- Commercial products expected to drive > 25% compound annual growth rate (CAGR) for Ironwood revenue between 2016 and 20201; pipeline of innovative product candidates expected to accelerate high-margin revenue growth into late 2020s and beyond -
- Near-term catalysts highlighted for key programs including IW-3718, IW-1973 and linaclotide delayed release-1 -
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"Ironwood's investments in innovation are delivering value for patients
and shareholders: we expect to have one of the fastest-growing toplines
in the biotech sector from 2016 through 2020," said
Highlights of Key Programs
IW-3718 for Uncontrolled Gastroesophageal Reflux Disease (uGERD)
Ironwood has completed enrollment in a Phase IIb dose-ranging clinical
trial of IW-3718, and data from this trial are expected in mid-2017. The
company believes positive data would substantially reduce one of the
more significant risks in the program, and that this potential medicine
could generate greater than
Unmet need: An estimated 10 million people in the
U.S.suffer from uGERD, and many millions more suffer globally. This distinct population of patients is taking proton pump inhibitors (PPIs) and continues to experience heartburn symptoms. Data from physician surveys indicate a treatment offering a modest improvement in symptom relief over PPIs alone would be expected to result in physician adoption.
- Program rationale: IW-3718, an investigational gastric retentive formulation of a bile acid sequestrant, is being evaluated to assess its safety and efficacy - including its effect on heartburn severity - when used on top of ongoing PPI therapy in patients with uGERD. Data from a Phase IIa study demonstrated that approximately two-thirds of patients who underwent bile reflux monitoring tested positive for bile reflux into the esophagus, and that patients with ongoing or recent esophagitis indicating they were actively refluxing bile or gastric acid who received IW-3718 with their PPI demonstrated encouraging improvements in relief of heartburn.
- Next steps: The data from the Phase IIb trial expected mid-year will include two key analyses: 1) degree of reduction in heartburn severity for IW-3718 plus PPI versus PPI alone, and 2) define the level for a clinically meaningful improvement based on a patient-reported outcome measure incorporated into the study, and correlate with IW-3718 treatment effects. Given the severity of symptoms in this patient population, the lack of prescription treatment options, industry analogs and market research, Ironwood currently believes an improvement in heartburn severity of at least 15% for IW-3718 plus PPI versus PPI alone would be meaningful to patients and physicians.
IW-1973 for Resistant Hypertension (rHTN), Heart Failure with Preserved Ejection Fraction (HFpEF) and Diabetic Nephropathy (DN)
In 2017, Ironwood expects to initiate Phase II clinical trials
evaluating the investigational soluble guanylate cyclase (sGC)
stimulator IW-1973 in three indications: rHTN, HFpEF and DN. The company
believes IW-1973 could generate annual peak sales greater than
Unmet need: rHTN, HFpEF and DN are estimated to impact 7 million, 3
million and 8 million patients in the
U.S.alone, respectively, and many millions more globally. There are a limited number of treatment options available for these conditions, which are associated with significant morbidity and mortality.
- Program rationale: Dysregulation of the nitric oxide-soluble guanylate cyclase-cyclical guanosine monophosphate (NO-sGC-cGMP) signaling pathway is believed to be linked to multiple vascular and fibrotic diseases, such as rHTN, HFpEF and DN. IW-1973 modulated the NO-sGC-cGMP pathway and improved vascular function, vascular inflammation, fibrosis and metabolism in nonclinical studies.
- Next steps: Ironwood expects to initiate Phase II clinical trials with IW-1973 in all three indications during the second half of 2017.
Linaclotide Delayed Release-1 for Irritable Bowel Syndrome with Constipation (IBS-C)
LINZESS® (linaclotide) is on track to exceed
- Unmet need: Market research has shown that abdominal pain is the most bothersome symptom for IBS-C patients and is what motivates them to seek treatment. Physicians and patients rate LINZESS highly for its effective relief of abdominal pain.
- Program rationale: Linaclotide DR1, an investigational medicine, is being studied to determine if it can provide delivery of linaclotide to the distal small intestine and colon, where the majority of the abdominal pain associated with IBS-C is believed to originate, and if it can improve abdominal pain relief in patients with IBS-C. Phase IIb data demonstrated that 300 mcg linaclotide DR1 resulted in numerically greater abdominal pain improvement compared to placebo and to the 290 mcg immediate release (IR) formulation of linaclotide.
Next steps: Ironwood and Allergan intend to begin a Phase III program
for linaclotide DR1 in adults with IBS-C in the second half of 2017,
pending discussions with
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About LINZESS (linaclotide)
LINZESS is the #1 prescribed brand for the treatment of adult patients
with irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC), based on QuintilesIMS data. Since its
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, 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 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
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.
- 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
- 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 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
About Uncontrolled Gastroesophageal Reflux Disease
An estimated 10 million people in the
IW-3718 is a novel, investigational gastric retentive formulation of a bile acid sequestrant, developed by Ironwood using the proprietary Acuform® drug delivery technology licensed from Depomed, Inc. IW-3718 is designed to remain in the stomach and duodenum (upper small intestine) over an extended period of time and to work in combination with a PPI to reduce the detrimental effects of bile and acid on the esophagus.
About Ironwood's sGC Program
Soluble guanylate cyclase (sGC), a central component of the NO-sGC-cGMP pathway, plays an important role in regulating diverse physiological processes such as blood flow, inflammation, fibrosis, and metabolism. Dysregulation of sGC may play a role in multiple vascular and fibrotic diseases with high unmet need such as diabetic nephropathy, resistant hypertension, heart failure, achalasia, sickle cell disease and vascular dementia. Ironwood established its expertise in this signaling pathway through the discovery and development of linaclotide, a guanylate cyclase C (GC-C) agonist. Stimulation of sGC is a clinically validated approach, and Ironwood leveraged its GC-C expertise to discover and develop multiple sGC stimulators. IW-1973 is currently being studied in diabetes patients with hypertension and IW-1701 is being studied in achalasia.
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including statements about the development, launch,
introduction and commercial potential of linaclotide, lesinurad, our
product candidates and the other products that we promote and the
drivers, timing, impact and results thereof (including near-term
value-creating catalysts); reduction of a significant risk from IW-3718,
if Phase IIb data is positive; market size, prevalence, growth and
opportunity, including peak sales and the potential demand for
linaclotide, lesinurad and our product candidates, as well as their
potential impact on applicable markets; the potential indications for,
and benefits of, linaclotide, lesinurad and our product candidates; the
anticipated timing of preclinical, clinical and regulatory developments
and the design, timing and results of clinical and preclinical studies;
the potential for, and timing of, regulatory submissions and approvals
for linaclotide, lesinurad and our product candidates, and the level of
risk associated with the path to approval; expected periods of patent
exclusivity; the strength of the intellectual property protection for
linaclotide, lesinurad and our product candidates and our intentions and
efforts to protect such intellectual property; our potential for
sustainable, high-margin growth and shareholder returns; consensus
expectations related to revenue growth for certain commercial biotech
companies; expectations concerning if and when we will become cash flow
positive; and our financial performance and results, and guidance and
expectations related thereto (including the drivers and timing thereof),
including expectations related to Ironwood revenue CAGR, cash flow
accretion, margin expansion and revenue growth, LINZESS
1 The > 25% Ironwood revenue CAGR calculation excludes any
current or future revenue recognized in the period related to milestone
payments to Ironwood, including approximately
Director, Corporate Communications
Director, Investor Relations
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