22nd Dec 2005 12:14
Shire announces filing of MESAVANCETM (mesalamine) for treatment of ulcerativecolitisPhiladelphia, US and Basingstoke, UK - December 22, 2005 -- 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 for MESAVANCE(SPD476), an investigational compound being studied for the induction ofclinical and endoscopic remission in patients with active, mild-to-moderateulcerative colitis. If approved, MESAVANCE would be the first availableonce-daily mesalamine treatment for active, mild-to-moderate ulcerativecolitis."The timely filing of our MESAVANCE NDA represents the fourth new productsubmission in 2005 for Shire and our partners," said Shire Chief ExecutiveMatthew Emmens. "We are proud of that achievement and we look forward tooffering the advantages of once-daily MESAVANCE to patients suffering fromulcerative colitis."The submission of a Marketing Authorization Application for MESAVANCE with theEuropean Medicines Agency is planned for first quarter 2006.MESAVANCE is the only ulcerative colitis treatment that utilizes novel MMXMulti Matrix SystemTM (MMX) drug delivery technology to provide delayed andextended release of mesalamine throughout the colon. Shire has licensed fromGiuliani S.p.A. the exclusive right to develop and commercialize MESAVANCE inthe US, Canada, Europe (excluding Italy) and the Pacific Rim. Giuliani S.p.A.retains the development and commercialization rights to SPD476 in Italy. MMXwas developed 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 editorsSPD476 (MESAVANCE)SPD476 is a novel, high-dose 5-aminosalicylic acid (5-ASA; mesalamine) in adelayed and extended release formulation (MMX) being studied for the inductionof remission of active, mild-to-moderate ulcerative colitis. The most commonadverse events reported in SPD476 Phase III studies were headaches (4.5%) andflatulence (3.4%).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), MESAVANCE TM (SPD476) (ulcerative colitis), ELAPRASE TM(idursulfase) (Hunter syndrome) and NRP104 (ADHD), including its schedulingclassification by the Drug Enforcement Administration in the United States;Shire plc's ability to benefit from the acquisition of Transkaryotic TherapiesInc.; 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, including ShirePharmaceuticals Group plc's Annual Report on Form 10-K for the year endedDecember 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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