5th Dec 2005 09:41
FDA Psychopharmacologic Drugs Advisory Committee supports safety and efficacyof DAYTRANA TMBasingstoke, UK and Philadelphia, US - December 2, 2005 - Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) confirmed today that a Psychopharmacologic DrugsAdvisory Committee recommended to the U.S. Food and Drug Administration (FDA)that DAYTRANA (methylphenidate transdermal system) is safe and effective.DAYTRANA is an investigational transdermal patch formulation formethylphenidate designed for once-daily use to treat attention deficithyperactivity disorder (ADHD) in children aged 6 to 12 years. At the request ofthe FDA, a meeting with the Advisory Committee was held today to review thesafety and effectiveness of DAYTRANA.The FDA asked the Advisory Committee to vote on (1) whether the product hasbeen shown to be effective for the treatment of ADHD, and (2) whether theproduct has been shown to be acceptably safe in the treatment of ADHD. On thefirst question, the Committee voted unanimously in favor of the efficacy of theproduct. On the second question, the Committee voted unanimously in favor ofthe safety of the product, but recommended that the FDA require post-marketingsurveillance and/or studies related to the product. The Advisory Committee alsorecommended to the FDA that consideration of oral ADHD products be given priorto use of the product, but by a vote of eleven to one rejected a proposal tolimit use of the product to patients who cannot use oral methylphenidateproducts."We are pleased that the Advisory Committee voted in favor of DAYTRANA's safetyand efficacy in children diagnosed with ADHD," said Shire Chief ExecutiveOfficer Matt Emmens. "This delivery option can provide a much neededalternative for parents and physicians to help children living with ADHD."Shire and Noven Pharmaceuticals, Inc. submitted an amended New Drug Application(NDA) for DAYTRANA to the FDA in June of this year. A decision from the FDA onDAYTRANA is scheduled to be announced on or before December 28, 2005. Therecommendation of the Advisory Committee is not binding on the FDA.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 Pharmaceuticals Group 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.About DAYTRANA and MethylphenidateIn the pivotal clinical studies, DAYTRANA was generally well tolerated andadverse events typically were mild to moderate, resolved with continued therapyand were consistent with known effects of methylphenidate. The most commonadverse events reported by patients who received DAYTRANA in clinical trialswere: nausea, vomiting, nasopharyngitis, weight decreased, anorexia, decreasedappetite, affect lability, insomnia, tic, and nasal congestion.Methylphenidate should not be administered to patients with: glaucoma; tics,Tourette's syndrome or a family history of Tourette's syndrome; current orrecent use of Monoamine Oxidase Inhibitors (MAOIs). Chronic abuse ofmethylphenidate may lead to dependence and careful supervision followingwithdrawal from abuse is warranted. Methylphenidate should not be given topatients with a history of drug dependence or alcoholism. Methylphenidateshould not be used for the prevention or treatment of severe depression ornormal fatigue states. Growth should be monitored in patients treated withmethylphenidate. Use with caution in patients with psychosis, history ofseizures or EEG abnormalities, hypertension, a history of drug dependence oralcoholism. Rare cases of visual disturbances have been reported withmethylphenidate use. Hematologic monitoring is advised during prolongedtherapy.About ADHDADHD affects approximately 7.8 percent of all school-age children, more than 4million in the United States. ADHD is considered the most commonly diagnosedpsychiatric disorder in children and adolescents. ADHD is a neurological braindisorder that manifests as a persistent pattern of inattention and/orhyperactivity-impulsivity that is more frequent and severe than is typicallyobserved in individuals at a comparable age and maturity. If untreated, ADHDcan acutely affect a child's life, leading to problems with family members,friends, sports, after-school activities and academics."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 (I2S)(iduronate-2-sulfase) (Hunter syndrome) and NRP104 (ADHD), including itsscheduling classification by the Drug Enforcement Administration in the UnitedStates; Shire plc's ability to benefit from the acquisition of TranskaryoticTherapies 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 Pharmaceuticals Group plc's Annual Report on Form10-K for the year ended December 31, 2004.Registered in England 2883758 Registered Office as aboveENDSHIRE PLCRelated Shares:
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