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Statement re the FDA drug safety committee meeting

10th Feb 2006 07:00

STATEMENT REGARDING THE UNITED STATES FOOD AND DRUG ADMINISTRATION DRUG SAFETYAND RISK MANAGEMENT ADVISORY COMMITTEE MEETINGBasingstoke, UK and Philadelphia, US - February 10, 2005As the leader in ADHD treatment, Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ),is supportive of the goals of yesterday's meeting of the US FDA Drug Safety andRisk Management Advisory Committee. However, we feel it is important to putseveral of the issues into perspective.The overall purpose of the meeting was to review the cardiovascular safetyissues associated with medicines used to treat attention deficit hyperactivitydisorder (ADHD). Data regarding the reported incidence rates of seriouscardiovascular adverse events - both in patients taking ADHD medicines andthose not taking ADHD medicines - were reviewed. Importantly, the reportedincidence rates were similar in both groups.While recognizing that the reported incidence rates of the rare seriouscardiovascular adverse events that were discussed are generally within therates that would be expected from the untreated general population, theAdvisory Committee nevertheless, in an 8-7 vote, recommended to the FDA that itinclude risk information about cardiovascular events in a "black box warning"for all stimulant medicines used to treat ADHD. While we fully support fulldisclosure and adequate warning, Shire believes that the interests ofphysicians and patients would be better served by further study to determinewhether there is, in fact, a relationship between these medicines andcardiovascular events. Obtaining this information is crucial prior to takingwhat would be an unprecedented action to include something in a black box thatis not been supported by sufficient data.Of note is the fact that our Adderall XR and Adderall already include a "blackbox warning" in their labels for safety concerns related to amphetamine abuseor misuse. The label also warns of the risk of sudden death in patients withstructural cardiac abnormalities. We stand behind this labelling and believethat further action is unwarranted.Most importantly, the benefits of treatment should not be overlooked. Asseveral participants pointed out, ADHD is a serious condition and if leftuntreated the disorder can result in serious consequences. Stimulant medicinessuch as amphetamines and methylphenidate are highly effective in treatingpatients with ADHD and have been used for over 50 years. We have confidence inShire's ADHD medicines - they have been prescribed over 50 million times andmore than 1 million patients have taken Adderall XR since its introduction in2001.Shire looks forward to working with the FDA to examine ways to ensure thatphysicians and patients have all of the necessary information needed beforedeciding whether to prescribe or take Adderall XR and Adderall.IMPORTANT SAFETY INFORMATIONAbout ADHDADHD is a neurological brain disorder that manifests as a persistent pattern ofinattention and/or hyperactivity-impulsivity that is more frequent and severethan typically observed in individuals at a comparable age and maturity level.Because everyone shows signs of these behaviors at times, the behaviors mustappear early in life (before age 7 years) and continue for at least six months,according to the ADHD diagnosis criteria as defined in the American PsychiatricAssociation's Diagnostic and Statistical Manual of Mental Disorders, FourthEdition, Text Revision (DSM-IV-TRĉ۪). Up to 65 percent of children with ADHD maystill exhibit symptoms into adulthood. In fact, approximately eight millionAmerican adults currently struggle with the inattention, impulsivity andhyperactivity symptoms of ADHD.Without an effective treatment program, the symptoms of ADHD may lead topotentially serious consequences. A survey has shown that when compared toadults without ADHD symptoms, adults with untreated ADHD were more than twiceas likely to have been arrested, 47 percent more likely to have received morethan one speeding ticket in the last year, twice as likely to have beendivorced and twice as likely to have held six or more jobs in the past decade.Further, evidence suggests that many adults with untreated ADHD may be at riskfor other problems, including poor performance in the workplace and poorself-image.Although there is no cure for ADHD, physicians and advocates are finding waysto help people with the condition learn to adapt to their school, home, socialand work settings. ADHD usually can be successfully managed with behavioraltherapy, structured coping techniques and medication. Psychostimulantmedications are thought to stimulate areas of the brain that control attention,impulses, and self-regulation of behavior, remain among the most successfultreatments for people with ADHD. Up to 70 percent of children with ADHD respondpositively to psychostimulants. Medication should be considered part of anoverall multi-modal treatment plan for ADHD.For further information on ADHD please visit www.adhdsupport.com, www.CHADD.orgor www.NMHA.org.About ADDERALL XRADDERALL XR was generally well tolerated in clinical studies. The most commonside effects in studies included: children - decreased appetite, difficultyfalling asleep, stomachache, and emotional lability; adolescents - loss ofappetite, difficulty falling asleep, stomachache, and weight loss; adults - drymouth, loss of appetite, difficulty falling asleep, headache, and weight loss.Adderall XR may not be right for everyone. Patients should speak with theirdoctor if they have a history of high blood pressure or any heart conditions,glaucoma, thyroid problems, emotional instability, mental illness, or a knownallergy to this type of medication. Abuse of amphetamines may lead todependence. Misuse of amphetamine may cause sudden death and seriouscardiovascular adverse events. These events have also been reported rarely withamphetamine use.If you are currently taking or have recently taken a type of antidepressantcalled a MAO inhibitor or have a pre-existing structural heart abnormality, youshould not take Adderall XR. There is a potential for worsening of motion orverbal tics and Tourette's syndrome. A patient should report any newpsychological symptoms to his or her physician.For further information please contact:Investor Relations Clĩa 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 (CNS), gastrointestinal (GI),general products (GP) and human genetic therapies (HGT) - all being areas inwhich Shire has a commercial presence. The structure is sufficiently flexibleto allow Shire to target new therapeutic areas to the extent opportunitiesarise through acquisitions. Shire believes that a carefully selected portfolioof products with a strategically aligned and relatively small-scale sales forcewill deliver strong results. Shire's focused strategy is to develop and marketproducts for specialty physicians. This approach aims to deliver increasedreturns and lower risks. Shire's in-licensing and merger and acquisitionefforts are focused on products in niche markets with strong intellectualproperty protection 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 DAYTRANATM (MTS/METHYPATCH) (ADHD), SPD503 (ADHD),SPD465 (ADHD), MESAVANCETM (SPD476) (ulcerative colitis), ELAPRASETM(idursulfase) (Hunter syndrome) and NRP104 (ADHD), including its schedulingclassification by the Drug Enforcement Administration in the United States;Shire plc's ability to benefit from the acquisition of Transkaryotic TherapiesInc.; Shire plc's ability to secure new products for commercialization and/ordevelopment; and other risks and uncertainties detailed from time to time inShire plc's and its predecessor registrant Shire Pharmaceuticals Group plc'sfilings with the US Securities and Exchange Commission, including ShirePharmaceuticals Group plc's Annual Report on Form 10-K for the year endedDecember 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 PLC

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