Shire Pharmaceuticals Group Plc

Fosrenol(R) Demonstrates Effective Phosphate Control With as Few as Three Tablets a Day

    Basingstoke, England (ots/PRNewswire) -

    - New Data Show FOSRENOL Is an Effective Monotherapy - Leading to Improved Phosphate Reduction in Dialysis Patients Previously Receiving Alternative Phosphate Binder Therapies

    New data show calcium-free FOSRENOL (lanthanum carbonate) further reduces phosphate levels in dialysis patients previously receiving other monotherapies or combined phosphate binders, including calcium carbonate and sevelamer hydrochloride[1]. The data, presented today at the XLIII ERA-EDTA Congress in Glasgow, also showed that FOSRENOL significantly increased the number of patients achieving Kidney Disease Outcome Quality Initiative (K/DOQI) targets compared to those who were previously treated with other monotherapies.

    Dr Alastair Hutchison from the Manchester Institute of Nephrology & Transplantation and one of the trial's lead investigators said, "These study results add further weight to the extensive data package which demonstrates FOSRENOL is an effective phosphate binder. FOSRENOL offers patients with hyperphosphataemia an effective treatment option which could simplify their management by reducing tablet burden to as little as one tablet taken during each meal."

    A total of 359 dialysis patients were treated with FOSRENOL as monotherapy and were available for analysis from this multicentre, open label study, following a switch from their previous binder therapy. Over 40% of patients were previously on combination phosphate binder therapy (2 or more binders). The study found that at 12 weeks of FOSRENOL monotherapy, patients' mean serum phosphate levels were 1.84 mmol/L compared with 1.99 mmol/L on other previously received phosphate binding therapies*. In addition, there was an increased percentage of patients who reached KDOQI targets. The study also demonstrated that FOSRENOL was well-tolerated throughout.

    (* For patients assessed at Week 12, the mean change from screening to Week 12 was -0.13 (P < 0.05).)

    Further data presented at the ERA-EDTA Congress showed that treatment with FOSRENOL was associated with a high level of patient and physician satisfaction, based on a number of assessments and linked to a reduction in tablet burden[2]. The majority of patients and physicians expressed a preference for FOSRENOL over previous phosphate binders.

    "Poor patient adherence is a problem often found in patients with hyperphosphataemia," says Dr Rajnish Mehrotra from the Harbor-UCLA Medical Center, California and one of the lead investigators of the trial. "These findings show that FOSRENOL may help to tackle this problem."

    Other data presented at the meeting also extended FOSRENOL's existing body of evidence. Data from 93 patients, 17 of whom were followed for up to 6 years in an open-label extension study, showed that FOSRENOL effectively maintained reductions in mean serum phosphate levels whilst remaining tolerated[3].

    These studies are promising news for the nearly one million people on dialysis worldwide who are at risk from the serious consequences of hyperphosphataemia, shown to be associated with long-term morbidity and mortality[4]. Up to 70 percent of CKD patients will develop hyperphosphataemia[5] which, if not managed successfully, may cause serious long-term health risks leading to renal osteodystrophy (resulting in bone pain, brittle bones and skeletal deformities), and potentially contribute to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients.[6] As a result, patients with hyperphosphataemia are often already taking as many as eight or nine different medications[7]. As FOSRENOL is associated with a lower tablet burden than existing phosphate binders, it may offer simplified dosing for these patients.

    Dr Raymond Pratt, Vice President Shire Global Medical Affairs, said, "Shire welcomes the presentation of these data which further add to the robust evidence supporting the effectiveness and tolerability of FOSRENOL in patients with hyperphosphataemia, as well as showing a high-level of patient and physician satisfaction. Shire is very proud to be able to offer a calcium-free alternative with proven efficacy and tolerability for patients in need of an effective and well-tolerated phosphate binder, which may also help to simplify the management of their condition."

    FOSRENOL has been available in the US for 18 months with over 44,000 patients receiving Fosrenol since launch and will continue to be launched across Europe in the remainder of 2006 and into 2007.

    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. 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. Accumulating evidence shows that hyperphosphataemia contributes to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients. 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.[8]

    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. Although these agents can be effective, some can cause potentially serious side effects including hypercalcaemia, bone toxicity and tolerability problems.

    Lanthanum carbonate (FOSRENOL(R))

    FOSRENOL(R) works by binding to dietary phosphate in the GI tract; once bound, the FOSRENOL(R)/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(R) involving over 5500 patients, some of whom have been treated for up to 6 years. This programme has demonstrated that FOSRENOL(R) is an effective phosphate binder with a tolerability profile for long-term use. FOSRENOL(R) 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(R) 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(R) 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.

    It is unknown whether lanthanum is excreted in human breast milk. The excretion of lanthanum in milk has not been studied in animals. Breast feeding is not recommended when the mother is treated with Fosrenol.

    Tissue deposition of lanthanum has been shown with Fosrenol in animal studies. In 105 bone biopsies from patients treated with Fosrenol for up to 4.5 years, rising levels of lanthanum were noted over time . No clinical data are available on deposition of lanthanum in other tissues. Safety data exceeding 24 months are currently limited. The risk/benefit from longer-term administration should be carefully considered.

    Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in clinical studies with Fosrenol.

    Approximately 24% of all ESRF patients who participated in registration clinical studies, reported a drug related adverse reaction, as determined by the investigator. No individual ADR was reported at a frequency greater than 10%. The most commonly reported 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 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.

    [1]. Hutchison A et al. Efficacy of Lanthanum Carbonate Monotherapy in Dialysis Patients Previously Receiving Alternative Phosphate Binder Therapy. Presented at the XLIII ERA-EDTA Congress, Glasgow, UK, 15-18 July, 2006.

    [2]. Mehrotra R et al. A New Formulation of Lanthanum Carbonate is Preferred by Patients and Physicians. Presented at the XLIII ERA-EDTA Congress, Glasgow, UK, 15-18 July, 2006.

    [3]. Hutchison A et al. Sustained Safety, Tolerability and Efficacy of Lanthanum Carbonate: Results from up to Six Years of Treatment. Presented at the XLIII ERA-EDTA Congress, Glasgow, UK, 15-18 July, 2006.

    [4]. Block G et al. Mineral Metabolism, Mortality, and Morbidity in Maintenance Hemodialysis. Am Soc Nephrol 2004; 15: 2208-18.

    [5]. Lederer E et al. Hyperphosphataemia. www.emedicine.com/med/topic1097.html. Accessed 23-Mar-06.

    [6]. Block G et al. 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

    [7]. United States Renal Data System. Medication Use Among Dialysis Patients in the DMMS. American Journal of Kidney Disease 1998; 32 (2) Suppl 1 (August): S60-68

    [8]. 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

ots Originaltext: Shire Pharmaceuticals Group Plc
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