23rd Feb 2005 07:00
ADDERALL XR‚® - Paragraph IV notice received Basingstoke, UK and Philadelphia, US - 2005 - Shire Pharmaceuticals Group plc(LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that it has received a ParagraphIV Notice letter from Teva Pharmaceuticals USA, Inc., advising of the filing ofan Abbreviated New Drug Application (ANDA) for its amphetamine combinationproduct, a generic version of Shire's mixed amphetamine salts product, ADDERALLXR‚®.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("819" Patent) and U.S. patent No. 6,605,300 ("300" Patent).Shire received previously Paragraph IV Notice letters from Barr LaboratoriesInc., IMPAX Laboratories Inc. and Colony Pharmaceuticals Inc. relating to theirANDAs for their respective generic versions of ADDERALL XR. As previouslyannounced, Shire has filed lawsuits in response to the Barr and IMPAX ANDANotice letters.Shire is currently reviewing the detail of the Paragraph IV Notice letter fromTeva. -ends- For further information please contact:Investor Relations Clƒ©a Rosenfeld (Rest of the world) +44 1256 894 160 Brian Piper (US and Canada) +1 484 595 8252 Media Jessica Mann (Rest of the world) +44 1256 894 280 Matthew Cabrey (US and Canada) +1 484 595 8248 Shire 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 projects and marketing products in theareas of central nervous system (CNS), gastrointestinal (GI), and renaldiseases. Shire has operations in the world's key pharmaceutical markets (US,Canada, UK, France, Italy, Spain and Germany) as well as a specialist drugdelivery unit in the US.For further information on Shire, please visit the Company's website: www.shire.com THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACTOF 1995Statements 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 Deficit& Hyperactivity Disorder (ADHD) franchise, patents, including but not limitedto, legal challenges relating to Shire's ADHD franchise, government regulationand approval, including but not limited to the expected product approval datesof METHYPATCH‚® (methylphenidate) and NRP104, including its schedulingclassification by the Drug Enforcement Agency in the United States, Shire'sability to secure new products for development, , the implementation of thecurrent reorganization and other risks and uncertainties detailed from time totime in Shire's filings, including its Annual Report on Form 10-K for the yearended December 31, 2003, with the Securities and Exchange Commission.ENDRelated Shares:
Shire