The gastro-intestinal (GI) therapeutic area is a specialty market with high, unmet needs. Its size, in terms of both revenue and the number of specialist physicians practicing in the area, makes this an attractive market that fits well with Shire's specialty-driven model. We can add value in this sector by using our particular capabilities, resources and expertise to bring specialist projects through the development and registration phases quickly. Our focused sales and marketing network, which targets specialist GI physicians, is well positioned to ensure market success in the commercialization phase.

Shire already has a long and successful history of working in GI therapeutic areas with PENTASA in the US and COLAZIDE in Europe and we are planning to expand our presence in GI medicine. The establishment of a Strategic Therapeutic Area Team (STAT) dedicated to this segment will enable us to work better and more collaboratively across borders to meet common goals. In addition to bringing a more global focus to our product strategy, it will also be conducive to faster product development, registration and commercialization. At the same time, it will enable Shire to evaluate potential GI products for their multinational potential more effectively.

We intend to extend and optimize new uses for our products through the STAT, both in existing and in new territories and to build a truly global franchise in this promising market segment.

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Ulcerative colitis: PENTASA and COLAZIDE

Ulcerative colitis is a chronic, relapsing type of inflammatory bowel disease in which part, or all, of the large intestine becomes inflamed and often ulcerated. Patients experience intermittent attacks separated by periods of remission, and can suffer from diarrhoea, bleeding and abdominal pain. About 30% of people with ulcerative colitis eventually undergo surgery, typically after 15 to 25 years of disease.

The mainstay treatment for inflammatory bowel disease is mesalamine (5-ASA) products. Our leading ulcerative colitis product, PENTASA, delivers mesalamine throughout the small and large bowel. In the US, Shire markets PENTASA as a 250mg capsule and in 2004 introduced a 500mg capsule to offer patients a more convenient and less burdensome formulation, as well as allowing physicians another prescribing option. Shire also markets COLAZIDE (balsalazide), an oral mesalamine formulation for the treatment of ulcerative colitis, in the UK and other European markets. Both products performed according to expectations in 2004, with PENTASA holding a 17.6% share of the US mesalamine market and COLAZIDE a 6% share of the UK market.

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A growing pipeline: SPD476 and SPD480

SPD476, a novel system for the delivery of an unprecedented 1.2g mesalamine, is in Phase 3 clinical development and nearing completion of pivotal clinical trials. This technology uses a proprietary system for targeting the release of high concentrations of mesalamine throughout the length of the colon, with the potential to reduce the burden for ulcerative colitis patients of having to take large numbers of tablets. In May 2002 Shire announced the in-licensing of the rights to this technology in North America, Europe (excluding Italy) and Japan under an agreement with Giuliani S.p.A. (this was extended to the Pacific Rim, Australia and New Zealand in 2003). Filings for regulatory approval of SPD476 are scheduled to be made in the US and Europe in the second half of 2005, and it will be Shire's third global product after FOSRENOL and XAGRID/AGRYLIN.

Although mesalamine is an existing and well-known treatment for ulcerative colitis, we believe SPD476 may improve its ease of use by being available in a once-daily or twice-daily formulation. This will help patients adhere to their medication and live better lives.

SPD480 is a rectally administered mesalamine aerosol foam for the treatment of certain types of ulcerative colitis and is also in the advanced stages of development (Phase 2). This formulation, in-licensed from Giuliani S.p.A., may also assist patients to adhere to their medication, as it may be more acceptable and easier to use than conventional liquid enema treatments.

In addition to developing SPD476 and SPD480, Shire is actively evaluating a variety of GI licensing and acquisition opportunities that will expand our GI product portfolio and contribute to our future growth.

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