FDA approves linaclotide

FDA approved Linzess linaclotide from Forest Laboratories Inc. (NYSE:FRX) and Ironwood Pharmaceuticals Inc. (NASDAQ:IRWD) to treat chronic constipation and irritable bowel syndrome with constipation (IBS-C). The partners will co-commercialize Linzess in the U.S., with a launch planned for next quarter. The price will be finalized in the coming weeks. The approval triggers an $85 million payment to Ironwood from Forest. Ironwood is eligible for up to an additional $100 million in sales-related milestones. Linzess is a guanylate cyclase C ( GCC; GUCY2C) agonist.

Linzess' label includes a boxed warning that the drug should not be used in patients 16 years of age and younger. The warning cites deaths in juvenile mice seen in preclinical toxicology studies of Linzess. As part of the approval, FDA is requiring the partners to conduct a pediatric development program that will initially consist of additional preclinical studies. Forest was up $0.38 to $35.04 on Thursday. Ironwood was off $0.24 to $12.42. ...