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Long-Term Safety Data on Lialda(TM) (mesalamine) for Patients With Ulcerative Colitis Published in Leading GI Journal
Date:6/17/2008

BASINGSTOKE, UK and PHILADELPHIA, US June 17 /PRNewswire-FirstCall/ -- Shire Limited (LSE: SHP, Nasdaq: SHPGY), the global specialty biopharmaceutical company, today announced the publication of data from a randomized, long-term safety and tolerability study (study 303) of ulcerative colitis (UC) drug Lialda(TM) (mesalamine). The primary endpoints of this study were to assess the safety and tolerability of Lialda in mild-to-moderate UC patients over 12 months. Data were published in the July issue of Gut, the official journal of the British Society of Gastroenterology, a leading international journal in gastroenterology.

"This published data demonstrates that Lialda is generally well tolerated and has a strong safety profile," said Gary R. Lichtenstein, MD, co-author of study 303 and director of the Center for Inflammatory Bowel Diseases at the Hospital of the University of Pennsylvania. "Not only does this data demonstrate Lialda's safety and tolerability, but secondary endpoints from the maintenance phase of the 303 study show that a majority of patients on Lialda continued to remain in remission through 12 months."

Specifically, the primary endpoints of the Phase III, open-label, 12-month extension study were to evaluate the safety and tolerability of Lialda dosed once (2.4g/day) or twice daily (1.2g twice daily) over 12 months, including adverse events (AEs), treatment exposure, and time to withdrawal. AEs refer to any untoward medical occurrence that happens in a clinical trial patient. AEs can be "treatment-related" (TRAEs) and occur as a result of the study drug or they can be considered unrelated to the study drug. In study 303, all AEs were classified in one of three categories according to severity: mild, moderate, or severe.

Results of the study showed Lialda demonstrated a good safety profile, with 37.9 percent of patients (safety population n=459) experiencing AEs, the majority of which were mild or moderate in intensity. Tre
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SOURCE Shire Limited
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