Shire Demonstrates Commitment to Improving Patient Adherence in End Stage Renal Disease as New Phosphate-Binder FOSRENOL(R) Launches in Europe



    /NOT FOR DISTRIBUTION IN THE US/

    
    -  New Research Provides Important Insights Into Adherence Issue

    -  Data Reveal Perceptual and Practical Barriers Including the Need for
       Phosphate Binders With Simplified Dosing
    

    BASINGSTOKE, England, June 25 /CNW/ - Shire plc (LSE: SHP, NASDAQ:   SHPGY,
TSX: SHQ). New data from a patient adherence survey presented on Friday 22nd
June at the XLIV ERA-EDTA Congress in Barcelona highlight that over 40% of
patients with chronic kidney disease (CKD) forget to take their
phosphate-binding medication.(1) Phosphate binders are used to treat
hyperphosphataemia (unusually high levels of phosphorous in the blood), which,
if not managed successfully, can lead to serious health consequences including
increased rates of cardiovascular morbidity and mortality and other
complications.(2)
    The research reveals that poor patient adherence to phosphate binders is
linked to practical barriers such as the complexity of the dosing regimen and
not understanding how to take them, as well as perceptual barriers regarding
patient beliefs about their need for medication and concerns about adverse
events.(1)
    Rob Horne, Professor of Behavioural Medicine at the School of Pharmacy,
University of London, conducted the research which assessed the behavioural
patterns of 221 patients with CKD across 8 centres in the UK.
    "CKD can have a devastating impact on patients' lives. The study shows
that adherence to phosphate-binding medication is adversely affected by a
number of factors, both practical and perceptual," said Professor Horne. "On
the practical side, daily treatment requires often complex dosing schedules on
top of an already difficult treatment regimen. This can include long dialysis
sessions, strict fluid and dietary restrictions and a complicated medication
schedule involving up to 25 tablets per day. Phosphate binders used to manage
hyperphosphataemia can alone add up to 12 tablets per day."
    "On the perceptual side, it is essential to recognise that personal
beliefs about the value of medication are important. Our study showed that non
adherence was linked to doubts about the need for treatment and concerns about
taking phosphate binders. We now need to develop more effective methods for
helping patients to get the best from their medicines by facilitating informed
choice and improved adherence. This should involve the provision of bespoke
information to meet individual needs and address concerns as well as efforts
to overcome the practical barriers to adherence by making the regimen as
convenient and easy to use as possible." he added.

    
    The research, using validated questionnaires(1), produced the following
    findings:

    -  Over 40% of patients forgot to take their phosphate-binder medication
       sometimes, often or always;

    -  38% forgot to take their medication at mealtimes;

    -  23% of patients reported altering their dose;

    -  19% decided to miss doses;

    -  21% took less medication than instructed.(1)
    

    Over 70%(3) of the estimated 1.5 million people with CKD on dialysis
worldwide(4) will develop hyperphosphataemia due to their failing kidneys
being unable to effectively rid their bodies of the excess phosphate absorbed
from food. If not managed successfully, hyperphosphataemia can lead to serious
health problems including renal osteodystrophy (a bone disorder resulting in
painful, brittle bones that may fracture or lead to deformities) and
cardiovascular disease which accounts for almost half of all deaths in
dialysis patients.(5)
    Despite the availability of existing therapies, effective phosphate
management remains a challenge with up to 75% of dialysis patients exceeding
the National Kidney Foundation Kidney Disease Outcomes Quality Initiative
(NKF/KDOQI) guidelines for serum phosphate levels less than 1.78 mmol/L
(5.5 mg/dL).(6)
    "This research highlights that a combination of treatment factors,
including tablet burden, can contribute to poor patient adherence which may
compromise their ability to meet specified global targets for phosphate
levels," said Professor Horne.
    FOSRENOL is a newly introduced treatment option in Europe for the
nephrologist to use in the management of hyperphosphataemia in CKD patients on
dialysis. It is a non-calcium based binder with a high affinity for phosphate
that binds to the phosphate in food to effectively reduce serum phosphorous
levels.(7) FOSRENOL can be used effectively as a monotherapy and is associated
with a lower tablet burden than existing phosphate binders with the majority
of patients requiring just one chewable tablet during each meal.(8) This
compares to other therapies that are often used in combination and may require
up to 12 tablets per day. This simplified dosing regime may remove some of the
practical barriers to patient adherence identified in the research.
    "Adherence is emerging as a key issue for patients with CKD, with many
still having phosphate levels above the recommended global target. Shire is
sponsoring Professor Horne's research as part of its commitment to exploring
new ways to improve patient adherence and ultimately better patient outcomes,"
said David Milton, Senior Vice President, Shire Renal Business Unit. "FOSRENOL
is our effective phosphate binder that offers the added benefit of a reduced
pill burden with the majority of CKD patients on dialysis requiring just one
tablet during each meal. As part of this commitment, Shire is also developing
additional FOSRENOL formulation options aimed at making it even simpler for
patients," he added.
    Over 5,000 patients have been treated with FOSRENOL during an extensive
clinical development programme(9), with a small number having been followed up
for up to six years.(10) In the US, over 76,000 patients have been prescribed
FOSRENOL since it was launched in 2005.(11)
    FOSRENOL is now available in 20 countries, including Canada, France,
Germany, Italy, UK and the US and continues to be launched in new markets
around the world.

    
    References:

    1.  Horne R et al. Adherence to phosphate binding medication: Insights
        from a survey using validated questionnaires. Presented at the
        XLIV ERA-EDTA Congress, Barcelona, Spain, 21-24 June, 2007.

    2.  Block G et al. Re-evaluation of risks associated with
        hyperphosphataemia and hyperparathyroidism in dialysis patients:
        recommendations for a change in management. Am J Kidney Dis 2000;
        35 (6): 1226-1237.

    3.  Albaaj F, Hutchison AJ. Lanthanum carbonate for the treatment of
        hyperphosphataemia in renal failure and dialysis patients. Expert
        Opin. Pharmacother 2005; 6(2): 319-328.

    4.  Global dialysis. Global dialysis: dialysis standards and statistics.
        Available at www.globaldialysis.com/stats.asp. Accessed on 18 May
        2007.

    5.  The National Institutes of Health National Institute of Diabetes and
        Digestive and Kidney Diseases. U.S. Renal Data System, USRDS 2005
        Annual Data Report: Atlas of End-Stage Renal Disease in the United
        States. Available at
        http://www.usrds.org/2005/pdf/06_morb_and_mort_05.pdf. Accessed on
        18 May 2007.

    6.  Kim J et al. Achievement of proposed NKF-K/DOQI Bone Metabolism and
        Disease Guidelines: results from the Dialysis Outcomes and Practice
        Patterns Study (DOPPS). J Am Soc Nephrol 2003; 14: 269A.

    7.  Hutchison AJ, Maes B, Vanwalleghem J et al. Long-term efficacy and
        tolerability of lanthanum carbonate: results from a 3-year study.
        Nephron Clin Pract 2006;102(2):c61-c71

    8.  Vemuri N et al. Lanthanum carbonate provides serum phosphorus control
        with a reduced tablet burden. Poster presented at ERA/EDTA, Glasgow,
        15-18 July 2006

    9.  Shire Data on File 08.2644

    10. Hutchison A et al on behalf of the SPD405-309 Lanthanum Study Group.
        Evidence for the long-term safety and tolerability of lanthanum
        carbonate. Poster presented at 38th Annual Meeting of the American
        Society of Nephrology, Philadelphia, 8-13 November 2005.

    11. Verispan 2007, Verispan Total Patient Tracker.
    

    Notes to Editors:

    Managing Hyperphosphataemia

    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 (0.8mmol/L) to 4.5 mg/dL (1.4mmol/L), the blood phosphorus levels of
many patients on dialysis exceed 6.5 mg/dL (2.1mmol/L). Such levels have been
linked to a significantly higher illness and death risk for patients who have
undergone at least one year of dialysis(i) with over 70 per cent of patients
developing hyperphosphataemia.(ii)
    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. (iii) Accumulating evidence shows that hyperphosphataemia
contributes to cardiovascular disease, which accounts for almost half of all
deaths among dialysis patients.(iv) 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.(v)
    Since dialysis and diet restrictions alone generally cannot control
phosphate levels, patients traditionally manage hyperphosphataemia by taking
phosphate binding agents with every meal and snack. Such binders "soak up"
phosphate in the gastrointestinal tract, before it can be absorbed into the
blood.

    FOSRENOL(R) (lanthanum carbonate)

    FOSRENOL(R) works by binding to dietary phosphate in the GI tract; once
bound, the lanthanum/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 worldwide clinical research
programme for FOSRENOL involving over 5000 patients(vi), with a small number
followed for up to 6 years.(vii) This programme has demonstrated that FOSRENOL
is an effective phosphate binder with a good tolerability profile for
long-term use. FOSRENOL was approved by the FDA in October 2004. In March 2005
regulatory authorities in the EU granted marketing authorisation for FOSRENOL
in sixteen member states, thus completing the first step in securing marketing
approval throughout Europe. Later, the European process was completed
resulting in recommendation for approval in the remaining 11 member states.
FOSRENOL is now available in 20 countries, including Canada, France, Germany,
UK and the US and continues to be launched in new markets around the world.
The company has out-licensed the rights to develop, market and sell FOSRENOL
in Japan to Bayer Yakuhin Ltd.
    Patients with renal insufficiency may develop hypocalcaemia. Serum
calcium levels should therefore be monitored at regular time intervals for
this patient population and appropriate supplements given.
    No data are available in patients with severe hepatic impairment. Caution
should, therefore, be exercised in these patients, as elimination of absorbed
lanthanum may be reduced.
    FOSRENOL should not be used during pregnancy.
    Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or
bowel obstruction were not included in clinical studies with Fosrenol.
    The most commonly reported Adverse Drug Reactions (ADRs) (greater than
1/100, 1/10) are gastrointestinal reactions such as abdominal pain,
constipation, diarrhoea, dyspepsia, flatulence, nausea and vomiting. These are
minimised by taking FOSRENOL with food and generally abated with time with
continued dosing. Hypocalcaemia was the only other commonly reported adverse
reaction.

    Shire Plc

    Shire's strategic goal is to become the leading specialty
biopharmaceutical company that focuses on meeting the needs of the specialist
physician. Shire focuses its business on attention deficit and hyperactivity
disorder (ADHD), human genetic therapies (HGT), gastrointestinal (GI) and
renal diseases. The structure is sufficiently flexible to allow Shire to
target new therapeutic areas to the extent opportunities arise through
acquisitions. Shire believes that a carefully selected portfolio of products
with a strategically aligned and relatively small-scale sales force will
deliver strong results.
    Shire's focused strategy is to develop and market products for specialty
physicians. Shire's in-licensing, merger and acquisition efforts are focused
on products in niche markets with strong intellectual property protection
either in the US or Europe.
    For further information on Shire, please visit the Company's website:
    www.shire.com.

    "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 materialise, 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 commercialisation; the impact of competitive
products, including, but not limited to the impact of those on Shire's
Attention Deficit and 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 date of SPD503 (guanfacine extended release)
(ADHD); Shire's ability to secure new products for commercialisation and/or
development; Shire's ability to benefit from its acquisition of New River
Pharmaceuticals Inc.; the successful development of JUVISTA and other risks
and uncertainties detailed from time to time in Shire plc's filings with the
Securities and Exchange Commission, particularly Shire plc's Annual Report on
Form 10-K for the year ended December 31, 2006.

    
    i.   Block GA et al. Association of serum phosphorus and calcium x
         phosphate product with mortality risk in chronic hemodialysis
         patients: A national study. Am J Kidney Dis 1998; 31: 607-617

    ii.  Kim J et al. Achievement of proposed NKF-K/DOQI Bone Metabolism and
         Disease Guidelines: results from the Dialysis Outcomes and Practice
         Patterns Study (DOPPS). J Am Soc Nephrol 2003; 14: 269A

    iii. Norris KC. Toward a new treatment paradigm for hyperphosphataemia in
         chronic renal disease. Dial Transplant 1998; 27 (12): 767-773

    iv.  Block G, Port FK. Re-evaluation of risks associated with
         hyperphosphataemia and hyperparathyroidism in dialysis patients:
         recommendations for a change in management. Am J Kidney Dis 2000;
         35 (6): 1226-1237

    v.   Foley R et al. Clinical epidemiology of cardiovascular disease in
         chronic renal disease. Am J Kidney Dis 1998; 32 (5) Suppl 3:112-119

    vi.  Shire Data on File 08.2644

    vii. Hutchison A et al on behalf of the SPD405-309 Lanthanum Study Group.
         Evidence for the long-term safety and tolerability of lanthanum
         carbonate. Poster presented at 38th Annual Meeting of the American
         Society of Nephrology, Philadelphia, 8-13 November 2005
    





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