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Data From a Head-to-Head Crossover Study Evaluating FOSRENOL(R) and Sevelamer Published Today
Date:10/7/2009

DUBLIN, October 7 /PRNewswire-FirstCall/ --

- For Medical and Healthcare Media Only -

- Direct Comparison of the Two non-Calcium Phosphate Binders Gives new Insights Into Relative Efficacy

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announces the publication in Clinical Nephrology of findings from a head-to-head clinical study comparing the efficacy of two non-calcium based phosphate binders, FOSRENOL(R) (lanthanum carbonate) and sevelamer hydrochloride (Genzyme's Renagel(R)) in chronic kidney disease (CKD) patients on haemodialysis.

In this 12-week crossover study, patients (n=182) were randomized to receive either FOSRENOL or sevelamer for four weeks, and then switched to the alternative phosphate binder for the same period. Product doses were pre-defined to allow a direct efficacy comparison. Doses were based on those used in previous clinical trials[1,2] and established clinical practice.[3]

The study's primary endpoint, change in serum phosphorus from baseline to end of treatment, was evaluated using several statistical analyses; the primary analysis used last observation carried forward (LOCF) for the intention to treat (ITT) population (n=174), meaning that if a patient dropped out of the study during treatment, their last post baseline serum phosphorus measurement was used as the end of treatment value. The pre-determined key secondary analysis assessed the completer population; defined as those patients who had completed four weeks' treatment with both phosphate binders and had a serum phosphorus value at the end of treatment.[4]

The analysis of LOCF for the ITT population showed a numerically greater reduction in serum phosphorus with FOSRENOL (1.7mg/dL) versus sevelamer (1.4mg/dL), although
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SOURCE Shire Plc
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