Ironwood & Forest Announce Linaclotide New Drug Application for the Treatment of Irritable Bowel Syndrome with Constipation &...
October 24 2011 - 2:00AM
Business Wire
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) and Forest
Laboratories, Inc. (NYSE: FRX) today announced that the U.S. Food
and Drug Administration (FDA) has accepted for review the New Drug
Application (NDA) for linaclotide for the treatment of irritable
bowel syndrome with constipation (IBS-C) and chronic constipation
(CC). With a standard 10-month review timeline, the FDA
Prescription Drug User Fee Act (PDUFA) target action date is
expected to occur in June 2012.
The companies submitted the NDA for linaclotide for the
treatment of IBS-C and CC based upon efficacy and safety results
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 clinical
trials: two trials in patients with IBS-C and two trials in
patients with CC. Additionally, over 3,200 patients have 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. 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 potential that the FDA convenes an advisory committee that does
not recommend approval of linaclotide or that recommends
modifications to the proposed label for linaclotide, the risk that
the FDA issues a complete response letter for linaclotide, 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 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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