FORM 6-K
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
Report
of Foreign Issuer
Pursuant
to Rule 13a-16 or 15d-16 of
the
Securities Exchange Act of 1934
For the
month of September
2019
Commission
File Number: 001-11960
AstraZeneca PLC
1
Francis Crick Avenue
Cambridge
Biomedical Campus
Cambridge
CB2 0AA
United
Kingdom
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AstraZeneca PLC
INDEX
TO EXHIBITS
1.
AstraZeneca
amends collaboration with Ironwood
for Linzess in
China
18
September 2019 07:00
BST
AstraZeneca amends collaboration with
Ironwood for Linzess in China
New agreement gives AstraZeneca full responsibility
for
developing, manufacturing and commercialising Linzess in
China
AstraZeneca has amended its collaboration
agreement with Ironwood
Pharmaceuticals, Inc. (Ironwood) in China mainland, China Hong Kong
and China Macau for Linzess* (linaclotide), a first-in-class new
treatment for patients with irritable bowel syndrome with
constipation (IBS-C). IBS-C is characterised by symptoms of
abdominal pain and constipation, is a chronic and prevalent
functional gastrointestinal disorder in China and there are
currently few treatment options for this
condition.
The amended agreement gives AstraZeneca sole responsibility for
developing, manufacturing and
commercialising Linzess in China mainland, China Hong Kong and China
Macau. Ironwood will no longer be involved in the research and
development or the commercialisation of Linzess; it will also transfer manufacturing
responsibility to AstraZeneca.
The two companies first entered into a collaboration to co-develop
and co-commercialise Linzessin 2012. Under the original collaboration
agreement, AstraZeneca and Ironwood were jointly responsible for
strategic oversight of the development and commercialisation
of Linzess in China, while AstraZeneca had primary
responsibility for local operational execution.
Linzess was approved by
the National Medical Products Administration for adults with IBS-C
in January 2019 in China, where it is expected to be launched in
2019.
Leon Wang, Executive Vice President, International and President of
AstraZeneca China, said: "Linzess is an important new treatment for this type
of IBS in China, where there is a specific high unmet medical need.
Today's amended agreement allows us to bring this innovative
medicine to patients more efficiently and will contribute further
to our strong growth in this significant
market."
Mark Mallon, Chief Executive Officer of Ironwood, said:
"AstraZeneca has substantial experience and capabilities in
developing and commercialising medicines in China. There are
approximately 14 million adults suffering from IBS-C in China alone
and we believe AstraZeneca is well-positioned to
bring Linzess to these patients."
Financial considerations
AstraZeneca will pay Ironwood three non-contingent payments,
totalling $35m, between 2021 and 2024. In addition, Ironwood could
receive up to $90m in milestone payments, contingent on the
achievement of certain sales targets. Ironwood will also be
eligible for royalties beginning in the mid-single-digit percent,
based on the annual net sales of Linzess in China mainland, China Hong Kong and China
Macau where Ironwood will no longer jointly fund the development
and commercialisation of Linzess or share in the profit from
sales.
About Linzess
Linzess is a guanylate
cyclase-C (GC-C) agonist that is thought, based on learnings from
non-clinical trials, to work in two ways. Linzess binds to the GC-C receptor locally within
the intestinal epithelium. Activation of GC-C results in increased
intestinal fluid secretion and accelerated transit and a decrease
in the activity of pain-sensing nerves in the intestine. The
clinical relevance of the effect on pain fibres, based on
non-clinical trials, has not been established. *Linzess® is
a registered trademark of Ironwood Pharmaceuticals,
Inc.
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 and
Metabolism (CVRM), and Respiratory. AstraZeneca operates in over
100 countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and
follow us on Twitter @AstraZeneca.
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Adrian Kemp
Company Secretary
AstraZeneca PLC
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned, thereunto duly authorized.
Date:
18 September
2019
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By: /s/
Adrian Kemp
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Name:
Adrian Kemp
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Title:
Company Secretary
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