Ironwood & Forest Announce Submission of New Drug Application for Linaclotide for the Treatment of Irritable Bowel Syndrome w...
August 09 2011 - 4:01PM
Business Wire
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest
Laboratories, Inc. (NYSE: FRX) today announced they have recently
submitted a New Drug Application (NDA) to the U.S. Food and Drug
Administration (FDA) for linaclotide, a guanylate cyclase type-C
(GC-C) agonist, 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 comprising
four double-blind placebo-controlled 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. In these trials,
statistically significant improvements in abdominal and bowel
symptoms were achieved for linaclotide-treated patients versus
placebo-treated patients for all primary and secondary
endpoints.
Safety data collected across the four placebo-controlled Phase 3
clinical trials demonstrated that diarrhea was the most commonly
reported adverse event and led to study discontinuation in 4
percent to 5 percent of linaclotide-treated patients compared to
fewer than 1 percent of patients receiving placebo. Additionally,
over 3,200 patients have enrolled in ongoing open-label safety
studies and more than 1,100 of those patients have received
linaclotide for at least 12 months.
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. An
issued composition of matter patent for linaclotide provides
protection to 2025. Ironwood and Forest plan to co-promote
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, 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 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 an
investigational drug for the treatment of irritable bowel syndrome
with constipation (IBS-C) and chronic constipation (CC). The
efficacy portion of linaclotide’s development program has been
completed and supports the recently submitted 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.
About Forest Laboratories, Inc.
Forest Laboratories’ (NYSE: FRX) longstanding global
partnerships and track record developing and marketing
pharmaceutical products in the United States have yielded its
well-established central nervous system and cardiovascular
franchises and innovations in anti-infective and respiratory
medicine. The Company’s pipeline, the most robust in its history,
includes product candidates in all stages of development across a
wide range of therapeutic areas. The Company is headquartered in
New York, NY. To learn more, visit www.FRX.com.
Except for the historical information contained herein, this
release contains forward-looking statements within the meaning of
the Private Securities Litigation Reform Act of 1995. These
statements involve a number of risks and uncertainties, including
the difficulty of predicting FDA approvals, the acceptance and
demand for new pharmaceutical products, the impact of competitive
products and pricing, the timely development and launch of new
products, and the risk factors listed from time to time in each of
Forest’s and Ironwood’s Annual Reports on Form 10-K, Quarterly
Reports on Form 10-Q, and other SEC filings. Neither Forest nor
Ironwood undertakes any obligation (and neither intends 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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