Focus on the science

Drug development at Specialty Pharma.

In many ways the research and development activity in our Specialty Pharma business looks very similar to what you would expect to find in a traditional pharmaceutical R&D department. The same protocols apply, and there's exactly the same need to take a new product through all the phases of pre-clinical and clinical trials. The most notable difference will be in the fact that Shire Specialty Pharma's R&D team focuses on late-stage products that can be brought to market quickly, and carry far lower risk, both for the Company, and its investors.

Specialty Pharma has also developed a significant expertize in applying proven technologies to produce new treatments. For example, we acquired the so-called 'CarrierWave' process as part of our acquisition of New River in 2007. Our main objective in buying that company was to develop a nextgeneration ADHD product to succeed ADDERALL XR, and we're already seeing the proof of that in the successful launch, and huge potential, of VYVANSE. But the technology that makes VYVANSE so effective, by using peptide chains and amino-acids to enhance the metabolism of the drug, could also have many other uses in other therapeutic areas. The Specialty Pharma Emerging business unit is actively seeking new opportunities to exploit 'CarrierWave' technology.

The gastrointestinal business unit is another good example. Specialty Pharma has particular expertise in the treatment of ulcerative colitis, with the number two treatment in the US Oral 5-ASA market*, but there are opportunities for Shire across the whole range of Inflammatory Bowel diseases, which are all treated by the same specialist gastro-enterologists. This might range from liver disease, to pancreatic enzyme replacement, which is particularly crucial for Cystic Fibrosis patients. The only treatment currently available here is derived from pig enzymes, but a human-derived compound might well be more effective. There could be a real opportunity for us here, which might also generate opportunities for Specialty Pharma and HGT to work collaboratively together.

SPD550; currently in Phase 2 of clinical development for Celiac disease and licensed during 2007, could provide the first available treatment for this condition. As Roger Adsett, Senior Vice President of the gastrointestinal business unit, says, “Our track record in developing and launching successful ulcerative colitis treatments, like PENTASA and LIALDA, make us an attractive business partner for companies who are looking to commercialize new compounds for this segment of the market.” It's also possible that LIALDA could prove to be an effective treatment for Diverticulitis, which is an acute and very painful condition affecting the bowel wall, and which can often only be relieved by surgery. There is no other drug treatment available, so if LIALDA can indeed help to prevent recurrent attacks, it would meet an important unmet need. It's currently in Phase 3 trials, and if successful we would hope to launch sometime between 2012 and 2015.