27th Oct 2005 14:30
Developmental Methylphenidate Patch Scheduled for FDA Advisory Committee ReviewPhiladelphia and Miami, US - October 27, 2005 - Shire Pharmaceuticals Group plc(LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) and Noven Pharmaceuticals, Inc. (NASDAQ:NOVN) announced today that the amended New Drug Application (NDA) for MTS(methylphenidate transdermal system) will be reviewed by FDA'sPsychopharmacologic Drugs Advisory Committee at their scheduled open session onDecember 2, 2005. MTS is a transdermal patch designed for once-daily use totreat attention deficit hyperactivity disorder (ADHD) in children aged 6 to 12years. The NDA amendment has been assigned a PDUFA date of December 28, 2005.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 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 humangenetic therapies. Shire has operations in the world's key pharmaceuticalmarkets (US, Canada, UK, France, Italy, Spain and Germany) as well as aspecialist drug delivery unit in the US.For further information on Shire, please visit the Company's website: www.shire.com.About NovenNoven Pharmaceuticals, Inc., headquartered in Miami, Florida, is a leadingdeveloper of advanced transdermal drug delivery technologies and prescriptiontransdermal products. Noven's prescription patches are sold in over 30countries, and a range of new patches are being developed in collaboration withShire Pharmaceuticals Group plc, Novartis Pharma AG, P&G Pharmaceuticals, EndoPharmaceuticals Inc. and others. Noven is committed to expanding the universeof available transdermal therapies for the benefit of patients, partners andshareholders. See www.noven.com for additional information.About MTS and MethylphenidateIn the pivotal clinical studies, MTS was generally well tolerated and adverseevents typically were mild to moderate, resolved with continued therapy andwere consistent with known effects of methylphenidate. The most common adverseevents reported by patients who received MTS in clinical trials were: nausea,vomiting, nasopharyngitis, weight decreased, anorexia, decreased appetite,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 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. 2Hampshire 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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