Shire Announces Completion of Decentralized Procedure in Europe for Immunoglobulin Treatment Cuvitru

Zug, Switzerland (ots/PRNewswire) -

- Cuvitru (IG 20mg/ml solution for subcutaneous injection) builds on
company's broad portfolio of IG treatments gained through
combination with Baxalta
- New option to treat primary and certain secondary
immunodeficiencies can help meet patient needs related to number of
infusion sites and infusion time

Shire plc (LSE: SHP, NASDAQ: SHPG) announced today the successful
completion of a decentralized procedure (DCP) to support approval by
17 authorities in Europe for Cuvitru (IG 20mg/ml solution for
subcutaneous injection), a treatment for pediatric and adult patients
with primary and certain secondary immunodeficiency disorders, a
group of disorders in which part of the body's immune system is
missing or does not function properly.[1] It is estimated that as
many as six million children and adults may be affected by primary
immunodeficiencies (PI) worldwide.[1]

With the addition of Cuvitru following the completion of the
combination with Baxalta, Shire has the broadest immunoglobulin (IG)
portfolio with intravenous, conventional and subcutaneous treatment
options. Cuvitru is a new IG treatment that does not contain proline;
it offers patients a new therapeutic option to meet their needs,
particularly related to the number of infusion sites and infusion
time. With the completion of the DCP, the 17 authorities mutually
recognize approvability based on a scientific assessment of the
product, and local marketing authorizations in Europe are expected to
begin later in 2016.

Regulatory evaluation for Cuvitru was based on the positive
results of a Phase 2/3 study that evaluated the efficacy, safety,
tolerability and pharmacokinetics of IGSC 20% in European patients
with PI. The study met its primary endpoint that measured the rate of
validated acute serious bacterial infections.

"With the completion of the assessment procedure, we can move
forward with seeking country approvals of Cuvitru in Europe as we
continue to build a comprehensive portfolio of IG treatments that can
address the distinct needs of people with PI around the world," said
Philip J. Vickers, Ph.D., Head of Research and Development, Shire.

Shire expects a regulatory decision for Cuvitru in the U.S. later
this year in response to Baxalta's submission for licensing late in
2015 based on a separate Phase II/III study. The company expects to
initiate additional global regulatory submissions in 2016.

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.[2] 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 genetically
determined, it is called primary immune deficiency.[3] It is
estimated that as many as six million children and adults may be
affected by PI worldwide.[1]

About Cuvitru 20mg/ml solution for subcutaneous injection in
Europe

After marketing authorization, Cuvitru 20mg/ml solution for
subcutaneous injection will be indicated as a subcutaneous
administration (SCIg) replacement therapy in adults, and children and
adolescents (0 - 18 years) in:

- Primary immunodeficiency syndromes with impaired antibody
production.
- Hypogammaglobulinaemia and recurrent bacterial infections in
patients with chronic lymphocytic leukaemia (CLL), in whom
prophylactic antibiotics have failed or are contra-indicated.
- Hypogammaglobulinaemia and recurrent bacterial infections in
multiple myeloma (MM) patients.
- Hypogammaglobulinaemia in patients pre- and post- allogeneic
haematopoietic stem cell transplantation (HSCT).

Detailed Important Risk Information

CONTRAINDICATIONS

Hypersensitivity to the active substance or to any of the
excipients.

Severe IgA deficiency and a history of hypersensitivity to human
immunoglobulin treatment.

Cuvitru must not be given intravascularly or intramuscularly.

WARNINGS and PRECAUTIONS

If Cuvitru is accidentally administered into a blood vessel
patients could develop shock.

The recommended infusion rate must be closely followed. Patients
must be closely monitored and carefully observed for any symptoms
throughout the infusion period.

Certain adverse reactions may occur more frequently in patients
who receive human normal immunoglobulin for the first time or, in
rare cases, when the human normal immunoglobulin product is switched
or when there has been a long interval since the previous infusion.

Potential complications can often be avoided by:

- initially injecting the product slowly
- ensuring that patients are carefully monitored for any symptoms
throughout the infusion period. In particular, patients naive to
human normal immunoglobulin, patients switched from an alternative
immunoglobulin product or when there has been a long interval since
the previous infusion should be monitored during the first infusion
and for the first hour after the first infusion, in order to detect
potential adverse signs.

All other patients should be observed for at least 20 minutes
after administration.

In case of adverse reaction, either the rate of administration
must be reduced or the infusion stopped. Suspicion of severe
hypersensitivity or anaphylactic-type reactions requires immediate
discontinuation of the injection. The treatment required depends on
the nature and severity of the adverse reaction.

In case of shock, standard medical treatment for shock should be
implemented.

Thromboembolic events (e.g. myocardial infarction, cerebral
vascular accident, deep vein thrombosis, and pulmonary embolism),
renal dysfunction/failure, aseptic meningitis syndrome, hemolysis and
interference with serological testing have been observed with IG
administered intravenously and cannot be excluded with use of
Cuvitru. Thrombotic events and hemolysis have also been reported in
association with the subcutaneous administration of immunoglobulin
products.

Human normal immunoglobulin is produced from human plasma and may
carry a risk of transmitting infectious agents.

Shire, Baxalta and Cuvitru are trademarks of Shire plc, its
subsidiaries or affiliates.

References

1. Bousfiha AA et al. Primary immunodeficiency diseases worldwide:
more common than generally thought. J Clin Immunol. 2013
Jan;33(1):1-7.

2. 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.

3. IDF Patient & Family Handbook for Primary Immunodeficiency
Diseases. 5th edition. Blaese. 2013.

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 have best-in-class products available in more than 100
countries across core therapeutic areas including Hematology,
Immunology, Neuroscience, Lysosomal Storage Disorders,
Gastrointestinal / Internal Medicine / Endocrine and Hereditary
Angioedema; a growing franchise in Oncology; and an emerging,
innovative pipeline in Ophthalmics.

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:

- disruption from the acquisition and integration of Baxalta
Incorporated ("Baxalta") may make it more difficult to conduct
business as usual or maintain relationships with patients,
physicians, employees or suppliers;
- the company may not achieve some or all of the anticipated benefits
of Baxalta's spin-off from Baxter International, Inc. ("Baxter")
and the acquisition may have an adverse impact on Baxalta's
existing arrangements with Baxter, including those related to
transition, manufacturing and supply services and tax matters;
- the failure to achieve the strategic objectives with respect to the
acquisition of Baxalta may adversely affect the company's financial
condition and results of operations;
- products and product candidates may not achieve commercial success;
- product sales from ADDERALL XR and INTUNIV are subject to generic
competition;
- the failure to obtain and maintain reimbursement, or an adequate
level of reimbursement, by third-party payers in a timely manner
for the company's products may affect future revenues, financial
condition and results of operations, particularly if there is
pressure on pricing of products to treat rare diseases;
- supply chain or manufacturing disruptions may result in declines in
revenue for affected products and commercial traction from
competitors; regulatory actions associated with product approvals
or 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;
- the successful development of products in various stages of
research and development 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 the company's ability
to sell or market products profitably, and fluctuations in buying
or distribution patterns by such customers can adversely affect the
company's revenues, financial condition or results of operations;
- investigations or enforcement action by regulatory authorities or
law enforcement agencies relating to the company'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;
- adverse outcomes in legal matters, tax audits and other disputes,
including the company's ability to enforce and defend patents and
other intellectual property rights required for its business, could
have a material adverse effect on the company's revenues, financial
condition or results of operations;
- Shire is undergoing a corporate reorganization and was the subject
of an unsuccessful acquisition proposal and the consequent
uncertainty could adversely affect the company's ability to attract
and/or retain the highly skilled personnel needed to meet its
strategic objectives;
- failure to achieve the strategic objectives with respect to Shire's
acquisition of NPS Pharmaceuticals Inc. or Dyax Corp. ("Dyax") may
adversely affect the company's financial condition and results of
operations;
- the company 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 the company's revenues,
financial condition or results of operations;
- the company may be unable to retain and hire key personnel and/or
maintain its relationships with customers, suppliers and other
business partners;
- difficulties in integrating Dyax or Baxalta into Shire may lead to
the 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, Dyax's or Baxalta's filings with the Securities and
Exchange Commission, including those risks outlined in "ITEM 1A: Risk
Factors" in Shire's and Baxalta's Annual Reports on Form 10-K for the
year ended December 31, 2015.

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 republish
revised forward-looking statements to reflect events or circumstances
after the date hereof or to reflect the occurrence of unanticipated
events.

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

Contact:
please contact:
Investor Relations
Sarah Elton-Farr seltonfarr@shire.com +44 1256 894157
Ian Karp ikarp@shire.com +1 781 482 9018
Robert Coates rcoates@shire.com +44 1256 894874

Media
Gwen Fisher gfisher@shire.com +1 484 595 9836
Debbi Ford debbi.ford@shire.com +1 224 727 2079

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