Pentasa(R) - Shire Receives Ruling From FDA on Citizen's Petition

By Shire Plc, PRNE
Monday, August 23, 2010

DUBLIN and PHILADELPHIA, August 24, 2010 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that its subsidiary Shire
Pharmaceuticals Inc. received a ruling from the FDA on its Citizen's Petition
relating to Pentasa.

The ruling granted-in-part and denied-in-part the requests from Shire.
Shire had requested the FDA to issue formal guidance, consistent with the
FDA's advice to Shire, requiring that bioequivalence to Pentasa be shown by
both rigorous dissolution testing and studies with clinical endpoints. The
FDA response to the Shire's Citizen's Petition granted the request with
regard to the dissolution testing and denied the request with respect to the
studies with clinical endpoints. The FDA response further imposed a
requirement for pharmacokinetic data to establish bioequivalence.

A copy of the FDA's ruling can be found in the Investors section of the
Company's website: www.shire.com.

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    Eric Rojas (North America)               +1-781-482-0999
    Relations

    Media       Jessica Mann (Rest of the World)        +44-1256-894-280
                Matthew Cabrey                           +1-484-595-8248
                (North America, Specialty Pharma)

Investor Relations: Eric Rojas (North America), +1-781-482-0999; Media: Jessica Mann (Rest of the World), +44-1256-894-280; Matthew Cabrey (North America, Specialty Pharma), +1-484-595-8248

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