Press Release

DUBLIN, November 24 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialtybiopharmaceutical company, today announced that it has submitted a MAA to theEuropean Medicines Agency for velaglucerase alfa, the company's enzymereplacement therapy in development for the treatment of Type 1 Gaucherdisease. This is the third marketing application for velaglucerase alfa thathas been submitted, with previous submissions in the United States andCanada.

Based on a global supply shortage of the currently approved and marketedtreatment for patients with Gaucher disease, and positive results from allthree velaglucerase alfa Phase III trials, CHMP has accepted the company'srequest for an accelerated assessment of the velaglucerase alfa MAA. The MAAreview is expected to begin in the December cycle. Under acceleratedassessment, the review timeline of the MAA is shortened from 210 days to 150days.

"Gaucher disease is a debilitating condition and the continuingimiglucerase supply shortage has had a significant impact on patients whohave lacked an alternative supply of enzyme therapy," said Timothy Cox, M.D.,Professor of Medicine at the University of Cambridge and the founder of theNational Centre for the Treatment of Gaucher disease at Addenbrooke'sHospital. "Shire's partnership with health regulators and physicians todevise and implement expanded access programs for velaglucerase alfa isgreatly appreciated by treating physicians and the Gaucher community atlarge. We welcome the news of the submission of the velaglucerase alfa MAA inEurope."

In Europe and other countries outside the U.S. patients continue toreceive velaglucerase alfa through pre-approval access programs that weredeveloped in partnership with national and regional authorities and designedspecifically to address the continuing supply shortage. In the U.S., patientscontinue to be enrolled in an FDA-approved treatment protocol that has beenopen since September 2009.

Background on Gaucher disease

Gaucher disease is an autosomal recessive disorder caused by mutations inthe GBA gene which results in a deficiency of the lysosomal enzymebeta-glucocerebrosidase. This enzymatic deficiency causes an accumulation ofglucocerebroside, primarily in macrophages. In this lysosomal storagedisorder (LSD), clinical features are reflective of the distribution ofGaucher cells in the liver, spleen, bone marrow, skeleton, and lungs. Theaccumulation of glucocerebrosidase in the liver and spleen leads toorganomegaly. Bone involvement results in skeletal abnormalities anddeformities as well as bone pain crises. Deposits in the bone marrow andsplenic sequestration lead to clinically significant anemia andthrombocytopenia.

Gaucher disease is the most prevalent LSD. Gaucher disease hasclassically been categorized into 3 clinical types. Type 1 is the mostcommon; it is distinguished from Type 2 and Type 3 by the lack of earlyneurological symptoms. Type 1 Gaucher disease is characterized by variabilityin signs, symptoms, severity, and progression.

Shire's velaglucerase alfa program included the largest and mostcomprehensive set of Phase III clinical trials conducted to date for Gaucherdisease. Over 100 patients at 24 sites in 10 countries around the world haveparticipated in the clinical studies.

Velaglucerase alfa is made using Shire's proprietary technology, in ahuman cell line. The enzyme produced has the exact human amino acid sequenceand has a human glycosylation pattern.

Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leading specialtybiopharmaceutical company that focuses on meeting the needs of the specialistphysician. Shire focuses its business on attention deficit hyperactivitydisorder (ADHD), human genetic therapies (HGT) and gastrointestinal (GI)diseases as well as opportunities in other therapeutic areas to the extentthey arise through acquisitions. Shire's in-licensing, merger and acquisitionefforts are focused on products in specialist markets with strongintellectual property protection and global rights. Shire believes that acarefully selected and balanced portfolio of products with strategicallyaligned 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 REFORMACT OF 1995

Statements included herein that are not historical facts areforward-looking statements. Such forward-looking statements involve a numberof risks and uncertainties and are subject to change at any time. In theevent such risks or uncertainties materialize, the Company's results could bematerially adversely affected. The risks and uncertainties include, but arenot limited to, risks associated with: the inherent uncertainty of research,development, approval, reimbursement, manufacturing and commercialization ofthe Company's Specialty Pharmaceutical and Human Genetic Therapies products,as well as the ability to secure and integrate new products forcommercialization and/or development; government regulation of the Company'sproducts; the Company's ability to manufacture its products in sufficientquantities to meet demand; the impact of competitive therapies on theCompany's products; the Company's ability to register, maintain and enforcepatents and other intellectual property rights relating to its products; theCompany's ability to obtain and maintain government and other third-partyreimbursement for its products; and other risks and uncertainties detailedfrom time to time in the Company's filings with the Securities and ExchangeCommission.

For further information please contact:

  InvestorCléa Rosenfeld (Rest of the World)+44-1256-894-160 RelationsEric Rojas (North America)  +1-617-551-9715 MediaJessica Mann (Rest of the World)  +44-1256-894-280Jessica Cotrone (North America, HGT) +1-617-613-4640