11th Apr 2005 11:00
Embargoed until7 am (EST) 12 noon (BST)ADDERALL XR‚® - Paragraph IV Notice UpdateBasingstoke, UK and Philadelphia, US - April 11, 2005 - Shire PharmaceuticalsGroup plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced on February 23rd, 2005that it had received a Paragraph IV Notice letter from Teva Pharmaceuticals USAInc., (Teva) advising of the filing of an Abbreviated New Drug Application(ANDA) for its amphetamine combination product, a generic version of Shire'smixed amphetamine salts product, ADDERALL XR‚®. Shire announces today that ithas chosen not to sue Teva.Barr, Impax, Colony and Teva may not launch a generic version of ADDERALL XRbefore receiving final approval of their respective ANDAs from the US Food andDrug Administration (FDA). Should Barr receive a tentative approval from theFDA, it cannot lawfully launch its generic version of ADDERALL XR before theearlier of the expiration of the currently pending 30-month stays or a districtcourt decision in its favor. Impax, Colony or Teva will not be able to lawfullylaunch a generic version of ADDERALL XR without the necessary final approvalfrom the FDA and the expiration of the "first to file's" exclusivity rights.The FDA may grant 180 days of generic market exclusivity to the "first tofile".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 an October 2005 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 sueColony.ADDERALL XR is protected by two patents that expire in 2018: ShireLaboratories' U.S. patent No. 6,322,819 ("819" Patent) and U.S. patent No.6,605,300 ("300" Patent). -ends- 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 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 Health Canada's suspension ofADDERALL XR sales in Canada and the expected product approval dates ofMETHYPATCH‚® (MTS) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476 (ulcerativecolitis), SPD 480 (ulcerative colitis) and NRP104 (ADHD), including itsscheduling classification by the Drug Enforcement Agency in the United States,Shire's ability to secure new products for development and other risks anduncertainties detailed from time to time in Shire's filings with the Securitiesand Exchange Commission, including its Annual Report on Form 10-K for the yearended December 31, 2004.Page 2 of 2Shire Pharmaceuticals Group plc 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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