24th Aug 2005 11:00
Shire Pharmaceuticals announces reinstatement of ADDERALL XR‚® in CanadaBasingstoke, UK and Philadelphia, US - August 24, 2005 - Shire PharmaceuticalsGroup plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announces that Health Canada isreinstating the marketing authorization of ADDERALL XR‚®, Shire's medicine fortreating Attention Deficit and Hyperactivity Disorder (ADHD), in Canadaeffective August 26, 2005. This announcement follows the acceptance by HealthCanada of the recommendations from the New Drug Committee (NDC), which wasappointed by Health Canada at Shire's request to review the February 9, 2005suspension in Canada of ADDERALL XR."ADDERALL XR is a safe and effective treatment for people diagnosed with ADHD,and Shire is very pleased that this medicine will once again be available forpatients in Canada," said Shire Chief Executive Officer Matt Emmens. "Weappreciate the work of the NDC, and we are gratified that Health Canadaaccepted their recommendations."The NDC, comprised of three highly qualified, independent experts in the fieldsof pediatric cardiology, pediatric development and behavioral problems, andpharmacoepidemiology, examined the scientific evidence made available to themby both Shire and Health Canada.The NDC recommendation for the reinstatement of ADDERALL XR in Canada,supported by both Health Canada and Shire, includes adoption of the revisionsto the Canadian Product Monograph and patient leaflet that Shire previouslyproposed in November 2004. The NDC has also recommended that Shire distribute aDear Healthcare Professional Letter and support independent continuing medicaleducation for Canadian physicians to reinforce their understanding of theissues around sudden/cardiac death in the general pediatric population.Health Canada has agreed to work with Shire to implement the recommendations ofthe NDC and Shire will work diligently to make Adderall XR available toCanadians in the coming weeks.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 humangenetics. 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.About ADDERALL XRADDERALL XR may not be right for everyone. ADDERALL XR was generally welltolerated in clinical studies. The most common adverse events in pediatrictrials included loss of appetite, insomnia, abdominal pain, and emotionallability. The most common side effects in the adolescent trial included loss ofappetite, insomnia, abdominal pain, and weight loss. The most common adverseevents in the adult trial included dry mouth, loss of appetite, insomnia,headache, and weight loss.The effectiveness of ADDERALL XR for long-term use has not been systematicallyevaluated in controlled trials. As with other psychostimulants indicated forADHD, there is a potential for exacerbating motor and phonic tics andTourette's syndrome. A side effect seen with the amphetamine class ispsychosis. Caution also should be exercised in patients with a history ofpsychosis. Abuse of amphetamines may lead to dependence.Misuse of amphetamine may cause sudden death and serious cardiovascular adverseevents.ADDERALL XR generally should not be used in children or adults with structuralcardiac abnormalities. ADDERALL XR is contraindicated in patients withsymptomatic cardiovascular disease, moderate to severe hypertension,hyperthyroidism and glaucoma, known hypersensitivity to this class ofcompounds, agitated states, history of drug abuse, or current or recent use ofMAO inhibitors. ADDERALL XR should be prescribed with close physiciansupervision."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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