CAMBRIDGE, Mass. & NEW YORK--(BUSINESS WIRE)--
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest Laboratories,
Inc. (NYSE: FRX) today announced that the U.S. Food and Drug
Administration (FDA) notified the companies 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).
An additional analysis of existing data was recently requested by the
FDA to further characterize the relative effect of the two doses of
linaclotide that were studied in the Phase 3 CC clinical trials. Since
this analysis was submitted to the FDA within three months of the user
fee goal date, the date has been extended by three months, in accordance
with applicable regulation. No new data have been requested by the
agency to complete the review. FDA action is now expected by September
2012. Ironwood and Forest continue to plan for a 2012 launch.
The efficacy and safety of linaclotide was studied in a clinical trial
program of more than 2,800 patients for the treatment of IBS-C and CC.
Additionally, over 3,200 patients were enrolled in ongoing open-label
safety trials and more than 2,000 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 in the United States. Ironwood and Forest
plan to co-promote linaclotide in the U.S. Ironwood has out-licensed
linaclotide to Almirall 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 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.
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 in Europe 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. Forest's pipeline, the most robust in its history,
includes product candidates in all stages of development across a wide
range of therapeutic areas. Forest 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 potential that the FDA
recommends modifications to the proposed label for linaclotide, the risk
that the FDA issues a complete response letter for linaclotide or does
not approve linaclotide for either or both of the IBS-C and CC
indications, the difficulty in predicting the acceptance and demand for
new pharmaceutical products, the impact of competitive products and
pricing, the variability in 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 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.
Forest Laboratories, Inc.
Frank J. Murdolo, 212.224.6714
Vice
President - Investor Relations
media.relations@frx.com
or
Ironwood
Pharmaceuticals, Inc.
Meredith Kaya, 617.374.5082
Investor
Relations
mkaya@ironwoodpharma.com
Source: Forest Laboratories, Inc. & Ironwood Pharmaceuticals, Inc.
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