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Publication of Shire plc's Annual Report 2008

the Company's filings with the Securities and Exchange Commission.

    1. Principal Risks and Uncertainties
    The Group's new products may not be a commercial success

Shire has launched a number of new products in the last four years, including key new products ELAPRASE, VYVANSE, LIALDA, FIRAZYR and FOSRENOL (Rest of World ('ROW')). The commercial success of these new products, as well as other new products that the Group may launch in the future, will depend on their approval and acceptance by physicians, patients and other key decision-makers, as well as the timing of the receipt of marketing approvals, the scope of marketing approvals as reflected in the product's label, the countries in which such approvals are obtained, the authorization of price and reimbursement in those countries where price and reimbursement is negotiated, and safety, efficacy, convenience and cost-effectiveness of the product as compared to competitive products.

The Group may not be able to grow revenues in its new products as quickly as anticipated if any or all of the following occur:

    - if competitive products are genericised and the impact on the market
      negatively affects the prescribing of branded treatments for the
      indications that the Group's new products treat;

    - if there are unanticipated adverse events experienced with the Group's
      new products not seen in clinical trials that impact the physician's
      willingness to prescribe the Group's new products;

    - if issues arise from clinical trials being conducted for post marketing
      purposes or for registration in another country or regulatory agencies
      in one country act in a way that causes concern for prescribers or
      patients in another country;

    - if patients, payors or physicians favor older treatments over newer

SOURCE Shire Plc
Copyright©2009 PR Newswire.
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