Shire Receives VYVANSE(R) Paragraph IV Notice Letters

By Shire Plc, PRNE
Tuesday, May 24, 2011

DUBLIN, May 25, 2011 -

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty
biopharmaceutical company, announces that its subsidiary Shire LLC has
received Paragraph IV Notice Letters from Amneal Pharmaceuticals, LLC.
("Amneal") and Watson Laboratories, Inc. ("Watson"), advising of the filing
of Abbreviated New Drug Applications ("ANDA") by each company for generic
version of all strengths of lisdexamfetamine dimesylate capsules, VYVANSE.
These are the second and third Paragraph IV Notice Letters directed to
VYVANSE received by Shire. The first Paragraph IV Notice Letter for Vyvanse
was received by Shire on May 18, 2011 from Sandoz.

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

Shire is currently reviewing the details of Amneal's and Watson's
Paragraph IV Notice Letters, which were directed to the patents listed in the
Orange Book.

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

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

Shire expects to receive additional Paragraph IV certifications filed
against Vyvanse on terms similar to those already received. Shire will
provide details of any further Paragraph IV certifications received, and any
litigation that is subsequently initiated, in its periodic filings on Forms
10-Q and 10-K.

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        Eric Rojas (          +1-781-482-0999
                    Sarah Elton-Farr                       +44(0)1256-894157
    Media           Jessica Mann (         +44(0)1256-894-280
                    Matthew Cabrey (     +1(0)484-595-8248


will not be displayed