8th Sep 2006 15:45
Shire Provides Update on U.S. Marketing Application of MESAVANCETM (mesalamine) with MMX technology Philadelphia, PA, US and Basingstoke, UK - September 8, 2006 -- Shire plc (LSE:SHP, NASDAQ: SHPGY, TSX: SHQ) announces that the Food and Drug Administration(FDA) has extended by 90 days the review period for the new drug application(NDA) for MESAVANCETM. This extension has been sought by the FDA to allowadditional time to review supplemental Phase I data recently submitted byShire. Shire and FDA agreed prior to submission that this data would besubmitted during the review process. The FDA advised us at close of US businessyesterday that the new action date for the application is January 21, 2007."Shire will continue to work closely with the FDA during this brief extensionof the MESAVANCE NDA review," said Matthew Emmens, Chief Executive Officer ofShire. "We still anticipate MESAVANCE will be approved and launched in the USand Europe during the first quarter 2007."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 editorsSHIRE 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."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 SPD503 (ADHD), SPD465 (ADHD), MESAVANCE¢â€ž¢(mesalamine with MMX technology) (SPD476) (ulcerative colitis), ELAPRASE¢â€ž¢ (I2S)(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 plc's Annual Report on Form10-K for the year ended December 31, 2005.About Giuliani S.p.A.Giuliani S.p.A., founded in 1889, is a privately owned specialty pharmaceuticalcompany withHeadquarters in Milan, Italy. It develops new products with high unmet medicalneed and substantialmarket opportunity. It is focused on developing and marketing products for thetreatment andmanagement of gastrointestinal (ulcerative colitis and Crohn's disease),metabolic (food intolerance)and dermatological (hair loss) disorders. Shire has licensed from GiulianiS.p.A. the exclusive right to develop and commercialize SPD476 in the US,Canada and Europe (excluding Italy). Giuliani S.p.A. retains the developmentand commercialization rights to SPD476 in Italy. # # # 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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