More Choice for CKD Patients in Europe as FOSRENOL® is Approved in a New Oral Powder Formulation

Nyon, Switzerland (ots/PRNewswire) -

Shire plc , the global specialty biopharmaceutical company, today
announced it has received approval through the European Decentralised
Procedure for an oral powder formulation of FOSRENOL (lanthanum
carbonate).

FOSRENOL is a non-calcium, non-resin phosphate binder indicated
as a phosphate binding agent for use in the control of
hyperphosphataemia in chronic renal failure patients on haemodialysis
or continuous ambulatory peritoneal dialysis (CAPD). FOSRENOL is also
indicated in adult patients with chronic kidney disease not on
dialysis with serum phosphate levels greater than or equal to1.78
mmol/L in whom a low phosphate diet alone is insufficient to control
serum phosphate levels.

The oral powder formulation was developed by Shire to give
patients more choice in how they take their phosphate binder.

The approval of FOSRENOL oral powder was granted by the Swedish
Medical Products Agency acting as reference member state. Submissions
for national marketing authorisations of FOSRENOL in oral powder form
have been made to Sweden and the other 27 European markets, with the
first national approvals anticipated in Q2 2012.

"Shire is delighted to receive European approval for the oral
powder formulation of FOSRENOL," said Angus Hogg, Product General
Manager at Shire. "Shire has developed this new formulation so that
patients have an additional choice and that patients who may find it
easier to take their treatment in powder form are able to do so. We
believe the new oral powder formulation of FOSRENOL demonstrates our
commitment to enabling people with life-altering conditions to lead
better lives."

The challenge of uncontrolled phosphate in CKD patients

Although poor serum phosphate control is associated with negative
outcomes, reducing phosphate levels continues to be a significant
challenge for clinicians. According to the Dialysis Outcomes and
Practice Patterns Study (DOPPS), a prospective, longitudinal,
observational study of haemodialysis patients in twelve countries,
approximately 50-70% of CKD patients on dialysis have phosphate
levels above the normal range*. This is despite the use of diet,
dialysis and phosphate binders.[1,2]

"Even with dietary intervention and dialysis, reducing phosphate
in patients with chronic kidney disease is an ongoing struggle," said
Professor Mario Cozzolino, Assistant Professor of Nephrology at the
Department of Medicine, Surgery, and Dentistry, at the University of
Milan, Italy. "Nephrologists need to ensure they have an efficacious
binder like FOSRENOL that can remove excess phosphate, however
binders will only work if a patient takes them as prescribed.
FOSRENOLoral powder provides an important additional option that
gives patients more choice in how they take their binder."

Another challenge for patients with CKD is they are often
prescribed multiple medications (on average between 9-12 different
medications) and therefore need to take a large number of pills each
day.[3,4] In one study, patients on dialysis took a median of 19
tablets every day, whilst for a quarter of those studied, the number
of tablets exceeded 25 per day.[3]

"We see quite high levels of non-adherence in CKD patients on
phosphate binders[5], partly because of the high pill burden," said
Professor Rob Horne, an expert on adherence at the UCL School of
Pharmacy, London, UK. "To help patients get the best from medicines,
healthcare practitioners need to tailor their support to address the
perceptual and practical barriers that reduce patients' motivation
and their ability to start and continue with treatment."

"This involves communicating why the medicine is necessary and
addressing concerns about potential adverse effects. It also involves
making the regimen as convenient and easy to take as possible. Having
a range of formulations can help with this process by offering
practical alternatives if the pill burden is an issue."

The efficacy and safety of FOSRENOL in adults has been
investigated in clinical studies that included over 6,000 subjects.
The estimated total patient exposure to FOSRENOL from launch to 31
December 2010 is estimated to be in excess of 225,200 patient
years.[6]

ABOUT FOSRENOL(R) (lanthanum carbonate)

FOSRENOL is indicated as a phosphate binding agent for use in the
control of hyperphosphataemia in chronic renal failure patients on
haemodialysis or continuous ambulatory peritoneal dialysis (CAPD).
Fosrenol is also indicated in adult patients with chronic kidney
disease not on dialysis with serum phosphate levels greater than or
equal to1.78 mmol/L in whom a low phosphate diet alone is
insufficient to control serum phosphate levels. [7]

FOSRENOL is not available in all countries and prescribing
information may differ between countries. Please consult your local
prescribing information.

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.[7] As a consequence, overall phosphate absorption from the diet
is decreased significantly.

FOSRENOL is available in a broad range of dosage strengths
including 500mg, 750mg, and 1000mg[7] which facilitates an effective
dosing regimen of one tablet per meal for the majority of patients.

FOSRENOL was first approved in Sweden in March 2004, and by the
US FDA in October 2004. FOSRENOL was subsequently approved in 28 EU
markets by the European Mutual Recognition Procedure and is now
launched in 41 markets worldwide.

Important Safety Information

Please consult the Summary of Product Characteristics (SPC)
before prescribing, particularly in relation to warnings and
precautions for use and undesirable effects.

FOSRENOL is contraindicated in patients with hypersensitivity to
lanthanum carbonate hydrate or to any of the excipients, and in
patients with hypophosphataemia. Fosrenol is not recommended in
children, adolescents or pregnancy. The risk/benefit for
continuing/discontinuing either Fosrenol or breast feeding should be
carefully considered.

The use of FOSRENOL in clinical studies beyond 2 years is
currently limited. However, treatment of subjects with Fosrenol for
up to 6 years has not demonstrated a change in the benefit/risk
profile. Rising levels of lanthanum in bone have been noted in
patients treated with FOSRENOL. Paired bone biopsies have showed no
differences in the development of mineralisation defects between
patients treated with lanthanum carbonate versus calcium carbonate or
alternative therapy. FOSRENOL should be used with caution in patients
with acute peptic ulcer, ulcerative colitis, Crohn's disease, bowel
obstruction (e.g. previous abdominal surgery, peritonitis) and
hepatic impairment. Monitoring of liver function and calcium levels
is recommended. Abdominal x-rays of patients taking Fosrenol may have
a radio-opaque appearance typical of an imaging agent.

Very common reactions (greater than or equal to1/10):

Headache, abdominal pain, diarrhoea, nausea, vomiting, allergic
skin reactions (including skin rashes, urticaria and pruritus)

Common reactions (greater than or equal to1/100 to <1/10):

Hypocalcaemia, constipation, dyspepsia, flatulence

Notes to editors

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
hyperactivity disorder, human genetic therapies, gastrointestinal
diseases and regenerative medicine as well as opportunities in other
therapeutic areas to the extent they arise through acquisitions.
Shire's in-licensing, merger and acquisition efforts are focused on
products in specialist markets with strong intellectual property
protection and global rights. Shire believes that a carefully
selected and balanced 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: http://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 materialize, the
Company's results could be materially adversely affected. The risks
and uncertainties include, but are not limited to, risks associated
with: the inherent uncertainty of research, development, approval,
reimbursement, manufacturing and commercialization of the Company's
Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative
Medicine products, as well as the ability to secure new products for
commercialization and/or development; government regulation of the
Company's products; the Company's ability to manufacture its products
in sufficient quantities to meet demand; the impact of competitive
therapies on the Company's products; the Company's ability to
register, maintain and enforce patents and other intellectual
property rights relating to its products; the Company's ability to
obtain and maintain government and other third-party reimbursement
for its products; and other risks and uncertainties detailed from
time to time in the Company's filings with the Securities and
Exchange Commission.

References:

1. KDIGO. Kidney Int 2009; 76 (suppl 113): S1-130.

2. DOPPS 2010.

3. Chiu YW et al. Clin J Am Soc Nephrol 2009; 4(6): 1089-1096.

4. Manley HJ et al. Nephrol Dial Transplant 2004; 19(7):
1842-1848.

5. Riley S et al. British Journal of Renal Med 2007; 12: 19-21.

6. Shire Data on File SPD405-20, 2011.

7. Shire plc. FOSRENOL EU SmPC.
http://www.medicines.org.uk/emc/medicine/19617

For further information please contact:
Investor Relations
Eric Rojas erojas@shire.com +1-781-482-0999
Sarah Elton-Farr seltonfarr@shire.com +44-1256-894157
Media
Jessica Mann (Corporate) jmann@shire.com +44-1256-894-280
Gwen Fisher (Specialty Pharma) gfisher@shire.com +1-484-595-9836
Nicole Barraud-Estoppey (Corporate) nbarraud@shire.com +41-79-961-99-12

* As defined by the Kidney Disease: Improving Global Outcomes
(KDIGO) Clinical Guidelines

ots Originaltext: Shire Pharmaceuticals Group Plc
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