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Shire Provides Update on Biologics License Application (BLA) Filing for REPLAGAL(R) (agalsidase alfa) With the U.S. Food and Drug Administration (FDA)
Date:2/24/2010

CAMBRIDGE, Massachusetts, February 24, 2010 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, announces it has received Fast Track designation from the FDA for REPLAGAL(R) (agalsidase alfa), its enzyme replacement therapy for Fabry disease.

Shire filed a BLA for REPLAGAL in December 2009. The FDA requested additional human pharmacokinetic data to confirm comparability between product that was manufactured in roller bottles, and that which is manufactured in bioreactors. Product made by the bioreactor process is already approved for commercial use in the European Union as well as a number of other countries.


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