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

lopment pipeline contains a number of products with rights outside of the US, including VYVANSE, DAYTRANA, velaglucerase alfa (GA-GCB), SPD550, PLICERA, AMIGAL, AT2220 and METAZYM.

Shire's continued expansion beyond North America will be driven by the development of products with patent protection in both the North and Latin American and European markets wherever possible. In 2009 and the 2010, subject to obtaining the relevant regulatory/governmental approvals, regions outside the US should see:

    - the continued roll out of MEZAVANT in certain EU countries;

    - the launch of DAYTRANA (EU and Canada);

    - the continued roll out of FIRAZYR in certain European and Latin
      American countries;

    - the launch of VYVANSE in Canada; and

    - the launch of Velaglucerase alfa in the EU.

This program of new product launches will require significant investment in advertising, promotional spend and in some cases, additional sales representatives.

The orphan disease nature of HGT products means that relatively low associated Selling, general and administrative ('SG&A') and sales infrastructure investment is required, making them ideal products for Shire to launch into new markets. In markets outside North America and Europe where products require significant SG&A and infrastructure investment, Shire will assess opportunities for internal investment versus distribution and/or out-license partners on a country-by-country basis.

Patents and Market Exclusivity

The loss or expiration of patent protection or market exclusivity with respect to any of the Group's major products could have a material adverse effect on future revenues and net income as generic manufacturers may produce similar drugs and be able to sell the Group's drugs at a lower price as their costs of development are significantly lower than Shire's.

The Group antic
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SOURCE Shire Plc
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