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2019-01-18

AstraZeneca: 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 China 2 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 Linzess in China, Hong Kong and
Macau. Outside China, linaclotide is marketed by Ironwood and
Allergan plc in the United States as Linzess and 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.com
(http://www.astrazeneca.com/) and follow us on Twitter @AstraZeneca
(https://twitter.com/AstraZeneca).

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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.

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