Policy & Regulation
AstraZeneca and Ironwood amend collaboration for Linzess in China
19 September 2019 -

Biopharmaceutical company AstraZeneca Plc (LON:AZN) announced on Wednesday the amendment of its collaboration agreement with Ironwood Pharmaceuticals Inc in China mainland, Hong Kong and Macau for Linzess (linaclotide), a first-in-class 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 these territories.

Ironwood will no longer be involved in the research and development or the commercialisation of Linzess and will also transfer manufacturing responsibility to AstraZeneca.

Reportedly, 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.

AstraZeneca will pay Ironwood three non-contingent payments, totalling USD35m, between 2021 and 2024. In addition, Ironwood could receive up to USD90m in milestone payments, contingent on the achievement of certain sales targets.

Also, Ironwood will be eligible for royalties beginning in the mid-single-digit percent, based on the annual net sales of Linzess in China mainland, Hong Kong and Macau, where Ironwood will no longer jointly fund the development and commercialisation of Linzess or share in the profit from sales.

AstraZeneca is focused on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in the three therapy areas of Oncology, Cardiovascular, Renal and Metabolism (CVRM) and Respiratory.