3rd Mar 2006 12:00
Shire sues Teva Pharmaceutical Industries Ltd. and Teva Pharmaceuticals USA,Inc.Basingstoke, UK and Philadelphia, US - March 3, 2006 - Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) announces that its subsidiary Shire Laboratories Inc.has filed a lawsuit in the US District Court for the Eastern District ofPennsylvania against Teva Pharmaceutical Industries Ltd. and TevaPharmaceuticals USA, Inc. (`Teva') for infringement of Shire Laboratories' USPatent Nos. 6,322,819 (`the `819 Patent') and 6,605,300 (`the `300 Patent').The lawsuit results from an Abbreviated New Drug Application filed by Teva forgeneric versions of 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALL XR‚®,pursuant to which Teva provided notice that it would seek to market its genericproducts before the expiration of the `819 and `300 Patents in 2018. Thelawsuit alleges that all of Teva's generic strengths infringe the patents insuit. Pursuant to Hatch-Waxman legislation, there will be a 30-month stay withrespect to Teva's proposed 25 mg dosage product.ADDERALL XR is Shire's Attention Deficit Hyperactivity Disorder medicine.For further information please contact:Investor Relations Clƒ©a 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. Shire'stherapeutic focus is on central nervous system (CNS), gastrointestinal (GI),human genetic therapies (HGT) and general products (GP). The structure issufficiently flexible to allow Shire to target new therapeutic areas to theextent that opportunities arise through acquisitions. Shire believes that acarefully selected portfolio of products with a strategically aligned andrelatively small-scale sales force will 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 DAYTRANATM (MTS/METHYPATCH) (ADHD), SPD503 (ADHD),SPD465 (ADHD), MESAVANCETM (SPD476) (ulcerative colitis), ELAPRASETM(idursulfase) (Hunter syndrome) and NRP104 (ADHD), including its schedulingclassification by the Drug Enforcement Administration in the United States;Shire plc's ability to benefit from the acquisition of Transkaryotic TherapiesInc.; Shire plc's ability to secure new products for commercialization and/ordevelopment; and other risks and uncertainties detailed from time to time inShire plc's and its predecessor registrant Shire Pharmaceuticals Group plc'sfilings with the US Securities and Exchange Commission, including ShirePharmaceuticals Group plc's Annual Report on Form 10-K for the year endedDecember 31, 2004. 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 Registered in England 2883758 Registered Office as aboveENDSHIRE PLCRelated Shares:
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