Shire's ($SHPGY) hopes to open up a big new market for its bowel drug Lialda were blighted today by the news that the drug had failed a late-stage study. Mesalamine, the active ingredient in Lialda, proved no better than a placebo after two years of treatment for diverticulitis. The disappointing readout leaves one more late-stage study underway, but Shire says that it has no plans to file for an approval, regardless of the outcome.
Investigators recruited patients in 10 countries for the lengthy study, expecting to find that the anti-inflammatory mesalamine could prevent a recurrence of diverticulitis between treatments. And while the company didn't outline the data, investigators say the drug failed both the primary and secondary endpoint. News of the study failure triggered a quick 4% slide in company shares.
"PREVENT2, a large, well-controlled trial, provided us with important information regarding diverticulitis." said Dr. Jeffrey Jonas, Shire's senior vice president of R&D for specialty and regenerative meds. "We will continue to analyze these data and those of the second study, PREVENT1, which was similar in design to PREVENT2 and will report later in the year. Although the results of the second trial are pending, it is our current intention not to pursue a regulatory filing for this indication for MMX mesalamine."
Lialda, an oral drug, is approved in the U.S. and Europe for ulcerative colitis.
- here's the release