Updated on 11 September 2013
"Linaclotide is approved in the US and in the European Union, and the initiation of this Phase III trial is a critical step along the regulatory pathway to support approval in China. We continue to make strides toward our goal of bringing linaclotide to appropriate adult patients around the world, and we look forward to continuing to collaborate with AstraZeneca to serve the unmet needs of patients in China," said Mark Currie, senior vice president, chief scientific officer, and president of research and development at Ironwood.
Based on a collaboration announced in October 2012, Ironwood and AstraZeneca are jointly responsible for the development and commercialization of linaclotide in China, with AstraZeneca primarily responsible for local operational execution.
Under the terms of the collaboration, AstraZeneca made an upfront payment of $25 million to Ironwood, and the two companies will share the net profits and losses associated with linaclotide in China, with AstraZeneca carrying 55 percent of each until a certain specified milestone is achieved, moving to a 50/50 split thereafter, the statement said.
Ironwood is also eligible for $125 million in additional commercial milestone payments contingent on the achievement of certain sales targets.