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

Geschrieben am 17-04-2017

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;
- 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.

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

4/17

ots Originaltext: Shire Pharmaceuticals Group Plc
Im Internet recherchierbar: http://www.presseportal.de

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

Original-Content von: Shire Pharmaceuticals Group Plc, übermittelt durch news aktuell


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