CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ:IRWD) announced today that the United
States Patent and Trademark Office (USPTO) has issued a Notice of
Allowance for a patent application covering methods of using LINZESS®
(linaclotide) to treat patients with irritable bowel syndrome with
constipation (IBS-C) or chronic idiopathic constipation (CIC). The
patent application, co-owned by Ironwood and Forest Laboratories, Inc.,
is expected to issue in mid-2014 and extend LINZESS patent protection
into 2031.
The patent application specifically applies to LINZESS, which is the
current U.S. commercial formulation of linaclotide. This formulation
combines the active ingredient linaclotide with certain excipients,
resulting in a product that is stable at room temperature for long
periods and suitable for oral dosing, in a capsule that dissolves in the
stomach and allows linaclotide to reach its target site of action along
the surface of the intestinal epithelium. Creating a room temperature
stable oral formulation for linaclotide, a fourteen amino acid peptide,
was one of the most significant challenges Ironwood and Forest overcame
in developing the molecule into a commercially-viable product. This
patent would be a significant addition to the LINZESS patent portfolio,
providing patent protection for LINZESS for several additional years.
LINZESS is approved and marketed in the United States for the treatment
of adult patients suffering from IBS-C or CIC. It is the first and only
guanylate cyclase-C (GC-C) agonist approved by the FDA. Composition of
matter patents currently cover LINZESS to 2024, and a pending patent
term extension would extend the composition of matter patent coverage to
2026. Ironwood and Forest also own pending patent applications covering
the LINZESS commercial formulation, which are expected to provide
further patent protection.
A notice of allowance is a written notification issued after the USPTO
makes a determination that a patent can be granted from an application.
The vast majority of patent applications that receive a notice of
allowance will proceed to issue as a U.S. patent; however, a notice of
allowance is not a guarantee of patent issuance.
About LINZESS (linaclotide)
LINZESS is the first and only guanylate cyclase-C (GC-C) agonist
approved by the FDA for the treatment of both irritable bowel syndrome
with constipation (IBS-C) and chronic idiopathic constipation (CIC) in
adults. LINZESS is a once-daily capsule that helps relieve the abdominal
pain and constipation associated with IBS-C, as well as the
constipation, infrequent stools, hard stools and incomplete evacuation
associated with CIC. The recommended dose is 290 mcg for IBS-C patients
and 145 mcg for CIC patients. LINZESS should be taken at least 30
minutes before the first meal of the day.
LINZESS is thought to work in two ways based on nonclinical studies.
LINZESS binds to the GC-C receptor locally, within the intestinal
epithelium. Activation of GC-C results in increased intestinal fluid
secretion and accelerated transit and a decrease in the activity of
pain-sensing nerves in the intestine. The clinical relevance of the
effect on pain fibers, which is based on nonclinical studies, has not
been established.
In placebo-controlled Phase III clinical trials of more than 2,800
adults, LINZESS was shown to reduce abdominal pain in IBS-C patients and
increase bowel movement frequency in both IBS-C patients and CIC
patients. Improvement in abdominal pain and constipation occurred in the
first week of treatment and was maintained throughout the 12-week
treatment period. Maximum effect on abdominal pain was seen at weeks 6-9
and maximum effect on constipation occurred during the first week. When
a subset of LINZESS-treated patients in the trials were switched to
placebo, they reported their symptoms returned toward pretreatment
levels within one week, while placebo-treated patients switched to
LINZESS reported symptom improvements. LINZESS is contraindicated in
pediatric patients up to 6 years of age. The use of LINZESS in pediatric
patients 6 through 17 years of age should be avoided. In nonclinical
studies, administration of a single, clinically relevant adult oral dose
of linaclotide caused deaths in young juvenile mice. LINZESS has not
been studied in pediatric patients. In adults with IBS-C or CIC treated
with LINZESS, the most commonly reported adverse event was diarrhea.
Ironwood and Forest Laboratories, Inc. are co-promoting LINZESS in the
United States. Linaclotide is marketed by Almirall, S.A. for the
treatment of adults with moderate to severe IBS-C in Europe under the
brand name CONSTELLA®. Ironwood also has partnered with Astellas Pharma
Inc. for development and commercialization of linaclotide in Japan and
with AstraZeneca for development and commercialization in China.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ:IRWD) is focused on creating medicines
that make a difference for patients, building value to earn the
continued support of our fellow shareholders, and empowering our team to
passionately pursue excellence. We discovered, developed and are
commercializing linaclotide, which is approved in the United States and
Europe. Our pipeline priorities include exploring further opportunities
for linaclotide, as well as leveraging our therapeutic expertise in
gastrointestinal disorders and our pharmacologic expertise in guanylate
cyclases to address patient needs across the upper and lower
gastrointestinal tract. Ironwood was founded in 1998 and is
headquartered in Cambridge, Mass. Connect with us at www.ironwoodpharma.com
or on Twitter at www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
LINZESS® and CONSTELLA® are trademarks owned by Ironwood
Pharmaceuticals, Inc.
Important Safety Information
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WARNING: PEDIATRIC RISK
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LINZESS is contraindicated in pediatric patients up to 6 years
of age. Use should be avoided in pediatric patients 6 through 17
years of age. In nonclinical studies, administration of a single,
clinically relevant adult oral dose of linaclotide caused deaths
in young juvenile mice.
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Contraindications
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LINZESS is contraindicated in pediatric patients up to 6 years of age.
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LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
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LINZESS is contraindicated in pediatric patients up to 6 years of age.
In nonclinical studies, deaths occurred within 24 hours in young
juvenile mice (1 to 3 week-old mice; approximately equivalent to human
pediatric patients less than 2 years of age) following administration
of one or two daily oral doses of linaclotide.
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Use of LINZESS should be avoided in pediatric patients 6 through 17
years of age. Linaclotide did not cause deaths in older juvenile mice
(approximately equivalent to humans age 12 to 17 years). Although
there were no deaths in older juvenile mice, given the deaths in young
juvenile mice and the lack of clinical safety and efficacy data in
pediatric patients, use of LINZESS should be avoided in pediatric
patients 6 through 17 years of age.
Diarrhea
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Diarrhea was the most common adverse reaction of LINZESS-treated
patients in the pooled IBS-C and CIC double-blind placebo-controlled
trials. Severe diarrhea was reported in 2% of LINZESS-treated
patients. The incidence of diarrhea was similar in the IBS-C and CIC
populations.
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Patients should be instructed to stop LINZESS if severe diarrhea
occurs and to contact their healthcare provider, who should consider
dose suspension.
Adverse Reactions
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In IBS-C clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence
(4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and
abdominal distension (2% vs 1%).
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In CIC clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence
(6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis
(3% vs 2%) and abdominal distension (3% vs 2%).
Please see full Prescribing Information including Boxed Warning: http://www.frx.com/pi/linzess_pi.pdf
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including, but not limited to, statements about the expected
issuance of the methods of use patent for which the USPTO issued a
notice of allowance; the expected period of patent protection associated
with the patent, if it's issued; the stability of LINZESS® in its room
temperature formulation; the potential patent term extension for the
linaclotide composition of matter patent; and the anticipated patent
protection associated with other pending patent applications. Each
forward‐looking statement is subject to risks and uncertainties that
could cause actual results to differ materially from those expressed or
implied in such statement. Applicable risks and uncertainties include,
but are not limited to, the risk that the USPTO does not issue the
methods of use patent, or any other patents for which there is an
outstanding patent application, in the timeline expected or at all; the
methods of use patent, or any other patent, is challenged or
invalidated, in whole or in part; any of our patents are deemed to
infringe on the intellectual property rights of other products or
product candidates; other manufacturers are able to create another room
temperature stable formulation of linaclotide that is not covered by
this or any of our other patents or patent applications; and LINZESS® is
not room temperature stable in its current formulation, or any
formulation, as long as expected. Applicable risks also include those
that are listed under the heading "Risk Factors" and elsewhere in
Ironwood's Annual Report on Form 10‐K for 2013, in addition to the risk
factors that are listed from time to time in Ironwood's Annual Reports
on Form 10‐K, Quarterly Reports on Form 10‐Q and any subsequent SEC
filings. Ironwood undertakes no obligation to update these
forward-looking statements to reflect events or circumstances occurring
after this press release. Except as otherwise noted, 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.
Media Relations:
Trista
Morrison, 617-374-5095
[email protected]
or
Investor
Relations:
Meredith Kaya, 617-374-5082
[email protected]
Source: Ironwood Pharmaceuticals, Inc.
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