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Treatment for Ulcerative Colitis

Shire Announces Filing of Mesavance (mesalamine) for Treatment of Ulcerative Colitis

PHILADELPHIA and BASINGSTOKE, England, December 22, 2005 -- Shire plc announced today that it has submitted a new drug application (NDA) to the US Food and Drug Administration for Mesavance (SPD476), an investigational compound being studied for the induction of clinical and endoscopic remission in patients with active, mild-to-moderate ulcerative colitis. If approved, Mesavance would be the first available once-daily mesalamine treatment for active, mild-to-moderate ulcerative colitis.

"The timely filing of our Mesavance NDA represents the fourth new product submission in 2005 for Shire and our partners," said Shire Chief Executive Matthew Emmens. "We are proud of that achievement and we look forward to offering the advantages of once-daily Mesavance to patients suffering from ulcerative colitis."

The submission of a Marketing Authorisation Application for Mesavance with the European Medicines Agency is planned for first quarter 2006.

Mesavance is the only ulcerative colitis treatment that utilises novel MMX Multi Matrix System(TM) (MMX) drug delivery technology to provide delayed and extended release of mesalamine throughout the colon. Shire has licensed from Giuliani S.p.A. the exclusive right to develop and commercialise Mesavance in the US, Canada, Europe (excluding Italy) and the Pacific Rim. Giuliani S.p.A. retains the development and commercialisation rights to SPD476 in Italy. MMX was developed by Cosmo S.p.A.

About SPD476 (Mesavance)

SPD476 is a novel, high-dose 5-aminosalicylic acid (5-ASA; mesalamine) in a delayed and extended release formulation (MMX) being studied for the induction of remission of active, mild-to-moderate ulcerative colitis. The most common adverse events reported in SPD476 Phase III studies were headaches (4.5%) and flatulence (3.4%).

Source: Shire plc

Posted: December 2005

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