Shire Recognizes Rare Disease Day 2014

February 28, 2014

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced its support of Rare Disease Day and invites others to join them in its continued commitment to the rare disease community. Observed annually on the last day of February, Rare Disease Day is coordinated at the international level by the European Organisation for Rare Diseases (EURORDIS) and by National Alliances and Patient Organizations at the national level.

There are estimated to be between 6,000 and 8,000 rare diseases worldwide.1 These diseases affect nearly 30 million people in the US and approximately 30 million people in Europe.1,2 A disease or disorder is classified as rare in Europe when it affects less than 1 in 2,000 people and in the U.S. when it affects fewer than 200,000 people.1,3 It is estimated that 75 percent of rare diseases affect children, and 30 percent of rare disease patients will die before the age of 5.1

The theme for this year’s Rare Disease Day, “Join Together for Better Care”, encourages everyone supporting the rare disease community to find ways to work together to help both patients and their families find common solutions for care and remind them they are not alone. Rare disease care has many facets and is a universal need, and only through joining together will we find ways to provide the different kinds of care that people living with rare diseases need to improve their lives.

“On this important day, we show our commitment to the rare disease community by joining forces to raise awareness of rare diseases worldwide,” said Jeff Poulton, Head of the Rare Disease Business Unit at Shire. “Shire’s purpose is to enable people with life-altering conditions to lead better lives and so we support the efforts of Rare Disease Day to better patient care. We hope that by working together we can help ensure patients with rare diseases receive consistent, reliable and effective treatments and services to meet their individual needs.”

Shire is sponsoring and participating in a variety of Rare Disease Day activities, and partnering with local patient organizations around the world, to help educate physicians and communities about rare diseases and advocate for those whose lives are impacted. Some of these initiatives include:

The Global Genes Project with Wear That You Care™ to raise awareness of rare genetic disorders;
EURORDIS Roundtable of Companies on the topic of “Unlocking Europe’s Potential in Rare Disease Therapies” on February 26 in Brussels, Belgium;
Rare Disease Day Legislative Advocates (RDLA) “Rare Disease Day Legislative Conference and Lobby Day” from February 25-27th in Washington DC, US;
Spanish Federation of Rare Diseases (FEDER) experts meeting on February 21st and the official Rare Disease Day event on February 28th in Madrid, Spain;
Lysosomal Storage Disease Department at the Queen Elizabeth Hospital in Birmingham, UK, rare disease event;
The 2nd National Editorial Award on Rare Disease and Rare Cancers organized by OMAR (Observatory Rare Disease) in Italy;
Rare Voices Australia (RVA) to hold a Rare Disease Day meeting, in partnership with Wesley Hospital, in Brisbane, and assisting RVA in holding a Friends of Rare Disease Parliamentary event at Parliament House in Canberra;
Rare Disease Day activities organized by the non-profit organization Promotion of Research on Intellectual Property (PRIP) Tokyo in Japan;
Argentinean Federation of Rare Diseases (FADEPOF) awareness campaign “Descubrinos, estamos acá” (“Discover us, we are here”) and activities for Rare Disease Day.

As a leader in rare diseases, Shire has a global focus on the research, development, registration and marketing of therapies for the treatment rare conditions.

For further information please contact:

Media
Lauren O'Brien [email protected] +41 22 419 4040
Gwen Fisher [email protected] +1 484 595 9836

NOTES TO EDITORS

Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty medicines to meet significant unmet patient needs.
We provide treatments in Neuroscience, Rare Diseases, Gastrointestinal and Internal Medicine and we are developing treatments for symptomatic conditions treated by specialist physicians in other targeted therapeutic areas.

www.shire.com

FORWARD - LOOKING STATEMENTS - "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995

Statements included in this announcement that are not historical facts are forward-looking statements. 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, Shire’s results could be materially adversely affected. The risks and uncertainties include, but are not limited to, that:

Shire’s products may not be a commercial success;
revenues from ADDERALL XR are subject to generic erosion and revenues from INTUNIV will become subject to generic competition starting in December 2014;
the failure to obtain and maintain reimbursement, or an adequate level of reimbursement, by third-party payors in a timely manner for Shire's products may impact future revenues, financial condition and results of operations;
Shire conducts its own manufacturing operations for certain of its Rare Diseases products and is reliant on third party contractors to manufacture other products and to provide goods and services. Some of Shire’s products or ingredients are only available from a single approved source for manufacture. Any disruption to the supply chain for any of Shire’s products may result in Shire being unable to continue marketing or developing a product or may result in Shire being unable to do so on a commercially viable basis for some period of time.
the development, approval and manufacturing of Shire’s products is subject to extensive oversight by various regulatory agencies and regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to significant delays, increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
the actions of certain customers could affect Shire 's ability to sell or market products profitably. Fluctuations in buying or distribution patterns by such customers can adversely impact Shire’s revenues, financial conditions or results of operations;
investigations or enforcement action by regulatory authorities or law enforcement agencies relating to Shire’s activities in the highly regulated markets in which it operates may result in the distraction of senior management, significant legal costs and the payment of substantial compensation or fines;
adverse outcomes in legal matters and other disputes, including Shire’s ability to enforce and defend patents and other intellectual property rights required for its business, could have a material adverse effect on Shire’s revenues, financial condition or results of operations;
Shire faces intense competition for highly qualified personnel from other companies, academic institutions, government entities and other organizations. Shire is undergoing a corporate reorganization and the consequent uncertainty could adversely impact Shire’s ability to attract and/or retain the highly skilled personnel needed for Shire to meet its strategic objectives;
failure to achieve Shire’s strategic objectives with respect to the acquisition of ViroPharma Incorporated may adversely affect Shire’s financial condition and results of operations;
and other risks and uncertainties detailed from time to time in Shire’s filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K.

References

EURORDIS. What is a rare disease? Factsheet. Available at:http://www.eurordis.org/sites/default/files/publications/Fact_Sheet_RD.pdf. Last accessed February 2014.
NORD. Available at: http://www.rarediseases.org/about
National Institutes of Health. FAQ about rare diseases. Available at: http://www.ncats.nih.gov/about/faq/rare/rare-faq.html. Last accessed February 2014.