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

nt tools for employees; development and commencement of rollout of corporate brand positioning; and maintenance of robust risk management practices including internal controls.

The markets in which the Group conducts its business are highly competitive and highly regulated. The health care industry is experiencing:

    - pressure from governments and healthcare providers to keep prices low
      while increasing access to drugs;

    - increased R&D costs as development programs are typically larger and
      take longer to get approval from regulators;

    - challenges to existing patents from generic manufacturers;

    - low cost generic drugs entering the market on expiration of patent
      protection; and

    - higher marketing costs due to the use of direct to consumer campaigns
      in the US and competition for market share.

Shire's strategy to become the leading specialty biopharmaceutical company has been developed to address these industry-wide competitive pressures. This strategy has resulted in a series of initiatives in the following areas:

Markets

Historically, Shire's portfolio of approved products has been heavily weighted towards the North American market. With the acquisition of Transkaryotic Therapies Inc ('TKT') in 2005 and the establishment of our HGT business, Shire has substantially increased its presence in Europe and thereby diversified the risk associated with being reliant on one geographic market. Through the TKT acquisition, Shire acquired ELAPRASE (global rights) and REPLAGAL (which is presently sold only outside the US) and through the Jerini acquisition, FIRAZYR (global rights). In addition, 2008 saw the European launch of FIRAZYR and the continued roll out of MEZAVANT and FOSRENOL in Europe.

For 2008, sales outside North America represented approximately 24% of product sales (2007: 24%). Shire's late stage deve
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SOURCE Shire Plc
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