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Corporate News, FDA



IRONWOOD PHARMA (IRWD) ANNOUNCES FDA FILING ACCEPTANCE AND PRIORITY REVIEW OF
SUPPLEMENTAL NEW DRUG APPLICATION FOR LINZESS

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Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company,
today announced that the U.S. Food and Drug Administration (FDA) has granted
Priority Review to the supplemental New Drug Application (sNDA) for LINZESS®
(linaclotide) for the treatment of children and adolescents ages 6-17 years-old
with functional constipation (FC). The FDA has assigned the application a
Prescription Drug User Fee Act (PDUFA) date of June 14th, 2023, four months
earlier than the standard review cycle.

The FDA grants priority review to therapies that have the potential to provide
significant improvements in the treatment, diagnosis, or prevention of serious
conditions and to pediatric supplements submitted pursuant to the Best
Pharmaceuticals for Children Act.2



“Pediatric functional constipation has a significant impact on young patients
and their families, yet there are no FDA-approved prescription therapies
available for this population,” said Michael Shetzline, M.D., Ph.D., chief
medical officer, senior vice president and head of research and drug development
at Ironwood Pharmaceuticals. “We welcome the FDA’s decision to grant priority
review, as it brings us even closer to potentially changing the treatment
landscape for pediatric patients ages 6-17 years-old with this condition.”

FC in children is defined as a chronic condition with hard, infrequent bowel
movements that are often difficult or painful to pass3. The condition affects an
estimated 6 million children aged 6-17 years-old in the U.S.1

“As a company focused on advancing the treatment of GI diseases, we have worked
with a sense of urgency to expand the clinical utility of linaclotide to this
underserved pediatric population with FC,” said Tom McCourt, chief executive
officer of Ironwood Pharmaceuticals. “If approved, we look forward to a
commercial launch mid-2023.”

The sNDA filing was based on the results of a large, multicenter, double-blind,
Phase III study evaluating linaclotide in patients ages 6-17 years-old with
functional constipation. A total of 330 patients were randomized in a 1:1 ratio
between linaclotide or placebo. Compared to placebo, linaclotide showed a
statistically significant and clinically meaningful improvement from baseline in
12-week spontaneous bowel movement (SBM) frequency rate (SBMs/week), meeting the
primary endpoint. Linaclotide-treated patients demonstrated a greater than
two-fold least squares mean change from baseline in SBMs/week (2.220) compared
to placebo (1.050) (p<0.0001). The secondary endpoint of change from baseline to
week 12 in stool consistency, assessed by Bristol Stool Form Scale (BSFS)
scores, also showed statistically significant improvement with linaclotide
compared to placebo. Overall, the Phase III study demonstrated that linaclotide
was well-tolerated in the pediatric population. The most common adverse event in
the pediatric Phase 3 study was diarrhea, which occurred in 4.3% of
linaclotide-treated patients versus 1.8% in the placebo group.

LINZESS is developed and marketed by Ironwood and AbbVie in the United States
and is currently indicated for the treatment of adults with irritable bowel
syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). It
is not approved for use in patients less than 18 years of age.

About Linaclotide

Linaclotide is a guanylate cyclase-C (GC-C) agonist that is thought to work in
two ways based on nonclinical studies. Linaclotide 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 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 chronic constipation. In China, (including Hong Kong and
Macau) Ironwood’s partner Astra Zeneca markets linaclotide under the brand name
LINZESS for the treatment of adults with IBS-C. Ironwood is also partnered with
AbbVie for development and commercialization of linaclotide in all other
territories worldwide. 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.

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 LESS THAN 2 YEARS OF
AGE



LINZESS is contraindicated in patients less than 2 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.

Contraindications

 * LINZESS is contraindicated in patients less than 2 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 2 years of age. In neonatal
   mice, linaclotide increased fluid secretion as a consequence of age-dependent
   elevated GC-C agonism resulting in mortality within the first 24 hours due to
   dehydration. There was no age-dependent trend in GC-C intestinal expression
   in a clinical study of children 2 to less than 18 years of age; however,
   there are insufficient data available on GC-C intestinal expression in
   children less than 2 years of age to assess the risk of developing diarrhea
   and its potentially serious consequences in these patients. The safety and
   effectiveness of LINZESS in patients less than 18 years of age have not been
   established.

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.

About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap 600® company, is a
leading gastrointestinal (GI) healthcare company on a mission to advance the
treatment of GI diseases and redefine the standard of care for GI patients. We
are pioneers in the development of LINZESS® (linaclotide), the U.S. branded
prescription market leader for adults with irritable bowel syndrome with
constipation (IBS-C) or chronic idiopathic constipation (CIC). Under the
guidance of our seasoned industry leaders, we continue to build upon our history
of GI innovation and challenge what has been done before to shape what the
future holds. We keep patients at the heart of our R&D and commercialization
efforts to reduce the burden of GI diseases and address significant unmet needs.

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston,
Massachusetts.

We routinely post information that may be important to investors on our website
at www.ironwoodpharma.com. In addition, follow us on Twitter and on LinkedIn.

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 the clinical utility of LINZESS as a treatment option for
pediatric patients aged 6-17 with FC; the efficacy and safety of linaclotide in
FC in pediatric patients; the potential for linaclotide to change the treatment
landscape for pediatric patients ages 6-17 years-old with FC; our expectations
regarding the PDUFA date for the sNDA; and, if the sNDA is approved, the
anticipation for a commercial launch and the timing thereof. These
forward-looking statements 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
effectiveness of development and commercialization efforts by us and our
partners; preclinical and clinical development, manufacturing and formulation
development of linaclotide and our product candidates; 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; the risk
that findings from our completed nonclinical and clinical studies may not be
replicated in later studies; the risk that we or our partners are unable to
obtain, maintain or manufacture sufficient LINZESS or our product candidates, or
otherwise experience difficulties with respect to supply or manufacturing; the
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,
including not approving our sNDA submission; 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 the development of either
our clinical pediatric programs in IBS-C and functional constipation and/or
IW-3300 is not successful or that any of our product candidates is not
successfully commercialized; 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; the impact of the COVID-19 pandemic; and the risks listed under the
heading "Risk Factors" and elsewhere in Ironwood's Annual Report on Form 10-K
for the year ended December 31, 2021, and in our subsequent SEC filings.

________________________
1 U.S. Census, 2017 National Population Projection Tables; Robin, Samantha G. et
al, Prevalence of Pediatric Functional Gastrointestinal Disorders Utilizing the
Rome IV Criteria, The Journal of Pediatrics, December 2017; Koppen, I. J. N. et
al., Prevalence of Functional Defecation Disorders in Children: A Systemic
Review and Meta-Analysis. J Pediatr. 2018.
2 U.S. FDA Guidance for Industry: Expedited Programs for Serious Conditions –
Drugs and Biologics, May 2014.
3 Di Lorenzo C, Hyams JS, Saps M, et al. Chapter 16: Childhood Functional
Gastrointestinal Disorders: Child/Adolescent. In: Drossman DA, Chang L, Chey WD,
et al. Rome IV: Functional Gastrointestinal Disorders: Disorders of Gut-Brain
Interaction. Raleigh, NC: Rome Foundation; 2016.



View source version on businesswire.com:
https://www.businesswire.com/news/home/20230213005077/en/

Media:

Beth Calitri, 978-417-2031

bcalitri@ironwoodpharma.com

Investors:

Greg Martini, 617-374-5230

gmartini@ironwoodpharma.com

Matt Roache, 617-621-8395

mroache@ironwoodpharma.com

Source: Ironwood Pharmaceuticals, Inc.




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automatically sends, such as IP address or browser type.

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