SHIRE PLC - FDA Grants Priority Review for Shire's velaglucerase

FDA Grants Priority Review for Shire's velaglucerase alfa for Type 1 Gaucher
Disease

FDA issued action date of February 28, 2010 under the Prescription Drug User
Free Act (PDUFA)


Cambridge, MA - November 4, 2009 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the
global specialty biopharmaceutical company, today announced that the United
States Food and Drug Administration (FDA) has granted Priority Review for the
New Drug Application (NDA) for velaglucerase alfa, the company's enzyme
replacement therapy in development for the treatment of Type 1 Gaucher disease.

Priority Review designation is given to drugs that offer major advances in
treatment, or provide a treatment where no adequate therapy exists, and
accelerates the target review timing from ten to six months. The FDA has issued
an action date for the NDA of February 28, 2010 under the Prescription Drug
User Fee Act (PDUFA).

In the U.S., patients continue to be enrolled in an FDA-approved treatment
protocol, under which Gaucher patients receive velaglucerase alfa prior to
commercialization. Shire has also engaged with national and regional
authorities outside the U.S. and patients are receiving velaglucerase alfa
through pre-approval access programs. Shire confirms it is on track with its
filing of the Marketing Authorization Application (MAA) in the EU for 2009.

Background on Gaucher disease
Gaucher disease is an autosomal recessive disorder caused by mutations in the
GBA gene which results in a deficiency of the lysosomal enzyme
beta-glucocerebrosidase. This enzymatic deficiency causes an accumulation of
glucocerebroside, primarily in macrophages. In this lysosomal storage disorder
(LSD), clinical features are reflective of the distribution of Gaucher cells in
the liver, spleen, bone marrow, skeleton, and lungs. The accumulation of
glucocerebrosidase in the liver and spleen leads to organomegaly. Bone
involvement results in skeletal abnormalities and deformities as well as bone
pain crises. Deposits in the bone marrow and splenic sequestration lead to
clinically significant anemia and thrombocytopenia.

Gaucher disease is the most prevalent lysosomal storage disorder, with an
incidence of about 1 in 20,000 live births. Gaucher disease has classically
been categorized into 3 clinical types. Type 1 is the most common; it is
distinguished from Type 2 and Type 3 by the lack of central nervous system
involvement. Type 1 Gaucher disease is characterized by variability in signs,
symptoms, severity, and progression.

Velaglucerase alfa supplements or replaces beta-glucocerebrosidase, the enzyme
that catalyzes the hydrolysis of glucocerebroside, reducing the amount of
accumulated glucocerebroside and correcting the pathophysiology of Gaucher
disease.

Shire's velaglucerase alfa program included the largest and most comprehensive
set of Phase III clinical trials conducted to date for Gaucher disease. Over
100 patients at 24 sites in 10 countries around the world have participated the
clinical studies. Velaglucerase alfa is made using Shire's proprietary
technology, in a human cell line. The enzyme produced has the exact human amino
acid sequence and has a human glycosylation pattern.


For further information please contact:

Investor          Clea Rosenfeld (Rest of the World)         +44 1256 894 160
Relations

                  Eric Rojas (North America)                 +1 617 551 9715

Media             Jessica Mann (Rest of the World)           +44 1256 894 280

                  Jessica Cotrone (North America, HGT)       +1 617 613 4640

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:
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.



Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX


Press Release

www.shire.com



END

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