28th Dec 2005 07:00
Shire receives FDA Approvable Letter for DAYTRANATM for the treatment of ADHD Philadelphia, PA, US and Basingstoke, UK - December 23, 2005 -- Shire plc (LSE:SHP, NASDAQ: SHPGY, TSX: SHQ) announced today it has received an approvableletter from the U.S. Food and Drug Administration (FDA) for DAYTRANA(methylphenidate transdermal system), an investigational transdermal patchformulation for methylphenidate designed for once-daily use to treat attentiondeficit hyperactivity disorder (ADHD) in children aged 6 to 12 years. Theapprovable letter contains proposed labeling, as well as requests for dataclarification, post-marketing surveillance, and post-marketing studies. Shireis now initiating dialogue with FDA to address these issues."This approvable letter for DAYTRANA is positive news for Shire and ourpartner, Noven Pharmaceuticals," said Shire Chief Executive Officer MatthewEmmens. "We look forward to working with the FDA to agree on the final labelingfor DAYTRANA. As the first and only non-oral medication for ADHD, DAYTRANA, ifultimately approved, will be a welcome new alternative to current therapies forpatients diagnosed with ADHD."Shire and Noven Pharmaceuticals, Inc. submitted an amended New Drug Application(NDA) for DAYTRANA to the FDA in June of this year. DAYTRANA is licensedglobally to Shire by Noven. Shire hopes to reach final agreement with the FDAconcerning DAYTRANA to allow for an on track launch during the first half of2006.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, 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 DAYTRANADAYTRANA is a Schedule II controlled substance. DAYTRANA was generally welltolerated in clinical studies. As with other products containingmethylphenidate (the active ingredient in DAYTRANA), common side effectsreported in children who received DAYTRANA were decreased appetite, insomnia,nausea, vomiting, weight loss, tic, and affect lability (mood swings). DAYTRANAshould not be used by children with allergies to methylphenidate or otheringredients in DAYTRANA. The patch should be applied daily to clean, dry skin,which is free of any cuts or irritation. Avoid applying external heat to thepatch. Skin irritation may occur. Methylphenidate should not be taken bychildren with significant anxiety, tension, or agitation; glaucoma; tics;Tourette's syndrome, or family history of Tourette's syndrome; or current/recent use of MAO inhibitors (a type of antidepressant). Abuse ofmethylphenidate may lead to dependence. Tell your healthcare professional ifyour child has had problems with alcohol or drugs or has had depression,abnormal thoughts/behaviors, visual disturbances, seizures, high bloodpressure, or heart conditions.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 risksor uncertainties materialize, Shire plc's results could be materiallyaffected. The risks and uncertainties include, but are not limited to; risksassociated with the inherent uncertainty of pharmaceutical research, productdevelopment, manufacturing and commercialization; the impact of competitiveproducts, including, but not limited to, the impact of those on Shire plc'sAttention Deficit and Hyperactivity Disorder ("ADHD") franchise; patents,including but not limited to, legal challenges relating to Shire plc's ADHDfranchise; government regulation and approval, including but not limited to theexpected product approval dates of DAYTRANATM (MTS/METHYPATCH) (ADHD), SPD503(ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476) (ulcerative colitis), ELAPRASE TM(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 ENDSHIRE PLCRelated Shares:
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