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Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its third quarter 2012 and recent business activities.
Third Quarter 2012 and Recent Highlights
The U.S. Food and Drug Administration (FDA) approved LINZESS as a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). LINZESS can help to relieve abdominal pain and constipation associated with IBS-C, and constipation and hard stools associated with CIC. Ironwood and Forest Laboratories, Inc. expect LINZESS to be available to U.S. patients in December 2012.
Ironwood and Almirall, S.A. received a positive opinion from the European Committee for Medicinal Products for Human Use (CHMP), recommending approval of linaclotide for the symptomatic treatment of moderate to severe IBS-C in adults in the E.U. A decision by the European Commission is expected in 2012. If approved, the product will be marketed under the brand name Constella ®.
Astellas, Ironwood’s linaclotide partner in Japan, initiated a double-blind, placebo-controlled, dose-ranging Phase 2 clinical trial of linaclotide in more than 500 Japanese adult patients with IBS-C.
Results from the two Phase 3 trials of linaclotide for the treatment of IBS-C in adults were published in the October 2012 issue of the American Journal of Gastroenterology (AJG).
Ironwood and Forest will present 10 abstracts at the American College of Gastroenterology (ACG) 2012 Annual Scientific Meeting being held in Las Vegas from October 19-24, 2012. Data being presented include analyses of abdominal and bowel symptoms from Phase 3 trials of linaclotide in IBS-C and CIC, as well as data about the economic burden of IBS-C and CIC and data on the use of patient-reported outcomes to assess the symptoms of these conditions.
Ironwood and Almirall will present six abstracts and two oral presentations at the 20 th United European Gastroenterology Week being held in Amsterdam from October 20-24, 2012. Data being presented include analyses of abdominal and bowel symptoms from Phase 3 trials of linaclotide in IBS-C.
Research & Development
In addition to the company’s ongoing efforts to evaluate linaclotide’s pharmacological potential in a variety of patient populations, Ironwood continues to pioneer the guanylate cyclase-C (GC-C) agonist space through the advancement of a second GC-C agonist, IW-9179. IW-9179 is currently being investigated in a Phase 2a clinical trial designed to evaluate its safety in approximately 80 patients with functional dyspepsia.
Ironwood continues to advance its broader pipeline, which includes early development candidates and discovery research efforts focused on gastrointestinal disease, central nervous system disorders, respiratory disease, and cardiovascular disease.
Ironwood received an $85 million milestone payment from Forest for FDA approval of LINZESS.
Including the $85 million milestone payment, Ironwood ended the third quarter of 2012 with approximately $193 million of cash, cash equivalents, and available-for-sale securities and used approximately $47 million of net cash for operations during the nine months ended September 30, 2012.