21st Jul 2006 17:35
SHIRE ANNOUNCES FILING OF SPD465 FOR THE TREATMENT OF ADULT ADHD Basingstoke, UK and Philadelphia, US - July 21, 2006 - Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) announced today that it has submitted a new drugapplication (NDA) to the U.S. Food and Drug Administration (FDA) for SPD465, aninvestigational amphetamine compound for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in the adult population. The application issubject to a 12-month FDA review period. SPD465 has the same active ingredientas ADDERALL XR⨠(mixed salts of a single-entity amphetamine product), but isdesigned to provide ADHD symptom control for up to 16 hours. Upon approval,this novel product will be the first and only ADHD stimulant product thatcontrols inattention, hyperactivity and impulsivity for up to 16 hours."The FDA filing for SPD465 is another milestone met and underscores Shire'scommitment to be the market leader in ADHD treatments by offering patients newsolutions to manage this chronic disorder," said Matthew Emmens, Shire ChiefExecutive Officer. "If approved, the 16-hour formulation of SPD465 would makeit the longest-acting stimulant medication for adult patients with ADHD, whilealso providing the efficacy of ADDERALL XR, the most prescribed brand of ADHDtreatment."ADHD 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.Scientists now agree that up to 65 percent of adolescents with ADHD willcontinue to have the ADHD diagnosis as adults. More than 9 million Americanadults currently exhibit symptoms of ADHD, based on independent research by theNational Institute of Mental Health. Approximately 36 percent of ADHDprescriptions are currently written for adult patients.For further information on ADHD please visit www.adderallxr.com, www.adhdsupport.com, www.CHADD.org or www.NMHA.org.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 editorsAbout SPD465SPD465, a mixed amphetamine salt formulation designed to provide sustainedrelease of medication and symptom control for up to 16 hours, is being studiedfor the treatment of ADHD in adults. The most common adverse events reported inSPD465 phase 3 studies were insomnia, decreased appetite and stomachache.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.Tell your doctor about any heart conditions, including structuralabnormalities, that you, your child, or a family member, may have. ADDERALL XRshould not be taken by patients who are currently taking or have recently takena type of antidepressant called a MAO inhibitor, have a history of high bloodpressure, problems with alcohol or drugs, agitated states, or glaucoma.Patients should also tell the doctor if they have seizures, visualdisturbances, thyroid problems, abnormal thoughts/behaviors, bipolar disorder,depression, or other mental illness, or a known allergy to this type ofmedication.Abuse of amphetamines may lead to dependence. Misuse of amphetamine may causesudden death and serious cardiovascular adverse events. These events have alsobeen reported rarely with amphetamine use. Aggression, new abnormal thoughts/behaviors, mania, and growth suppression have been associated with use of drugsof this type. There is a potential for worsening of motion or verbal tics andTourette's syndrome. Report any new psychological symptoms to the doctor andinform the doctor immediately of any symptoms that suggest heart problems, suchas chest pain or fainting.Shire 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 attention deficit and hyperactivity disorder (ADHD),human genetic therapies (HGT), gastrointestinal (GI) and renal diseases. Thestructure is sufficiently flexible to allow Shire to target new therapeuticareas to the extent opportunities arise through acquisitions. Shire believesthat a carefully selected portfolio of products with a strategically alignedand relatively small-scale sales force will deliver strong results.Shire's focused strategy is to develop and market products for specialtyphysicians. Shire's in-licensing, merger and acquisition efforts are focused onproducts in niche markets with strong intellectual property protection eitherin 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 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, Shireplc's results could be materially affected. The risks and uncertaintiesinclude, but are not limited to: risks associated with the inherent uncertaintyof pharmaceutical research, product development, manufacturing andcommercialization; the impact of competitive products, including, but notlimited to, the impact of those on Shire plc's Attention Deficit andHyperactivity Disorder ("ADHD") franchise; patents, including but not limitedto, legal challenges relating to Shire plc's ADHD franchise; governmentregulation and approval, including but not limited to the expected productapproval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476)(ulcerative colitis), ELAPRASE TM (I2S) (Hunter syndrome) and NRP104 (ADHD),including its scheduling classification by the Drug Enforcement Administrationin the United States; Shire plc's ability to benefit from the acquisition ofTranskaryotic Therapies 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 plc's Annual Report on Form 10-K for the year endedDecember 31, 2005. # # # Adderall XR⨠is a registered trademark of companies within the Shire group.Diagnostic and Statistical Manual of Mental Disorders is a registered trademarkof the American Psychiatric Association.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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