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Publication of Shire plc's Annual Report 2008
Date:3/25/2009

if government regulation is stricter for the Group's new products than for existing treatments; - if the new products suffer a loss of patent protection or competitors successfully challenge or circumvent the Group's patents or regulatory exclusivity; - if planned geographical expansion into emerging markets is not successful; or - if the size of the patient population for the new product is less than expected or the Group fails to identify new patients for the new products.

If the Group is unable to commercialize ELAPRASE, VYVANSE, LIALDA, FIRAZYR, FOSRENOL (ROW) or any of its new products successfully, there may be a material adverse effect on the Group's revenues, financial condition and results of operations.

Any decrease in the combined sales of VYVANSE and ADDERALL XR will significantly reduce revenues and earnings

In 2008, the combined sales of VYVANSE and ADDERALL XR were $1,420.6 million, representing approximately 47% of the Group's total revenues. Sales of ADDERALL XR are expected to decrease significantly due to generic competition that is anticipated to commence on April 1, 2009. Any factors that decrease the sales of ADDERALL XR more significantly than expected could have a material adverse effect on the Group's financial condition and results of operations. In addition, the entrance of generic competitors for ADDERALL XR or other leading attention deficit and hyperactivity disorder ('ADHD') medications could impact the sales of VYVANSE. Other factors that could impact the sales of VYVANSE or ADDERALL XR include, but are not limited to:

    - faster than anticipated erosion of ADDERALL XR sales by
      generic competitors;

    - the development and marketing of competitive pharmaceuticals to VYVANSE
      and ADDERALL XR;

    - issues impacting the production of VYVANSE or ADDERALL XR or the supply
      of 
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SOURCE  Shire Plc
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