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FOSRENOL (R) maintains bone health status of end-stage renal disease patients

ST. LOUIS, Mo. Oct. 29, 2004 - Shire Pharmaceuticals Group plc (NASDAQ: SHPGY, LSE: SHP.L, TSE: SHQ CN) announces that long-term treatment with FOSRENOL (lanthanum carbonate), a new non-calcium, non-aluminum phosphate binder, does not promote bone softening or cause harmful effects on bone, according to data presented today at the American Society of Nephrology (ASN) annual meeting in St. Louis, Mo.

Even with a low-phosphorus diet, most ESRD patients develop hyperphosphatemia (high phosphate levels in the blood). Without effective treatment, hyperphosphatemia may lead to renal osteodystrophy, a collection of bone diseases characterized by bone pain, brittle bones, skeletal deformities and fractures.

"Since ESRD patients often have fragile bones, it is critical that phosphate binders not worsen bone status," said Dr. Eliseo Salinas, Shire's Chief Scientific Officer and Executive Vice President of Global Research & Development. "Patients who take FOSRENOL over the long-term generally are able to maintain their bone health status."

The U.S. Food and Drug Administration recently approved FOSRENOL on Oct. 26. According to experts, FOSRENOL may help simplify the management of hyperphosphatemia because it is an effective, easy-to-take, chewable tablet that does not have to be taken with fluids.

Data from over 400 bone biopsies representing the largest bone biopsy data set in ESRD patients were presented at ASN.

In an important study, which evaluated bone biopsies in 197 subjects (100 patients receiving FOSRENOL and 97 patients receiving comparator) prior to and after one year of treatment revealed no evidence of softening of the bone (osteomalacia) in patients receiving FOSRENOL.

In another poster presentation, investigators used five measures of bone structure and content to examine bone samples from 11 patients who completed more than four years of treatment with FOSRENOL. Treatment with FOSRENOL for more than fou
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29-Oct-2004


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