Shire takes hit as bowel disease drug Lialda fails in Ph III trial

The shares of Ireland-headquartered Shire (LSE: SHP) dropped 4.9% to £20.14 in mid afternoon trading last Friday, after it announced top-line results of the PREVENT2 trial, a Phase III investigational study of once-daily SPD476, MMX mesalamine, in patients with a history of diverticulitis, which failed to meet its target.

MMX mesalamine is registered as Lialda and is approved for the induction of remission in patients with active, mild to moderate ulcerative colitis and for the maintenance of remission of ulcerative colitis. Sales of Lialda/Mezavant (mesalamine) were $372 million last year, up 27% on 2010, and a new indication of diverticulitis had been expected to double that figure. JP Morgan analysts have even suggested peak sales of $2 billion with the added indication.

The study, conducted in 10 countries worldwide including the USA, did not meet the primary endpoint in reducing the rate of recurrence of diverticulitis over a two-year treatment period. In addition, SPD476, MMX mesalamine did not show a significant difference compared to placebo on the key secondary endpoint of the study.