Shire Provides Update on Biologics License Application (BLA) Filing for REPLAGAL(R) (agalsidase alfa) With the U.S. Food and Drug Administration (FDA)

CAMBRIDGE, Massachusetts, February 24, 2010 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces it has received Fast Track designation
from the FDA for REPLAGAL(R) (agalsidase alfa), its enzyme replacement
therapy for Fabry disease.

Shire filed a BLA for REPLAGAL in December 2009. The FDA requested
additional human pharmacokinetic data to confirm comparability between
product that was manufactured in roller bottles, and that which is
manufactured in bioreactors. Product made by the bioreactor process is
already approved for commercial use in the European Union as well as a number
of other countries.

As a result of this request, Shire withdrew its December BLA filing, and,
at the suggestion of the FDA, requested and received Fast Track designation.
Shire will immediately initiate the rolling submission of the REPLAGAL BLA,
and will submit the requested pharmacokinetic data around mid-year.

Fast Track designation is an FDA-approved process that facilitates the
development and expedites the review of drugs to treat serious diseases and
fill an unmet medical need with the goal of getting important new treatments
to patients earlier. This process allows a company to file the sections of
the BLA as they become available instead of filing all the sections at once.
It also enables the agency to commence its review and proceed on a rolling
basis as the additional sections are completed and submitted for review.

"We will continue to work closely with the FDA in the coming months on
the rolling BLA submission for REPLAGAL, "said Sylvie Grégoire, President,
Shire Human Genetic Therapies. "We remain committed to continuing to provide
Fabry patients in the United States with REPLAGAL under the treatment
protocol."

REPLAGAL is currently approved for the treatment of Fabry disease in 45
countries and has been available to U.S. patients since December 2009 under
an FDA-approved treatment protocol filed at the request of FDA. The REPLAGAL
early access program was put in place as a result of the supply disruption of
the only currently marketed treatment for Fabry disease in the U.S.

Financial guidance for 2010 provided in Shire's year-end results press
release and earnings call on February 19, 2010 remains unchanged.

About REPLAGAL(R) (agalsidase alfa)

REPLAGAL is a human form of enzyme alpha-galactosidase A (a-Gal A)
manufactured in a human cell line by gene activation. REPLAGAL is approved in
45 countries worldwide. REPLAGAL is not currently approved for commercial
sale in the U.S.

REPLAGAL is the only human-cell-line-derived form of enzyme replacement
therapy (ERT) that is indicated for the long-term treatment of patients with
a confirmed diagnosis of Fabry disease ([alpha]-galactosidase A deficiency).

About Fabry disease

Fabry disease is a lysosomal storage disorder (LSD) that interferes with
the body's ability to break down a specific fatty substance (
globotriaosylceramide or Gb3) which accumulates within the body due to
deficiency of a specific enzyme ([alpha]-galactosidase A).

Fabry disease affects both males and females and can present with a
number of signs or symptoms of variable degree, such as cardiovascular and/or
renal dysfunction, intense or burning pain, heat intolerance, skin lesions,
gastrointestinal complaints, hearing loss, and ocular problems.

Lifespan is typically reduced in patients with Fabry disease by
approximately 20 years in men and 15 years in women, compared with the
general population.[1,2] The principal causes of death are renal failure,
cardiomyopathy and cerebrovascular events (e.g. stroke).[3]

Fabry disease affects an estimated 8,000 to 10,000 people worldwide.

References

1. MacDermot KD, Holmes A, Miners AH. Anderson-Fabry disease: clinical
manifestations and impact of disease in a cohort of 60 obligate carrier
females. J Med Genet 2001;38:769-75.

2. MacDermot KD, Holmes A, Miners AH. Natural history of Fabry disease in
affected males and obligate carrier females. J Inherit Metab Dis 2001;24
Suppl 2:13-14.

3. Mehta A, Widmer U. Natural history of Fabry disease. In: Mehta A, Beck
M, Sunder-Plassmann G, editors. Fabry disease: perspectives from 5 years of
FOS. Oxford: Oxford PharmaGenesis Ltd; 2006: p. 183-8.

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.

    For further information please contact:

    Investor Relations:
    Cléa 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.

    Jessica Cotrone (North America, HGT),
    +1-781-482-9538.

For further information please contact: Investor Relations: Cléa 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. Jessica Cotrone (North America, HGT), +1-781-482-9538.