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Publication of Shire plc's Annual Report 2008

amphetamine salts including but not limited to the ability to get sufficient quota from the US Drug Enforcement Agency ('DEA'); - technological advances (including the approval of new competing products for ADHD treatments); - changes in reimbursement policies of third-party payers; - government action/intervention; - marketing or pricing actions by competitors; - public opinion towards ADHD treatments; - any change in the label or other such regulatory intervention; - product liability claims; and - changes in prescription-writing practices.

Any decrease in the sales of 3TC could significantly reduce earnings

The Group receives royalties from GlaxoSmithKline ('GSK') on the worldwide sales of 3TC. In 2008, the Group's royalty income relating to 3TC sales was $140.2 million (2007: $145.3 million). This royalty income stream generates a larger proportion of net income relative to the Group's own product sales as there are minimal costs associated with its generation.

Any factors that decrease sales of 3TC by GSK could significantly reduce the Group's earnings. These include:

    - development and marketing of competitive pharmaceuticals,
      including generic versions;

    - loss of patent protection or ability of competitors to
      challenge or circumvent patents;

    - reduction in the production of 3TC;

    - technological advances;

    - government action/intervention;

    - marketing or pricing actions by GSK's competitors;

    - any change in the label or other such regulatory intervention;

    - public opinion towards AIDS treatments; and

    - product liability claims.

The failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payers in a timely manner for certain of the Group's products and parallel importation may impact future re

SOURCE Shire Plc
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