Tolerability Data for Shire's CUVITRU Accepted for Oral Presentation at the American College Of Allergy, Asthma & Immunology Annual Meeting

Lexington, Massachusetts (ots/PRNewswire) -

Data reveals key findings on the tolerability of CUVITRU [Immune
Globulin Subcutaneous (Human), 20% Solution] for patients, regardless
of treatment infusion volume and rates

Shire plc (LSE: SHP, NASDAQ: SHPG) will present additional data
supporting the tolerability of CUVITRU [Immune Globulin Subcutaneous
(Human), 20% Solution] in patients two years of age and older with
primary immunodeficiency (PI) diseases in North America at the 2016
Annual Scientific Meeting of the American College of Allergy, Asthma
& Immunology in San Francisco. The presentation will highlight key
findings on established tolerability of CUVITRU for PI patients who
received CUVITRU in the Phase II/III North American clinical trial.
Of note, increased infusion volumes and rates were not associated
with an increase in causally-related local adverse reactions, and
infusions were well-tolerated during onboarding and throughout the
study.

"As the latest treatment to be added to Shire's industry-leading
IG portfolio, CUVITRU exemplifies our commitment to reducing the
burden of PI for patients living with this challenging, often
debilitating condition," said Philip J. Vickers, Ph.D., Head of
Research and Development, Shire. "As a customizable therapy, CUVITRU
offers patients and physicians multiple options to tailor their IG
treatment to fit their needs and preferences, such as varying the
volume/site, the dosing frequency, and infusion rate."

PI is a group of more than 300 genetic disorders in which part of
the body's immune system is missing or functions improperly, in some
cases making it more difficult to fight off infections.[1],[2] PI
affects six million people worldwide, of which approximately 250,000
reside in the U.S.[3],[4] Most people with PI have abnormally low or
nonexistent IG levels, and may benefit from IG replacement treatment
to help the body prevent infections. Since it only offers temporary
protection, many people with PI require IG replacement treatment
throughout their lives.[5]

"ACAAI's annual meeting is a welcome opportunity for the
immunology community to learn more about the benefits CUVITRU can
offer patients with PI looking to take control of their IG
treatment," said Sudhir Gupta, MD, PH.D., MACP, Chief of Basic and
Clinical Immunology, and Director, Programs in Primary
Immunodeficiency and Aging, at University of California, Irvine. "The
data reinforces that patients can work with their physician to
individualize their dosage and administration schedule, allowing for
greater flexibility and control within their normal daily routine."

As demonstrated in the clinical trials, CUVITRU offers patients
the ability to infuse up to 60 mL (12 grams) per site and up to 60 mL
per hour per site, as tolerated, allowing for fewer infusion sites
and shorter infusion durations compared to other conventional
subcutaneous IG treatments. The data to be presented at ACAAI offers
additional evidence that patients achieved the increased rate and
volume, without compromising tolerability. Approximately 72% of
patients in the clinical trial achieved the maximum infusion rate of
60 mL per hour per site, occurring after a median time of 3 infusions
with no association between infusion rate and causally related local
adverse event (AE) rates. Importantly, 99.8% infusions of CUVITRU
were completed without a rate reduction, interruption, or
discontinuation indicating the infusions were well tolerated. In
addition, 75% of infusions delivered a volume of 30 mL per site or
greater, with no association between volume per site and
causally-related local AEs.[6] The full clinical trial results can be
found in Journal of Clinical Immunology
(http://rd.springer.com/article/10.1007/s10875-016-0327-9).

CUVITRU is the latest product in Shire's industry-leading IG
portfolio. The U.S. Food and Drug Administration approved CUVITRU in
September 2016. Shire also received successful completion of a
decentralized procedure to support CUVITRU approval by 17 authorities
in Europe in June 2016. The company expects to initiate additional
global regulatory submissions for CUVITRU in late 2016 and 2017.

For more information on CUVITRU, please visit
http://www.cuvitru.com.

About Primary Immunodeficiency

Primary immunodeficiencies (PI) are a group of more than 300
disorders in which part of the body's immune system is missing or
does not function properly.[1] Normally, the immune system protects
the body from pathogenic microorganisms like bacteria, viruses, and
fungi, which can cause infectious diseases. When any part of a
person's immune system is absent or dysfunctional, the individuals
are susceptible to infections, and it may take longer to recover from
infections. When a defect in the immune system is inherited and
genetically determined, it is called primary immune deficiency.[2]

About CUVITRU [Immune Globulin Subcutaneous (Human), 20% Solution]

CUVITRU is an Immune Globulin Subcutaneous (Human) (IGSC), 20%
Solution indicated as replacement therapy for primary humoral
immunodeficiency (PI) in adult and pediatric patients two years of
age and older.

CUVITRU is for subcutaneous infusion only.

Detailed Important Risk Information

BOXED WARNING: THROMBOSIS

Thrombosis may occur with immune globulin products, including
CUVITRU. Risk factors may include: advanced age, prolonged
immobilization, hypercoagulable conditions, history of venous or
arterial thrombosis, use of estrogens, indwelling vascular catheters,
hyperviscosity and cardiovascular risk factors.

For patients at risk of thrombosis, administer CUVITRU at the
minimum dose and infusion rate practicable. Ensure adequate hydration
in patients before administration. Monitor for signs and symptoms of
thrombosis and assess blood viscosity in patients at risk of
hyperviscosity.

CONTRAINDICATIONS

CUVITRU is contraindicated in patients who have had an
anaphylactic or severe systemic hypersensitivity reaction to the
subcutaneous administration of human immune globulin and in
IgA-deficient patients with antibodies against IgA and a history of
hypersensitivity to human immune globulin treatment.

WARNINGS and PRECAUTIONS

Hypersensitivity: Severe hypersensitivity reactions may occur,
even in patients who have tolerated previous treatment with human
immune globulin. IgA-deficient patients with antibodies to IgA are
at greater risk of developing potentially severe hypersensitivity and
anaphylactic reactions.

Renal Dysfunction/Failure: Monitor renal function and urine
output and consider lower, more frequent dosing in patients who are
at risk of developing renal dysfunction because of pre-existing renal
insufficiency or predisposition to acute renal failure.

Thrombosis: Monitor for signs and symptoms of thrombosis and
assess blood viscosity for those at risk for hyperviscosity.

Aseptic Meningitis Syndrome (AMS): Monitor for clinical signs and
symptoms of AMS.

Hemolysis: Monitor for clinical signs and symptoms of hemolysis
and delayed hemolytic anemia.

Transfusion-Related Acute Lung Injury (TRALI): Monitor for
pulmonary adverse reactions associated with TRALI.

Transmittable Infectious Agents: Because CUVITRU is made from
human plasma, it may carry a risk of transmitting infectious agents,
such as viruses and other pathogens. No confirmed cases of
transmission of viral diseases or variant Creutzfeldt-Jakob disease
(vCJD) have been associated with CUVITRU.

Interference with Laboratory Tests: False positive serological
test results, with the potential for misleading interpretation, may
occur as the result of passively transferred antibodies.

ADVERSE REACTIONS

The most common adverse reactions observed in clinical trials in
>= 5% of patients were: local adverse reactions, systemic adverse
reactions including headache, nausea, fatigue, diarrhea, and
vomiting.

Please see Full Prescribing Information, including Boxed Warning
regarding Thrombosis, available at:
http://www.shirecontent.com/PI/PDFS/Cuvitru_USA_ENG.pdf.

SHIRE and the Shire Logo are registered trademarks of Shire
Pharmaceutical Holdings Ireland Limited or its affiliates. CUVITRU
is a trademark or registered trademark of Baxalta Incorporated, a
wholly owned, indirect subsidiary of Shire plc.

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.

References

1. Picard C, Al-Herz W, et al. Primary Immunodeficiency Diseases: an
Update on the Classification from the International Union of
Immunological Societies Expert Committee for Primary
Immunodeficiency. J Clin Immunol. 2015 Nov;35(8):696-726.
2. IDF Patient & Family Handbook for Primary Immunodeficiency
Diseases. 5th edition. Blaese. 2013.
3. Bousfiha AA et al. Primary immunodeficiency diseases worldwide:
more common than generally thought. J Clin Immunol. 2013
Jan;33(1):1-7.
4. Immune Deficiency Foundation. Primary immune deficiency diseases
in America: 2007. The third national survey of patients. May 2009.
5. Immune Deficiency Foundation, "Immunoglobulin Therapy & Other
Medical Therapies for Antibody Deficiencies:" http://primaryimmune
.org/treatment-information/immunoglobulin-therapy/ . October 19,
2015.
6. Gupta S. "Tolerability of the New Human Immune Globulin
Subcutaneous, 20% Preparation in Primary Immunodeficiency
Diseases" Annual Scientific Meeting of the American College of
Allergy, Asthma & Immunology, San Francisco. November 10-14, 2016.

Investor Relations
Sarah Elton-Farr seltonfarr@shire.com +44(0)1256-894157
Ian Karp ikarp@shire.com +1-781-482-9018
Robert Coates rcoates@shire.com +44(0)1256-894874
Media
Gwen Fisher gfisher@shire.com +1-484-595-9836
Debbi Ford debbi.ford@shire.com +1-617-949-9083

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