Shire to Support Appeal Against Outcome of Judicial Review of NICE Guidance Which Denies Newly Diagnosed Patients with Mild Alzheimer's Disease Access to Drugs on the NHS

BASINGSTOKE, England, 01 Oct 2007 -  – Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) the global specialty biopharmaceutical company, confirms that it will act as an interested party to the application to Appeal announced by Eisai against the High Court judgment handed down by Judge Linda Dobbs on 10th August 2007.

Eisai has today applied to the Court of Appeal for permission to appeal the recent High Court ruling on the process by which the National Institute for Health and Clinical Excellence (NICE) reached its decision on the cost-effectiveness of drugs in the early stages of Alzheimer’s disease (AD).

Dr Ian Howe, Shire’s Medical Director said: "Shire is continuing as an interested party in the appeal against this judgment, and the NICE Guidance, as we believe that NICE has acted unfairly. NICE failed to reveal a working version of the cost-effectiveness model on which they based their decision that the drugs are not cost-effective in the early stages of the disease, a decision that excludes newly diagnosed patients with mild AD from NHS support.

This issue of procedural fairness will now be challenged through the High Court."

Shire welcomed the Judicial Review's conclusion that NICE had acted unlawfully by not taking enough account of the discriminatory nature of the test (the MMSE) by which patients are assessed as being mild or moderate. However, the revised guidance that NICE were forced to issue will, in practice, only provide NHS support for a small percentage of newly diagnosed patients.

Dr Howe continues: "We believe that all AD patients should have access to these drugs on the NHS as they are effective at the early stages as well as later stages of the disease. NICE agrees that these drugs, licensed for both mild and moderate AD, are clinically effective."

The processes, including lack of transparency, used by NICE to reach its decisions are not only being challenged in the High Court with regard to AD. They are also being investigated by the House of Commons Health Select Committee concerning the reasons for growing lack of confidence in NICE, the decisions it makes, and the Appeal process against those decisions. The Health Select Committee next takes evidence regarding NICE on
11th October 2007.

ENDS/


For further information please contact:
Shire
Jessica Mann
+44 1256 894 280

Public relations
Rhonda Smith
+44 1264 710428
+44 7887 714957

Note to editors:

In the UK and Ireland, Shire markets REMINYL® (galantamine hydrobromide) and REMINYL® XL (galantamine hydrobromide) acetylcholinesterase inhibitors that are licensed for the symptomatic treatment of mild and moderately severe dementia of the Alzheimer’s type.

SHIRE PLC

Shire’s strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit and hyperactivity disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. The structure is sufficiently flexible to allow Shire to target new therapeutic areas to the extent opportunities arise through acquisitions. Shire’s in-licensing, merger and acquisition efforts are focused on products in niche markets with strong intellectual property protection either in the US or Europe. Shire believes that a carefully selected portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company’s website: www.shire.com

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