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Shire Provides Update on U.S. Marketing Application of Mesavance (mesalamine) With MMX Technology

PHILADELPHIA and BASINGSTOKE, England, September 8, 2006 -- Shire plc announces that the Food and Drug Administration (FDA) has extended by 90 days the review period for the new drug application (NDA) for Mesavance. This extension has been sought by the FDA to allow additional time to review supplemental Phase I data recently submitted by Shire. Shire and FDA agreed prior to submission that this data would be submitted during the review process. The FDA advised us at close of US business yesterday that the new action date for the application is January 21, 2007.

"Shire will continue to work closely with the FDA during this brief extension of the Mesavance NDA review," said Matthew Emmens, Chief Executive Officer of Shire. "We still anticipate Mesavance will be approved and launched in the US and Europe during the first quarter 2007."

Source: Shire plc

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Posted: September 2006

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