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Shire plc (SHP)

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Wednesday 25 May, 2011

Shire plc

Shire Receives VYVANSE(R) Paragraph IV Notice L...

Shire Receives VYVANSE® Paragraph IV Notice Letters

Dublin, Ireland - 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, 2012.

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.

For further information please contact:

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

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:


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.

Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PX

Press Release