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Fosrenol (TM) reduces damaging high levels of phosphate in end-stage kidney disease patients

Philadelphia, Pa., USA Shire Pharmaceuticals Group plc (NASDAQ: SHPGY, LSE: SHP.L, TSE: SHQ CN) announces that long-term (two year) treatment with FOSRENOL™ (lanthanum carbonate) reduces damaging high phosphate levels, which most end-stage renal disease (ESRD) patients experience, according to data from two studies presented at the American Society of Nephrology (ASN) 35th Annual Meeting.

According to the two trials, lanthanum carbonate is well tolerated and associated with the reduced occurrence of high calcium levels, a side effect of some current therapies that has been linked to increased calcification of the coronary arteries in the heart.

Shire has submitted lanthanum carbonate under the trade name of FOSRENOL for regulatory review in the United States, European Union and Canada. The product is under development in Japan.

"Data from the two trials illustrate that lanthanum carbonate has the potential to reduce dangerously high phosphate levels safely and effectively. Previous data from a separate phase 3 long-term safety study indicate that there is no demonstrable link between lanthanum administration and bone toxicity. These data suggest that lanthanum carbonate will deliver tangible clinical benefits to dialysis patients," says William F. Finn, M.D., professor of medicine at the University of North Carolina School of Medicine at Chapel Hill, regarding his interim analysis of 1,203 ESRD dialysis patients enrolled in a two-year trial at 96 U.S. sites, presented at the ASN meeting.

Studies show lanthanum carbonate has a good safety and efficacy profile in the treatment of hyperphosphatemia in dialysis patients

Finn's study [ASN Poster SA-P0600] showed that after one year of therapy, patients receiving lanthanum carbonate had similar reductions in average phosphorus levels compared to those on standard therapies, including aluminum salts, calcium salts or sevelamer. The study also showed that patients in the
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Contact: Michele Roy , Shire
450-978-7938
Porter Novelli
2-Nov-2002


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