18th Jul 2005 11:00
CARBATROL‚® Paragraph IV Litigation UpdateNostrum Pharmaceuticals, Inc.'s Motion for Summary Judgment Denied.Basingstoke, UK and Philadelphia, US - July 18, 2005 - Judge Mary LittleCooper, of the United States Federal District Court in Trenton, New Jersey, andpresiding judge in the Shire Pharmaceuticals Group plc (LSE: SHP, NASDAQ:SHPGY, TSX: SHQ) Paragraph IV patent infringement lawsuit against NostrumPharmaceuticals, Inc. (Nostrum), has denied Nostrum's motion for summaryjudgment.The lawsuit was instituted by Shire in 2003 after Nostrum filed an AbbreviatedNew Drug Application (ANDA) seeking approval from the Food and DrugAdministration (FDA) for Nostrum's generic version of CARBATROL‚®. In thelawsuit, Shire is asserting that Nostrum has infringed U.S. Patent No.5,326,570 ("the '570 patent"), one of Shire's patents that claim carbamazepineformulations which also includes CARBATROL. In its motion for summary judgment,Nostrum urged the Court to rule it does not infringe the `570 patent and todismiss the lawsuit. Immediately after both parties presented their respectivepositions on the summary judgment motion in an oral hearing held on Friday July15, 2005, Judge Cooper denied Nostrum's motion. Consequently, the lawsuitbetween Shire and Nostrum will continue to move toward trial. No trial date hasbeen set by the Court at this time.In addition to continuing the litigation between Shire and Nostrum, the Court'sruling has the effect of maintaining the 30 month stay of approval of Nostrum'sANDA imposed under the Hatch-Waxman Act. The 30 month stay on Nostrum's ANDAexpires in February of 2006. According to the Hatch-Waxman Act, a genericcompany sponsoring a Paragraph IV-certified ANDA may only launch its productupon the earlier of a favorable district court ruling or the expiry of the 30month stay, in addition to receiving regulatory approval from the FDA of theANDA.Shire remains committed to protecting the patents which it has relating toCARBATROL, its product for treatment of epilepsy.CARBATROL is a product in Shire's portfolio of treatment for epilepsy and isprotected by two patents. In addition to the `570 patent, Shire also owns U.S.Patent No. 5,912,013 ("the '013 patent") which expire in 2011 and 2016respectively.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 consummate and benefit from its proposed 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. 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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