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

First-in-class guanylate cyclase agonist

AstraZeneca today 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.

About IBS-C treatment in China

Irritable bowel syndrome is a prevalent, chronic, debilitating disorder in China² and IBS-C is one of its subtypes. In most patients the main symptom is recurrent constipation, accompanied by defecation-related abdominal pain and abdominal distension symptoms. The quality of life of patients is affected due to its frequent recurrence.

About Linzess

Linzess (linaclotide) is a guanylate cyclase-C agonist for the treatment of IBS-C. It binds to the GC-C receptor locally, within the intestinal epithelium. Activation of the GC-C results in increased intestinal fluid secretion, accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. Trials have shown that the most common adverse reaction to Linzess was mild or moderate diarrhoea without significant clinical consequences.³

In 2012, AstraZeneca and Ironwood Pharmaceuticals, Inc. collaborated to jointly develop and commercialise Linzessin China, Hong Kong and Macau. Outside China, linaclotide is marketed by Ironwood and Allergan plc in the United States as Linzessand is marketed by Allergan for the treatment of adults with moderate-to-severe IBS-C in Europe under the brand name Constella. Astellas has the exclusive rights to develop and commercialise linaclotide in Japan as Linzess.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.comand follow us on Twitter @AstraZeneca.

References

1. Yunsheng Yang. Linaclotide in irritable bowel syndrome with constipation: A Phase 3 randomized trial in China and other regions[J]. Journal of Gastroenterology and Hepatology, 2018,33(5).

2. Zhang Lu, Duan Liping, Liu Yixuan el. Meta analysis of the prevalence and risk factors of irritable bowel syndromes in Chinese population [J]. Chinese Journal of Internal Medicine. 2014;53(12):969-975. DOI: 10.3760/cma.j.issn.0578-1426.2014.12.011.

3. William D. Chey, MD. Linaclotide for Irritable Bowel Syndrome with Constipation: A 26-Week, Randomized, Double-blind, Placebo-Controlled Trial to Evaluate Efficacy and Safety [J]. The American Journal of Gastroenterology, 2012,107:12.