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INTUNIV(TM) - Shire Files Suit Against Actavis Elizabeth LLC and Actavis Inc.

DUBLIN and PHILADELPHIA, May 13, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces that its subsidiary Shire LLC has filed a lawsuit in the U.S. District Court for the District of Delaware against Actavis Elizabeth LLC and Actavis Inc. (collectively "Actavis") for the infringement of U.S. Patent Nos. 5,854,290 (the '290 patent), 6,287,599 (the '599 patent), and 6,811,794 (the '794 patent).

The lawsuit results from an Abbreviated New Drug Application (ANDA) filed by Actavis for generic versions of 1 mg, 2 mg, 3 mg and 4 mg guanfacine hydrochloride extended release tablets, INTUNIV(TM), which seeks to market such generic products before the expiration of the '290, '599, and '794 patents. The regulatory exclusivity period for INTUNIV(TM) runs through September 2, 2012.

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 affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of pharmaceutical research, product development, manufacturing and commercialization including, but not limited to, the establishment in the market of VYVANSE(TM) (lisdexamfetamine dimesylate) (Attention Deficit Hyperactivity Disorder ("ADHD")); the impact of competitive products, including, but not limited to, the impact of those on the Company's ADHD franchise; patents, including but not limited to, legal challenges relating to the Company's ADHD franchise; government regulation and approval, including but not limited to the expected product approval date of INTUNIV(TM) (guanfacine extended release) (ADHD); the Company's ability to secure new products for commercialization and/or development; the Company's proposed offer for Jerini AG, including but not limited to, the Company's ability to successfully complete the offer and integrate Jerini AG, as well as realize the anticipated benefits of the acquisition; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission, including the Company's Annual Report on Form 10-K for the year ended December 31, 2007.

    For further information please contact:

    Investor Relations: Clea Rosenfeld (Rest of the World) +44-1256-894-160
                        Eric Rojas (North America)         +1-781-482-0999
    Media:              Jessica Mann (Rest of the World)   +44-1256-894-280
                        Matthew Cabrey (North America)     +1-484-595-8248

SOURCE Shire plc
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