AstraZeneca PLC AstraZeneca amends collaboration with Ironwood (7649M)
18 Settembre 2019 - 8:01AM
UK Regulatory
TIDMAZN
RNS Number : 7649M
AstraZeneca PLC
18 September 2019
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 Linzess in 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(R) 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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