20th Oct 2005 11:00
ADDERALL XR⨠- Shire Files Legal Suit against Barr Laboratories and ImpaxLaboratories for Infringement of U.S. Patent No. 6,913,768Basingstoke, UK and Philadelphia, US - October 20, 2005 - Shire PharmaceuticalsGroup plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that its subsidiaryShire Laboratories Inc. has filed a lawsuit in the U.S. District Court of theSouthern District of New York against Barr Laboratories, Inc. ("Barr") andImpax Laboratories, Inc. ("Impax") for infringement of Shire Laboratories U.S.Patent No. 6,913,768 ("`768 Patent").The lawsuit results from ANDAs (Abbreviated New Drug Applications) filed byBarr and Impax seeking FDA approval to market and sell generic versions ofShire's 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg ADDERALL XR⨠products. The`768 patent issued to Shire on July 5, 2005.The present case should not affect the existing litigation in the SouthernDistrict of New York between Shire and Barr involving U.S. Patents Nos.6,322,819 (`819) and 6,605,300 (`300), which is scheduled to go to trial inJanuary 2006. Likewise, the new case against Impax should not affect theongoing litigation between Shire and Impax in the District Court of Delaware,also involving the `819 and `300 patents, which is scheduled to go to trial onFebruary 23, 2006.ADDERALL XR⨠is Shire's leading Attention Deficit Hyperactivity Disorder("ADHD") medicine.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 Pharmaceuticals Group plcShire Pharmaceuticals Group plc (Shire) is a global specialty pharmaceuticalcompany with a strategic focus on meeting the needs of the specialist physicianand currently focuses on developing and marketing products in the areas ofcentral nervous system (CNS), gastrointestinal (GI), renal diseases and humangenetic therapies. Shire has operations in the world's key pharmaceuticalmarkets (US, Canada, UK, France, Italy, Spain and Germany) as well as aspecialist drug delivery unit in the US.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 forward-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's results could be materially affected. Therisks and uncertainties include, but are not limited to, risks associated withthe 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's Attention Deficitand Hyperactivity Disorder (ADHD) franchise, patents, including, but notlimited to, legal challenges relating to Shire's ADHD franchise, governmentregulation and approval, including, but not limited to, the expected productapproval dates of MTS (METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476(ulcerative colitis), I2S (iduronate-2-sulfatase) (Hunter syndrome), and NRP104(ADHD), including its scheduling classification by the Drug Enforcement Agencyin the United States, Shire's ability to benefit from its acquisition of TKT,Shire's ability to secure new products for commercialization and/or developmentand other risks and uncertainties detailed from time to time in Shire's filingswith the Securities and Exchange Commission, including its Annual Report onForm 10-K for the year to December 31, 2004. 2Hampshire 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 Pharmaceuticals Group PLCRelated Shares:
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