Shire Leads New Initiative to Reveal Challenges Facing Rare Disease Community

- Impact Report to assess holistic needs of rare disease patient and medical communities

LEXINGTON, Massachusetts, Nov. 19, 2012 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) today announced a new initiative – the Shire Rare Disease Impact Report – to research the health, psycho-social, societal and economic impact of rare diseases in patient and medical communities. Comprehensive surveys of patients, caregivers, physicians, payors and thought leaders in the United States and the United Kingdom are underway. Survey results will be published and available in the first half of 2013.

Rare diseases are conditions that affect a small portion of the population and are often chronic, progressive, degenerative, Iife-threatening and disabling.(1) While individual rare diseases are uncommon and disparate, collectively there are approximately 7,000 different types of rare diseases and disorders affecting an estimated 350 million people worldwide.(2)

The Shire Rare Disease Impact Report aims to uncover the unique challenges facing the rare disease community in areas such as diagnosis, scientific understanding, treatment options, and social services. The Impact Report will contribute to the continued effort to better understand these complex diseases and how best to optimally manage them for the greatest patient benefit.

"Despite the progress that has been made over the past few decades in the rare disease space, there is still an urgent need to better understand this community and its needs," says Nicole Boice, founder and CEO, Global Genes | R.A.R.E Project. "I'm thrilled to be involved in the development of this Rare Disease Impact Report as its findings will help elevate awareness for the rare disease community and guide future research and education for affected patients and their families."

An external advisory board anchored by thought leaders in the medical, advocacy, health policy and health economics fields will lend its expertise to the development of the Impact Report. Advisory board members include Nicole Boice, founder and CEO, Global Genes | R.A.R.E Project; Dr. Priya S. Kishnani, Division Chief, Medical Genetics, Duke University Medical Center; Tomas Philipson, Daniel Levin professor of public policy studies, The University of Chicago; Alastair Kent, director, Genetic Alliance UK; Dr. Christian J. Hendriksz, Clinical Lead, Adult Inherited Metabolic Disorders, Salford Royal NHS Foundation Trust; and Mike Drummond, professor of health economics, University of York.

Shire Human Genetic Therapies (HGT), the rare disease business of Shire, has over twenty years of experience discovering, developing, manufacturing, and commercializing novel therapies and solutions for rare diseases. The Company has built and invested in a pipeline of innovative products and solutions to treat rare diseases. The Rare Disease Impact Report will be the first research to go beyond identifying unmet medical needs within the rare disease community.

"At Shire, patients are at the heart of everything we do and we continually strive to provide support for those touched by rare diseases," said Sylvie Gregoire, president, Shire HGT. "We hope the findings from this Rare Disease Impact Report will provide the rare disease community at large with new, unique insights on how best to address the holistic needs of the rare disease community and drive important conversations and innovation. Shire is delighted to take the lead in bringing this to the attention of all those who can transform the lives of rare disease patients for the better."

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Notes to editors

SHIRE PLC

Shire's strategic goal is to become the leading specialty biopharmaceutical company that focuses on meeting the needs of the specialist physician. Shire focuses its business on attention deficit hyperactivity disorder, human genetic therapies, gastrointestinal diseases and regenerative medicine as well as opportunities in other therapeutic areas to the extent they arise through acquisitions. Shire's in-licensing, merger and acquisition efforts are focused on products in specialist markets with strong intellectual property protection and global rights. Shire believes that a carefully selected and balanced portfolio of products with strategically aligned and relatively small-scale sales forces will deliver strong results.

For further information on Shire, please visit the Company's website: www.shire.com.

"SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included herein that are not historical facts are forward-looking statements. Such forward-looking statements involve a number of risks and uncertainties and are subject to change at any time. In the event such risks or uncertainties materialize, the Company's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, risks associated with: the inherent uncertainty of research, development, approval, reimbursement, manufacturing and commercialization of the Company's Specialty Pharmaceuticals, Human Genetic Therapies and Regenerative Medicine products, as well as the ability to secure new products for commercialization and/or development; government regulation of the Company's products; the Company's ability to manufacture its products in sufficient quantities to meet demand; the impact of competitive therapies on the Company's products; the Company's ability to register, maintain and enforce patents and other intellectual property rights relating to its products; the Company's ability to obtain and maintain government and other third-party reimbursement for its products; and other risks and uncertainties detailed from time to time in the Company's filings with the Securities and Exchange Commission.

References

1. European Organisation for Rare Diseases (EURORDIS) website. "Rare Diseases: understanding this Public Health Priority." http://www.eurordis.org/IMG/pdf/princeps_document-EN.pdf. Accessed October 25, 2012.
2. The Global Genes Project website. "RARE Facts and Statistics." http://globalgenes.org/rarefacts/. Accessed October 25, 2012.

SOURCE Shire plc