Shire Receives VYVANSE(R) Paragraph IV Notice Letter

By Shire Plc, PRNE
Wednesday, May 18, 2011

DUBLIN, May 19, 2011 - Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that its subsidiary Shire LLC has
received a Paragraph IV Notice Letter from Sandoz Inc. ("Sandoz") advising of
the filing of an Abbreviated New Drug Application ("ANDA") for a generic
version of all strengths of lisdexamfetamine dimesylate capsules, VYVANSE.
This is the first Paragraph IV Notice Letter directed to VYVANSE received by
the company.

VYVANSE is protected by sixteen FDA Orange Book listed patents, all of
which expire in 2023.

Shire is currently reviewing the details of Sandoz's Paragraph IV Notice
Letter, which was directed to all of the patents listed in the Orange Book.

Under the Hatch-Waxman Act, Shire has 45 days from the receipt of the
Notice Letter to determine if it will file a patent infringement suit. If
Shire brings suit pursuant to the Hatch-Waxman regulations, a 30-month stay
of approval will be imposed by the FDA on Sandoz's ANDA.

The Hatch-Waxman exclusivity period for VYVANSE runs until February 23,

For further information please contact:

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

    Investor       Eric Rojas (            +1-781-482-0999
    Relations      Sarah Elton-Farr (  +44-1256-894157

    Media          Jessica Mann (           +44-1256-894-280
                   Matthew Cabrey (       +1-484-595-8248


New Products / Services News

Shire Plc News

will not be displayed