AstraZeneca has amended its collaboration agreement with Ironwood Pharmaceuticals in China mainland, China Hong Kong and China Macau for Linzess (linaclotide), a new treatment for patients with irritable bowel syndrome with constipation (IBS-C).

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.

Collaboration in 2012

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.

“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,” says Leon Wang, Executive Vice President, International and President of AstraZeneca China.

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.

Photo of Leon Wang, Executive Vice-President, International: AstraZeneca