Innovation is fundamental to our business, including development of new treatments for unmet patient needs.

We balance the risks of developing different treatments. With the acquisition of Premacure for example, we added SHP607 to our Pipeline – our Phase 2 clinical program for the prevention of the rare eye disorder Retinopathy of Prematurity ("ROP"). This acquisition also gives us access to neonatology, a growing market with many underserved specialist patient needs.

Phase 2 multi-center trial ongoing in Sweden

Patients

  • In the US and EU, there are approximately 78,000 and 68,000 premature infants born annually < 32 weeks of gestational ageNumber of premature infants: US-CDC National Vital Statistics Reports, Births: Final Data for 2010; EU-EU Peristat 2010 and Blencowe, et al. Lancet 2012; 379:2162–72
  • Surgery is currently the only widely recognized treatment option

Product

  • IGF-1 protein replacement therapy administered preventatively by continuous IV infusion in first 24-48 hours of life
  • Delivered until endogenous production of IGF-1 begins at ~30-32 weeks gestational age

Progress

  • Phase 2 studies ongoing, with headline data expected 1H 2015
  • Dose optimization completed
  • 2013 Achievements

    March

    Late-stage pipeline enhanced with the acquisition of Premacure, which is developing a Phase 2 protein replacement therapy for the prevention of ROP.

    View the full Year in Review

    View the full Year in Review

Leading the way in specialty

Our strategic focus is on providing innovative treatments for patients with rare and other specialized conditions.

Impact

We focus on specialized conditions, where we have expertise and where we can potentially have the biggest impact on patients’ lives.

Range

Our focus ranges from Neuroscience including ADHD to a spectrum of rare diseases including Hunter syndrome, Gaucher disease and Hereditary Angioedema.

Progress

All our chosen areas are very different but they share the same core quality of being highly specialized conditions where there is great unmet need and where we can make a big difference for patients.

The future

In the years ahead we will maintain our focus on specialty conditions with a particular emphasis on more rare diseases where we can lead the way in meeting patient needs with innovative treatments.

  • 2013 Achievements

    November

    Positive top-line results shown for VYVANSE capsules in adults with Binge Eating Disorder.

    View the full Year in Review

    View the full Year in Review

From the way we work together to the distinctive qualities of our treatments, we strive for excellence throughout our business.

Our work exploring how LDX, the active ingredient in VYVANSE, can be used to treat BED is a great example of how we aim to excel – by building on our strengths and, as ever, focusing on people with high unmet specialist needs.

We're working on extending LDX to treat binge eating disorder

  • 1BED in adults is a huge unmet need and according to physicians there are few treatments of any kind available
  • 2The seriousness of the disorder is increasingly acknowledged in the physician community
  • 3The market is ready for safe and effective treatment
  • 4Estimates suggest that there are around 3 million adults with BED in the US and about 9 out of 10 of them are undiagnosed
  • 5Of those that are diagnosed not all are being treated
  • 6Health care practitioners are generally dissatisfied with the mixed results from the current treatment options that include counseling and cognitive behavioral therapy, or off label anti-depressant and anti-psychotic drugs
  • 7With the two pivotal Phase 3 eating disorder trials now fully enroled, our Phase 3 program is ahead of schedule
  • 2013 Achievements

    November

    ViroPharma acquisition announced to strengthen Rare Diseases portfolio.

    View the full Year in Review

    View the full Year in Review

We aim to deliver significantly above average industry growth levels.

Take for example FIRAZYR, our leading acute treatment for the rare genetic disease Hereditary Angiodema (HAE). With only around half of sufferers in the US currently treated, FIRAZYR has great potential for future growth.

FIRAZYR

A leader with great growth potential

Patients

  • Estimated 7,000-8,000 US HAE sufferersBased on Shire’s market research
  • Only around half of sufferers currently treatedBased on Shire’s market research

Products

  • Portable, on-demand, subcutaneous self-administered presentation
  • Average patient on Firazyr is treating 12-18 acute attacks per yearBased on Shire’s market research

Progress

  • FIRAZYR has the leading market share in US of HAE attacks treated acutelyBased on Shire’s market research
  • Over 1,600 patients in US have received FIRAZYR commercial therapy to date

Potential

  • Potential for significant growth in the future with only 50% of the market treated
  • 2013 Achievements

    May

    Flemming Ornskov, CEO sets out his strategy for Shire’s future and outlines a re-alignment of its business structure to drive future growth and innovation.

    View the full Year in Review

    View the full Year in Review

We know that we have to always embrace change to stay ahead and deliver our growth ambitions.

  • View our strategy and business model

    We are focused on growing Shire by developing and marketing innovative specialty medicines that address significant unmet patient needs.

    View our strategy and business model

Working together as

  • In 2013 we reorganized the company to form a simpler, more cohesive and streamlined organization - One Shire
  • We now have four market-focused business units and a single innovation-driven R&D organization supported by unified global corporate functions
  • Significant cost savings have come from creating One Shire
  • We have also been able to streamline decision making and improve our commercial excellence, which has underpinned accelerated growth
  • Our unified way of working comes to life through our employees who together form One Shire. Their great contributions and unwavering commitment to meeting the needs of our patients make all the difference