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Fosrenol (Lanthanum Carbonate) Renal Bone Disease Study Results New Data Also Show Reduction in Phosphate Levels Maintained for One Year OVIEDO, SPAIN -- June 7, 2002 -- Shire Pharmaceuticals Group plc announces that Fosrenol™ (lanthanum carbonate), its new phosphate binder for use in dialysis patients, has been shown not to cause adverse effects on renal bone disease over 12 months of therapy, according to the most comprehensive controlled bone biopsy study ever undertaken in this field. The new data is in a poster, presented for the first time at the international symposium "Advances in Renal Osteodystrophy" in Oviedo, Spain (6-7 June 2002) by the principal investigator and leading bone disease specialist Professor Marc De Broe, of the University of Antwerp's Department of Nephrology. Poor control of blood calcium or phosphate levels in chronic renal failure patients can result in bone disease and secondary hyperparathyroidism. Currently available medications such as calcium or aluminium-based phosphate binders can be associated with new or worsening bone disease. These concerns make it important to monitor carefully the effects of new phosphate binders on bone metabolism. Such a comprehensive investigation into the impact of these treatments has not previously been undertaken and it is very encouraging to see that Fosrenol is well tolerated and may offer important advantages over other phosphate binders based on the results of this study. In this phase III multicentre study, 98 patients who were starting renal dialysis for the first time were randomised to receive either lanthanum carbonate or calcium carbonate (a standard reference treatment), titrated to a dose which was well tolerated and gave acceptable control of serum phosphate (up to 3,750 mg lanthanum carbonate / day or up to 9,000 mg calcium carbonate / day). Bone biopsies were taken at the beginning and end of the 12-month study period and, at each visit, blood samples were taken to assess phosphate, calcium, parathyroid hormone and other biochemical and haematological parameters. A total of 60 paired biopsies (i.e. baseline and follow-up) were suitable for histological assessment on completion of the study (30 per treatment group). Histological examination of the biopsies (to assess structure and bone biology) together with analysis of biochemical and haematological variables, yielded the following findings: Bone disorder Lanthanum carbonate Calcium carbonate Pre-Treatment After 12 months treatment Pre-Treatment After 12 months treatment Osteomalacia 3% 0% 3% 0% Adynamic bone disease 15% 0% 13% 10% One important additional finding of the study was the widespread incidence of renal bone disease discovered in patients who were new to dialysis. Pre-treatment baseline examination of patients enrolled on the study found that over 90% of patients had altered bone biology prior to commencing dialysis treatment. These new data demonstrate that treatment with Fosrenol was not associated with any adverse effects on bone over 12 months of continuous therapy. Furthermore, in the lanthanum patients, there was no evolution towards low bone turnover states. This is in contrast to treatment with calcium carbonate and aluminium hydroxide, where low bone turnover has been shown to develop. Earlier research has shown that compared to calcium-containing phosphate binders, Fosrenol produces significantly fewer episodes of hypercalcaemia. Metastatic and vascular calcification, resulting from hypercalcaemia, has well-recognised cardiovascular risks, and significantly contributes to overall morbidity and mortality in dialysis patients. "We welcome the results of this study, the most comprehensive controlled biopsy study of renal bone disease ever carried out", said Dr Wilson Totten, Group R&D Director, Shire Pharmaceuticals Group plc. "The research has provided important new insights into the presence and evolution of bone disease in chronic kidney disease, and vividly illustrates the potential advantages of Fosrenol in the management of patients at risk of hyperphosphataemia." Hyperphosphatemia and its consequences Chronic kidney failure is complicated by hyperphosphataemia -- high phosphate levels in the blood -- caused by the inability of the kidneys to filter out excess phosphate from food. Even with a low-phosphate diet as many as 80% of Europe's 225,000 dialysis patients develop hyperphosphataemia(1) and need treatment with a phosphate-binder, such as Fosrenol. The most well-known consequence of hyperphosphataemia is the bone disease renal osteodystrophy, which causes bone 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(2). References: 1. Numbers of patients on dialysis broadly equates to patients with end stage kidney disease. Source: Market Research, Insight International, Dec 01/Jan 02 2. Davies MR, Hruska K. Pathophysiological mechanisms of vascular calcification in end-stage renal disease. Kidney Int. 2001 Aug;60(2):472-9 Lanthanum carbonate (Fosrenol™) Fosrenol works by binding to dietary phosphate in the stomach; once bound, the Fosrenol/phosphate complex cannot pass through the stomach 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 almost 1700 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 rapidly growing international specialty pharmaceutical company with a strategic focus on three therapeutic areas -- central nervous system disorders (CNS), oncology and anti-infectives. Shire also has two platform technologies: advanced drug delivery and Biologics. Shire's core strategy is based on research and development combined with in-licensing and a focus on eight key pharmaceutical markets. For further information on Shire, please visit the company's website: http://www.shire.com . Shire was granted an exclusive agreement to develop, manufacture, use and sell Fosrenol worldwide by the patent holder, AnorMed Inc. THE "SAFE HARBOUR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. The statements in this press release 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 that such risks or uncertainties materialise, 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 and commercialisation, the impact of competitive products, patents, government regulation and approval, and other risks and uncertainties detailed from time to time in periodic reports produced by Shire, including the Annual Report filed on Form 10K by Shire with the Securities and Exchange Commission. SOURCE: Shire Pharmaceuticals Group plc E-mail this page to a friend or colleague! To print, use this version