13th Oct 2005 06:00
ADDERALL XR‚® - Shire submits Citizen Petition on efficacy and safety concernswith the FDABasingstoke, UK and Philadelphia, US October 13, 2005 - Shire PharmaceuticalsGroup plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that on October 12,2005 it submitted a Citizen Petition with the Food and Drug Administration(FDA) to require more rigorous bioequivalence testing or additional clinicaltesting for generic or follow-on drug products that reference ADDERALL XR‚®,before they can be approved. Compliance of these requested criteria will ensurethat generic formulations of ADDERALL XR or follow-on drug products will beclinically effective and safe.Shire has requested that the FDA require applicants who seek to obtainregulatory approval of generic or follow-on versions of ADDERALL XR toestablish bioequivalence through a study producing identical or superimposableplasma concentration time curves and pharmacokinetic profile. The FDA haspreviously determined when reviewing Shire's new drug application for ADDERALLXR that this is the only way that is sufficiently predictive of desiredattention deficit hyperactivity disorder (ADHD) clinical patient outcomes to besubstitutable for a clinical efficacy trial. If a generic or follow-on drugsponsor is unable or unwilling to meet these criteria for establishingbioequivalence, the FDA should require an adequate and well-controlled clinicalinvestigation demonstrating the clinical effectiveness and safety of thegeneric or follow-on drug product in the treatment of ADHD.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 and marketing products in the areas ofcentral nervous system (CNS), gastrointestinal (GI), renal diseases and humangenetic therapies. Shire has operations in the world's key pharmaceuticalmarkets (US, Canada, UK, France, Italy, Spain and Germany) as well as aspecialist drug delivery 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 Deficitand Hyperactivity Disorder (ADHD) franchise, patents, including, but notlimited to, legal challenges relating to Shire's ADHD franchise, governmentregulation and approval, including, but not limited to, the expected productapproval dates of MTS (METHYPATCH) (ADHD), SPD503 (ADHD), SPD465 (ADHD), SPD476(ulcerative colitis), I2S (iduronate-2-sulfatase) (Hunter syndrome), and NRP104(ADHD), including its scheduling classification by the Drug Enforcement Agencyin the United States, Shire's ability to benefit from its 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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