LEXINGTON, Massachusetts, July 6 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ:
SHPGY), the global specialty biopharmaceutical company, announces that, at the
request of the FDA, in view of a potential restriction on the availability of
the current approved and marketed treatment for Gaucher Disease patients, it has
filed a treatment protocol for velaglucerase alfa, its enzyme replacement
therapy in development for the treatment of Gaucher Disease.

If approved by the FDA, the treatment protocol would allow physicians to treat
Gaucher Disease patients with velaglucerase alfa ahead of commercial
availability in the US. Under the conditions of the treatment protocol, Shire
would provide velaglucerase alfa free of charge initially, in order to provide
access to patients as quickly as possible.

Velaglucerase alfa is made with Shire's proprietary technology, in a human cell
line. The enzyme produced has the exact human amino acid sequence and carries a
human glycosylation pattern.

Shire has sufficient supply of velaglucerase alfa to meet anticipated patient

Shire is working with the FDA to file a New Drug Application (NDA) for
velaglucerase alfa as early as possible.

Shire will provide further updates when available via press releases and/or its
website (http://www.shire.com) on its progress with its discussions with the FDA
and other regulatory bodies about the development of velaglucerase alfa as an
alternative choice for Gaucher Disease patients.

Background on Gaucher Disease

Gaucher Disease is an autosomal recessive disease and the most prevalent
Lysosomal Storage Disorder (LSD), with an incidence of about 1 in 20,000 live
births. Despite the fact that Gaucher Disease consists of a phenotype, with
varying degrees of severity, it has been sub-divided in three subtypes according
to the presence or absence of neurological involvement. It is also the most
common genetic disease affecting Ashkenazi Jewish people (Eastern, Central and
Northern European ancestry), with a carrier frequency of 1 in 10 (Dr. John
Barranger and Dr. Ed Ginns 1989). This panethnic disease involves many organ
systems, such as liver, spleen, lungs, brain, metabolism and bone marrow.

Gaucher Disease results from a specific enzyme deficiency in the body, caused by
a genetic mutation received from both parents. The disease course is quite
variable, ranging from no outward symptoms to severe disability and death.
Carrier status can be detected through blood or saliva to identify potential
carriers of the Gaucher gene. Gaucher Disease can be diagnosed early through a
blood test.

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:


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.

For further information please contact:

Investor Relations Clea Rosenfeld (Rest of the World) +44-1256-894-160 Eric
Rojas (North America) +1-617-551-9715 Media Jessica Mann (Rest of the World)
+44-1256-894-280 Matthew Cabrey (North America) +1-484-595-8248 Jessica Cotrone
(North America) +1-617-613-4640

SOURCE: Shire Plc

For further information please contact: Investor Relations: Clea Rosenfeld (Rest
of the World) +44-1256-894-160p; Eric Rojas (North America) +1-617-551-9715;
Media: Jessica Mann (Rest of the World) +44-1256-894-280; Matthew Cabrey (North
America) +1-484-595-8248; Jessica Cotrone (North America) +1-617-613-4640