DUBLIN, October 18, 2010 /PRNewswire/ -- Shire plc , 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 http://www.prixgalien.co.uk

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 refrigeration.

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

[* Median time to first symptom improvement reported by the patient was 48 minutes in FAST 1 (P0.001) and FAST 2 (P0.001);(1) Median time to end of attack was 8.5 hours in FAST 1 (P=0.08) and 10.0 hours in FAST 2 (P0.001)]

About Hereditary Angioedema (HAE) 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 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 (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: 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 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 Commission.

References

(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

SOURCE: Shire plc

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