Shire Recognizes MPS Awareness Day 2018 with Digital Campaign and Global Events Focused on Increasing Diseases Awareness

LEXINGTON, Mass., May 15, 2018 /PRNewswire/ -- Shire plc (LSE: SHP, NASDAQ: SHPG) announces its third annual #FlyforMPS campaign to allow rare champions around the world to recognize and raise awareness for patients and caregivers affected by MPS (mucopolysaccharide) diseases. These rare, genetic, metabolic diseases affect one in 25,000 births.¹

Shire's #FlyforMPS campaign was created in support of MPS Awareness Day, held annually on May 15^th. The campaign's website, www.mpsday.com, features disease awareness information, stories of patients living with different MPS diseases around the world, an image gallery encouraging people to submit photos in support of the MPS community and an interactive game. To help raise awareness, the campaign invites people to read and share patient stories on their social media platforms, with each share 'fueling' a virtual plane to fly to a new destination to visit a new MPS patient. The campaign was developed in collaboration with the National MPS Society and U.K. MPS Society.

"Every day, Shire works as a champion for the millions of people affected by rare, genetic diseases, to progress potentially ground-breaking research, improve time to diagnoses, provide support and address some of the grave unmet needs of patients around the world," said Sarah Creviston, Vice President and Global Head of Patient Advocacy and Public Affairs, Shire. "Our #FlyforMPS campaign is an illustration of our dedication to the MPS community and our commitment to advocate for rare disease patients around the world."

"International MPS Awareness Day is an opportunity to recognize children and families who both live and have lost their lives to MPS Diseases. MPS Day started in the United States in 2006 as voted on by both the House and Senate. We are thrilled this has grown to a global campaign over the years." said Terri Klein, CEO and President, National MPS Society. "Campaigns like #FlyforMPS help us achieve our goals of increasing awareness about these conditions, while also making sure that MPS patients are never forgotten."

To learn more about Shire's #FlyforMPS campaign and to join the movement to raise awareness for MPS, visit www.MPSDay.com.

About Mucopolysaccharide (MPS) Diseases
Mucopolysaccharidoses (MPS) are a group of rare, genetic, metabolic diseases known as lysosomal storage diseases (LSDs). Patients with these conditions do not have enough, or any, of an enzyme that is needed to break down a sugar, called a mucopolysaccharide or glycosaminoglycan (GAG) in the body.¹ As a result, GAGs build up and can cause damage throughout the body, including in the heart, bones, joints, respiratory system and central nervous system, leading to a shortened life span.¹

There are seven types of MPS disease, each caused by a different missing or inadequate enzyme required to break down GAGs.¹ All of the MPS disorders are progressive, meaning they worsen with time.² They are also heterogeneous in nature, meaning they can affect different people differently, often resulting in a spectrum of clinical severity from mildly affected to severe.^2,3

The seven different types of MPS include²:

• MPS I (Hurler, Hurler-Scheie, or Sheie syndrome)
• MPS II (Hunter syndrome)
• MPS III A-D (Sanfilippo syndrome)
• MPS IV A, B (Morquio syndrome)
• MPS VI (Maroteaux-Lamy syndrome)
• MPS VII (Sly syndrome)
• MPS IX

People with MPS share some similar features but the severity of the different MPS diseases varies greatly.³ All MPS diseases are inherited in a recessive pattern, meaning that some people might be carriers of the disease but not actually have MPS. MPS II is different from the other MPS diseases because its inheritance is X-linked, meaning that mainly males are affected.²

About MPS Awareness Day
MPS Awareness Day is an annual awareness day dedicated to honour patients and caregivers affected by this category of rare genetic diseases. Each year on May 15^th, organizations around the world work to improve awareness, with the goal of achieving earlier diagnosis, improving research into treatment options and gaining a better understanding of the needs of those living with MPS. MPS Awareness Day is organized by the National MPS Society and the International MPS Network.

For information about U.S. activities for MPS Awareness Day, go to https://mpssociety.org/.

NOTES TO EDITORS

About Shire

Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest.

We feel a strong sense of urgency to address unmet medical needs and work tirelessly to improve people's lives with medicines that have a meaningful impact on patients and all who support them on their journey.

www.shire.com

Forward-Looking Statements

Statements included herein that are not historical facts, including without limitation statements concerning future strategy, plans, objectives, expectations and intentions, projected revenues, the anticipated timing of clinical trials and approvals for, and the commercial potential of, inline or pipeline products, 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, Shire's results could be materially adversely affected. The risks and uncertainties include, but are not limited to, the following:

• Shire's products may not be a commercial success;
• increased pricing pressures and limits on patient access as a result of governmental regulations and market developments may affect Shire's future revenues, financial condition and results of operations;
• Shire depends on third parties to supply certain inputs and services critical to its operations including certain inputs, services and ingredients critical to its manufacturing processes. 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 manufacture of Shire's products is subject to extensive oversight by various regulatory agencies. Regulatory approvals or interventions associated with changes to manufacturing sites, ingredients or manufacturing processes could lead to, among other things, significant delays, an increase in operating costs, lost product sales, an interruption of research activities or the delay of new product launches;
• the nature of producing plasma-based therapies may prevent Shire from timely responding to market forces and effectively managing its production capacity;
• Shire has a portfolio of products in various stages of research and development. The successful development of these products is highly uncertain and requires significant expenditures and time, and there is no guarantee that these products will receive regulatory approval;
• 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 affect Shire's revenues, financial conditions or results of operations;
• failure to comply with laws and regulations governing the sales and marketing of its products could materially impact Shire's revenues and profitability;
• Shire's products and product candidates face substantial competition in the product markets in which it operates, including competition from generics;
• Shire's patented products are subject to significant competition from generics;
• adverse outcomes in legal matters, tax audits 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 the Shire's revenues, financial condition or results of operations;
• Shire may fail to obtain, maintain, enforce or defend the intellectual property rights required to conduct its business;
• Shire faces intense competition for highly qualified personnel from other companies and organizations;
• failure to successfully execute or attain strategic objectives from Shire's acquisitions and growth strategy may adversely affect the Shire's financial condition and results of operations;
• Shire's growth strategy depends in part upon its ability to expand its product portfolio through external collaborations, which, if unsuccessful, may adversely affect the development and sale of its products;
• a slowdown of global economic growth, or economic instability of countries in which Shire does business, could have negative consequences for Shire's business and increase the risk of non-payment by Shire's customers;
• changes in foreign currency exchange rates and interest rates could have a material adverse effect on Shire's operating results and liquidity;
• Shire is subject to evolving and complex tax laws, which may result in additional liabilities that may adversely affect the Shire's financial condition or results of operations;
• if a marketed product fails to work effectively or causes adverse side effects, this could result in damage to Shire's reputation, the withdrawal of the product and legal action against Shire;
• Shire is dependent on information technology and its systems and infrastructure face certain risks, including from service disruptions, the loss of sensitive or confidential information, cyber-attacks and other security breaches or data leakages that could have a material adverse effect on Shire's revenues, financial condition or results of operations;
• Shire faces risks relating to the expected exit of the United Kingdom from the European Union;
• Shire incurred substantial additional indebtedness to finance the Baxalta acquisition, which has increased its borrowing costs and may decrease its business flexibility;
• Shire's ongoing strategic review of its Neuroscience franchise may distract management and employees and may not lead to improved operating performance or financial results; there can be no guarantee that, once completed, Shire's strategic review will result in any additional strategic changes beyond those that have already been announced;
• the potential uncertainty resulting from the announcement by Takeda Pharmaceutical Company Limited that it is considering making a possible offer for Shire; and

a further list and description of risks, uncertainties and other matters can be found in Shire's most recent Annual Report on Form 10-K and in Shire's subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in "ITEM1A: Risk Factors", and in Shire's subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire's website.

All forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by this cautionary statement. Readers are cautioned not to place undue reliance on these forward-looking statements that speak only as of the date hereof. Except to the extent otherwise required by applicable law, we do not undertake any obligation to update or revise forward-looking statements, whether as a result of new information, future events or otherwise.

¹ MPS Society. Diseases - MPS. Available from http://www.mpssociety.org.uk/diseases/. Last accessed April 2018.
² Jueckra A, et al. Prevalence rates of mucopolysaccharidoses in Poland. Appl Genetics. 2015; 56:205–210.
³ NORD 2011, Mucopolysaccharidoses, P2.

SOURCE Shire plc

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