- Ironwood Pharmaceuticals (NASDAQ:IRWD) reports that commercialization partner AstraZeneca (NYSE:AZN) is set to file a marketing application in early 2016 with the Chinese Food and Drug Administration (CFDA) seeking approval for linaclotide for the treatment of adult patients with irritable bowel syndrome with constipation (IBS-C). If cleared, it will be the first prescription drug available in China for both male and female patients with IBS-C.
- A Phase 3 study conducted mainly in China met all of its primary and secondary endpoints. 60% of linaclotide-treated patients were Abdominal Pain/Discomfort Responders compared to 48.8% for placebo (p=0.001) while 31.7% of the linaclotide group were IBS Degree of Relief Responders versus 15.4% for placebo (p<0.0001). Full results from the trial will be presented at a future medical meeting.
- Ironwood and AstraZeneca are jointly responsible for the development and commercialization of linaclotide in China. AstraZeneca has the bulk of the responsibility for local operations. Per their collaboration, AstraZeneca paid Ironwood an upfront fee of $25M. P&L will be shared on a 55/45 basis (favoring AstraZeneca) that will adjust to 50/50 after a certain milestone is achieved. Ironwood is also eligible for additional commercial milestones of $125M.
- Linaclotide is marketed in the U.S. as Linzess by Actavis and Ironwood and in Europe as Constella by Almirall.