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FDA Approves Lanthanum Carbonate To Reduce Phosphate Levels in End-Stage Renal Disease Patients

October 27, 2004 -- The U.S. Food and Drug Administration (FDA) today approved FOSRENOL(R) (lanthanum carbonate), a new non-calcium, non-aluminium phosphate binder that reduces high serum phosphate levels in patients with end-stage renal disease (ESRD).

Even with a low phosphorus diet, most people undergoing kidney dialysis develop hyperphosphataemia (high phosphorus levels in the blood). (1,2) Without effective treatment, this condition often leads to renal osteodystrophy, a collection of bone diseases that causes bone pain, brittle bones, skeletal deformities and fractures.(3) Accumulating evidence also shows that hyperphosphataemia contributes to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients.(4,5,6)

The FDA approval is welcomed by US nephrologists. "Maintaining ESRD patients' serum phosphorus levels within a normal range has been very challenging because phosphorus is continually being absorbed into the body from food, and dialysis does not completely eliminate it from patients' blood," said William F. Finn, M.D., professor of medicine at the University of North Carolina School of Medicine at Chapel Hill. "FOSRENOL has been shown to be effective and well- tolerated in clinical studies, and is likely to aid in simplifying the management of hyperphosphatemia for patients and physicians."

The U.S. approval follows Swedish regulatory approval for FOSRENOL granted in March this year. Shire is pursuing further European approvals for this product via the Mutual Recognition Process.

"Effective reduction of phosphate levels in patients with kidney disease could make a real impact on their lives" said Dr Alastair Hutchison, Manchester Institute of Nephrology & Transplantation, UK. "In my opinion, existing therapies have numerous shortcomings - from long-term safety issues to high pill burdens and poor intestinal tolerability. I believe FOSRENOL moves us closer to the ideal phosphate binder, since it can be integrated easily into patients' day-to-day schedules and has shown reliable efficacy and safety in a number of well designed clinical trials".

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."

References:
1. US Renal Data System. USRDS 2003 Annual Data Report: Atlas of end-stage renal disease in the US. National Institute of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda MD 2002, p16.

2. http://www.emedicine.com/emerg/topic266.htm. "Hyperphosphatemia," by Leigh A Patterson, MD, Staff Physician, Department of Emergency Medicine, Charity Hospital, Louisiana State University, December 11, 2001.

3. Martin KJ, Gonzalez EA. Strategies to minimize bone disease in renal failure. Am J Kidney Dis 2001;38(6):1430-36.

4. Molowa DT. First annual nephrology survey. JP Morgan Securities Inc., Equity Research, February 13, 2002.

5. Salusky IB, Goodman WG. Cardiovascular calcification in end-stage renal disease. Nephrol Dial Transplant 2002;17:336-9.

6. Block GA, Port FK. Re-evaluation of risks associated with hyperphosphatemia and hyperparathyroidism in dialysis patients: recommendations for a change in management. Am J Kidney Dis 2000;35:1226-37.

7. Joy MS, Finn WF, on behalf of The Lanthanum 302 Study Group. Randomized, double-blind, placebo-controlled, dose-titration, phase III study assessing the efficacy and tolerability of lanthanum carbonate: a new phosphate binder for the treatment of hyperphosphatemia. Am J Kidney Dis 2003;42(1):96-107.

8. Hutchison A, Webster I, Gill M, Schmieder R. Safety, Tolerability and Efficacy of Lanthanum Carbonate in Haemodialysis Patients: a 12 month study. (301). Poster presented at the 40th ERA-EDTA World Congress of Nephrology, Berlin, Germany, 8-12 June 2003.

9. Hutchison A, Webster I, Gill M, Schmieder R. Maintained Safety, Tolerability and Efficacy of Lanthanum Carbonate During Long-Term Therapy in Haemodialysis Patients. Poster presented at the 36th Annual American Society of Nephrology, San Diego, California, 14-17 November 2003.

10. Fosrenol US PI v12.

Notes to editors:
Lanthanum carbonate (FOSRENOL(R))
FOSRENOL works by binding to dietary phosphate in the GI tract; once bound, the FOSRENOL/phosphate complex cannot pass through the intestinal lining into the blood stream and is eliminated from the body. As a consequence, overall phosphate absorption from the diet is decreased significantly. Shire has conducted an extensive clinical research programme for FOSRENOL involving over 1750 patients, some of whom have been treated for 36 months or more. This programme has demonstrated that FOSRENOL is an effective phosphate binder with a proven safety profile for long-term use. Earlier this year regulatory authorities in Sweden granted marketing authorization for FOSRENOL. As Sweden is the reference member state in the European Union Mutual Recognition Procedure for FOSRENOL, this approval was the first step in securing marketing approval throughout Europe. The company has out-licensed the rights to develop, market and sell FOSRENOL in Japan to Bayer Yakuhin Ltd.

Source: Shire Pharmaceuticals Group plc

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