Ulcerative colitis remission rates from long-term safety study of LIALDA presented at DDW

Washington, D.C. May 22, 2007 A long-term phase III, open-label 12-14 month extension study (303) presented at the British Society of Gastroenterology (BSG) meeting in Glasgow, Scotland in March 2007 showed Shire plc's (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) LIALDA (mesalamine) is well tolerated in mild to moderate UC patients. Today, secondary endpoints of study 303 were presented as post-hoc analyses at Digestive Disease Week (DDW).

Approved by the FDA on January 16, 2007, for the induction of remission in patients with active, mild to moderate UC, LIALDA is the first and only oral once-daily mesalamine on the market. Safety and effectiveness have been established for up to eight weeks. LIALDA is being evaluated for longer term use.

Long-term remission and relapse rates on LIALDA (abstract # T1296)

A post-hoc analysis of study 303 evaluated maintenance of remission and relapse rates over 12 months. Remission was defined using stringent clinical and endoscopic criteria: modified UC Disease Activity Index (UC-DAI) score of ≤1, with scores of 0 for rectal bleeding and stool frequency, a combined Physician's Global Assessment and sigmoidoscopy score of ≤1, with a sigmoidoscopy score reduction of ≥1 point from baseline and no mucosal friability. Relapse was defined as withdrawing from the study due to a need for alternative therapy for UC.

Overall, a total of 459 patients entered the maintenance phase of study 303. Of these patients, 362 patients met the stringent remission criteria (clinical and endoscopic as defined above) at baseline (in parent studies 301 and 302 - LIALDA's eight-week, phase III, placebo-controlled trials that demonstrated efficacy for the induction of remission in active, mild to moderate UC) and received LIALDA once daily (2.4g/day; n=171) or twice daily (2.4g/day; n=191) for 12 months as part of study 303.

The analysis found that 67.8 percent of the 171 patients on once-dai

Contact: Ashleigh Duchene
Shire plc

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