Shire receives European approval for FOSRENOL

Shire PlcOct 28 2009

FOSRENOL(R) (lanthanum carbonate) Now Approved in the EU to Treat hyperphosphataemia >1.78mmol/L in Chronic Kidney Disease Patients Not on Dialysis

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced it has received approval through the European Mutual Recognition Procedure for an extension to the current indication for FOSRENOL(R) (lanthanum carbonate), paving the way to make the non-calcium, non-resin phosphate binder available throughout the EU to control hyperphosphataemia in chronic kidney disease (CKD) patients who are not on dialysis with a serum phosphorus level greather than or equal to 1.78mmol/L (5.5mg/dL).

The extension was sanctioned by the Swedish Medicines Products Agency as reference member state. Submissions for national marketing authorizations have been made to Sweden and the other 28 European markets with first national approvals anticipated in Q4 2009.

"Failure to control phosphate in the earlier stages of chronic kidney disease carries well documented risks, and is associated with reduced bone health and poor cardiovascular outcomes," said Dr. Alastair Hutchison, Manchester Royal Infirmary, UK. "The extension to the existing indication for FOSRENOL provides nephrologists in the EU with an important additional option to help tackle the challenge of uncontrolled phosphate at an earlier stage in the progression of kidney disease, before the need for dialysis treatment."

"This is an important development in helping CKD patients better manage their elevated phosphate and we are pleased that FOSRENOL is now approved as a treatment option for these patients in the EU," said Gian Piero Reverberi, Senior Vice President, International Specialty Pharmaceuticals, 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.