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New Analyses of Long-Term LIALDA(TM) (mesalamine) Data Presented at ACG
Date:10/15/2007

it was demonstrated that 67 percent (233/348) and 64.7 percent (66/102) of the patients with left-sided or extensive disease, respectively, were in remission at 12 months.

Post-hoc analysis of secondary endpoints of pivotal trials shows LIALDA offers initial resolution of UC symptoms within weeks

Also being presented at ACG are secondary endpoints from LIALDA's pivotal trials, the 301 and 302 studies, which were eight-week, phase III, placebo-controlled, double-blind, double-dummy studies.

Time to Initial Symptom Resolution with LIALDA for Active, Mild to Moderate Ulcerative Colitis

Poster Presentation: Monday, October 15, 2007, Exhibit Hall B, #619

An important endpoint for both patients and physicians when treating active, mild-to-moderate ulcerative colitis is the time between initiation of therapy and initial symptom resolution. A post-hoc analysis of pooled data from the LIALDA 301 and 302 studies examined the treatment time required for patients to experience initial symptom resolution of rectal bleeding and normalization of stool frequency. Patients with active, mild-to-moderate UC were randomized to receive LIALDA 2.4g/day (given once or twice daily) or 4.8g/day (given once daily) or placebo, for eight weeks. The time required for patients to reach an initial resolution of symptoms was analyzed and defined as the time between the first dose of medication and the first day of symptom resolution. A total of 517 patients were included. This post-hoc analysis showed median time to initial resolution of symptoms (stool frequency and rectal bleeding) was 25, 26 and 44 days, in the LIALDA 2.4g/day (n=172), 4.8g/day (n=174) and placebo (n=171) groups, respectively. The data in this post-hoc analysis included both stool frequency and rectal bleeding when determining the median time to initial resolution of symptoms.

Other posters to be presented at ACG include:

-- The effect of prolonged therapy with LIALDA in patients with
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SOURCE Shire plc
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