Ironwood Pharmaceuticals provided an update on its Q3 business activities. Q3 and Recent Highlights include: FDA approved LINZESS as a once-daily treatment for adult men and women suffering from irritable bowel syndrome with constipation or chronic idiopathic constipation; Ironwood and Almirall, S.A. received a positive opinion from the European Committee for Medicinal Products for Human Use recommending approval of linaclotide for the symptomatic treatment of moderate to severe IBS-C in adults in the E.U.; 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; Ironwood continues to pioneer the guanylate cyclase-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 M milestone payment, Ironwood ended the Q3 with approximately $193M of cash, cash equivalents, and available-for-sale securities and used approximately $47Mof net cash for operations during the nine months ended September 30.
- Pharmaceuticals & Drug Trials