Shire shares have taken a bashing following late-stage data which showed that its ulcerative colitis drug Lialda has failed as a potential treatment for diverticulitis.
Specifically, the Ireland-headquartered company announced top-line results of the Phase III PREVENT2 trial, which showed that Lialda (melamine), taken once-daily, did not reduce the rate of recurrence of diverticulitis over a two-year treatment period. Also the drug, which is sold in Europe as Mezavant, did not show a significant difference compared to placebo for the digestive disease.
Jeffrey Jonas, head of R&D for Shire’s specialty pharmaceuticals and regenerative medicine businesses, said the firm will analyse these data and those of another trial, PREVENT1, which will report later in the year. However, "although the results of the second trial are pending," he added that "it is our current intention not to pursue a regulatory filing for this indication for mesalamine.”
Analysts at UBS issued a research note saying that the diverticulitis indication could have provided a $400 million boost to Lialda sales, "but that the chance of success was extremely low". Shire's stock fell 4.6% to £20.20.
Meantime, Shire has also presented data that show favourable treatment effect and tolerability of Replagal (agalsidase alfa) in Fabry patients who switched from Genzyme's Fabrazyme (agalsidase beta) or were naive to enzyme replacement therapy after one year of treatment.
The data was presented at the America College of Medical Genetics annual meeting in Charlotte, North Carolina and the study was established to provide US Fabry patients with access to Replagal during the Fabrazyme supply shortage. However, last month, Shire surprised observers by pulling its file in the USA to get approval for Replagal as it believes the US Food and Drug Administration requires additional controlled trials for approval.
Finally, Michael Cola has resigned as president of Shire's specialty pharmaceuticals business after being with the company for seven years. Chief executive Angus Russell will assume responsibility for leading the business until a new president is appointed.