7th Jun 2005 11:00
ADDERALL XR‚® - Paragraph IV Notice Update - Second Notice Letter From Teva Pharmaceuticals USA, Inc. Basingstoke, UK and Philadelphia, US - June 7, 2005 - Shire PharmaceuticalsGroup plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) remains committed to protectingthe patents which it has relating to ADDERALL XR‚®, its product for treatment ofAttention Deficit Hyperactivity Disorder (ADHD).Shire has received a second Paragraph IV notice letter from TevaPharmaceuticals USA, Inc. advising of an amendment to Teva's existing ANDA forgeneric versions of ADDERALL XR‚®. The amendment is directed to additionalstrengths of 5 mg, 15 mg, and 20 mg dosages. As previously announced Teva'sFebruary 2005 Paragraph IV notice letter was directed only to 10 mg and 30 mgdosages.Shire has also previously announced the receipt of Paragraph IV notice lettersadvising of the filing of ANDAs for generic versions of ADDERALL XR‚® from BarrLaboratories, Inc., Impax Laboratories, Inc. and Colony Pharmaceuticals Inc.Shire has filed lawsuits against Barr and Impax, the first and second companiesto send notice letters. Shire is currently reviewing the details of Teva'sParagraph IV notice letter directed to 5 mg, 15 mg and 20 mg dosages. Shire haspreviously chosen not to sue Teva for the ANDA directed to the 10 mg and 30 mgdosages.Barr, Impax, Colony and Teva may not launch a generic version of ADDERALL XR‚®before 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 before the earlier of theexpiration of the currently pending 30-month stays or a district court decisionin its favor. Neither Impax, Colony nor Teva will be able to lawfully launch ageneric version of ADDERALL XR‚® without the necessary final approval from theFDA and the expiration of the "first to file's" exclusivity rights. The FDA maygrant 180 days of generic market exclusivity to the "first to file".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 30 month stay for the 30 mg product began in November 2003 and forthe new strengths of 5 mg, 10 mg, 15 mg, 20 mg and 25 mg in December 2004. TheImpax court case has been consolidated and is scheduled to go to trial inFebruary 2006.ADDERALL XR‚® is an important product in Shire's portfolio of treatments forADHD and is protected by two patents which expire in 2018: Shire Laboratories'U.S. Patent No. 6,322,819 ("the '819 patent") and U.S. Patent No. 6,605,300("the '300 patent").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 of MTS(METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476 (ulcerative colitis),SPD480 (ulcerative colitis) and NRP104 (ADHD), including its schedulingclassification by the Drug Enforcement Agency in the United States, Shire'sability to consummate and benefit from its proposed acquisition of TKT, Shire'sability to secure new products for commercialization and/or development andother 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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