District Court Upholds FDA's Grant of 5-Year Market Exclusivity to VYVANSE(R)

By Shire Plc, PRNE
Wednesday, March 3, 2010

PHILADELPHIA, March 4, 2010 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that the United States District Court
for the District of Columbia ("Court"), following extensive briefing by the
parties and an oral hearing, has upheld the decision of the U.S. Food and
Drug Administration ("FDA") to grant 5-year New Chemical Entity ("NCE")
exclusivity to lisdexamfetamine dimesylate-currently marketed by Shire U.S.
Inc. for the treatment of attention-deficit hyperactivity disorder under the
name VYVANSE(R).

On February 23, 2007, after reviewing the requisite clinical studies
submitted on behalf of VYVANSE, the FDA determined that VYVANSE qualified as
an NCE within the meaning of the governing statutes and regulations. As an
NCE, VYVANSE is entitled to 5-year market exclusivity. The FDA therefore
appropriately refused to file the Abbreviated New Drug Application ("ANDA")
submitted by Actavis Elizabeth, LLC for generic lisdexamfetamine dimesylate.
On February 24, 2009, Actavis sued the FDA in the District Court of the
District of Columbia challenging the NCE decision. On April 13, 2009, the FDA
opened a public docket to consider Actavis's challenge to the FDA's
regulations governing NCE exclusivity and the corresponding award of
exclusivity to VYVANSE. On October 23, 2009, following a thorough
administrative review, the agency affirmed lisdexamfetamine, the active
ingredient in VYVANSE, is a new active moiety and that its prior designation
of VYVANSE as an NCE was proper.

Shire is pleased that on March 4, 2010, following the extensive briefing
of the parties and an oral hearing, the Court upheld the FDA's decision (and
reaffirmation) that VYVANSE is entitled to 5-year market exclusivity. The
Court correctly determined that FDA's actions complied with federal
administrative law standards as a reasonable exercise of the agency's
scientific expertise. The five-year exclusivity period for VYVANSE expires on
February 23, 2012, and precludes generic manufacturers from submitting an
ANDA to FDA until that time, or until February 23, 2011 should a generic
applicant challenge the United States patents covering Vyvanse, which remain
in effect until June 29, 2023.

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:

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

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; Matthew Cabrey (North America, Specialty Pharma) +1-484-595-8248.

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