17th May 2006 12:00
Shire Provides Update on U.S. Marketing Application of ELAPRASE(TM)Cambridge, MA US and Basingstoke, UK - May 17, 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 biologics license application(BLA) for ELAPRASE(TM) (idursulfase). This extension will allow the FDAadditional time to review data and analyses they recently requested duringlabel discussions. Therefore, the FDA advised us at close of US businessyesterday that the new action date for the application is August 24, 2006."Shire will continue to work closely with the FDA during this brief extensionof the ELAPRASE BLA review and through this cooperative effort we expect thatELAPRASE will be approved and launched by the third quarter 2006," said MatthewEmmens, Chief Executive Officer of Shire. "There is no existing treatment forpatients with Hunter syndrome and Shire is confident that the FDA recognizesthe importance of making ELAPRASE available to these patients."The US BLA for ELAPRASE was submitted in November 2005 and was granted priorityreview, requiring the FDA to take action within six months. A marketingauthorization application for ELAPRASE has been submitted to the EuropeanMedicines Agency, and Shire expects a response on that application before theend of the year.ELAPRASE has been developed for the treatment of Hunter syndrome, a seriousgenetic disorder, mainly affecting males, that interferes with the body'sability to break down and recycle specific chemicals calledmucopolysaccharides, also known as glycosaminoglycans or GAG. Hunter syndromeis one of several related lysosomal storage diseases. -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 editorsAbout Hunter SyndromeHunter syndrome (MPS II) is a serious genetic disorder mainly affecting malesthat interferes with the body's ability to break down and recycle specificchemicals called mucopolysaccharides, also known as glycosaminoglycans or GAG.Hunter syndrome is one of several related lysosomal storage diseases.Shire estimates there are approximately 2,000 patients worldwide afflicted withHunter syndrome in countries where reimbursement may be possible.More information about Hunter syndrome can be found at http://www.hunterpatients.com.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. The structure is sufficiently flexible toallow Shire to target new therapeutic areas to the extent opportunities arisethrough acquisitions. Shire believes that a carefully selected portfolio ofproducts with a strategically aligned and relatively small-scale sales forcewill 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 risks oruncertainties materialize, Shire plc's results could be materially affected.The risks and uncertainties include, but are not limited to: risks associatedwith the 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 plc's AttentionDeficit and Hyperactivity Disorder ("ADHD") franchise; patents, including butnot limited to, legal challenges relating to Shire plc's ADHD franchise;government regulation and approval, including but not limited to the expectedproduct approval dates of SPD503 (ADHD), SPD465 (ADHD), MESAVANCE TM (SPD476)(ulcerative colitis), ELAPRASE TM (I2S) (Hunter syndrome) and NRP104 (ADHD),including its scheduling classification by the Drug Enforcement Administrationin the United States; Shire plc's ability to benefit from the acquisition ofTranskaryotic Therapies Inc.; Shire plc's ability to secure new products forcommercialization and/or development; and other risks and uncertaintiesdetailed from time to time in Shire plc's and its predecessor registrant ShirePharmaceuticals Group plc's filings with the US Securities and ExchangeCommission, including Shire plc's Annual Report on Form 10-K for the year endedDecember 31, 2005.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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