Shire Pharmaceuticals Group Plc

New Analyses Demonstrate Positive Effect on Bone With Fosrenol(R) Treatment Compared With Standard Therapy

    Basingstoke, England and San Diego, California, November 20 (ots/PRNewswire) -

    - Further Data Support the Contribution of FOSRENOL(R) (Lanthanum Carbonate) to the Overall Renal Health of the ESRD Patient While Reducing Mean Phosphate Levels to Within Guideline Targets

    New data presented on Friday 17th November at the American Society of Nephrology (ASN) Annual Meeting, show FOSRENOL is an effective phosphate binder with a similar efficacy profile to standard therapy1. The 2 year data demonstrate that patients treated with FOSRENOL showed similar phosphate control and lower serum calcium levels than standard therapy. Treatment with FOSRENOL for 2 years had no adverse effects on bone histology and was not associated with an increased incidence of osteomalacia (bone softening). More patients treated with FOSRENOL also demonstrated increases in bone formation rate than patients receiving standard therapy1.

    Professor Hartmut Malluche, lead investigator of the study, said 'Patients with end-stage renal disease are seriously ill and the burden of their illness is often compounded by co-existing conditions. They can experience significant bone problems as a result of hyperphosphataemia, which can sometimes be exacerbated by their treatment for the condition. These data show that FOSRENOL not only effectively controls hyperphosphataemia, but also demonstrates some positive effects on bone status compared with standard therapy over the 2 year study period.'

    During year two, a greater proportion of patients in the standard therapy group showed movement of bone volume away from the normal range compared with the FOSRENOL group (50 percent versus 31 percent). Similarly, improvements toward normal bone formations rates were seen in 38 percent of patients receiving FOSRENOL at both one and two years. Patients in the standard therapy group showed improvements of only 24 and 12 percent at one and two years, and bone formation worsened in 63 percent of the patients in the two-year group[1]. The results were not measured for statistical significance.

    FOSRENOL's therapeutic profile is further reinforced by the publication of new cognitive function data in Kidney International this month[2]. This data assessed the comparative cognitive decline in dialysis patients taking FOSRENOL and standard therapy to control phosphate levels. Cognitive decline is a significant problem in this population and it is important that any treatment does not affect this further. These long term two year data show that FOSRENOL does not adversely affect the decline of cognitive function compared to standard therapy[2]. There is a paucity of evidence looking at cognitive function in this patient population and this study provides important additional insight into the overall decline in cognitive function in these patients.

    Dr Raymond Pratt, Vice President Shire Pharmaceutical Development, said: 'These results further add to the robust body of evidence on FOSRENOL, with studies successfully conducted in more than 5,500 patients, and with a small number followed for up to 6 years now. Shire is proud of this comprehensive data which support the benefits FOSRENOL can bring to patients with CKD on dialysis.'

    These studies are promising news for the estimated 1.4 million people on dialysis worldwide[3] who are at risk from the serious consequences of hyperphosphataemia, shown to be associated with long-term morbidity and mortality[4]. The majority of CKD patients will eventually develop hyperphosphataemia[5] which, if not managed successfully, may cause serious long-term health risks including renal osteodystrophy (resulting in bone pain, brittle bones and skeletal deformities)[6], and potentially contribute  to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients[7,8]. As a result, patients on dialysis are often already taking as many as eight or nine different medications9. As FOSRENOL is associated with a lower tablet burden than existing phosphate binders (as few as one pill per meal), it may offer simplified dosing for these patients10.

    FOSRENOL has been available in the US for 22 months with over 53,000 patients receiving Fosrenol since launch. The first European launches took place at the end of 2005 and Shire continues to bring Fosrenol to market around the world across this year and into 2007, subject to national licensing, pricing and reimbursement negotiations.

    References

    1. Malluche HH, Pratt RD. Renal osteodystrophy: Comparison of evolution over 1 and 2 years during treatment with lanthanum carbonate or standard phosphate binders. Presented at ASN Renal Week, San Diego, November 14-19 2006.

    2. Altman P, Barnett ME, Finn WF. Cognitive function in stage 5 CKD patients on hemodialysis: no adverse effects of lanthanum carbonate compared with standard phosphate-binder therapy. Kidney Int advance online publication, October 11, 2006

    3. Grassman A, Gioberge S, Moeller S, Brown G. ESRD patients in 2004: global overview of patient numbers, treatment modalities and associated trends. Nephrol Dial Transplant 2005; 20: 2587-2593.

    4. Block G, Klassen PS, Lazarus MJ, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol 2004; 15:2208-18.

    5. Lederer E, Ouseph R, Erbeck K. Hyperphosphataemia. www.emedicine.com/med/topic1097.html. Accessed 23-Mar-06.

    6. Martin K, Gonzalez A. Strategies to minimize bone disease in renal failure. Am J Kidney Dis 2001; 38: 1430-36

    7. Salusky IB, Goodman WG. Cardiovascular calcification in end-stage renal disease. Nephrol Dial Transplant 2002; 17: 336-339.

    8. 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.

    9. United States Renal Data System. Medication use among dialysis patients in DMMS. Am J

    Kidney Dis 1998; 32 (2) Suppl 1 (August): S60-68.

    10. Mehrotra R. Efficacy and safety of reformulated higher dosage lanthanum carbonate. Presented at ASN Renal Week, San Diego, November 14-19 2006.

    Notes to Editors:

    Managing Hyperphosphataemia

    Phosphorus, an element found in nearly all foods, is absorbed from the gastrointestinal tract into the blood stream. When the kidneys fail, they no longer effectively filter out phosphates, even with the help of blood-cleansing dialysis machines. While the normal adult range for phosphorus is 2.5 (0.8mmol/L) to 4.5 mg/dL (1.4mmol/L), the blood phosphorus levels of many patients on dialysis exceed 6.5 mg/dL (2.1mmol/L). Such levels have been linked to a significantly higher illness and death risk for patients who have undergone at least one year of dialysis[i]. Most dialysis patients develop hyperphosphataemia.

    Hyperphosphataemia disrupts the delicate interplay between the body's levels of calcium, parathyroid hormone (PTH) and vitamin D. Over time, hyperphosphataemia can ultimately lead to calcification of the heart, lung and some arteries[ii]. Accumulating evidence shows that hyperphosphataemia contributes to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients[iii]. In fact, studies have shown that cardiovascular mortality in dialysis patients aged 25-34 years is more than 5 times greater than that in people aged 65-74 in the general population[iv].

    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.

    ---------------------------------

    [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

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