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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

eding and stool frequency as a modified UC-DAI sub-score of 0.

Overall, a total of 341 patients with active, mild to moderate UC were analyzed as part of this post hoc analysis of an 8-week study. Patients in the Kamm study received LIALDA 2.4g/day once daily (n=84), 4.8g/day once daily (n=85), Asacol 2.4g/day three times daily (n=86); or placebo (n=86).

The post hoc analysis found that regardless of the definition used for remission, treatment with LIALDA 2.4g/day, or 4.8g/day, or Asacol 2.4g/day resulted in similar median times to symptom resolution that were shorter than placebo. The Kamm study was not designed to compare LIALDA to Asacol. Asacol was included in the study as a reference arm only.

-- Symptom resolution of rectal bleeding at the first day and first of

three days, respectively:

-- LIALDA 2.4g/day: 9 days and 18 days

-- LIALDA 4.8g/day: 9 days and 17 days

-- Placebo: 14 days and 35 days

-- Normalization of stool frequency at the first day and first of three

days, respectively:

-- LIALDA 2.4g/day: 20 days and 33 days

-- LIALDA 4.8g/day: 23 days and 38 days

-- Placebo: 38 days and 53 days

-- Resolution of both rectal bleeding and normalization of stool

frequency at the first day and first of three days, respectively:

-- LIALDA 2.4g/day: 27 days and 37 days

-- LIALDA 4.8g/day: 29 days and 45 days

-- Placebo: 44 days and 56 days

Important Safety Information for LIALDA

LIALDA tablets are indicated for the induction of remission in patients with active, mild to moderate ulcerative colitis. Safety and effectiveness of LIALDA beyond 8 weeks have not been established.

LIALDA is contraindicated in patients with hypersensitivity to salicylates (including mesalamine) or to any of the components of LIALDA. Caution should be exercised
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SOURCE Shire plc
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