FDA nod for use of Ironwood and Forest's Linzess in certain cases of IBS and constipation

The US Food and Drug Administration last week approved Linzess (linaclotide), co-marketed by US drugmakers Ironwood Pharmaceuticals (Nasdaq: IRWD) and Forest Laboratories (NYSE: FRX), to treat chronic idiopathic constipation and to treat irritable bowel syndrome with constipation (IBS-C) in adults. The companies expect to make the drug available to US patients in the fourth-quarter of this year.

Linaclotide will compete with Amitiza (lubiprostone) from Japan’s Takeda Pharmaceuticals (TYO: 4502) which generated 18.7 billion yen ($237.6 million) for the Japanese drugmaker in the 12 months ended in March. Peak sales for linaclotide may reach $1.35 billion, according to Edward Nash, an analyst with Cowen & Co, quoted by Bloomberg. Gregory Wade, an analyst with Wedbush Securities quoted by the New York Times, expects sales of Linzess to exceed $2 billion a year by 2019. However, he estimated sales of just $40 million in 2013, increasing to $165 million in 2014.

$1.4 billion market by 2018