Public Release: 

First global approval for FOSRENOL (lanthanum carbonate)

Sweden approves innovative treatment to reduce phosphate risk in patients with end stage renal failure; now FOSRENOL to enter EU mutual recognition procedure

Resolute Communications

Basingstoke, UK - 24 March 2004 - Sweden's MPA has today granted the first regulatory approval in the world for FOSRENOL (lanthanum carbonate), a non-calcium, non-aluminium phosphate binding medicine developed to control phosphate levels in renal dialysis patients. Sweden will now become the Reference Member State in the EU Mutual Recognition Procedure for FOSRENOL, and this is the first step in securing marketing approval throughout Europe. A submission has also been made by Shire to gain marketing approval for FOSRENOL in the United States.

FOSRENOL is a treatment for high phosphate levels in the blood (hyperphosphataemia), which occurs in patients with end stage renal failure. Even with a low phosphate diet as many as 80% of dialysis patients develop hyperphosphataemia.1,2 Estimates show that there are 225,000 people undergoing dialysis in Europe, 290,000 people with end stage renal failure in the US, and 167,000 people in the Pacific Rim who need dialysis treatment. Without effective treatment, hyperphosphataemia can lead to renal osteodystrophy - a bone disease which causes pain, skeletal deformities, and can result in fractures. Recent research also suggests that hyperphosphataemia is associated with the development of cardiovascular disease, which accounts for nearly 50% of all deaths in dialysis patients 3,4.

In studies, FOSRENOL has been shown to be an effective and well tolerated phosphate binder, lowering serum phosphate levels within eight weeks and maintaining this long-term, with some patients treated for 36 months (three years) or more.5,6 A recently-published 12-month study in new dialysis patients showed that treatment with FOSRENOL led towards normalization of pre-existing bone disease, compared to patients treated with calcium carbonate, a commonly used phosphate binding medicine.7

Dr Wilson Totten, Chief Scientific Officer of Shire, said: "This first approval for FOSRENOL represents an important milestone for Shire. For clinicians and patients alike, we believe FOSRENOL represents a significant milestone, as a real, effective and well-tolerated alternative to current therapies."

Shire recently confirmed its out-licensing of the rights to develop, market and sell FOSRENOL in Japan to Bayer Yakuhin Ltd. Shire has acquired the rights to the global patents for FOSRENOL, excluding Japan, from AnorMED Inc.

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For further information please contact:
Global
Anna Korving / Simon Royston, Resolute Communications
+44 20 7357 8187

US
Christine Gerstle / Marion Glick, Porter Novelli
+1 212 601 8144

References:
1. US Renal Data System. USRDS 2003 Annual Data Report: Atlas of end-stage renal disease in the US. US Renal Data System, National Institute of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda MD 2003, p16
2. Market Research, Insight International, Dec 01 / Jan 02
3. Salusky IB & Goodman WG. Cardiovascular calcification in end-stage renal disease. Nephrol Dial Transplant 2002; 17: 336 - 339
4. Norris KC. Toward a new treatment paradigm for hyperphosphataemia in chronic renal disease. Dialysis & Transplantation 1998; 27 (12): 767 - 773
5. Hutchison A, Webster I, Gill M, Schmieder R. Safety, Tolerability and Efficacy of Lanthanum Carbonate in Haemodialysis Patients: a 12 month study. (301). Poster presented at the 40th ERA-EDTA World Congress of Nephrology, Berlin, Germany, 8-12 June 2003.
6. Hutchison A, Webster I. Lanthanum Carbonate, a Novel, Non-Aluminium, Non-Calcium Phosphate Binder, is Effective and Well Tolerated in Hyperphosphataemia. (301) Poster presented at 9th Asian Pacific Congress of Nephrology, Pattaya, Thailand, 16-20 February 2003.
7. D'Haese PC et al. A multicenter study on the effects of lanthanum carbonate (FOSRENOL®) and calcium carbonate on renal bone disease in dialysis patients. Kidney International 2003 (63) Suppl 85:s73-s78

Notes to editors:
Photograph available at: http://www.shire.com/default.asp?wci=WebItem&wce=224

Lanthanum carbonate (FOSRENOL®)
FOSRENOL works by binding to dietary phosphate in the GI tract; once bound, the FOSRENOL/phosphate complex cannot pass through the intestinal lining into the blood stream and is eliminated from the body. As a consequence, overall phosphate absorption from the diet is decreased significantly. Shire has conducted an extensive clinical research programme for FOSRENOL involving over 1750 patients, some of whom have been treated for 36 months or more. This programme has demonstrated that FOSRENOL is an effective phosphate binder with a proven safety profile for long-term use.

Shire Pharmaceuticals Group plc
Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

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

THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995
Statements included herein that are not historical facts, are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact on Shire's Attention Deficit Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including but not limited to the expected product approval date of lanthanum carbonate (FOSRENOL®), METHYPATCH®, XAGRID® and the adult indication for ADDERALL XR® and other risks and uncertainties detailed from time to time in our filings, including the Annual Report filed on Form 10-K by Shire with the Securities and Exchange Commission.

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