Ironwood Pharmaceuticals Earns $15 Million Milestone From Astellas Pharma Inc.

November 20, 2014

By Riley McDermid, BioSpace.com Breaking News Editor

Cambridge, Mass.-based Ironwood Pharmaceuticals, Inc. said Thursday that it has earned a $15 million development milestone payment from Astellas Pharma Inc. , its partner for bowel drug linaclotide in Japan, triggered by Astellas’s enrollment of the first patient in a randomized, double-blind, placebo-controlled Phase III clinical trial.

The trial of linaclotide will be conducted on adult patients with irritable bowel syndrome with constipation (IBS-C) in Japan and is slated to finish in 2016.

The two firms partnered in 2009 on a licensing agreement to develop and commercialize linaclotide in Japan for the treatment of IBS-C, chronic constipation and other gastrointestinal conditions.

Under the terms of that deal, Astellas paid Ironwood a $30 million upfront licensing fee. In addition to today’s $15 million milestone payment, the terms allow for additional development milestone payments that could total up to $30 million, consisting of $15 million upon filing for regulatory approval in Japan and $15 million upon receipt of approval.

Ironwood will also receive royalties based on sales volume, terms which will apply if linaclotide is also approved in Japan to treat adults with chronic constipation.

Linaclotide is a guanylate cyclase-C (GC-C) agonist that binds to the GC-C receptor locally, within the intestinal epithelium. That then results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.

The drug is marketed by Ironwood and Actavis plc in the United States as LINZESS by Almirall, S.A. as CONSTELLA in Europe. Ironwood also has partnered with AstraZeneca for development and commercialization of linaclotide in China.