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Analysis of Ulcerative Colitis (UC) Time to Symptom Resolution Data from Pivotal Study of LIALDA(TM) (mesalamine) Presented at DDW
Date:5/20/2008

SAN DIEGO, May 20 /PRNewswire-FirstCall/ -- A post hoc analysis showing time to symptom resolution data from a study (study 302) of Shire plc's (LSE: SHP, Nasdaq: SHPGY) ulcerative colitis (UC) drug, LIALDA(TM), will be presented today at Digestive Disease Week (DDW). Study 302 (further referred to as "Kamm study," led by Dr Michael A. Kamm, from St Mark's Hospital in London, UK), demonstrated LIALDA was effective in inducing remission in patients with active, mild to moderate ulcerative colitis compared to placebo and these study results were published in the January 2007 issue of Gastroenterology.

"The time between initiation of therapy and initial symptom resolution is an important endpoint in the treatment of UC for both patients and physicians," said Gary Lichtenstein, director of the Inflammatory Bowel Disease Program at the University of Pennsylvania, investigator on this post hoc analysis. "This analysis was important as it showed LIALDA benefits patients by significantly lowering the time it takes patients to experience relief from their UC symptoms as compared to placebo."

Time to initial symptom resolution on LIALDA

Poster Presentation: May 20, 2008, San Diego Convention Center -- Sails Pavilion, #T1140

A post hoc analysis of the Kamm study (study 302) examined the treatment time required for patients to experience initial symptom resolution over eight weeks. In this analysis, time to initial symptom resolution was assessed as either the time between the first dose of study medication and the first day of symptom resolution (rectal bleeding or normalization of stool frequency or both) or the time between the first dose of study medication and the first day of three consecutive days of symptom resolution. Initial symptom resolution of rectal bleeding, normalization of stool frequency or both was assessed by a modified UC-Disease Activity Index (UC-DAI) scoring system. Resolution of symptoms was defined for both rectal ble
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SOURCE Shire plc
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