trending Market Intelligence /marketintelligence/en/news-insights/trending/rg0fxbmoxmz_sapijjwnjw2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *

* Required

In this list

Japanese regulator approves Ironwood's irritable bowel syndrome drug

South Korean Multichannel Industry To Survive With Right Strategies

South Korean Telcos Drive Next Wave Of Growth Through Home IoT Opportunities

Mining Exploration Insights: Financing Falls To 8-Month Low In October

Taking Advantage of Issuance Trends in 2020


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.