SHIRE PLC - Shire Submits European MAA for velaglucerase alfa

Nov 24, 2009 (PR Newswire Europe via COMTEX) --
SHPGY | Quote | Chart | News | PowerRating -- e>Shire Submits European Marketing Authorization Application (MAA) for
velaglucerase alfa for the Treatment of Type 1 Gaucher Disease

Committee for Medicinal Products for Human Use (CHMP) Grants Accelerated
Assessment

Dublin, Ireland - 24 November 2009 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the
global specialty biopharmaceutical company, today announced that it has
submitted a MAA to the European Medicines Agency for velaglucerase alfa, the
company's enzyme replacement therapy in development for the treatment of Type 1
Gaucher disease. This is the third marketing application for velaglucerase alfa
that has been submitted, with previous submissions in the United States and
Canada.

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

"Gaucher disease is a debilitating condition and the continuing imiglucerase
supply shortage has had a significant impact on patients who have lacked an
alternative supply of enzyme therapy," said Timothy Cox, M.D., Professor of
Medicine at the University of Cambridge and the founder of the National Centre
for the Treatment of Gaucher disease at Addenbrooke's Hospital. "Shire's
partnership with health regulators and physicians to devise and implement
expanded access programs for velaglucerase alfa is greatly appreciated by
treating physicians and the Gaucher community at large. We welcome the news of
the submission of the velaglucerase alfa MAA in Europe."

In Europe and other countries outside the U.S. patients continue to receive
velaglucerase alfa through pre-approval access programs that were developed in
partnership with national and regional authorities and designed specifically to
address the continuing supply shortage. In the U.S., patients continue to be
enrolled in an FDA-approved treatment protocol that has been open since
September 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 LSD. 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 early neurological
symptoms. Type 1 Gaucher disease is characterized by variability in signs,
symptoms, severity, and progression.

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 in
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.

2

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Press Release

www.shire.com



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