FDA approves Fosrenol(R) in end-stage renal disease (ESRD...( us closer to the ideal phosphate binde...),Health

In clinical trials, patients treated with FOSRENOL achieved rapid, significant reductions in serum phosphorus within one week of starting therapy ⁷, and reached target levels within eight weeks.⁸ FOSRENOL has also demonstrated long-term efficacy and safety, with some patients maintaining reduced phosphate levels for 36 months or more.⁹ Additionally, bone biopsies taken from patients who had been treated with FOSRENOL for up to four years showed that patients maintained healthy bone throughout the duration of treatment.¹⁰

Matthew Emmens, Chief Executive of Shire commented: "The approval of FOSRENOL in the U.S. is another milestone for Shire. FOSRENOL provides a much-needed treatment for end-stage renal disease patients, since less than a third are able to control phosphate levels with existing medications. Without effective treatment, patients can suffer serious health complications such as bone disorders and life-threatening heart and circulation problems. Final launch preparations begin immediately and we anticipate that U.S. physicians will be able to prescribe FOSRENOL to their patients from the end of the year."

'"/>

Contact: Elizabeth Park
elizabeth.park@resolutecommunications.com
44-207-357-8187
Resolute Communications
27-Oct-2004