Profile: Ironwood Pharmaceuticals Inc (IRWD.O)
23 Mar 2017
Ironwood Pharmaceuticals, Inc., incorporated on January 5, 1998, is a biotechnology company. The Company is advancing product opportunities in areas of unmet need, including irritable bowel syndrome with constipation (IBS C), and chronic idiopathic constipation (CIC), hyperuricemia associated with uncontrolled gout, uncontrolled gastroesophageal reflux disease (uncontrolled GERD), and vascular and fibrotic diseases. The Company operates in human therapeutics business segment. The Company's product, linaclotide, is available to adult men and women suffering from IBS C or CIC in the United States under the trademarked name LINZESS, and is available to adult men and women suffering from IBS C in certain European countries under the trademarked name CONSTELLA. Linaclotide is being developed and commercialized in other parts of the world by certain of its partners. It is also advancing IW-3718, a gastric retentive formulation of a bile acid sequestrant with the potential to provide symptomatic relief in patients with uncontrolled GERD.
The Company manages its global supply and distribution of linaclotide and lesinurad through a combination of contract manufacturers and collaboration partners. ZURAMPIC is approved for use in combination with a xanthine oxidase inhibitor (XOI), for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA), levels with a XOI alone. The Company is engaged in the discovery and development of linaclotide to advance development programs, including IW-1973 and IW-1701, targeting soluble guanylate cyclase (sGC). The Company is advancing two linaclotide colonic release formulations: Linaclotide colonic release-1 (CR1), which is a second generation product candidate with the potential to improve abdominal pain relief in adult IBS C patients, and Linaclotide colonic release-2 (CR2), which is a product candidate with the potential to improve abdominal pain in patients with additional gastrointestinal (GI) disorders, where lower abdominal pain is a predominant symptom, such as non-constipation subtypes of irritable bowel syndrome (IBS).
The Company together with its partner is exploring development opportunities to enhance the clinical profile of LINZESS by studying linaclotide in additional indications and populations to assess its potential to treat various GI conditions. It is also evaluating linaclotide as a potential treatment of the GI dysfunction associated with opioid induced constipation (OIC). As of December 31, 2016, the Company together with its partner had initiated two Phase II clinical pediatric studies in IBS C patients age 7 to 17 and functional constipation patients age 6 to 17. The Company has initiated a Phase IIb clinical study of IW-3718 in patients with uncontrolled GERD. The Company is developing DUZALLO, a fixed-dose combination product of lesinurad and allopurinol, an XOI, which is included under the Lesinurad License. The Food and Drug Administration (FDA) accepted for review a new drug application (NDA) for DUZALLO for the treatment of hyperuricemia in patients with uncontrolled gout.
The Company's sGC candidate, IW-1973, is targeting diabetic complications resulting from vascular dysfunction and fibrosis, such as resistant hypertension and diabetic nephropathy. The Company has initiated a Phase IIa open-label, placebo-controlled clinical study of IW 1973 in patients with Type 2 diabetes and hypertension. The Phase IIa study is designed to evaluate the tolerability, pharmacokinetic and pharmacodynamic effects of IW-1973 across multiple doses, as well as to explore its effect on biomarkers. The Company has initiated a Phase IIa randomized, double blind, placebo controlled, single dose clinical study of IW 1701 designed to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of IW 1701 in patients with Type II achalasia.
The Company competes with Takeda Pharmaceuticals Limited, Synergy Pharmaceuticals, Inc., Mylan N.V., Takeda Pharmaceuticals Americas, Inc. and Sucampo AG.
Ironwood Pharmaceuticals Inc
301 Binney St
CAMBRIDGE MA 02142-1030
Company Web Links
- BRIEF-Ironwood pharmaceuticals qtrly loss per share $0.09
- BRIEF-Ironwood Pharmaceuticals and Allergan entered into amendment to license agreement, dated April 30, 2009
- BRIEF-Astellas and Ironwood report positive top-line results from phase III Linaclotide trial in Japan
- BRIEF-Ironwood Pharma Q3 adj shr loss $0.18 vs est $-0.23