Ironwood and Forest Announce FDA Has Extended the Review Period for Linaclotide to September 2012
April 23 2012 - 2:30AM
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.
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