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February 10, 2014
08:07 EDTFRX, IRWDIronwood 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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November 20, 2014
09:02 EDTIRWDIronwood earns $15M milestone from Astellas Pharma
Ironwood Pharmaceuticals has earned a $15M development milestone payment from Astellas Pharma Inc., its partner for linaclotide in Japan. This milestone was triggered by Astellasís enrollment of the first patient in a randomized, double-blind, placebo-controlled Phase III clinical trial of linaclotide in adult patients with irritable bowel syndrome with constipation in Japan. Astellas expects to complete the Phase III trial in 2016. Ironwood and Astellas entered into a licensing agreement in 2009 to develop and commercialize linaclotide in Japan for the treatment of IBS-C, chronic constipation and other gastrointestinal conditions. Per the agreement, Astellas paid Ironwood a $30M upfront licensing fee. In addition to the $15M development milestone payment upon enrollment of the first patient in the Phase III trial, the agreement also includes additional development milestone payments that could total up to $30M, consisting of $15M upon filing for regulatory approval in Japan and $15M upon receipt of approval. The agreement also provides for Ironwood to receive royalties which escalate based on sales volume. Astellas also plans to expand its development of linaclotide in Japan and is entering into a Phase II clinical trial with linaclotide in adults with chronic constipation. If approved, the same royalty terms would apply.

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