Shire Receives 2010 Prix Galien UK Award for FIRAZYR(R) (icatibant)

By Shire Plc, PRNE
Sunday, October 17, 2010

Not for Distribution to US Media

DUBLIN, October 18, 2010 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, today announced that it has been awarded the Prix
Galien UK Orphan Drug Medal for FIRAZYR (icatibant), a treatment for acute
attacks of hereditary angioedema (HAE). The award was presented at a ceremony
on October 13, 2010, at the House of Lords in London, England.

The Prix Galien is the highest distinction in the UK for pharmaceutical
research and development and recognizes the technical, scientific and
clinical research skills necessary to develop innovative medicines.

FIRAZYR was launched in the UK in 2008 and represented the first new
class of treatment for acute attacks of HAE in three decades. It is the first
subcutaneous treatment for HAE, providing genuine innovation in the approach
to the treatment of this under-recognized rare condition.

"It's an honour to be recognized by such an esteemed organization for our
efforts to drive innovation in the challenging arena of orphan diseases,"
said Sylvie Grégoire, President of Shire Human Genetic Therapies. "This award
is also a tribute to the FIRAZYR team who remain dedicated to helping a
small, but very deserving, patient community gain access to an important new
treatment option for this debilitating and sometimes fatal condition."

Four companies were short-listed in this year's award category for orphan
drugs, including Shire. In line with this year's entry criteria, each of the
short-listed products were launched or granted a new indication in the UK
between 1 January 2008 and 31 March 2010.

About the Prix Galien

The Prix Galien is an internationally recognised award within the
pharmaceutical industry, which recognizes outstanding achievement in original
research and development. The awards take place every two years, and remain
the only awards ceremony of its type, judged by an esteemed panel of the
industry's own customers. The UK judging panel comprises some of the most
influential voices from within UK's National Health Services including
Professor Sir Michael Rawlins, Chairman, National Institute for Clinical
Excellence. The Orphan Drug Award is given to a pharmaceutical product that
has already been granted a licence and is a genuine advance in therapy for a
rare disease. For more information, visit

About Firazyr (icatibant)

FIRAZYR is the first subcutaneous injection for the symptomatic treatment
of acute attacks of hereditary angioedema (HAE) in adults (with a
C1-esterase-inhibitor deficiency). FIRAZYR was approved in the European Union
on July 15, 2008 for EU member states and is now approved in 36 countries
around the world. The active substance, icatibant, is a specific bradykinin
B2 receptor antagonist. It represents a novel and targeted approach to the
treatment of HAE attacks by blocking effects of bradykinin, the key mediator
of oedema formation. Icatibant provides rapid* symptom improvement and
shortens the duration of an attack.(1) Icatibant is a synthetic decapeptide
(a peptide containing ten amino acids). The drug is supplied in a pre-filled
3 ml syringe and should be administered subcutaneously by a healthcare
professional. Icatibant can be stored at up to 25 degrees Celsius without

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

[* Median time to first symptom improvement reported by the
patient was 48 minutes in FAST 1 (P<0.001) and FAST 2 (P<0.001);(1) Median
time to end of attack was 8.5 hours in FAST 1 (P=0.08) and 10.0 hours in FAST
2 (P<0.001)]

About Hereditary Angioedema (HAE)
is a rare genetic disease characterised by recurrent sudden attacks of
oedema (swelling) of the skin (hands, arms, feet, legs, thighs, face,
genitals) or the mucous membranes (gastrointestinal tract, larynx or voice
box). HAE is estimated to effect between 1 in 10,000 and 1 in 50,000 people.
The swelling can be disfiguring and painful, especially in case of abdominal
attacks. Laryngeal attacks are potentially life-threatening due to the risk
of suffocation. Unlike angioedemas caused by allergic reactions, signs and
symptoms such as hives and itching do not occur in HAE. Patients often first
notice redness or tingling over the area of skin that will be affected by
swelling, before the HAE attack. HAE is caused by an inherited deficiency in
a protein called C1-esterase inhibitor (C1-INH).

Normally, C1-INH is involved in the regulation of the so called
complement system which helps the body to fight off infections. C1-INH also
controls the activity of enzymes of the fibrinolytic, clotting and kinin
pathways. C1-INH deficiency results in an increased release of a peptide
called bradykinin, which is the key mediator of symptoms in HAE. Bradykinin
is a naturally occurring peptide in the blood and an increase in its levels
within the blood causes a widening of spaces within the cell walls of blood
vessels, and swelling/ oedema occurs. Blocking the B2 receptors of the
bradykinin interrupts its action and stops the progression of further
swelling/ oedema so the HAE attack subsides.

Notes to editors


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 (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)
diseases 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:

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 Pharmaceutical and Human Genetic Therapies products,
as well as the ability to secure and integrate 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


(1) Cicardi M, Banerji A et al. Icatibant, a New Bradykinin-Receptor
Antagonist, in Hereditary Angioedema. N Engl J Med 2010;363:532-41

For further information please contact:

    Media          Jessica Mann (Rest of the World)     +44-1256-894-280
                   Jessica Cotrone (North America, HGT) +1-781-482-9538

Media, Jessica Mann (Rest of the World), +44-1256-894-280, Jessica Cotrone (North America, HGT) +1-781-482-9538

will not be displayed