Press Release

Shire receives label agreement in Europe for ulcerative colitis treatment, Mezavant™ (mesalazine)

14 Dec 2006 - Basingstoke, UK and Philadelphia, US – December 14th 2006 – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that core labelling information, part of Shire’s Marketing Authorisation Application for MEZAVANT, has been agreed by the regulatory agencies for the 15 European countries (including UK, Germany, France and Spain) participating in the decentralised procedure. Following closure of the decentralised procedure, associated national approvals should follow in the first quarter of 2007, enabling Shire to make a phased launch of MEZAVANT in Europe.

MEZAVANT is the only ulcerative colitis treatment that utilizes novel MMX MULTI MATRIX SYSTEM™ drug delivery technology to provide gastro-resistant, prolonged release of mesalazine throughout the colon in a once daily dose. Available as a single strength tablet, containing mesalazine 1200mg, MEZAVANT will be indicated both for the induction of clinical and endoscopic remission in patients with mild to moderate, active ulcerative colitis; and for maintenance of remission. In 2005, over 450,000 patients were identified to be suffering with ulcerative colitis in Europe. In the US, the new drug application (NDA) was submitted to the U.S. Food and Drug Administration on December 22, 2005 and the PDUFA date is January 21, 2007.

Shire has in-licensed the exclusive rights from Giuliani S.p.A. to develop and commercialize MEZAVANT in the US, Canada, Europe (excluding Italy) and the Pacific Rim. Giuliani S.p.A. has developed MEZAVANT from proof of concept to Phase IIa and retains the development and commercialization rights in Italy and in South and Central America. Cosmo Pharmaceuticals S.p.A., Milan developed the MMX MULTI MATRIX SYSTEM technology and owns the trademark, MMX MULTI MATRIX SYSTEM.