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Shire Second Quarter Product Sales Up 16%
Date:8/1/2012

by changing profit mix, we now expect our full year Non GAAP effective tax rate to be in the range of 18% to 20% in 2012. We believe this now represents a good planning range for our core effective tax rate until at least the end of 2014.

Overall, we are on track to deliver double digit full year earnings growth in 2012.

In 2013, the total revenues from ADDERALL XR will reduce following the recent launch of a generic competitor. We are monitoring the impact of this and other dynamics, prioritizing our investments and carefully managing our cost base. Our objective is to deliver sound earnings growth in 2013, and increased growth beyond that, driven by our young and diversified product portfolio and the significant market opportunities we have identified.

SECOND QUARTER 2012 AND RECENT PRODUCT AND PIPELINE DEVELOPMENTS


Products


ADDERALL XR - for the treatment of Attention Deficit Hyperactivity Disorder ("ADHD")

  • On June 22, 2012 the US Food and Drug Administration ("FDA") responded to Shire's ADDERALL XR citizen petition. The FDA's response requires that all abbreviated new drug applications ("ANDAs") must establish bioequivalence using partial area under the curve measurements at five hours and beyond five hours, for both d- and l- amphetamine.

    The FDA also approved the ANDA for generic ADDERALL XR filed by Actavis Elizabeth LLC ("Actavis"). Shire is not aware of the FDA having approved any other ADDERALL XR ANDAs.

    The approval of Actavis' ANDA has resulted in a significant reduction to the royalty rate payable on sales of authorized generic ADDERALL XR by Impax Laboratories Inc. ("Impax"). This reduction will be partially offset by a small royalty payable by Actavis, and Shire now expects lower ADDERALL XR royalty income in future periods. There are other variables which could also affect the future revenue stream from ADDERALL XR, including, but not limit
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SOURCE Shire plc
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4. Shire Announces that the US Food and Drug Administration has Responded to its Citizen Petition for Adderall XR and has Approved One Abbreviated New Drug Application for Generic Adderall XR
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