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February 10, 2014
08:07 EDTIRWD, FRXIronwood receives NOA for patent expected to extend LINZESS patent protection
Ironwood Pharmaceuticals (IRWD) announced that the United States Patent and Trademark Office has issued a Notice of Allowance for a patent application covering methods of using LINZESS to treat patients with irritable bowel syndrome with constipation or chronic idiopathic constipation. The patent application, co-owned by Ironwood and Forest Laboratories (FRX), is expected to issue in mid-2014 and extend LINZESS patent protection into 2031. LINZESS is approved and marketed in the United States for the treatment of adult patients suffering from IBS-C or CIC. It is the first and only guanylate cyclase-C agonist approved by the FDA.
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October 20, 2014
08:08 EDTIRWDIronwood presents IW-9179 Phase IIa clinical study data
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October 16, 2014
15:10 EDTIRWDAmerican College of Gastroenterology to hold annual meeting
ACG Annual Scientific Meeting 2014 to be held in Philadlephia, PA on October 17-22.
08:02 EDTIRWDIronwood announces initiation of Phase II linaclotide trial
Ironwood Pharmaceuticals (IRWD) announced the initiation of a Phase II clinical trial evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data are expected in the second half of 2015. The clinical trial is being conducted jointly by Ironwood and Actavis plc (ACT), Ironwood’s co-development and co-promotion partner for linaclotide in the United States. Linaclotide is a guanylate cyclase-C agonist approved by the FDA for the treatment of adults with irritable bowel syndrome with constipation or chronic idiopathic constipation. Linaclotide is not currently approved for the treatment of OIC. The randomized, double-blind, placebo-controlled, multi-site Phase II clinical trial is expected to enroll approximately 240 adult patients with chronic, non-cancer pain who have been receiving a stable dose of an opioid analgesic and suffer from constipation, defined as fewer than three spontaneous bowel movements per week. Patients will be randomized to receive 145 mcg of linaclotide, 290 mcg of linaclotide, or placebo for eight weeks. The primary endpoint of the trial is an increase in SBM frequency. Additionally, a number of secondary endpoints and exploratory analyses intended to inform future development plans are included in the study design.

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