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Higher dose formulation of FOSRENOL approved to reduce serum phosphorus in esrd patients

PHILADELPHIA, Nov. 28 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved a new, higher dose formulation of the chewable(1) non-calcium phosphate binder FOSRENOL(R) (lanthanum carbonate). The new, higher dose strengths of 750 milligrams (mg) and 1.0 gram (g) will be available in the U.S. by year end. This formulation will help to reduce the number of pills end-stage renal disease (ESRD) patients must take to achieve target phosphorus levels, thereby helping to simplify the treatment of hyperphosphatemia. FOSRENOL(R) is marketed by Shire Pharmaceuticals.

Even with a low phosphorus diet, 60 percent of ESRD patients on dialysis in the United States may develop hyperphosphatemia (high phosphorus levels in the blood) and up to 70 percent are considered noncompliant when using currently prescribed phosphate binders. Without effective treatment, hyperphosphatemia may lead to increased rates of death, renal bone disease, hyperparathyroidism and calcification of tissues. Also, evidence shows hyperphosphatemia may contribute to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients. FOSRENOL(R) is indicated to reduce serum phosphorus in patients with ESRD.

"As a result of the FDA approval, FOSRENOL(R) is now available in a new formulation, offering water-sparing, chewable tablets that are smaller than the original formulation. Additionally, FOSRENOL(R) is now available in a broader range of dosage strengths, including the new higher strengths of 750 milligram and 1.0 gram tablets," said Eliseo Salinas, M.D., Shire's Chief Scientific Officer and Executive Vice President of Global Research & Development. "The newly formulated, higher dosage strengths of FOSRENOL(R) allow patients the potential to achieve phosphorus control with as little as three tablets per day."

According to recent data presented at the American Society of Nephrology annual meeting in Philadelphia, PA, the new, highe
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Contact: Matt Cabrey
mcabrey@us.shire.com
484-595-8800
Porter Novelli
28-Nov-2005


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