10th Mar 2006 13:30
Shire announces status of ongoing FDA review of NDA for DAYTRANATM for thetreatment of ADHDPhiladelphia, PA, US and Basingstoke, UK - March 10, 2006 -- Shire plc (LSE:SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that the U.S. Food and DrugAdministration (FDA) has confirmed that Shire's resubmission for DAYTRANA inresponse to information that the FDA requested in its December 23, 2005approvable letter for DAYTRANA's New Drug Application is being treated as aClass I resubmission. The review period for Class I resubmissions is 60 days,and since Shire's resubmission was made on February 9, 2006, the anticipatedFDA action date is April 9, 2006.DAYTRANA (methylphenidate transdermal system (MTS)) is an investigationaltransdermal patch formulation for methylphenidate designed for once-daily useto treat attention deficit hyperactivity disorder (ADHD) in children aged 6 to12 years. Shire is planning to launch DAYTRANA, if approved, during the firsthalf of 2006.DAYTRANA is licensed globally to Shire by Noven Pharmaceuticals, Inc.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 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) (ADHD), SPD503 (ADHD), SPD465(ADHD), MESAVANCETM (SPD476) (ulcerative colitis), ELAPRASETM (I2S) (Huntersyndrome) and NRP104 (ADHD), including its scheduling classification by theDrug Enforcement Administration in the United States; Shire plc's ability tobenefit from the acquisition of Transkaryotic Therapies Inc.; Shire plc'sability to secure new products for commercialization and/or development; andother risks and uncertainties detailed from time to time in Shire plc's and itspredecessor registrant Shire Pharmaceuticals Group plc's filings with the USSecurities and Exchange Commission, including Shire plc's Annual Report on Form10-K for the year ended December 31, 2005. # # # 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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