Shire Pharmaceuticals Group Plc

Shire plc: Data Show A Bleeding Episode Occurs Every Three to 15 Seconds in People Living With Hemophilia Worldwide

Zug, Switzerland (ots/PRNewswire) - On World Hemophilia Day 2017, Shire challenges the community to collectively improve global standards of care for rare bleeding disorders

Shire plc (LSE: SHP, NASDAQ: SHPG), a leading biotechnology company focused on serving individuals with rare diseases, joins the global bleeding disorders community in honoring the 28th annual World Hemophilia Day (WHD).[1] On this day, Shire highlights initial findings from its estimate of the Global Annual Bleed Rate (GABR), which shows a bleeding episode occurs every three to 15 seconds worldwide, more than three times current global estimates.[2] These findings build on existing data from the World Federation of Hemophilia (WFH), which show only 25 percent of individuals living with hemophilia worldwide receive proper diagnosis and care, only 8 percent of which receive prophylaxis or regular treatment to prevent bleeds.[3],[4] This research reinforces Shire's ongoing commitment to innovative data collection to improve global standards of care for individuals living with rare bleeding disorders.

"As the global leader in hematology, we are committed to efforts, such as estimating the GABR, that improve our understanding of the global landscape for hemophilia and the true experience of those living with this debilitating bleeding disorder," said Leonard Valentino, M.D., Global Head of Hematology Medical Affairs, Shire.

Shire developed the GABR in collaboration with renowned hemophilia institutions, including WFH. Our shared aim is to identify regions of the world with the greatest need for improved diagnosis and care for hemophilia patients. Together, we created a literature-based model to estimate the GABR at both country and global levels. A full report of the GABR model is expected to be published later in 2017.[2]

"Shire is proud to support the global hemophilia community in honoring World Hemophilia Day," continued Valentino. "On this day and every day, Shire is dedicated to supporting hemophilia patients through advancing early diagnosis, prophylaxis, individualized treatment options and innovative research and development efforts."

This year, Shire is embracing WFH's theme for World Hemophilia Day of "Hear Their Voices" and joining its partners and local advocacy organizations to raise awareness of those living with bleeding disorders. Throughout the day and across the world, Shire employees are wearing red to show our support for the community and holding celebrations to acknowledge the voices and stories of those living with bleeding disorders, including:

- In the United States, Shire is holding a public awareness rally in 
  Chicago and inviting members of the local hemophilia community to 
  join and voice their support for the global bleeding disorders 
  community. To learn more about this event, visit http://www.bleedin
  gdisorders.com/bleeding-disorders-community-support.
- In Germany, Shire is engaging media and inviting patients to share 
  their perspective and the impact of hemophilia on their lives.
- In Brazil, Shire is partnering with Federacao Nacional de Hemofilia
  to illuminate public monuments as part of WFH's "Light it Up Red!" 
  initiative to help raise awareness of hemophilia.
- In China, Shire is participating in the "Run for Love" campaign to 
  show support for the bleeding disorders community. Further, 
  throughout the Asia Pacific region, Shire is hosting "Hear Their 
  Voices" sharing sessions for patients and caregivers to share their
  personal experiences with hemophilia. 

About Hemophilia

Hemophilia is a challenging chronic disease that causes longer-than-normal bleeding due to absent or deficient clotting factor in the blood.[5] Hemophilia A is more common than hemophilia B;[5] hemophilia A affects about 150,000 people, whereas hemophilia B affects about 30,000 people worldwide.[4]

Treatment regimens typically include on-demand and/or regular prophylactic infusions of factor replacement therapy to control or prevent the risk of bleeding.[6],[7] People with hemophilia, working closely with their healthcare professionals, can live healthy lives with proper care and adequate treatment.[6]

Approximately 5-7 percent of people living with hemophilia develop inhibitors.[8] Inhibitors are a rare but serious complication in patients with hemophilia.[9] They form when the body's immune system attacks the molecules in factor therapy, causing it to be ineffective.[9] Bypassing agents help bypass the inhibitor to help the body form a clot and stop bleeding.[9]

References

1. Hickman RJ. "April 17 is World Hemophilia Day." Rare Disease 
   Report website. http://www.raredr.com/news/april-17-hemophilia-day
   . Published April 18, 2016. Accessed March 15, 2017.
2. Thompson C. et al. "Estimating the Global Annual Bleed Rate in 
   Haemophilia." European Association for Haemophilia and Allied 
   Disorders. Paris, France. February 1-3, 2017. Available at: http:/
   /onlinelibrary.wiley.com/doi/10.1111/hae.13150/full#hae13150-sec-0
   190.
3. World Federation of Hemophilia. "What will it take to Close the 
   Gap?" World Federation of Hemophilia website. Last updated January
   2014.
4. World Federation of Hemophilia. Report on the Annual Global Survey
   2015. World Federation of Hemophilia website. 
http://www1.wfh.org/publication/files/pdf-1669.pdf. Accessed April
   10, 2017
5. World Federation of Hemophilia. "What is hemophilia?" World 
   Federation of Hemophilia website. 
http://www.wfh.org/en/page.aspx?pid=646. Accessed March 6, 2017.
6. World Federation of Hemophilia. "About Bleeding Disorders: 
   Treatment." World Federation of Hemophilia website. 
http://www.wfh.org/en/page.aspx?pid=642. Accessed January 12, 
   2017.
7. National Hemophilia Foundation. "Hemophilia A." National 
   Hemophilia Foundation website. https://www.hemophilia.org/Bleeding
   -Disorders/Types-of-Bleeding-Disorders/Hemophilia-A. Accessed 
   March 6, 2017.
8. Wight J. Paisley S. "The Epidemiology of Inhibitors in Haemophilia
   A: A Systematic Review." Haemophilia 2003.
9. World Federation of Hemophilia. "What are inhibitors?" World 
   Federation of Hemophilia website. 
http://www.wfh.org/en/page.aspx?pid=651 . Accessed January 12, 
   2017. 

NOTES TO EDITORS

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

http://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, 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;
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  products and is reliant on third party contract manufacturers to 
  manufacture other products and to provide goods and services. Some 
  of Shire's products or ingredients are only available from a single
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  oversight by various regulatory agencies. Regulatory approvals or 
  interventions associated with changes to manufacturing sites, 
  ingredients or manufacturing processes could lead to significant 
  delays, an increase in operating costs, lost product sales, an 
  interruption of research activities or the delay of new product 
  launches;
- certain of Shire's therapies involve lengthy and complex processes,
  which may prevent Shire from timely responding to market forces and
  effectively managing its production capacity;
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  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;
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  competition in the product markets in which it operates, including 
  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 combined company's revenues, 
  financial condition, or results of operations;
- inability to successfully compete for highly qualified personnel 
  from other companies and organizations;
- failure to achieve the strategic objectives with respect to Shire's
  acquisition of NPS Pharmaceuticals, Inc., Dyax Corp. ("Dyax") or 
  Baxalta Inc. ("Baxalta") may adversely affect 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, as well as changes in 
  foreign currency exchange rates and interest rates, that adversely 
  impact the availability and cost of credit and customer purchasing 
  and payment patterns, including the collectability of customer 
  accounts receivable;
- failure of a marketed product to work effectively or if such a 
  product is the cause of adverse side effects could result in damage
  to the Shire's reputation, the withdrawal of the product and legal 
  action against Shire;
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  law enforcement agencies relating to Shire's activities in the 
  highly regulated markets in which it operates may result in 
  significant legal costs and the payment of substantial compensation
  or fines;
- 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 incurred substantial additional indebtedness to finance the 
  Baxalta acquisition, which may decrease its business flexibility 
  and increase borrowing costs;
- difficulties in integrating Dyax or Baxalta into Shire may lead to 
  the combined company not being able to realize the expected 
  operating efficiencies, cost savings, revenue enhancements, 
  synergies or other benefits at the time anticipated or at all; and
- other risks and uncertainties detailed from time to time in Shire's
  filings with the Securities and Exchange Commission, including 
  those risks outlined in "ITEM 1A: Risk Factors" in Shire's 
  Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. 

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.

S31431

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Contact:

, please contact:

Investor Relations
Ian Karp
ikarp@shire.com
+1-781-482-9018
Robert Coates
rcoates@shire.com
+44-1256-894874
Media
Molly Poarch
molly.poarch@shire.com
+1-312-965-3413



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