21st Apr 2006 07:00
Shire Receives Interim Response From FDA on ADDERALL XR‚® Citizen PetitionPhiladelphia, PA, US and Basingstoke, UK - April 20, 2006 -- Shire plc (LSE:SHP, NASDAQ: SHPGY, TSX: SHQ) announces that on April 20, 2006 it receivedcorrespondence from the United States Food and Drug Administration ("FDA")informing Shire that the FDA has not yet resolved the issues raised in Shire'spending ADDERALL XR Citizen Petition. The FDA states that due to the complexissues raised requiring extensive review and analysis by the FDA's officials, adecision cannot be reached at this time. The FDA's interim response is inaccordance with FDA regulations concerning Citizen Petitions.As previously announced in October 2005, Shire filed a Citizen Petition withthe FDA to require more rigorous bioequivalence testing or additional clinicaltesting for generic or follow-on drug products that reference ADDERALL XRbefore they can be approved. Compliance with these requested criteria willensure that generic formulations of ADDERALL XR will be clinically effectiveand safe. -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 PLCShire's strategic goal is to become the leading specialty pharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on central nervous system, gastrointestinal, generalproducts and human genetic therapies - all being areas in which Shire has acommercial presence. The structure is sufficiently flexible to allow Shire totarget new therapeutic areas to the extent opportunities arise throughacquisitions. Shire believes that a carefully selected portfolio of productswith strategically aligned and relatively small-scale sales forces will deliverstrong results. Shire's strategy is to develop and market products forspecialty physicians. Shire's in-licensing and merger and acquisition effortsare focused on products in niche markets with strong intellectual propertyprotection either in the US or Europe.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 forwarding-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 plc's results could be materially affected.The risks and uncertainties include, but are not limited to: risks associatedwith the 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 plc's AttentionDeficit and Hyperactivity Disorder ("ADHD") franchise; patents, including butnot limited to, legal challenges relating to Shire plc's ADHD franchise;government regulation and approval, including but not limited to the expectedproduct approval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE¢â€ž¢ (SPD476)(ulcerative colitis), ELAPRASE¢â€ž¢ (I2S) (Hunter syndrome) and NRP104 (ADHD),including its scheduling classification by the Drug Enforcement Administrationin the United States; Shire plc's ability to benefit from the acquisition ofTranskaryotic Therapies Inc.; Shire plc's ability to secure new products forcommercialization and/or development; and other risks and uncertaintiesdetailed from time to time in Shire plc's and its predecessor registrant ShirePharmaceuticals Group plc's filings with the US Securities and ExchangeCommission, including Shire plc's Annual Report on Form 10-K for the year endedDecember 31, 2005. # # # 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 ENDSHIRE PLCRelated Shares:
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