Since dialysis and diet restrictions alone generally cannot control phosphate levels, patients traditionally manage hyperphosphataemia by taking phosphate binding agents with every meal and snack. Such binders "soak up" phosphate in the gastrointestinal tract, before it can be absorbed into the blood.
FOSRENOL(R) (lanthanum carbonate)
FOSRENOL(R) works by binding to dietary phosphate in the GI tract; once bound, the lanthanum/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 5500 patients, with a small number followed for up to 6 years now. This programme has demonstrated that FOSRENOL is an effective phosphate binder with a good tolerability profile for long-term use. FOSRENOL was approved by the FDA in October 2004 and is now available for prescription in the US. In March 2005 regulatory authorities in the EU granted marketing authorization for FOSRENOL in sixteen member states, thus completing the first step in securing marketing approval throughout Europe. FOSRENOL has since been launched in Ireland, Sweden, Finland, Denmark and Austria. The final step in the European process was recently completed resulting in recommendation for approval in the remaining 11 member states. Further roll-outs are underway across the rest of Europe and other countries around the world. The company has out-licensed the rights to develop, market and sell FOSRENOL in Japan to Bayer Yakuhin Ltd.
Patients with renal insufficiency may develop hypocalcaemia. Serum calcium levels should therefore be monitored at regular time intervals for this patient population and appropriate supplements given.
No data are available in patients with severe hepatic impairment. Caution should, therefore, be exercised in these patients, as elimination of absorbed lanthanum may be reduced.
FOSRENOL should not be used during pregnancy.
Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with Fosrenol.
The most commonly reported Adverse Drug Reactions (ADRs) (>1/100, 1/10) are gastrointestinal reactions such as abdominal pain, constipation, diarrhoea, dyspepsia, flatulence, nausea and vomiting. These are minimized by taking FOSRENOL with food and generally abated with time with continued dosing. Hypocalcaemia was the only other commonly reported adverse reaction.
Shire
Shire (LSE: SHP) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing and marketing products in the areas of attention deficit and hyperactivity disorder (ADHD), gastrointestinal (GI), renal diseases and human genetic therapies. 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.
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[i] Block GA et al. Association of serum phosphorus and calcium x phosphate product with mortality risk in chronic hemodialysis patients: A national study. American Journal of Kidney Diseases 1998; 31: 607-617
[ii] Norris KC. Toward a new treatment paradigm for hyperphosphataemia in chronic renal disease. Dialysis & Transplantation 1998; 27 (12): 767-773
[iii] Block G, Port FK. Re-evaluation of risks associated with hyperphosphataemia and hyperparathyroidism in dialysis patients: recommendations for a change in management. Am J Kidney Dis 2000; 35 (6): 1226- 1237
[iv] Foley R et al. Clinical epidemiology of cardiovascular disease in chronic renal disease. American Journal of Kidney Disease 1998; 32 (5) Suppl 3:112-119
For further information, please contact: SHIRE, Media, Jessica Mann, +44-1256-894-280. Investor Relations, Cléa Rosenfeld, +44-1256-894-160. Resolute Communications: Glen Halliwell, +44-207-397-7479. Julia Kirby, +44-79-6617-2179 (on site)
