Public Release: 

New global trials help to make FOSRENOL(R) the most extensively studied modern phosphate binder

Resolute Communications

The new studies - which will focus on reaching target serum phosphate levels as defined by the K/DOQI guidelines (Kidney Disease Outcomes Quality initiative)1 - will strengthen FOSRENOL's position as the most extensively studied modern phosphate binder.

The trials will build on earlier phase III studies with FOSRENOL, reviewed today at the ERA-EDTA2 Congress in Lisbon, which demonstrated that patients with end stage renal disease (ESRD) treated with FOSRENOL can largely avoid the damaging consequences of hyperphosphataemia (excessively high phosphate levels in the blood) seen in as many as 80% of dialysis patients3.

"Effective management of hyperphosphataemia is a crucial part of management for patients on dialysis", commented Professor Jorge Cannata-Andia, of the Hospital Central de Asturias, Oviedo, Spain. "This silent condition has dangerous consequences as it disrupts the delicate interplay between the body's levels of calcium, parathyroid hormone and vitamin D, resulting in calcium deposits in the vasculature, which contribute to cardiovascular disease, and renal bone disease, which may give rise to skeletal deformities, pain and fractures."

Paradoxically, use of calcium-based phosphate binders - the current mainstay of treatment for hyperphosphataemia - can exacerbate vascular calcification by increasing blood calcium levels beyond acceptable levels (hypercalcaemia). In addition, calcium-based phosphate binders are associated with long-term bone problems of their own 4,5. In contrast, a much lower incidence of hypercalcaemia has been seen with FOSRENOL 6,7, which lowers serum phosphate to target levels within eight weeks and maintains this long-term 6,8 without increasing blood calcium levels.

Moreover, extensive bone biopsy studies have shown that 59% of patients treated with FOSRENOL moved towards normalisation of pre-existing bone disease compared with 21% on calcium carbonate. 9

"The data we have seen today at the ERA-EDTA Shire symposium represent a comprehensive package of safety and efficacy data for this new phosphate binder", commented Professor Jorge Cannata-Andia, who chaired the symposium. "Taken together, these data demonstrate that FOSRENOL lowers phosphate levels effectively and has the potential to reduce some of the most serious clinical consequences of hyperphosphataemia. We welcome Shire's initiative to continue research with FOSRENOL and look forward to the results from the new trials in Europe and North America."

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For further information please contact:

Onsite: Elizabeth Park, Resolute Communications 44-798-998-8440
Anna Korving, Resolute Communications 44-771-042-0523

In London: Ane Tobro, Resolute Communications 44-207-357-8187

In the US: Victoria Amari, Porter Novelli 212-601-8195

References

1. Eknoyan G, Levin A, Levin NW. Bone metabolism and disease in chronic kidney disease. Am J Kidney Dis 2003; 42 (4, Suppl 3): S62
2. 41st Congress of the European Renal Association / European Dialysis & Transplant Association, Lisbon, Portugal, 15-18 May, 2004
3. Market Research, Insight International, Dec 01 / Jan 02
4. Salusky IB & Goodman WG. Cardiovascular calcification in end-stage renal disease. Nephrol Dial Transplant 2002; 17: 336 - 339
5. Norris KC. Toward a new treatment paradigm for hyperphosphataemia in chronic renal disease. Dial Transplant 1998; 27 (12): 767 - 773
6. 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.
7. D'Haese PC et al. A multicenter study on the effects of lanthanum carbonate (FosrenolTM) and calcium carbonate on renal bone disease in dialysis patients. Kidney Int 2003; (63) Suppl 85: s73-s78
8. Hutchison A, Webster I. Lanthanum Carbonate, a Novel, Non-Aluminium, Non-Calcium Phosphate Binder, is Effective and Well Tolerated in Hyperphosphatemia. (301) Poster presented at 9th Asian Pacific Congress of Nephrology, Pattaya, Thailand, 16-20 February 2003
9. Freemont, A. The Effects of the Phosphate binders Lanthanum Carbonate and Calcium Carbonate on Bone: A Comparative Study in Patients with Chronic Kidney Disease. Poster presented at the 41th ERA/EDTA Congress, Lisbon, Portugal, 15-18 May 2004

NOTES TO EDITORS

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 original language of this press release is English.

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