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AstraZeneca’s Linzess approved in China

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AstraZeneca’s partner Ironwood Pharmaceuticals has received marketing authorization 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 guanylate cyclase‐C (GC‐C) receptor agonist and 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.

“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,” said Mark Mallon, who will become CEO of Ironwood following completion of Ironwood’s planned separation.

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.

Photo of Mark Mallon, new CEO of Ironwood: AstraZeneca