10th Feb 2005 07:00
Shire Pharmaceuticals Group plcHampshire International Business Park,Chineham, Basingstoke RG24 8EP UKTel +44 1256 894000 Fax +44 1256 894708http://www.shire.comFor immediate release Shire announces suspension of ADDERALL XR(R) sales in Canada BASINGSTOKE, UK, PHILADELPHIA, PA, US February 9, 2005 Shire PharmaceuticalsGroup plc (LSE: SHP; NASDAQ: SHPGY; TSX: SHQ) announces that Health Canada hasrequested the suspension of sales of Shire's attention deficit hyperactivitydisorder (ADHD) treatment, ADDERALL XR(R) in Canada following Health Canada'sinterpretation of adverse event data as part of routine label updating. Although Shire is complying with this request the Company strongly disagreeswith the conclusions drawn by Health Canada and is considering appropriateresponsive action.Matthew Emmens, Chief Executive Officer, commented:"We are surprised by this action from Health Canada. Shire remains confident inthe safety and efficacy of ADDERALL XR."The marketing and availability of ADDERALL XR in the United States isunaffected. Shire remains confident in the safety and effectiveness of thisdrug for the treatment of ADHD when used in accordance with the approvedlabeling.ADDERALL XR was approved by Health Canada on January 21, 2004 and launched inFebruary 2004. Approximately 11,000 patients are currently prescribed ADDERALLXR in Canada. ADDERALL XR contributed around US $10m of Shire's annual revenuein its first year on the Canadian market.The labeling updating with Health Canada was part of Shire's regular ongoingprocess of revising the product label with information gathered during thelifetime of the drug.The interpretation of the same data by the US FDA led to a revised US label forADDERALL XR in September 2004, clarifying that the drug generally should not beused in children or adults with structural cardiac abnormalities.For further information please contact:Shire Pharmaceuticals Group plcInvestor Relations Clĩa Rosenfeld (UK and Europe) +44 1256 894 160 Brian Piper (US and Canada) +1 484 595 8252 Media Jessica Mann (UK and Europe) +44 1256 894280 Matthew Cabrey (US and Canada) +1 484 595 8248 Notes to editorsShireShire Pharmaceuticals Group Plc is a global pharmaceutical company with astrategic focus on meeting the needs of the specialist physician and currentlyfocuses on developing projects and marketing products in the areas of centralnervous system, gastrointestinal and renal diseases. Shire has operations inthe world's key pharmaceutical markets (U.S, Canada, U.K., France, Italy, Spainand Germany).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 the expected product approval datesof METHYPATCH⨠(methylphenidate) and NRP104, including its schedulingclassification by the Drug Enforcement Agency in the United States, Shire'sability to secure new products for development, the implementation of thecurrent reorganization and other risks and uncertainties detailed from time totime in Shire's filings, including its Annual Report on Form 10-K for the yearended December 31, 2003, with the Securities and Exchange Commission. ENDRelated Shares:
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