3rd Oct 2006 12:35
ADDERALL XR‚® - Paragraph IV notice receivedBasingstoke, UK and Philadelphia, US - October 03, 2006 - Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) - announces that it has received a Paragraph IV noticeletter from Andrx Pharmaceuticals, L.L.C. (Andrx) advising of the filing of anAbbreviated New Drug Application (ANDA) for its amphetamine combinationproduct, a generic version of Shire's mixed amphetamine salt product, ADDERALLXR‚®.Shire is currently reviewing the details of the Paragraph IV Notice letter fromAndrx.Shire has received Paragraph IV Notice letters from Barr Laboratories, Inc.(Barr), IMPAX Laboratories, Inc. (IMPAX), Colony Pharmaceuticals, Inc.(Colony), and Teva Pharmaceuticals USA, Inc. (Teva). As previously announced,Shire filed lawsuits against Barr, Impax and Teva. The Barr and Impax lawsuitshave been settled. The Teva litigation is ongoing in United States DistrictCourt of Pennsylvania.Andrx may not launch a generic version of ADDERALL XR‚® before it receives finalapproval of its ANDA from the U.S. Food and Drug Administration (FDA). If Shiredecides to file a complaint on this Paragraph IV Notice letter, the lawsuittriggers a stay of FDA approval of up to 30 months from the Company's receiptof Andrx's notice to allow the Court to resolve the suit. Even if Andrxreceives a tentative approval from the FDA, it can not lawfully launch itsgeneric version before the earlier of the expiration of the relevant stay, adistrict court decision in its favor and the expiration of any exclusivityrights that may attach to earlier filed ANDAs. The FDA may grant 180 days ofgeneric market exclusivity to the "first to file."ADDERALL XR‚® is the lead product in Shire's portfolio of treatments forAttention Deficit and Hyperactivity Disorder (ADHD) and is protected by twopatents which expire in 2018: Shire Laboratories' U.S. Patent No. 6,322,819 andU.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 attention deficit and hyperactivity disorder (ADHD),human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. Thestructure is sufficiently flexible to allow Shire to target new therapeuticareas to the extent opportunities arise through acquisitions. Shire believesthat a carefully selected portfolio of products with a strategically alignedand relatively 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 CONNEXYN¢â€ž¢ (SPD503) (ADHD), SPD465 (ADHD), MESAVANCE ¢â€ž¢(SPD476) (ulcerative colitis), and NRP104 (ADHD), including its schedulingclassification by the Drug Enforcement Administration in the United States;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, particularly Shireplc's Annual Report on Form 10-K for the year ended December 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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