19th Jan 2006 07:00
ADDERALL XR‚® - Paragraph IV Notice Update -Third Notice Letter from Teva Pharmaceuticals USA, Inc.Basingstoke, UK and Philadelphia, US - January 18, 2006 - Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) announces that it has received a third Paragraph IVnotice letter from Teva Pharmaceuticals USA, Inc. advising it of an amendmentto Teva's existing ANDA for generic versions of ADDERALL XR‚®. The amendment isdirected to an additional strength of 25 mg. As previously announced, Teva'sFebruary 2005 Paragraph IV notice letter was directed only to 10 mg and 30 mgdosages and Teva's June 2005 Paragraph IV notice letter was directed only to 5mg, 15 mg and 20 mg dosages. Shire is currently reviewing the details of Teva'slatest Paragraph IV notice letter.ADDERALL XR‚® is an important product in Shire's portfolio of treatments forADHD and is protected by two patents which expire in 2018: Shire Laboratories'U.S. Patent No. 6,322,819 and U.S. Patent No. 6,605,300.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. Shirefocuses its business on central nervous system (CNS), gastrointestinal (GI),general products (GP) and human genetic therapies (HGT) - all being areas inwhich Shire has a commercial presence. The structure is sufficiently flexibleto allow Shire to target new therapeutic areas to the extent opportunitiesarise through acquisitions. Shire believes that a carefully selected portfolioof products with a strategically aligned and relatively small-scale sales forcewill deliver strong results. Shire's focused strategy is to develop and marketproducts for specialty physicians. This approach aims to deliver increasedreturns and lower risks. Shire's in-licensing and merger and acquisitionefforts are focused on products in niche markets with strong intellectualproperty protection either in 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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