Linzess (linaclotide) approved in China for the treatment of irritable bowel syndrome with constipation

AstraZeneca announced that its partner Ironwood Pharmaceuticals, Inc. has received marketing authorisation from the National Medical Products Administration (NMPA) for Linzess (linaclotide) in China for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C). Linzess is a first-in-class guanylate cyclase‐C (GC‐C) receptor agonist and the approval offers an important treatment option for adult patients in China.

The NMPA approval is based on a Phase III global, multicentre, clinical trial, jointly conducted by AstraZeneca China and Ironwood, in five countries, which evaluated the efficacy and safety of Linzess in patients with IBS-C.1

Leon Wang, Executive Vice President, International and President of AstraZeneca China, said: “As a first-in-class medicine for the treatment of irritable bowel syndrome with constipation, Linzess fills an important gap in the treatment for this debilitating disease, which impacts an estimated 14 million adult patients in China. AstraZeneca continues to focus on introducing innovative medicines into China and this approval is another significant step towards achieving our ambition of enabling Chinese patients to have access to new medicines as early as possible.”

Mark Mallon, who will become CEO of Ironwood following completion of Ironwood’s planned separation, said: “I am delighted with this week’s approval of Linzess in China. Irritable bowel syndrome with constipation causes frequent and bothersome abdominal and constipation symptoms, and Linzess has a well-established efficacy and safety profile in this disease. We have a strong partnership with AstraZeneca, and as I transition into my new role at Ironwood, I look forward to continuing to work with the team to help make Linzess available to millions of suffering patients.”

Mark Mallon was the president of AstraZeneca China from 2011 to 2012, during which period Ironwood and AstraZeneca entered into the 2012 linaclotide collaboration agreement.

Launch of Linzess in China is expected in the second half of 2019. Under the terms of the collaboration, AstraZeneca will record Product Sales and share the net profits and losses associated with Linzess in China, with AstraZeneca carrying 55 percent of each until a certain specified milestone is achieved, moving to a 50/50 split thereafter. Ironwood will also be eligible for up to $125 million in additional commercial milestone payments contingent on the achievement of certain sales targets.