CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today announced that its
European partner Almirall, S.A. submitted a Marketing Authorization
Application (MAA) to the European Medicines Agency (EMA) for
linaclotide, a guanylate cyclase type-C (GC-C) agonist, for the
treatment of irritable bowel syndrome with constipation (IBS-C). The
submission includes efficacy and safety data from a Phase 3 program
comprising two double-blind placebo-controlled trials measured against
the endpoints required by the EMA and two open-label long term safety
studies. A total of more than 1,600 patients with IBS-C received a
once-daily dose of either linaclotide or placebo across the two Phase 3
clinical trials. In these trials, statistically significant improvements
in abdominal and bowel symptoms were achieved for linaclotide-treated
patients versus placebo-treated patients for the co-primary and
secondary endpoints.
Safety data collected across the two Phase 3 IBS-C clinical trials
demonstrated that diarrhea was the most commonly reported adverse event
and led to study discontinuation in 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 2,000 of those patients have received
linaclotide for at least 12 months.
The trials were designed to support regulatory submissions for
linaclotide in both Europe and the U.S. In August 2011, Ironwood and its
U.S. partner Forest Laboratories, Inc. submitted a New Drug Application
for linaclotide to the U.S. Food and Drug Administration.
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 in Europe to 2024. 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 much as 4 percent of the European
population suffers from it. IBS-C can have an impact on daily living.
There are currently few available therapies to treat this disorder.
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. The efficacy portion of linaclotide's
development program has been completed and supports the recent 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.
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 or EMA 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 Ironwood's Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q, and other SEC filings. Ironwood does not
undertake any obligation 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.
Ironwood Pharmaceuticals, Inc.
Susan Brady, 617-621-8304
Corporate
Communications
sbrady@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
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