Shire Pharmaceuticals Group Plc

FDA Approved Fosrenol Maintains Long Term Bone Health in First Ever Five Year Bone Biopsy Data for a Phosphate Binder

    St Louis, Missouri (ots/PRNewswire) - Shire Pharmaceuticals Group plc (NASDAQ: SHPGY, LSE: SHP.L, TSE: SHQ CN)  announced that long-term treatment with FOSRENOL(R) (lanthanum carbonate) for  up to five years, shows no deterioration in bone health according to new data  presented today for the first time at the American Society of Nephrology  (ASN) 37th Annual Meeting.(1) Fosrenol received FDA approval on 26 October in  the USA where it is indicated to reduce serum phosphate in patients with end  stage renal disease (ESRD),supplementing the approval granted by the Swedish  regulatory authorities (MPA) earlier this year.

    "This is the first time we have seen five year data of this kind with any phosphate binder, and the data delivers promising news for dialysis patients at risk of bone disease. It contributes to the overall safety and efficacy profile of Fosrenol as the new non-aluminium, non-calcium therapy of choice for patients with hyperphosphataemia, which may provide substantial clinical benefits to people with end stage renal disease." said Professor Tony Freemont, Professor of Osteoarticular Pathology, University of Manchester, clinical pathologist involved in this study.

    Bone disease is a serious and potentially devastating long-term health risk of hyperphosphataemia, a complication of renal failure that occurs in as many as 80% of dialysis patients.(2,3) It leads to bone pain, brittle bones (which can result in fractures) and skeletal deformities. (4)

    There is a reduced life expectancy with chronic kidney disease, which, depending on frequency of dialysis, and underlying disease, can vary from 14.2 years (low risk) to 3.5 years (high risk).(5) In this context, study results with five year data represent important evidence of long-term efficacy and tolerability for Fosrenol, which will shortly be available to prescribe in the US following FDA Approval, as well as evidence to address bone health risks in this patient population.

    The study, presented by Professor H Malluche, and his co-authors including Dr M.C. Faugere and Professor A. Freemont, includes bone biopsies obtained from patients who had received Fosrenol in a long-term safety study for up to five years.1 When indicators of bone health were evaluated, no biopsies showed any sign of osteomalacia (softening of the bones), which has in the past been associated with the use of aluminium-based phosphate binders6, thereby supporting the long-term safety profile of Fosrenol.

    This data is just part of a comprehensive package of data for Fosrenol. Evidence of efficacy and safety is also demonstrated by new data being presented at this year's ASN congress, including results from a study showing no negative effects on cognitive function (the ability to think, reason and learn) compared with standard therapy - a problem that has in the past been associated with some phosphate binder treatments. (6)

    References

    1) No evidence of osteomalacia in dialysis patients treated with lanthanum carbonate (Fosrenol) up to 5 years. Malluche HH et al. Poster presented at American Society Nephrology Annual Congress, 2004

    2. US Renal Data System. USRDS 2003 Annual Data Report: Atlas of end-stage renal disease in the US. Chapter Thirteen, International Comparisons, pg 208

    3. Market Research, Insight International, Dec 01/Jan 02 Hyperphosphataemia Exploratory Research J1524

    4. Martin, J.M et al. Strategies to Minimize Bone Disease in Renal Failure. Am J Kidney Dis 2001; 38 (6):1430-1436

    5. Medicine 1999 Chronic Renal Failure p.46

    6. Malluche HH & Monier-Faugere MC. Hyperphosphatemia: pharmacologic intervention yesterday, today and tomorrow. Clin Nephrol 2000; 54 (4):309-317.

    Notes to Editors:

    Managing Hyperphosphatemia

    Phosphorus, an element found in nearly all foods, is absorbed from the gastrointestinal tract into the blood stream. When the kidneys fail, they no longer effectively filter out phosphates, even with the help of blood-cleansing dialysis machines. While the normal adult range for phosphorus is 2.5 to 4.5 mg/dL, the blood phosphorus levels of many patients on dialysis exceed 6.5 mg/dL. Such levels have been linked to a significantly higher illness and death risk for patients who have undergone at least one year of dialysis. Most dialysis patients, including some 243,000 Americans, develop hyperphosphataemia.

    Hyperphosphataemia disrupts the delicate interplay between the body's levels of calcium, parathyroid hormone (PTH) and vitamin D. Over time, hyperphosphataemia can ultimately lead to calcification of the heart, lung and some arteries. Accumulating evidence shows that hyperphosphataemia contributes to cardiovascular disease, which accounts for almost half of all deaths among dialysis patients .In fact, studies have shown that cardiovascular mortality in dialysis patients aged 25-34 years is more than 5 times greater than that in people aged 65-74 in the general population.

    Since diet restrictions alone generally cannot control phosphate levels, patients traditionally manage hyperphosphataemia with phosphate binding agents, typically calcium or sevelamer, or occasionally aluminum salts, at every meal and snack. Such binders "soak up" phosphate in the gastrointestinal tract, before it can be absorbed into the blood. Although these agents can be effective, they can cause potentially serious side effects including hypercalcaemia, bone toxicity and tolerability problems.

    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.

    Shire Pharmaceuticals Group plc

    Shire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceutical company with a strategic focus on meeting the needs of the specialist physician and currently focuses on developing projects and marketing products in the areas of central nervous system (CNS), gastrointestinal (GI), and renal diseases. Shire has operations in the world's key pharmaceutical markets (US, Canada, UK, France, Italy, Spain and Germany) as well as a specialist drug delivery unit in the US.

    For further information on Shire, please visit the Company's website: www.shire.com

    THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

    Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, Shire's results could be materially affected. The risks and uncertainties include, but are not limited to, risks associated with the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization, the impact of competitive products, including, but not limited to, the impact on Shire's Attention Deficit & Hyperactivity Disorder (ADHD) franchise, patents, including but not limited to, legal challenges relating to Shire's ADHD franchise, government regulation and approval, including but not limited to the expected product approval dates of METHYPATCH(R) (methylphenidate), XAGRID(R) (anagrelide hydrochloride) and BIPOTROL(R) (carbamazepine), the implementation of Shire's planned reorganization and other risks and uncertainties detailed from time to time in Shire's filings with the Securities and Exchange Commission, including Shire's most recent annual report on Form 10-K.

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