24th Aug 2006 17:15
SHIRE ANNOUNCES NDA SUBMISSION OF GUANFACINE EXTENDED-RELEASE FOR THE TREATMENTOF ADHD IN CHILDREN AND ADOLESCENTSShire Seeks FDA Approval of First Selective Alpha-2A-Adrenoceptor Agonist ADHDTreatment, Which, if Approved, Broadens the ADHD Portfolio for ShireBasingstoke, UK and Philadelphia, US - August 24, 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 itsinvestigational compound guanfacine extended release (previously referred to asSPD503), which, if approved, would be the first once-daily selectivealpha-2A-adrenoceptor agonist for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children aged 6 to 17 years. Shire hasproposed the trade name CONNEXYN¢â€ž¢ for the product. The application is subjectto a 10-month FDA review period."The NDA submission of guanfacine extended release is another Shire milestonein the development of our ADHD portfolio, demonstrating further our ability toexecute on our strategy for continued growth," said Matthew Emmens, Shire'sChief Executive Officer. "As the first selective alpha-2A-adrenoceptor agonistsubmitted to the FDA for the treatment of ADHD, CONNEXYN, if approved, wouldenhance our product portfolio as a new non-stimulant ADHD medication,reaffirming our commitment to the ADHD community in providing a range ofeffective treatment options for this disorder."Shire plans to continue development of guanfacine extended release byinitiating a Phase IIIb clinical trial to assess its safety and efficacy inchildren with ADHD who also exhibit oppositional behavior ( )."With this submission, as well as the recent approval and launch of DAYTRANA¢â€ž¢,the regulatory submission of SPD465, and the anticipated FDA response thisOctober concerning NRP104, we have been successful in advancing our ADHDpipeline considerably," added Emmens.For further information please contact:Investor Relations Clƒ©a 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 guanfacine extended releaseShire is seeking approval of 1, 2, 2.5, 3, 3.5 and 4 mg once-daily GuanfacineExtended Release doses for the control of ADHD symptoms throughout the day inchildren aged 6 to 17 years. The Guanfacine Extended Release NDA includes datafrom two placebo-controlled trials in children and adolescents ages 6 to 17evaluating the compound's safety and efficacy in controlling ADHD symptomsevaluated on a once-weekly basis using the ADHD Rating Scale-IV, which includedboth hyperactive/impulsive and inattentive subscales.Guanfacine extended release is a once-daily formulation of the selectivealpha-2A-adrenoceptor agonist. Unlike some other ADHD treatments, guanfacineextended release is not a central nervous system stimulant or a controlledsubstance and has no known potential for abuse or dependence.Adrenergic receptors are present on almost all kinds of cells in the body andact as receptors for two neurotransmitters, epinephrine (adrenaline) andnorepinephrine, used by nerve cells to communicate. An agonist is a moleculethat acts similar to these neurotransmitters by also binding to receptors. Itis hypothesized that guanfacine HCl binds to the alpha-2A-adrenergic cellreceptor to act directly in the part of the brain called the prefrontal cortex,an area that is associated with working memory, behavioral inhibition,attention and cognitive control, as well as the ability to orchestrate thoughtand action.About ADHDADHD affects approximately 7.8 percent of all school-age children, or about 4.4million children in the U.S. 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. While there is no"cure" for ADHD, medication can be an effective part of a treatment plan tomanage your child's ADHD symptoms.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 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 CONNEXYN¢â€ž¢ (SPD503) (ADHD), SPD465 (ADHD),MESAVANCE TM (SPD476) (ulcerative colitis), and NRP104 (ADHD), including itsscheduling classification by the Drug Enforcement Administration in the UnitedStates; 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, particularly Shireplc's Annual Report on Form 10-K for the year ended December 31, 2005. # # # 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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