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Japanese regulator approves Ironwood's irritable bowel syndrome drug

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Japanese regulator approves Ironwood's irritable bowel syndrome drug

Japan's Ministry of Health, Labor and Welfare approved Ironwood Pharmaceuticals Inc.'s LINZESS for the treatment of adults with irritable bowel syndrome with constipation.

The approval triggers a $15 million milestone payment from development and commercialization partner Astellas Pharma Inc., which secured the marketing approval.

Under the agreement, Astellas paid Ironwood a $30 million upfront licensing fee, a $15 million development milestone payment upon enrollment of the first patient in a phase 3 trial, and a $15 million milestone payment upon the new drug application submission. The agreement also provides for Ironwood to receive royalties, which escalate based on sales volume.

Data from a phase 3 trial in Japan indicate that patients treated with 500 mcg of linaclotide showed statistically significant improvement compared to placebo-treated patients.

Another phase 3 trial of the drug in patients with chronic constipation is ongoing in Japan, with top-line data expected in 2017.

Astellas is expected to launch LINZESS in the first half of 2017.