– Mark Mallon
to step down as CEO; Board appoints Thomas McCourt as interim CEO
–
– Julie
McHugh to become Executive Chair of the Board of Directors
–
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused
healthcare company, today announced that Mark Mallon plans to step
down as chief executive officer and a member of the Ironwood Board
of Directors in order to pursue another leadership opportunity,
effective March 12, 2021. The Ironwood Board has named Thomas
McCourt, Ironwood’s president, as interim CEO effective upon Mr.
Mallon’s departure. Julie McHugh, Ironwood’s Board chair, will
become executive chair of the Board of Directors effective upon Mr.
Mallon’s departure and, in that capacity, will continue to lead the
Board of Directors as well as provide counsel and guidance to the
senior management team through the transition.
The Board plans to initiate a candidate search with the
assistance of a leading executive search firm to identify Mr.
Mallon’s permanent successor.
“On behalf of the entire Board, I want to thank Mark for his
leadership during a transformative time in Ironwood’s history,”
said Julie McHugh, chair of Ironwood’s Board. “The Board is
confident that Ironwood is on the right path to long term value
creation. The resilience and strength of LINZESS, especially during
the COVID-19 pandemic, combined with continued profit and cash
generation in 2020 provides a solid foundation for the future. With
a strong bench of leadership talent and the support of the Board,
we will strive to continue to build on our positive momentum while
remaining true to our vision of becoming the leading GI-focused
healthcare company in the U.S.”
Ms. McHugh continued, “Since joining Ironwood in 2009, Tom has
been a key member of the leadership team and was critical to the
successful launch and commercialization of LINZESS. Tom is a GI
healthcare industry veteran with a deep understanding of Ironwood’s
business, making him an ideal fit for this role as the Board
conducts its search. I look forward to continuing to work with Tom
and to lead the Board in my role as executive chair.”
Mr. McCourt said, “I look forward to serving as interim CEO as
we work to execute our strategy of maximizing LINZESS, building an
innovative GI development portfolio and delivering sustainable
profits and cash. We are steadfast in our mission of advancing the
treatment of GI diseases and redefining the standard of care for GI
patients. With disciplined execution, we believe Ironwood is well
positioned for 2021 and beyond.”
“I’m proud of the strong foundation we have built together, and
Ironwood’s disciplined execution in 2020 underscores the
outstanding focus and commitment of the entire Ironwood team,” said
Mr. Mallon. “My decision to leave Ironwood was not easy, but I
believe the chance to pursue multiple passions of mine is the right
decision for me and my family. I have every confidence in
Ironwood’s ability to continue driving growth in its efforts to
deliver value for patients and shareholders with Tom at the
helm.”
About Thomas McCourt
Tom McCourt joined Ironwood in 2009 and has served as president
since April 2019. Prior to April 2019, he served as senior vice
president of marketing and sales and chief commercial officer.
Prior to joining Ironwood, Mr. McCourt led the U.S. brand team for
denosumab at Amgen Inc. from April 2008 to August 2009. Prior to
that, Mr. McCourt was with Novartis AG from 2001 to 2008, where he
directed the launch and growth of ZELNORM™ for the treatment of
patients with IBS-C and CIC and held a number of senior commercial
roles, including vice president of strategic marketing and
operations. Mr. McCourt was also part of the founding team at
Astra-Merck Inc., leading the development of the medical affairs
and science liaison group and then serving as brand manager for
PRILOSEC® and NEXIUM®. Mr. McCourt serves on the board of directors
of Acceleron Pharma Inc., including as a member of the audit
committee and the chair of the nominating and governance committee,
and on the board of trustees for the American Society of
Gastrointestinal Endoscopy (ASGE). Mr. McCourt has a degree in
pharmacy from the University of Wisconsin.
About Julie McHugh
Julie McHugh joined Ironwood’s board of directors in February
2014 and has served as the chair since April 2019. Ms. McHugh most
recently served as chief operating officer for Endo Health
Solutions, Inc., or Endo, from March 2010 through May 2013, where
she was responsible for the specialty pharmaceutical and generic
drug businesses. Prior to joining Endo, Ms. McHugh was the chief
executive officer of Nora Therapeutics, Inc. Before that she served
as company group chairman for the worldwide virology business unit
of Johnson & Johnson, or J&J, and previously she was
president of Centocor, Inc., a J&J subsidiary. While at
J&J, Ms. McHugh oversaw the development and launches of several
products, including Remicade® (infliximab), Prezista® (darunavir)
and Intelence® (etravirine), and she was responsible for oversight
of a research and development portfolio including compounds
targeting HIV, hepatitis C, and tuberculosis. Prior to joining
Centocor, Inc., Ms. McHugh led the marketing communications for
gastrointestinal drug Prilosec® (omeprazole) at Astra-Merck Inc.
She currently chairs the board of visitors for the Smeal College of
Business of Pennsylvania State University as well as serves on the
board of directors of Aerie Pharmaceuticals, Inc., Lantheus
Holdings, Inc. and Trevena, Inc., all publicly held companies, and
The New Xellia Group, a privately held company. She previously
served on the board of directors for ViroPharma Inc., Epirus
Biopharmaceuticals, Inc., the Biotechnology Industry Organization,
the Pennsylvania Biotechnology Association and the New England
Healthcare Institute. Ms. McHugh received her M.B.A. degree from
St. Joseph’s University and her B.S. degree from Pennsylvania State
University.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a GI-focused
healthcare company dedicated to creating medicines that make a
difference for patients living with GI diseases. We discovered,
developed and are commercializing linaclotide, the U.S. branded
prescription market leader for adults with irritable bowel syndrome
with constipation (IBS-C) or chronic idiopathic constipation
(CIC).
Ironwood was founded in 1998 and is headquartered in Boston,
Mass. For more information, please visit our website at
www.ironwoodpharma.com or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely
posted in both these locations.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand for the treatment of adult
patients with irritable bowel syndrome with constipation (IBS-C) or
chronic idiopathic constipation (CIC), based on IQVIA data.
LINZESS is a once-daily capsule that helps relieve the abdominal
pain, constipation, and overall abdominal symptoms of bloating,
discomfort and pain associated with IBS-C, as well as the
constipation, infrequent stools, hard stools, straining, and
incomplete evacuation associated with CIC. The recommended dose is
290 mcg for IBS-C patients and 145 mcg for CIC patients, with a
72-mcg dose approved for use in CIC depending on individual patient
presentation or tolerability. LINZESS should be taken at least 30
minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 6
years of age. The safety and effectiveness of LINZESS in pediatric
patients less than 18 years of age have not been established. In
neonatal mice, linaclotide increased fluid secretion as a
consequence of guanylate cyclase-C (GC-C) agonism resulting in
mortality within the first 24 hours due to dehydration. Due to
increased intestinal expression of GC-C, patients less than 6 years
of age may be more likely than patients 6 years of age and older to
develop severe diarrhea and its potentially serious consequences.
In adults with IBS-C or CIC treated with LINZESS, the most commonly
reported adverse event was diarrhea.
LINZESS is not a laxative; it is the first medicine approved by
the FDA in a class called GC-C agonists. LINZESS contains a peptide
called linaclotide that activates the GC-C receptor in the
intestine. Activation of GC-C is thought to result 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 the United States, Ironwood and AbbVie co-develop and
co-commercialize LINZESS for the treatment of adults with IBS-C or
CIC. In Europe, AbbVie markets linaclotide under the brand name
CONSTELLA® for the treatment of adults with moderate to severe
IBS-C. In Japan, Ironwood's partner Astellas markets linaclotide
under the brand name LINZESS for the treatment of adults with IBS-C
or CIC. Ironwood also has partnered with AstraZeneca for
development and commercialization of LINZESS in China, and with
AbbVie for development and commercialization of linaclotide in all
other territories worldwide.
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment
of both irritable bowel syndrome with constipation (IBS-C) and
chronic idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN
PEDIATRIC PATIENTS
LINZESS is contraindicated in patients
less than 6 years of age. In nonclinical studies in neonatal mice,
administration of a single, clinically relevant adult oral dose of
linaclotide caused deaths due to dehydration. Use of LINZESS should
be avoided in patients 6 years to less than 18 years of age. The
safety and effectiveness of LINZESS have not been established in
patients less than 18 years of age.
Contraindications
- LINZESS is contraindicated in patients less than 6 years of age
due to the risk of serious dehydration.
- LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
- LINZESS is contraindicated in patients less than 6 years of
age. The safety and effectiveness of LINZESS in patients less than
18 years of age have not been established. In neonatal mice,
linaclotide increased fluid secretion as a consequence of GC-C
agonism resulting in mortality within the first 24 hours due to
dehydration. Due to increased intestinal expression of GC-C,
patients less than 6 years of age may be more likely than patients
6 years of age and older to develop severe diarrhea and its
potentially serious consequences.
- Use of LINZESS should be avoided in pediatric patients 6 years
to less than 18 years of age. 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
years to less than 18 years of age.
Diarrhea
- Diarrhea was the most common adverse reaction in
LINZESS-treated patients in the pooled IBS-C and CIC double-blind
placebo-controlled trials. The incidence of diarrhea was similar in
the IBS-C and CIC populations. Severe diarrhea was reported in 2%
of 145 mcg and 290 mcg LINZESS-treated patients, and in <1% of
72 mcg LINZESS-treated CIC patients. If severe diarrhea occurs,
dosing should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than
placebo)
- In IBS-C clinical trials: 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 trials of a 145 mcg dose: 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%). In a CIC trial of a 72 mcg dose: diarrhea
(19% vs 7% placebo) and abdominal distension (2% vs <1%).
Please see full Prescribing Information including Boxed Warning:
http://www.allergan.com/assets/pdf/linzess_pi
LINZESS® and CONSTELLA® are registered trademarks of Ironwood
Pharmaceuticals, Inc. Any other trademarks referred to in this
press release are the property of their respective owners. All
rights reserved.
Forward-Looking Statements
This press release contains forward-looking statements.
Investors are cautioned not to place undue reliance on these
forward-looking statements, including statements about anticipated
leadership transitions, including the expected date and duration
thereof, and the Company’s ability to execute on its vision and
mission. These forward-looking statements (except as otherwise
noted) speak only as of the date of this press release and Ironwood
undertakes no obligation to update these forward-looking
statements. 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 those related to the possibility that the
leadership transitions do not occur as anticipated for any reason
or on the expected timing; effectiveness of development and
commercialization efforts by us and our partners; preclinical and
clinical development, manufacturing and formulation development;
the risk that clinical programs and studies may not progress or
develop as anticipated, including that studies are delayed or
discontinued for any reason, such as safety, tolerability,
enrollment, manufacturing, economic or other reasons, including due
to the impacts of the COVID-19 pandemic; the risk that findings
from our completed nonclinical and clinical studies may not be
replicated in later studies; efficacy, safety and tolerability of
linaclotide and our product candidates; the risk that the
therapeutic opportunities for LINZESS or our product candidates are
not as we expect; decisions by regulatory and judicial authorities;
the risk that we may never get sufficient patent protection for
linaclotide and other product candidates, that patents for
linaclotide or other products may not provide adequate protection
from competition, or that we are not able to successfully protect
such patents; developments in the intellectual property landscape;
challenges from and rights of competitors or potential competitors;
the risk that our planned investments do not have the anticipated
effect on our company revenues; the risk that we are unable to
manage our expenses or cash use, or are unable to commercialize our
products as expected; and the risks listed under the heading "Risk
Factors" and elsewhere in Ironwood's Quarterly Report on Form 10-Q
for the quarter ended September 30, 2020 and in our subsequent SEC
filings. In addition, the COVID-19 pandemic and the associated
containment efforts have had a serious adverse impact on the
economy, the severity and duration of which are uncertain.
Government stabilization efforts will only partially mitigate the
consequences. The extent and duration of the impact on our business
and operations is highly uncertain. Factors that will influence the
impact on our business, operations and financial results include
the duration and extent of the pandemic, the extent of imposed or
recommended containment and mitigation measures, and the general
economic consequences of the pandemic. The pandemic could have a
material adverse impact on our business, operations and financial
results for an extended period of time.
SOURCE: Ironwood Pharmaceuticals, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210208005799/en/
Investors and Media: Meredith Kaya, 617-374-5082
mkaya@ironwoodpharma.com
Media: Beth Calitri, 978-417-2031
bcalitri@ironwoodpharma.com
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