Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) announced today that it is
reducing headcount by approximately 10 percent to align its workforce
with its strategy to grow a leading gastrointestinal (GI) therapeutics
company.
As detailed at Ironwood’s Investor
Day in December 2013, the Company’s strategy is driven by four
priority growth platforms: 1) maximizing the potential of LINZESS®
(linaclotide), both by building on its successful launch for adult
patients with irritable bowel syndrome with constipation (IBS-C) or
chronic idiopathic constipation (CIC) and by exploring the potential
utility of linaclotide in additional indications and populations where
there exists large unmet need; 2) leveraging Ironwood’s commercial
capabilities; 3) advancing a pipeline of multiple GI and guanylate
cyclase clinical development programs; and 4) continuing to operate
productively and efficiently by prioritizing investments in key value
drivers. As maximizing LINZESS is core to Ironwood’s strategy,
Ironwood’s field-based sales force and medical science liaison team are
excluded from the workforce reduction.
“We are grateful to all of our employees for their passion and hard work
in bringing LINZESS to adult patients; we’ve now developed significant
expertise in gastrointestinal diseases and in guanylate cyclase
pharmacology, providing us with a strong foundation and promising path
forward as we continue to build a leading GI company,” said Peter Hecht,
chief executive officer of Ironwood. “While it is difficult to part with
any of our talented colleagues, we believe this action effectively
aligns our resources with our strategy and positions us to maximize
value both for patients and for our fellow shareholders.”
Ironwood estimates that it will incur aggregate charges of approximately
$4.0 million to $4.5 million for severance and benefit costs in
connection with its reduction in workforce, of which approximately 85
percent to 95 percent are expected to result in cash expenditures. The
reduction in workforce is expected to be complete during the first
quarter of 2014. The Company continues to focus on driving growth
through productive and efficient operations, and expects continued
reductions in net cash used in operating activities in 2014 through
continued revenue growth and expense management. More information
regarding the reduction in workforce is available in the Form 8-K
Ironwood filed today with the Securities and Exchange Commission (SEC).
The archived webcast of Ironwood’s December 2013 Investor Day is
available for replay on Ironwood's website until March 12, 2014.
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
WARNING: PEDIATRIC RISK
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.
Contraindications
-
LINZESS is contraindicated in pediatric patients up to 6 years of age.
-
LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
-
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.
-
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
-
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.
-
Patients should be instructed to stop LINZESS if severe diarrhea
occurs and to contact their healthcare provider, who should consider
dose suspension.
Adverse Reactions
-
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%).
-
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 Ironwood’s
business strategy, structure and operations; the cause, size, timing and
impact of Ironwood’s reduction in workforce and related activities; the
functional source within Ironwood of the positions eliminated in such
reduction; the estimated charges and costs expected to be incurred in
connection with such reduction; the percent of such charges expected to
result in cash expenditures; and Ironwood’s financial performance and
results, including its growth, revenues and anticipated increased
operating efficiencies. 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, without limitation, the difficulties in
and effect of implementing Ironwood’s business strategy and investments,
such as the risk that Ironwood’s planned investments do not have their
anticipated effect; the difficulties in and effect of implementing
Ironwood’s reduction in workforce, such as claims arising out of the
reduction; the risks related to the difficulty of predicting the
financial impact or timing of Ironwood’s reduction in workforce,
including the risk that the actual financial and other impacts of the
reduction could vary materially from the outcomes anticipated; the
risk that Ironwood’s strategy and planned investments do not have the
anticipated effect on LINZESS or Ironwood’s revenues; the risk that
Ironwood and its partner, Forest Laboratories, Inc., are unable to
successfully commercialize LINZESS; and the risk that Ironwood is unable
to effectively reduce its operating expenses to a sufficient magnitude
or for a sufficient period of time. Applicable risks also include those
listed under the heading “Risk Factors” and elsewhere in Ironwood’s
Quarterly Report on Form 10-Q for the quarter ended September 30, 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.
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