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Shire Secures European Wide Label Extension for FOSRENOL(R) in Chronic Kidney Disease
Date:10/28/2009

cals, Shire. "We are firmly committed to serving the needs of renal patients and ensuring that FOSRENOL is available to the prescribers and patients who can benefit from it."

In relation to the US, Shire continues to evaluate its options for securing a label extension to include CKD patients not on dialysis.

    Notes to Editors

    ABOUT FOSRENOL(R) (lanthanum carbonate)

    FOSRENOL is indicated:

    - In the EU as a phosphate binding agent for use in the control of
      hyperphosphataemia in chronic renal failure patients on haemodialysis
      or continuous ambulatory peritoneal dialysis. FOSRENOL is also
      indicated in adult patients with chronic kidney disease not on dialysis
      with serum phosphate levels greater than or equal to 1.78 mmol/L in
      whom a low phosphate diet alone is insufficient to control serum
      phosphate levels.(1)

    - In the US to reduce serum phosphate in patients with end stage renal
      disease.(2)

    - FOSRENOL is not available in all countries and prescribing information
      may differ between countries. Please consult your local prescribing
      information.(2)

    - FOSRENOL works by binding to dietary phosphate in the GI tract; once
      bound, the lanthanum/phosphate complex cannot pass through the
      intestinal lining into the blood stream and is eliminated from the
      body.(1) As a consequence, overall phosphate absorption from the diet
      is decreased.

    - FOSRENOL is available in a broad range of dosage strengths including
      500mg, 750mg, and 1000mg tablets1 which facilitates an effective dosing
      regimen of one tablet per meal for the majority of patients.

    - FOSRENOL was first approved in Sweden in March 2004, and by the US FDA
      in October 2004. FOSRENOL was subsequently approved in all EU markets
      by the European Mutual Recognition Procedure and is now launched in 37
      markets worldwide. It continues to be approved and made availa
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SOURCE Shire Plc
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