Shire Completes FOSRENOL(R) Roll-Out in Major European Markets With Launch in Spain


    Non-Calcium Phosphate Binder for the Management of Hyperphosphataemia
    Now Available in 24 Countries

    BASINGSTOKE, England, Jan. 17 /CNW/ - Shire plc (LSE: SHP, NASDAQ:   SHPGY,
TSX: SHQ) announces that with the launch today in Spain of FOSRENOL (lanthanum
carbonate), a non-calcium phosphate binder, Shire is celebrating the
completion of the launch roll-out in the major European markets. FOSRENOL is
the first of the company's medicines developed in-house from research molecule
to market.
    FOSRENOL is an effective monotherapy treatment for the management of
hyperphosphataemia(1) (excess phosphate, which the body cannot excrete(2)) in
patients with End Stage Renal Disease (ESRD). Hyperphosphataemia is a problem
which affects more than 70% of the 1.5 million people worldwide who require
kidney dialysis.(3)(4)
    Chronic Kidney Disease (CKD) is a progressive condition classified in
five stages culminating in Stage 5 (or ESRD), a condition typified by a
complete loss of kidney function, usually requiring the patient to undergo
dialysis or kidney transplantation.
    CKD is recognized as a growing 'silent epidemic' affecting up to 1 in 10
people(5), due in part to rising obesity rates and an increasing number of
people with diabetes.(6) CKD can cause numerous serious health consequences
for patients, including hyperphosphataemia.
    Effective phosphate control is critical for these patients because, if
not managed successfully, hyperphosphataemia can lead to significant health
problems. These include CKD-related mineral and bone disorder, resulting in
painful, brittle bones that may fracture or become deformed and cardiovascular
disease, which accounts for almost half of all deaths in dialysis patients.
    "As CKD progresses, its management becomes increasingly challenging for
patients as dietary restrictions and fluid limitations become paramount," said
David Milton, Senior Vice President, Shire Renal Business Unit. "By the time
they reach CKD stage 5, patients are not only likely to be on dialysis, but
are often taking as many as 10 to 12 different medications(9), which can
amount to 25 tablets a day or more, for the different complications of CKD
including hyperphosphataemia.
    "Shire is proud to have developed FOSRENOL from research molecule to the
healthcare market as an effective non-calcium monotherapy treatment option for
ESRD patients with hyperphosphataemia. FOSRENOL is provided as a simple one
tablet per meal dose for the majority of patients," added Milton.
    "Shire participated with the other phosphate binder manufacturers at a
recent Shire requested US Food and Drug Administration Cardiovascular and
Renal Drugs Division Advisory Committee. The majority of the members on the
Advisory Committee voted to recommend the use of phosphate binders to treat
hyperphosphataemia in CKD Stage 4 patients. As a result Shire is working to
identify the regulatory pathway forward for the use of FOSRENOL in this group
of patients," he added.
    To date, over 5,200 patients have been treated with FOSRENOL during an
extensive clinical development program.(10) Globally over 100,000 patients
have been prescribed FOSRENOL since it was launched in 2005.(10) FOSRENOL has
an extensive long-term safety data package extending out to six years.
    Following its launch in Spain, FOSRENOL is now available in 24 countries

    Notes to editors:

    About Hyperphosphataemia

    Phosphate, which is found in nearly all foods, is absorbed from the
gastrointestinal (GI) tract into the blood stream. When the kidneys fail, they
no longer effectively filter out phosphate, even with the help of
blood-cleansing dialysis. While the normal adult range for phosphate is
0.8mmol/L (2.5 mg/dL) to 1.4mmol/L (4.5 mg/dL), the blood phosphorus levels of
many patients on dialysis can exceed 2.1mmol/L (6.5 mg/dL ). Such levels have
been linked to a significantly higher complications and death risk for
patients who have undergone at least one year of dialysis(11) with over 70 per
cent of these patients developing hyperphosphataemia.(3)
    Chronic Kidney Disease disrupts the delicate interplay between the body's
levels of calcium, parathyroid hormone (PTH) and vitamin D, leading to
hyperphosphataemia. Over time, hyperphosphataemia can ultimately lead to
calcification in the heart, lung and some arteries.(12) Accumulating evidence
shows that hyperphosphataemia contributes to cardiovascular disease, which
accounts for almost half of all deaths among dialysis patients.(13) 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
    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

    About FOSRENOL(R) (lanthanum carbonate)

    FOSRENOL is indicated to reduce serum phosphate in adult patients with
    FOSRENOL 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
    FOSRENOL is available in a broad range of dosage strengths including 
500-milligram (mg), 750-mg, and 1000-mg tablets.(1) Patients taking FOSRENOL
can achieve serum phosphate target levels with as little as one tablet per
    FOSRENOL was approved by the FDA in October 2004. In March 2005
regulatory authorities in the EU granted marketing authorization 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 eleven member
states. FOSRENOL is now available in 24 countries, including Italy, 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) are
gastrointestinal reactions such as abdominal pain, constipation, diarrhoea,
dyspepsia, flatulence, nausea and vomiting. These are minimized by taking
FOSRENOL with food and generally abate with time with continued dosing.
Hypocalcaemia was the only other commonly reported adverse reaction.
    Full prescribing information is available on request.


    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'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. Shire believes that a carefully selected portfolio
of products with strategically aligned and relatively small-scale sales forces
will deliver strong results.

    For further information on Shire, please visit the Company's website:

    Shire is a proud partner of World Kidney Day (WKD); Thursday 13th March
2008. For further information on WKD visit

    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 including, but not limited to, the successful development of
JUVISTA(R) (Human TGFbeta3) and GA-GCB (velaglucerase alfa); manufacturing and
commercialization including, but not limited to, the launch and establishment
in the market of VYVANSE(TM)(lisdexamfetamine dimesylate) (Attention Deficit
and Hyperactivity Disorder ("ADHD")); the impact of competitive products
including, but not limited to, the impact of those on Shire's 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 INTUNIV(TM) (guanfacine extended
release) (ADHD); Shire's ability to secure new products for commercialization
and/or development; 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.



    (2)  Venes D and CL Thomas (eds). Taber's Cyclopedic Medical Dictionary.
         20th ed. Philadelphia, Pa: FA Davis Company. 2001; 1037, 1173, 1543.
         Available at (15 January 2008)

    (3)  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

    (4)  Global dialysis. Global dialysis: dialysis standards and statistics.
         Available at (18 May 2007)

    (5)  World Kidney Day, available at
         (15 Jan 2008)

    (6)  Pezarella MA. Chronic Kidney Disease: The Silent Epidemic. Hospital
         Medicine 2003

    (7)  National Kidney Foundation (NKF). K/DOQI clinical practice
         guidelines for bone metabolism and disease in chronic kidney
         disease. Am J Kidney Disease 2004; 42: 24-45, 55-63, 69-71

    (8)  Vanholder R, et al. (2005) Chronic kidney disease as cause of
         cardiovascular morbidity and mortality. Dial Transplant; 20: 1048-

    (9)  Manley et al. Nephrol Dial Transplant. 2004; 19: 1842 - 1848

    (10) Data on file, Shire Pharmaceuticals Group Limited

    (11) 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

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

    (13) 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

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

For further information:

For further information: Ann Blumenstock, Resolute, Phone:
+44-207-357-8187, Cell: +44-7788-543-537, Email :; Con Franklin, Phone :
+44-207-015-1354, Cell: +44-7974-434-151, Email :

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