10th May 2005 12:45
PRODUCT DEVELOPMENT UPDATE SESSION - May 10thBasingstoke, UK and Philadelphia, PA - 10 May 2005 - Shire PharmaceuticalsGroup plc (LSE: SHP, NASDAQ: SHPGY; TSX: SHQ) today provided an update on itsdevelopment pipeline via a webcast presentation and conference call. MatthewEmmens, Chief Executive Officer, offered introductory remarks, with the mainsession then hosted by Eliseo Salinas, Chief Scientific Officer and GregFlexter, Executive Vice President and General Manager, North America.Matthew Emmens, Chief Executive Officer, said:"During 2004, we received six new drug approvals in Europe and in the US - a100% success rate and a record for the Company. During 2005 Shire aims to buildon that success with the planned filings of four key products that are intendedto build its leadership position in the ADHD market and expand its offerings inthe GI market."UPDATE SESSION DETAILSThe briefing focused on Phase 2 and Phase 3 data for four key Shire developmentcandidates within the Central Nervous System (CNS) and Gastrointestinal (GI)therapeutic areas: MTS (ADHD), SPD503 (ADHD), NRP104 (ADHD) and SPD476(ulcerative colitis). Highlights of the update were as follows:CNS - ADHDMTS (methylphenidate transdermal system)MTS is a methylphenidate-containing transdermal patch being developed inconjunction with Noven Pharmaceuticals Inc. * Phase 2 double-blind, placebo-controlled analog classroom study (n = 80) met its primary endpoint and showed significant improvement in performance and behavior versus placebo, with a safety profile consistent with that reported for approved oral methylphenidate products. * Phase 3 double-blind, placebo-controlled naturalistic study (n = 268) met its primary endpoint and showed significant improvement in performance and behavior versus placebo, with a safety profile consistent with that reported for approved oral methylphenidate products. * Class II resubmission targeted for Q2 2005. Subject to 6 month review period. SPD503 (guanfacine)SPD503, guanfacine hydrochloride in extended-release tablets, is anon-stimulant, non-scheduled product with a differentiated mechanism of actionfor treating ADHD. * Phase 3 randomized, double-blind, parallel-group, placebo-controlled safety and efficacy studies in children and adolescents aged 6-17 with ADHD met primary endpoints as determined by the ADHD Rating Scale versus placebo. Sedation and fatigue were the most common adverse events, with a greater incidence at the higher doses. * Anticipated Q4 2005 submission. NRP104NRP104 is a novel prodrug of d-amphetamine with reduced abuse potential beingdeveloped in collaboration with New River Pharmaceuticals Inc. * A Phase 2 trial presented by New River Pharmaceuticals in March, 2005 showed patients treated with NRP104 demonstrated statistically significant improvement on a primary endpoint compared to placebo across all three doses, with adverse events consistent with other stimulant ADHD therapies. * Results from a Phase 3 trial will be presented by New River Pharmaceuticals at the 2005 UBS Global Pharmaceuticals Conference on Monday, May 23, 2005 in New York City. * Anticipated New River Pharmaceuticals submission in Q4 2005. GISPD476A novel hydrophilic matrix formulation of 5-ASA (aminosalicylate) for thetreatment of ulcerative colitis. Shire's first global gastrointestinal productopportunity. * Phase 3 trials demonstrated significant improvement over placebo for the primary endpoint of remission in patients with acute, mild to moderate ulcerative colitis with adverse events comparable to placebo. * Anticipated Q3 2005 submission. ENDS The details of the live conference call which starts at 9 am EDT / 2 pm BST areas follows:UK dial in +44 (0) 1452 568 061 US / Canada dial in +1 866 224 2972 Password Shire Live Webcast:The call will also be available live over the Internet via audio webcast,accessible through www.shire.com in the Investor Relations section. A slidepresentation to accompany the call will also be available on the Shire websiteduring the call.Archived Presentation:The presentation will be available through www.shire.com in the InvestorRelations section.For further information please contact:Investor Relations Clea Rosenfeld (Rest of 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 projects and marketing products in theareas of central nervous system (CNS), gastrointestinal (GI), and renaldiseases. Shire has operations in the world's key pharmaceutical markets (US,Canada, UK, France, Italy, Spain and Germany) as well as a specialist drugdelivery unit in the US.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, 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 ADHD franchise,patents, including but not limited to, legal challenges relating to Shire'sADHD franchise, government regulation and approval, including but not limitedto Health Canada's suspension of ADDERALL XR sales in Canada and the expectedproduct approval dates of MTS (METHYPATCH) (ADHD), SPD503 (ADHD), SPD465(ADHD), SPD476 (ulcerative colitis), SPD480 (ulcerative colitis) and NRP104(ADHD), including its scheduling classification by the Drug Enforcement Agencyin the United States, Shire's ability to consummate and benefit from itsproposed acquisition of Transkaryotic Therapies inc. (TKT), Shire's ability tosecure new products for commercialization and/or development and other risksand uncertainties detailed from time to time in Shire's filings with theSecurities and Exchange Commission, including its Annual Report on Form 10-Kfor the year to December 31, 2004.New RiverNew River Pharmaceuticals Inc. is a specialty pharmaceutical company focused ondeveloping novel pharmaceuticals that are safer and improved versions of widelyprescribed drugs, including amphetamines and opioids. For further informationon New River, please visit the company's website at www.nrpharma.com.Noven Pharmaceuticals, Inc.Noven 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 withNovartis Pharma AG, Shire Pharmaceuticals Group plc, P&G Pharmaceuticals, EndoPharmaceuticals Inc. and others. With the most advanced and broadly applicabletransdermal technology in its class, Noven is committed to expanding theuniverse of available transdermal therapies for the benefit of patients,partners and shareholders. See www.noven.com for additional information.Cosmo SpAThe formulation for SPD476 was developed by Cosmo SpA. Cosmo also owns the drugdelivery and process patents covering this compound. Cosmo SpA is an R&D basedpharmaceutical company. Its R&D covers advanced drug delivery with applicationsin gastro intestinal disorders, new chemical entities and biotechnology. Inaddition, it manufactures pharmaceuticals and offers development services toother pharmaceutical companies. Cosmo is based in Lainate (Milan), Italy, whereits production plant and principal R&D laboratories are situated. Itsbiotechnology R&D is located in La Jolla, California, USA. 4 1Hampshire 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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