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Shire looks set to drop diverticulitis drug

Says it's unlikely to pursue regulatory filing after disappointing phase III trial results

Shire has reported disappointing results from a phase III trial of SPD476, a candidate drug for diverticulitis, and says it is now unlikely that it will press on with a regulatory filing.

SPD476 is a once-daily formulation of mesalamine, a drug widely-used to treat inflammatory bowel disease. It is already approved in the US under the Lialda brand name and as Mezavant/Mezavant XL in Europe to treat ulcerative colitis.

The PREVENT 2 study enrolled 592 patients with a history of diverticulitis, a condition in which pouches develop in the intestine that become inflamed and infected. The two-year study compared the impact of three different doses of SPD476 versus placebo on the rate of diverticulitis.

It found no significant difference between the two groups at any of the dosages tested on either the primary or secondary endpoints, according to the company.

"We will continue to analyse these data and those of the second study, PREVENT1, which was similar in design to PREVENT2 and will report later in the year," commented Dr Jeffrey Jonas, Shire's senior vice president of R&D.

"Although the results of the second trial are pending, it is our current intention not to pursue a regulatory filing for this indication," he added.

Combined sales of Lialda and Mezavant reached $372m last year, a rise of 27 per cent over 2010, and the product has a market share of around 21 per cent in the US.

Analysts at Jefferies had previously suggested that approval in diverticulitis could double the franchise's peak sales potential from $500m to $1bn, according to a Reuters report.

Shares in Shire fell almost 5 per cent on the day of the announcement, which came shortly after the firm announced it would withdraw its application for Fabry disease treatment Replagal (agalsidase alfa) in the US.

2nd April 2012

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