18th May 2006 12:34
Shire brings legal suit against Corepharma LLCBasingstoke, UK and Philadelphia, US - May 18, 2006 - Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) announces that its subsidiary Shire Laboratories Inc.has filed a lawsuit in the U.S. District Court for the District of New Jerseyagainst Corepharma LLC ("Corepharma") for infringement of Shire Laboratories'U.S. Patent Nos. 5,326,570 ("`570 Patent") and 5,912,013 ("'013 Patent").The lawsuit results from an Abbreviated New Drug Application ("ANDA") filed byCorepharma for generic versions of Shire's 100 mg, 200 mg, and 300 mg CARBATROL⨠products, as to which Corepharma provided notice to Shire that it is seekingFDA approval to market its generic products prior to the expiration of the `570and `013 Patents. Pursuant to Hatch-Waxman legislation, the lawsuit triggers astay of FDA approval of up to 30 months from Corepharma's notice to allow thecourt to resolve the suit. -ends- For further information please contact:Investor Relations Clĩa Rosenfeld (Rest of the World) +44 1256 894 160 Brian Piper (North America) +1 484 595 8252 Media Jessica Mann (Rest of the World) +44 1256 894 280 Matthew Cabrey (North America) +1 484 595 8248 Notes to editorsSHIRE PLCShire's strategic goal is to become the leading specialty pharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on central nervous system, gastrointestinal, generalproducts and human genetic therapies. The structure is sufficiently flexible toallow Shire to target new therapeutic areas to the extent opportunities arisethrough acquisitions. Shire believes that a carefully selected portfolio ofproducts with a strategically aligned and relatively small-scale sales forcewill deliver strong results.Shire's focused strategy is to develop and market products for specialtyphysicians. Shire's in-licensing, merger and acquisition efforts are focused onproducts in niche markets with strong intellectual property protection eitherin the US or Europe.For further information on Shire, please visit the Company's website:www.shire.com."SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF1995Statements included herein that are not historical facts are forwarding-lookingstatements. Such forward-looking statements involve a number of risks anduncertainties and are subject to change at any time. In the event such risks oruncertainties materialize, Shire plc's results could be materially affected.The risks and uncertainties include, but are not limited to: risks associatedwith the inherent uncertainty of pharmaceutical research, product development,manufacturing and commercialization; the impact of competitive products,including, but not limited to, the impact of those on Shire plc's AttentionDeficit and Hyperactivity Disorder ("ADHD") franchise; patents, including butnot limited to, legal challenges relating to Shire plc's ADHD franchise;government regulation and approval, including but not limited to the expectedproduct approval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476)(ulcerative colitis), ELAPRASE TM (I2S) (Hunter syndrome) and NRP104 (ADHD),including its scheduling classification by the Drug Enforcement Administrationin the United States; Shire plc's ability to benefit from the acquisition ofTranskaryotic Therapies Inc.; Shire plc's ability to secure new products forcommercialization and/or development; and other risks and uncertaintiesdetailed from time to time in Shire plc's and its predecessor registrant ShirePharmaceuticals Group plc's filings with the US Securities and ExchangeCommission, including Shire plc's Annual Report on Form 10-K for the year endedDecember 31, 2005.Hampshire International Business Park Chineham Basingstoke Hampshire RG24 8EP United Kingdom Tel +44 (0)1256 894000 Fax +44 (0)1256 894708 www.shire.com Press Release ENDSHIRE PLCRelated Shares:
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