25 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: AstraZeneca and Ironwood Pharmaceuticals announced an agreement to co‐develop and co-commercialize Ironwood's linaclotide in China. Linaclotide is the first and only guanylate cyclase‐C (GC‐C) agonist approved by the US FDA, in August.
In May, Ironwood filed a clinical trial application with the State Food and Drug Administration in China for a phase III clinical trial to assess the efficacy and safety of linaclotide in adult patients suffering from irritable bowel syndrome with constipation (IBS‐C).
IBS‐C, which is characterized 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.
Under the terms of the collaboration, AstraZeneca will make an upfront payment of $25 million to Ironwood and 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. Ironwood will also be eligible for $125 million in additional commercial milestone payments contingent on the achievement of certain sales targets.