3rd Feb 2006 12:00
Shire announces European filings of SPD476 (mesalazine) for treatment ofulcerative colitisPhiladelphia, US and Basingstoke, UK - February 3, 2006 -- Shire plc (LSE: SHP,NASDAQ: SHPGY, TSX: SHQ) announced today that it has submitted MarketingAuthorization Applications to European Regulatory Agencies for SPD476, aninvestigational compound being studied for the induction and maintenance ofclinical and endoscopic remission in patients with active mild-to-moderateulcerative colitis. If approved, SPD476 would offer a once-daily mesalazinetreatment for active mild to moderate ulcerative colitis."The European submissions for SPD476 represent the achievement of anotherimportant milestone for Shire," said Shire Chief Executive Matthew Emmens."Currently there is no once-daily oral treatment for ulcerative colitis so welook forward to offering patients the efficacy and convenience of SPD476."Last year the mesalazine market segment for ulcerative colitis, in which SPD476will compete, was worth around $1.6 billion.As previously announced, Shire submitted a New Drug Application for SPD476 tothe U.S. Food & Drug Administration in December 2005. Shire also recently fileda New Drug Submission for SPD476 with Health Canada.SPD476 is the only ulcerative colitis treatment that utilizes novel MMX MultiMatrix SystemTM (MMX) drug delivery technology to provide delayed and extendedrelease of mesalazine throughout the colon. Shire has licensed from GiulianiS.p.A. the exclusive rights to develop and commercialize SPD476 in the US,Canada, Europe (excluding Italy) and the Pacific Rim. Giuliani S.p.A. retainsthe development and commercialization rights to SPD476 in Italy. MMX wasdeveloped by Cosmo S.p.A. -ends- 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 editorsSPD476SPD476 is a novel, high-dose 5-aminosalicylic acid (5-ASA; mesalazine) in adelayed and extended release formulation (MMX) being studied for the inductionand maintenance of remission of active, mild-to-moderate ulcerative colitis.The most common adverse events reported in SPD476 Phase III studies wereflatulence, nausea or headaches, which were not dose related and occurred inless than 3% of patients receiving SPD476.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 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.Giuliani S.p.A.Giuliani S.p.A., founded in 1889, is a privately owned specialty pharmaceuticalcompany with Headquarters in Milan, Italy. It develops new products with highunmet medical need and substantial market opportunity. It is focused ondeveloping and marketing products for the treatment and management ofgastrointestinal (ulcerative colitis and Crohn's disease), metabolic (foodintolerance) and dermatological (hair loss) disorders.Cosmo S.p.A.The 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."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), SPD476 (ulcerative colitis), ELAPRASE TM (idursulfase)(Hunter syndrome) and NRP104 (ADHD), including its scheduling classification bythe Drug Enforcement Administration in the United States; Shire plc's abilityto benefit 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 Pharmaceuticals Group plc'sAnnual Report on Form 10-K for the year ended December 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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