Shire plc

Gastro-Intestinal (GI)

Mike Yasick is unequivocal about his role as head of Shire's GI STAT. 'I lead a diverse group of Shire team members whose objective is to build our GI portfolio and successfully commercialize the GI products we have and optimize our marketed products. We are helping to develop not only global products and strategy in this promising therapeutic area, but also ensuring that we have the optimal financial and human resources available to implement our strategy.'

Mr Yasick is particularly well qualified for the challenge, with 20 years of experience in the pharmaceuticals industry in sales, marketing, new product development and commercialization. He says he was attracted to Shire because it offered the 'perfect mix' between a solid, well-resourced business typical of a big pharmaceutical company and the entrepreneurial environment of a start-up, with a clear mission to be a leading specialist pharma company. The Company's employees are accomplished, energetic and enthusiastic. It is led by a new management team composed both of people who have built Shire into a billion dollar Company as well as people with fresh ideas and best practices from every model of the pharmaceutical industry.

Since taking on his new position in 2004, Mr Yasick has been focusing on implementing Shire's new global operating model in the GI therapy area. 'The biggest challenge has been to put together complete commercialization plans that ensure we have all the bases covered. When you consider the sweeping changes in roles and structure we have seen at Shire in the past year, combined with the challenges of meeting launch objectives and submitting a NDA for our newest product, MESAVANCE, you feel truly rewarded with these achievements!'

Mr Yasick says Shire's GI team has a welldeserved reputation within the Company as being highly collaborative and effective. 'The business model relies on people in the functions and markets working together in product strategy teams led by product general managers and our team has embraced this style of work. Shire is unique in that accountability for performance is shared by the markets, functions and the business. This creates an environment where ideas and initiatives can be challenged and tested by many experts. The result is a development and commercialization process that optimizes the value of our brands for the Company and the help that we provide to patients.'

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The power of teamwork

In Mr Yasick's opinion, strong teamwork will be a key success driver for Shire moving forward. 'You get the most robust analysis and solutions when people with different perspectives work together. The role of STAT is to define the objectives, set metrics to track and evaluate performance and to allow our talented teams to produce the outcomes we need to achieve our goals.' People want to work together when they can see the benefit of their collaboration and when they feel their efforts are valued by the teams, he adds. 'The real motivation for teamwork comes from a shared vision of the future and from creating an environment of empowerment. We have to both trust each other and be willing to challenge each other to achieve the best results.'

The GI STAT is composed of a small, dedicated group of employees with an average of more than 20 years of experience in the pharmaceutical industry. For example, the general manager of MESAVANCE, Roger Adsett, was the US commercial lead for the launch of one of the largest GI brands in the world; and the GI STAT's Scientific Lead, Robyn Karlstadt, is a certified GI physician who has authored dozens of papers and was a writer and editor of a GI section in a text book. Dr Karlstadt was also a key member of the launch team for a multi-billion dollar GI brand. 'Our team knows what makes successful brands and has hands-on experience in executing those plans,' says Mr Yasick. 'Our collective past success is the best reason to be confident in our ability to deliver in the future.'

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Strong track record

The GI STAT will be building on Shire's already strong track record in the GI therapeutic area, leveraging its extensive capabilities, resources and expertise to bring specialist projects through the development and registration phases in the most effective manner. 'With our sales and marketing network targeting GI physicians, we have had considerable success in the commercialization phase,' notes Mr Yasick.

Shire has established itself among the market leaders in drug therapies for UC. UC is a chronic, relapsing type of Inflammatory Bowel Disease (IBD) 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 diarrhoea, bleeding and abdominal pain. The most frequently used treatments for UC are mesalamine-containing products.

Shire has two marketed products containing the mainstay treatment for IBD, mesalamine (5-ASA): PENTASA and COLAZIDE. PENTASA delivers mesalamine throughout the small and large bowel and is marketed in the US in 250mg and 500mg capsules and COLAZIDE is an oral mesalamine formulation for the treatment of UC in the UK. 'PENTASA and COLAZIDE offer us a powerful jumpstart for our efforts to expand our relationship with GI specialists and serve the growing needs of their patients,' affirms Mr Yasick.

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MESAVANCE milestone

The GI STAT achieved a major milestone in 2005 with the filing of a NDA to the FDA for MESAVANCE, which would be the first available once-daily mesalamine treatment for active, mild-to-moderate UC. MAAs for MESAVANCE were submitted during the first quarter of 2006 to the EMEA and the Canadian Regulatory Authorities. 'This is the first simultaneous global regulatory filing for Shire and it represents a terrific effort by the R&D team and the Product Strategy Team to make it happen'.

'We are very excited about the market potential of this new product and by delivering on our promise to achieve these submissions,' says Mr Yasick. 'There are approximately a million patients worldwide with UC and more than 70% of them are being treated with mesalamine-based products. I believe this has a chance to be one of the most important product launches in mild to moderately severe UC in more than five years. The entire Company is behind MESAVANCE and we will launch it with passion and enthusiasm.'

MESAVANCE utilizes a novel multimatrix delivery system to provide the highest strength of 5-ASA* per tablet of any product available. With this technology, UC patients are able to treat their disease for the first time with a once daily dose of medicine. The unique technology ensures continued and prolonged exposure of the colonic mucosa to the active ingredient, allowing 24-hour treatment. The MMX Multi- Matrix System™ which enables this was developed by Cosmo S.p.A and is a patented technology licensed from Giuliani S.p.A. (Giuliani). Shire has commercial and development rights to this technology in the US, Canada, the Pacific Rim and Europe (with the exception of Italy where Giuliani retains all rights). 'Our Phase 3 program was very rigorous. We worked with the FDA, and a panel of global GI experts to create very strict endpoints. Also, in one of our Phase 3 studies, we utilized a reference arm containing Asacol™**, the market leader, at its indicated dose,' notes Mr Yasick. 'Both products showed improvement in symptoms compared to a placebo. However, MESAVANCE showed significantly higher rates of disease remission versus a placebo while Asacol**† did not.'

IBD is a life-long disease that requires constant treatment. Failing to adequately treat IBD can lead to greater numbers of flare-ups, more resource utilization (greater cost), poor quality of life, and greater risk of colorectal cancer. 'MESAVANCE meets a need in the market to improve compliance and reduce pill burden,' says Mr Yasick. 'It also raises the level of performance of this class of drugs. Going beyond simple symptom relief to inducing disease remission is a significant advance in treating UC. Among the pH dependent mesalamine products, only MESAVANCE has been clinically proven to do that†. With PENTASA and MESAVANCE, Shire will have the only two products in their class to demonstrate in clinical studies the ability to control symptoms and induce remission of disease. MESAVANCE will be further differentiated from other products in the class because Shire decided to use the innovative Phase 3 study design. Global experts were surprised that we would be willing to include the market leader as a reference arm, and they were impressed with the results of the studies.'

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Seizing opportunities

Shire's GI STAT is actively evaluating a variety of GI licensing and acquisition opportunities to expand its GI portfolio for the treatment of IBD and other conditions and contribute to future growth. 'IBD is treated with several classes of drugs,' explains Mr Yasick. 'These include anti-TNF and other agents that target pro-inflammatory cytokines, immunosuppressives and glucoticosteroids that are used stepwise and in combination to treat IBD. Given our position with PENTASA, COLAZIDE and MESAVANCE, these would be great additions to the Shire portfolio. In addition, we are looking at other products which GI physicians could use to treat hepatic disorders, non-acid esophageal disorders, pancreatic insufficiency and the like.'

By extending and optimizing new uses for Shire's products through the GI STAT, both in existing and in new territories, Shire intends to build a truly global franchise in this promising market segment. 'We have a team of talented people with a track record of success in GI and in launching products to GI specialists,' says Mr Yasick. 'We intend to make the most of this opportunity we have to create a new standard for the pharmaceuticals industry. Through excellent execution, we intend to prove the value of the specialist pharmaceuticals model.'

  *5-aminosalicylic acid or known as mesalamine or mesalazine.

**Asacol is a trade mark of Proctor & Gamble.

 †Study presented November 1, 2005 at the 70th Annual American College of Gastroenterology in Honolulu, Hawaii.

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