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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.
http://www.shire.com

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 Group
plc, Hampshire International Business Park,Chineham, Basingstoke RG24
8EP UK, Tel +44-1256-894000 Fax +44-1256-894708