood will host a conference call and webcast at
About LINZESS (linaclotide)
LINZESS is the first and only guanylate cyclase-C (GC-C) agonist
approved by the
LINZESS binds to the GC-C receptor locally in the intestine, with no measurable blood plasma concentrations, resulting in an increase in both intracellular and extracellular concentrations of cyclic guanosine monophosphate (cGMP). Elevations in intracellular cGMP are believed to stimulate secretion of intestinal fluid and accelerate gastrointestinal transit resulting in increased frequency of bowel movements. Elevations in extracellular cGMP are believed to decrease activity of pain-sensing nerves, which is thought to be responsible for a reduction in intestinal pain, according to nonclinical models.
Ironwood and Forest will co-promote LINZESS in
About Irritable Bowel Syndrome with Constipation (IBS-C)
Irritable bowel syndrome with constipation (IBS-C) is a chronic
functional gastrointestinal disorder that affects as many as 13 million
About Chronic Idiopathic Constipation (CIC)
Chronic idiopathic constipation (CIC) is a functional gastrointestinal disorder in which individuals experience infrequent bowel movements (less than three times per week) for at least three months. Patients who suffer from CIC may also experience a sensation of incomplete evacuation and hard stools. As many as 35 million Americans may suffer from symptoms associated with CIC.
Important Safety Information
WARNING: PEDIATRIC RISK
LINZESS is contraindicated in pediatric patients up to 6 years of age. Use should be avoided in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice.
- LINZESS is contraindicated in pediatric patients up to 6 years of age.
- LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
- LINZESS is contraindicated in pediatric patients up to 6 years of age. In nonclinical studies, deaths occurred within 24 hours in young juvenile mice (1 to 3 week-old mice; approximately equivalent to human pediatric patients less than 2 years of age) following administration of one or two daily oral doses of linaclotide.
- Use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. Linaclotide did not cause deaths in older juvenile mice (approximately equivalent to humans age 12 to 17 years). Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 through 17 years of age.
- Diarrhea was the most common adverse reaction of LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. Severe diarrhea was reported in 2% of LINZESS-treated patients. The incidence of diarrhea was similar in the IBS-C and CIC populations.
- Patients should be instructed to stop LINZESS if severe diarrhea occurs and to contact their healthcare provider, who should consider dose suspension.
- In IBS-C clinical trials, the most common adverse reactions in LINZESS-treated patients (incidence ≥2% and greater than placebo) were diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
- In CIC clinical trials, the most common adverse reactions in LINZESS-treated patients (incidence ≥2% and greater than placebo) were diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%).
No drug-drug interaction studies have been conducted with LINZESS. Linaclotide and its active metabolite are not measurable in plasma following administration of the recommended clinical doses; hence, no systemic drug-drug interactions or drug interactions mediated by plasma protein binding of linaclotide or its metabolite are anticipated
Linaclotide does not interact with the cytochrome P450 enzyme system based on the results of in vitro studies. In addition, linaclotide is neither a substrate nor an inhibitor of the efflux transporter P-glycoprotein (P-gp).
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 anticipated time period
in which LINZESS will be available for IBS-C and CIC patients,
linaclotide's potential as a treatment for IBS-C or CIC, the potential
approval of linaclotide in the E.U. as a result of the positive CHMP
opinion, Astellas's development plans for linaclotide in
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and available-for-sale securities||$||193,323||$||164,016|
|Accounts receivable, net||182||652|
|Prepaid expenses and other assets||7,877||2,899|
|Total current assets||202,347||167,567|
|Property and equipment, net||36,470||33,625|
|Liabilities and Stockholders' Equity|
|Accounts payable, net and accrued expenses||$||27,636||$||24,568|
|Current portion of capital lease obligations||280||233|
|Current portion of deferred rent||4,531||4,042|
|Current portion of deferred revenue||3,130||36,291|
|Total current liabilities||35,577||65,134|
|Capital lease obligations||361||422|
|Total stockholders' equity||182,108||109,856|
|Total liabilities and stockholders' equity||$||246,518||$||208,977|
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended
Nine Months Ended
|Research and development||23,453||22,905||85,201||61,869|
|General and administrative||25,352||10,929||66,926||30,958|
|Total operating expenses||48,805||33,834||152,127||92,827|
|Income (loss) from operations||47,608||(21,616||)||(28,862||)||(59,110||)|
|Other income (expense), net||27||986||93||1,235|
|Net Income (loss) before income tax expense||47,635||(20,630||)||(28,769||)||(57,875||)|
|Income tax expense||—||3||—||3|
|Net income (loss)||$||47,635||$||(20,633||)||$||(28,769||)||$||(57,878||)|
|Net income (loss) per share—basic||$||0.44||$||(0.21||)||$||(0.27||)||$||(0.58||)|
|Net income (loss) per share—diluted||$||0.42||$||(0.21||)||$||(0.27||)||$||(0.58||)|
|Weighted average number of common shares used in net income (loss) per share —basic||107,266,823||100,174,100||106,036,522||99,699,545|
|Weighted average number of common shares used in net income (loss) per share —diluted||114,337,327||100,174,100||106,036,522||99,699,545|
Vice President, Corporate Communications
Associate Director, Investor Relations
News Provided by Acquire Media