2004-10-29

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 Groupplc (NASDAQ: SHPGY, LSE: SHP.L, TSE: SHQ CN) announced thatlong-term treatment with FOSRENOL(R) (lanthanum carbonate) for up tofive years, shows no deterioration in bone health according to newdata presented today for the first time at the American Society ofNephrology (ASN) 37th Annual Meeting.(1) Fosrenol received FDAapproval on 26 October in the USA where it is indicated to reduceserum phosphate in patients with end stage renal disease(ESRD),supplementing the approval granted by the Swedish regulatoryauthorities (MPA) earlier this year.

"This is the first time we have seen five year data of this kindwith any phosphate binder, and the data delivers promising news fordialysis patients at risk of bone disease. It contributes to theoverall safety and efficacy profile of Fosrenol as the newnon-aluminium, non-calcium therapy of choice for patients withhyperphosphataemia, which may provide substantial clinical benefitsto people with end stage renal disease." said Professor TonyFreemont, Professor of Osteoarticular Pathology, University ofManchester, clinical pathologist involved in this study.

Bone disease is a serious and potentially devastating long-termhealth risk of hyperphosphataemia, a complication of renal failurethat occurs in as many as 80% of dialysis patients.(2,3) It leads tobone pain, brittle bones (which can result in fractures) and skeletaldeformities. (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) Inthis context, study results with five year data represent importantevidence of long-term efficacy and tolerability for Fosrenol, whichwill shortly be available to prescribe in the US following FDAApproval, as well as evidence to address bone health risks in thispatient population.

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

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

References

1) No evidence of osteomalacia in dialysis patients treatedwith 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 ofend-stage renal disease in the US. Chapter Thirteen, InternationalComparisons, pg 208

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

4. Martin, J.M et al. Strategies to Minimize Bone Disease in RenalFailure. 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. ClinNephrol 2000; 54 (4):309-317.

Notes to Editors:

Managing Hyperphosphatemia

Phosphorus, an element found in nearly all foods, is absorbed fromthe gastrointestinal tract into the blood stream. When the kidneysfail, they no longer effectively filter out phosphates, even with thehelp of blood-cleansing dialysis machines. While the normal adultrange for phosphorus is 2.5 to 4.5 mg/dL, the blood phosphorus levelsof many patients on dialysis exceed 6.5 mg/dL. Such levels have beenlinked to a significantly higher illness and death risk for patientswho have undergone at least one year of dialysis. Most dialysispatients, including some 243,000 Americans, develophyperphosphataemia.

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

Since diet restrictions alone generally cannot control phosphatelevels, patients traditionally manage hyperphosphataemia withphosphate binding agents, typically calcium or sevelamer, oroccasionally aluminum salts, at every meal and snack. Such binders"soak up" phosphate in the gastrointestinal tract, before it can beabsorbed into the blood. Although these agents can be effective, theycan 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 theintestinal lining into the blood stream and is eliminated from thebody. As a consequence, overall phosphate absorption from the diet isdecreased significantly. Shire has conducted an extensive clinicalresearch programme for FOSRENOL involving over 1750 patients, some ofwhom have been treated for 36 months or more. This programme hasdemonstrated that FOSRENOL is an effective phosphate binder with aproven safety profile for long-term use. Earlier this year regulatoryauthorities in Sweden granted marketing authorization for FOSRENOL.As Sweden is the reference member state in the European Union MutualRecognition Procedure for FOSRENOL, this approval was the first stepin securing marketing approval throughout Europe. The company hasout-licensed the rights to develop, market and sell FOSRENOL in Japanto Bayer Yakuhin Ltd.

Shire Pharmaceuticals Group plc

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

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

THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIESLITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts areforward-looking statements. Such forward-looking statements involve anumber of risks and uncertainties and are subject to change at anytime. In the event such risks or uncertainties materialize, Shire'sresults could be materially affected. The risks and uncertaintiesinclude, but are not limited to, risks associated with the inherentuncertainty of pharmaceutical research, product development,manufacturing and commercialization, the impact of competitiveproducts, including, but not limited to, the impact on Shire'sAttention Deficit & Hyperactivity Disorder (ADHD) franchise, patents,including but not limited to, legal challenges relating to Shire'sADHD franchise, government regulation and approval, including but notlimited to the expected product approval dates of METHYPATCH(R)(methylphenidate), XAGRID(R) (anagrelide hydrochloride) andBIPOTROL(R) (carbamazepine), the implementation of Shire's plannedreorganization and other risks and uncertainties detailed from timeto time in Shire's filings with the Securities and ExchangeCommission, including Shire's most recent annual report on Form 10-K.

http://www.shire.com

ots Originaltext: Shire Pharmaceuticals Group PlcIm Internet recherchierbar: http://www.presseportal.de

Contact:For further information, please contact: SHIRE Global (outside US & Canada) Jessica Mann - Shire Media Relations +44-1256-894-280; Cléa Rosenfeld - Shire Investor Relations +44-1256-894-221; Elizabeth Park- Resolute Communications +44-7989-988-440 on-site; Julia Kirby - Resolute Communications +44-20-7357 8187; Shire Pharmaceuticals Groupplc, Hampshire International Business Park,Chineham, Basingstoke RG248EP UK, Tel +44-1256-894000 Fax +44-1256-894708

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

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