Press Release

Shire Completes Fosrenol® Roll-Out in Major European Markets With Launch in Spain

Non-calcium phosphate binder for the management of hyperphosphataemia now available in 24 countries

BASINGSTOKE UK - 16 January 2008 - Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that with the launch today in Spain of FOSRENOL (lanthanum carbonate), a non-calcium phosphate binder, Shire is celebrating the completion of the launch roll-out in the major European markets. FOSRENOL is the first of the company’s medicines developed in-house from research molecule to market.

FOSRENOL is an effective monotherapy treatment for the management of hyperphosphataemia1 (excess phosphate, which the body cannot excrete2) in patients with End Stage Renal Disease (ESRD). Hyperphosphataemia is a problem which affects more than 70% of the 1.5 million people worldwide who require kidney dialysis.3, 4

Chronic Kidney Disease (CKD) is a progressive condition classified in five stages culminating in Stage 5 (or ESRD), a condition typified by a complete loss of kidney function, usually requiring the patient to undergo dialysis or kidney transplantation.

CKD is recognized as a growing ‘silent epidemic’ affecting up to 1 in 10 people5, due in part to rising obesity rates and an increasing number of people with diabetes.6 CKD can cause numerous serious health consequences for patients, including hyperphosphataemia.

Effective phosphate control is critical for these patients because, if not managed successfully, hyperphosphataemia can lead to significant health problems. These include CKD-related mineral and bone disorder, resulting in painful, brittle bones that may fracture or become deformed and cardiovascular disease, which accounts for almost half of all deaths in dialysis patients. 7, 8

“As CKD progresses, its management becomes increasingly challenging for patients as dietary restrictions and fluid limitations become paramount,” said David Milton, Senior Vice President, Shire Renal Business Unit. “By the time they reach CKD stage 5, patients are not only likely to be on dialysis, but are often taking as many as 10 to 12 different medications9, which can amount to 25 tablets a day or more, for the different complications of CKD including hyperphosphataemia.

“Shire is proud to have developed FOSRENOL from research molecule to the healthcare market as an effective non-calcium monotherapy treatment option for ESRD patients with hyperphosphataemia. FOSRENOL is provided as a simple one tablet per meal dose for the majority of patients,” added Milton.

“Shire participated with the other phosphate binder manufacturers at a recent Shire requested US Food and Drug Administration Cardiovascular and Renal Drugs Division Advisory Committee. The majority of the members on the Advisory Committee voted to recommend the use of phosphate binders to treat hyperphosphataemia in CKD Stage 4 patients. As a result Shire is working to identify the regulatory pathway forward for the use of FOSRENOL in this group of patients,” he added.

To date, over 5,200 patients have been treated with FOSRENOL during an extensive clinical development program.10 Globally over 100,000 patients have been prescribed FOSRENOL since it was launched in 2005.10 FOSRENOL has an extensive long-term safety data package extending out to six years.

Following its launch in Spain, FOSRENOL is now available in 24 countries worldwide.