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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). 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. 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., 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.
"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.
Hemophilia is a challenging chronic disease that causes longer-than-normal bleeding due to absent or deficient clotting factor in the blood. Hemophilia A is more common than hemophilia B; hemophilia A affects about 150,000 people, whereas hemophilia B affects about 30,000 people worldwide.
Treatment regimens typically include on-demand and/or regular prophylactic infusions of factor replacement therapy to control or prevent the risk of bleeding., People with hemophilia, working closely with their healthcare professionals, can live healthy lives with proper care and adequate treatment.
Approximately 5-7 percent of people living with hemophilia develop inhibitors. Inhibitors are a rare but serious complication in patients with hemophilia. They form when the body's immune system attacks the molecules in factor therapy, causing it to be ineffective. Bypassing agents help bypass the inhibitor to help the body form a clot and stop bleeding.
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
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.
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; - Shire conducts its own manufacturing operations for certain of its 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 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 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 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; - 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; - Shire's products and product candidates face substantial 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; - 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 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.
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