19th Jul 2005 11:00
ADDERALL XR‚® - Paragraph IV Notice UpdateBasingstoke, UK and Philadelphia, US - July 19, 2005 - Shire PharmaceuticalsGroup plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced on June 7, 2005 that ithad received a second Paragraph IV notice letter from Teva Pharmaceuticals USA,Inc. ("Teva") advising of an amendment to Teva's existing ANDA for genericversions of ADDERALL XR‚®. The amendment is directed to additional strengths of5 mg, 15 mg, and 20 mg dosages. As previously announced, Teva's February 2005Paragraph IV notice letter was directed only to 10 mg and 30 mg dosages. Shireannounces today that it has chosen not to sue Teva.Barr, Impax, Colony and Teva may not launch a generic version of ADDERALL XRbefore receiving a final approval of their respective ANDAs from the US Foodand Drug Administration (FDA). Should Barr receive a tentative approval fromthe FDA, it cannot lawfully launch its generic version of ADDERALL XR beforethe earlier of the expiration of the currently pending 30-month stays or adistrict court decision in its favor. Impax, Colony or Teva will not be able tolawfully launch a generic version of ADDERALL XR without the necessary finalapproval from the FDA and the expiration of the "first to file's" exclusivityrights. The FDA may grant 180 days of generic market exclusivity to the "firstto file".Shire remains committed to protecting the patents which it has relating toADDERALL XR, its product for treatment of Attention Deficit HyperactivityDisorder (ADHD). Shire has filed lawsuits against Barr and Impax - the firsttwo companies to submit paragraph IV notices.The Barr court case is scheduled to go to trial in January 2006. In the Barrcase, the 30 month stay for the '819 patent began in January 2003 and withrespect to the '300 patent it began in August 2003.The Impax case has a February 2006 trial date. The Impax 30 month stay for the30 mg product began in November 2003 and for 5 mg, 10 mg, 15 mg, 20 mg and 25mg strengths in December 2004. As with Teva, Shire has chosen not to sureColony.Shire Laboratories' U.S. Patent Nos. 6,322,819 and 6,605,300 expire in 2018.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 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."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 ADHD franchise,patents, including but not limited to, legal challenges relating to Shire'sADHD franchise, government regulation and approval, including but not limitedto Health Canada's suspension of ADDERALL XR‚® sales in Canada and the expectedproduct approval dates of MTS (METHYPATCH) (ADHD), SPD503 (ADHD), SPD465(ADHD), SPD476 (ulcerative colitis), SPD480 (ulcerative colitis) and NRP104(ADHD), including its scheduling classification by the Drug Enforcement Agencyin the United States, Shire's ability to consummate and benefit from itsproposed acquisition of TKT, Shire's ability to secure new products forcommercialization and/or development and other risks and uncertainties detailedfrom time to time in Shire's filings with the Securities and ExchangeCommission, including its Annual Report on Form 10-K for the year to December31, 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 Pharmaceuticals Group PLCRelated Shares:
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