Shire Provides Update on Biologics License Application (BLA) Filing forREPLAGAL (agalsidase alfa) with the U.S. Food and Drug Administration (FDA)Cambridge, Massachusetts, US – February 24, 2010 – Shire plc (LSE: SHP, NASDAQ:SHPGY), the global specialty biopharmaceutical company, announces it hasreceived Fast Track designation from the FDA for REPLAGAL (agalsidase alfa),its enzyme replacement therapy for Fabry disease.Shire filed a BLA for REPLAGAL in December 2009. The FDA requested additionalhuman pharmacokinetic data to confirm comparability between product that wasmanufactured in roller bottles, and that which is manufactured in bioreactors.Product made by the bioreactor process is already approved for commercial usein the European Union as well as a number of other countries.As a result of this request, Shire withdrew its December BLA filing, and, atthe suggestion of the FDA, requested and received Fast Track designation. Shirewill immediately initiate the rolling submission of the REPLAGAL BLA, and willsubmit the requested pharmacokinetic data around mid-year.Fast Track designation is an FDA-approved process that facilitates thedevelopment and expedites the review of drugs to treat serious diseases andfill an unmet medical need with the goal of getting important new treatments topatients earlier. This process allows a company to file the sections of the BLAas they become available instead of filing all the sections at once. It alsoenables the agency to commence its review and proceed on a rolling basis as theadditional sections are completed and submitted for review."We will continue to work closely with the FDA in the coming months on therolling BLA submission for REPLAGAL, "said Sylvie Grgoire, President, ShireHuman Genetic Therapies. "We remain committed to continuing to provide Fabrypatients in the United States with REPLAGAL under the treatment protocol."REPLAGAL is currently approved for the treatment of Fabry disease in 45countries and has been available to U.S. patients since December 2009 under anFDA-approved treatment protocol filed at the request of FDA. The REPLAGAL earlyaccess program was put in place as a result of the supply disruption of theonly currently marketed treatment for Fabry disease in the U.S.Financial guidance for 2010 provided in Shire’s year-end results press releaseand earnings call on February 19, 2010 remains unchanged.About REPLAGAL (agalsidase alfa)REPLAGAL is a human form of enzyme alpha-galactosidase A (a-Gal A) manufacturedin a human cell line by gene activation. REPLAGAL is approved in 45 countriesworldwide. REPLAGAL is not currently approved for commercial sale in the U.S.REPLAGAL is the only human-cell-line-derived form of enzyme replacement therapy(ERT) that is indicated for the long-term treatment of patients with aconfirmed diagnosis of Fabry disease (-galactosidase A deficiency).About Fabry diseaseFabry disease is a lysosomal storage disorder (LSD) that interferes with thebody’s ability to break down a specific fatty substance (globotriaosylceramideor Gb3) which accumulates within the body due to deficiency of a specificenzyme (-galactosidase A).Fabry disease affects both males and females and can present with a number ofsigns or symptoms of variable degree, such as cardiovascular and/or renaldysfunction, intense or burning pain, heat intolerance, skin lesions,gastrointestinal complaints, hearing loss, and ocular problems.Lifespan is typically reduced in patients with Fabry disease by approximately20 years in men and 15 years in women, compared with the general population.1,2The principal causes of death are renal failure, cardiomyopathy andcerebrovascular events (e.g. stroke).3Fabry disease affects an estimated 8,000 to 10,000 people worldwide.References1. MacDermot KD, Holmes A, Miners AH. Anderson-Fabry disease: clinicalmanifestations and impact of disease in a cohort of 60 obligate carrierfemales. J Med Genet 2001;38:769-75.2. MacDermot KD, Holmes A, Miners AH. Natural history of Fabry disease inaffected males and obligate carrier females. J Inherit Metab Dis 2001;24 Suppl2:13-14.3. Mehta A, Widmer U. Natural history of Fabry disease. In: Mehta A, Beck M,Sunder-Plassmann G, editors. Fabry disease: perspectives from 5 years of FOS.Oxford: Oxford PharmaGenesis Ltd; 2006: p. 183-8.For further information please contact:Investor Cla Rosenfeld (Rest of the World) +44 1256 894 160Relations Eric Rojas (North America) +1 617 551 9715Media Jessica Mann (Rest of the World) +44 1256 894 280 Jessica Cotrone (North America, HGT) +1 781 482 9538Notes to editorsSHIRE PLCShire’s strategic goal is to become the leading specialty biopharmaceuticalcompany that focuses on meeting the needs of the specialist physician. Shirefocuses its business on attention deficit hyperactivity disorder (ADHD), humangenetic therapies (HGT) and gastrointestinal (GI) diseases as well asopportunities in other therapeutic areas to the extent they arise throughacquisitions. Shire’s in-licensing, merger and acquisition efforts are focusedon products in specialist markets with strong intellectual property protectionand global rights. Shire believes that a carefully selected and balancedportfolio of products with strategically aligned and relatively small-scalesales forces will deliver strong results.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, the Company’s results could be materially adverselyaffected. The risks and uncertainties include, but are not limited to, risksassociated with: the inherent uncertainty of research, development, approval,reimbursement, manufacturing and commercialization of the Company’s SpecialtyPharmaceutical and Human Genetic Therapies products, as well as the ability tosecure and integrate new products for commercialization and/or development;government regulation of the Company’s products; the Company’s ability tomanufacture its products in sufficient quantities to meet demand; the impact ofcompetitive therapies on the Company’s products; the Company’s ability toregister, maintain and enforce patents and other intellectual property rightsrelating to its products; the Company’s ability to obtain and maintaingovernment and other third-party reimbursement for its products; and otherrisks and uncertainties detailed from time to time in the Company’s filingswith the Securities and Exchange Commission.Registered in Jersey, No. 99854, 22 Grenville Street, St Helier, Jersey JE4 8PXPress Releasewww.shire.comEND(c) 2010 PR Newswire Europe Limited. All Rights Reserved., All Rights Reserved.

In the corner of the lab of Shire Human Genetic Therapies in Cambridge, you'll find a guy with DEVELOPMENT SPECIALIST written across his lab coat, unassumingly purifying proteins. But if you wanted to find this science guy two months ago, you would've needed an extensive GPS system and a boatload of courage. And even then, you may not have tracked him down — after all, the jungles and deserted roads of the Amazon aren't exactly tourist-friendly.

For 10 weeks last fall, Somerville resident Douglas Gunzelmann trekked the TransAmazonica, a 3700-mile highway through South America, on a bicycle — something only a handful of people have accomplished. Here's an added Digital Age novelty: he blogged about it the whole time, at amazonpilgrim.com. The blog chronicles his journey in nine chapters, with photos and an interactive map that tracked his progress from Lima, Peru, to the mouth of the river in Belem. Not only is Gunzelmann a survivor, then; he's also resourceful enough to find an Internet connection in the middle of Brazilian boonies.

Even more incredible: this Bostonian had almost zero background in long-distance cycling and minimal Portuguese-language skills. But he wasn't completely unprepared. "My research was googling," Gunzelmann offers, adding, "Training didn't consist of much."

Confessedly a man who is prone to conjuring up far-fetched plans, Gunzelmann was this time decisive about his trek, inspired by a National Geographic article. "I said, 'I'm going to do this."

He took four months off his lab day job and, further endowing the trip with purpose, began his journey on his 29th birthday. Riding took up most of his time, as Gunzelmann cycled as many as 12 hours per day. As he rode by shantytowns, some so desolate they were named by the kilometer marker on the road, Gunzelmann witnessed class divisions of the indigenous and mestizo peoples, the prevalence of drinking by the few truck drivers on the road, and the occasional rioting that led to impassable streets.

"What I imagined my journey would be barely resembles what I found," Gunzelmann admits on his blog. But his lack of experience didn't thwart the events that followed. He ate sheep brains and watched cock fights, held a poacher's gun and a machete, and now knows the difference between a puma and a jaguar thanks to personal experience.

Asked if he'll be doing anything like this again, Gunzelmann hesitates: "One crazy thing at a time."