Regulatory Approval - FDA Approves Shire's Xiidra(TM) (lifitegrast ophthalmic solution) 5% - The Only Treatment Indicated for the Signs and Symptoms of Dry Eye Disease

Lexington, Massachusetts (ots/PRNewswire) -

- An estimated 16 million people in the U.S. are diagnosed with dry
eye disease
- Xiidra is the first prescription eye drop FDA-approved to treat
both the signs and symptoms of dry eye disease
- U.S. launch of Xiidra planned for third quarter 2016

Shire plc (LSE: SHP, NASDAQ: SHPG) announces that the U.S. Food
and Drug Administration (FDA) has approved Xiidra (lifitegrast
ophthalmic solution) 5%, a twice-daily eye drop solution indicated
for the treatment of the signs and symptoms of dry eye disease in
adult patients. Xiidra is the only prescription eye drop indicated
for the treatment of both signs and symptoms of this condition. Shire
expects to launch Xiidra in the United States in the third quarter of
2016.

"The approval of Xiidra marks a new day in treatment options for
patients with dry eye disease, with the only prescription eye drop
approved in the U.S. specifically to treat both the signs and
symptoms of the condition," said Flemming Ornskov, M.D., MPH, CEO,
Shire. "As Shire's first FDA-approved medicine in ophthalmics, this
significant milestone advances our goal of becoming the global leader
in this category, where there are unmet patient needs. We have a
robust ophthalmics pipeline, and we look forward to leveraging Xiidra
as our entrée into the space as we continue to develop additional
innovative eye care treatment options."

An estimated 16 million adults in the U.S. are diagnosed with dry
eye disease. An often chronic ocular disease, dry eye is associated
with inflammation that may eventually lead to damage to the surface
of the eye. An eye care professional can diagnose dry eye disease
based on signs and symptoms and determine management options, which
could include the use of a prescription treatment.

"The clinical program supporting the approval of Xiidra is the
largest for an investigational-stage dry eye disease candidate to
date, including more than 2,500 patients," said Edward Holland, M.D.,
Professor of Clinical Ophthalmology, University of Cincinnati and a
clinical trial investigator for Xiidra. "The clinical trial program
design took into consideration many of the challenges of past dry eye
research. It's exciting to see Xiidra as the first prescription eye
drop FDA-approved for both the signs and symptoms of the condition."

Xiidra is a prescription eye drop solution used to treat the signs
and symptoms of dry eye disease. It is dosed twice per day,
approximately 12 hours apart, in each eye. The safety and efficacy of
Xiidra was studied in 1,181 patients (of which 1,067 patients
received lifitegrast 5%) in four placebo-controlled 12-week trials.
Each of the four studies assessed the effect of Xiidra on both the
signs and symptoms of dry eye disease at baseline, week two, six and
12. Assessment of symptoms was based on change from baseline in
patient reported eye dryness score (EDS; 0-100 visual analogue
scale). Assessment of signs was based on inferior corneal staining
score (ICSS; 0-4 scale). In all four studies, a larger reduction in
EDS was observed with Xiidra at six and 12 weeks. In two of the four
studies, an improvement in EDS was seen with Xiidra at two weeks. At
week 12, a larger reduction in ICSS favoring Xiidra was observed in
three of the four studies. The most common adverse reactions reported
in 5 to 25 percent of patients were instillation site irritation,
altered taste sensation (dysgeusia) and reduced visual acuity.

"Dry eye is a common complaint to eye care professionals, with
millions of U.S. adults experiencing the symptoms of this often
chronic disease," said Kelly K. Nichols, O.D., MPH, Ph.D., FAAO, Dean
of the University of Alabama at Birmingham School of Optometry. "It
is critical for eye care professionals to have a dialogue with
patients who report symptoms because dry eye can be a progressive
ocular surface disease."

The inflammation associated with dry eye is thought to be
primarily mediated by T-cells and associated cytokines. One effect of
this process may be increased expression of intracellular adhesion
molecule-1 (ICAM-1); ICAM 1 may be overexpressed in corneal and
conjunctival tissues in dry eye disease. Lifitegrast is a
small-molecule integrin antagonist that binds to the integrin
lymphocyte function-associated antigen-1 (LFA-1), a cell surface
protein found on leukocytes, and blocks the interaction of LFA-1 with
its cognate ligand intercellular adhesion molecule-1 (ICAM-1).
LFA-1/ICAM-1 interaction can contribute to the formation of an
immunological synapse resulting in T-cell activation and migration to
target tissues. In vitro studies demonstrated that lifitegrast may
inhibit T-cell adhesion to ICAM-1 in a human T-cell line and may
inhibit secretion of inflammatory mediators (cytokines) in human
peripheral blood mononuclear cells. The exact mechanism of action of
lifitegrast in dry eye disease is not known.

What is Xiidra?

Xiidra is a prescription eye drop used to treat the signs and
symptoms of dry eye disease.

Important Safety Information

The most common side effects of Xiidra include eye irritation,
discomfort or blurred vision when the drops are applied to the eyes,
and an unusual taste sensation (dysgeusia). To help avoid eye injury
or contamination of the solution, do not touch the container tip to
your eye or any surface. If you wear contact lenses, remove them
before using Xiidra and wait for at least 15 minutes before placing
them back in your eyes.

It is not known if Xiidra is safe and effective in children under
17 years of age.

For additional information, click here
(http://www.shirecontent.com/PI/PDFS/XIIDRA_USA_ENG.pdf) for full
Prescribing Information including Patient Information and discuss
with your doctor.

You are encouraged to report negative side effects of prescription
drugs to the FDA. Visit http://www.fda.gov/medwatch or call
1-800-FDA-1088.

About Dry Eye Disease

Dry eye is a multifactorial disease of the tears and ocular
surface. It is diagnosed by an eye care professional based on patient
reported symptoms, such as eye dryness, overall eye discomfort,
stinging, burning, a gritty feeling or fluctuating blurry vision, as
well as signs, which can be objectively evaluated by an eye care
professional through various tests to determine the presence of dry
eye disease. The symptoms of dry eye can interrupt daily activities
such as reading, driving, working, using technology, watching TV, and
spending time outside in bright light and cold or windy conditions.
Aging and gender (female) are recognized as traditional risk factors
of dry eye disease while modern risk factors include prolonged
digital/computer screen time, contact lens wear and cataract or
refractive surgery. Dry eye is an often chronic ocular disease
associated with inflammation that may eventually lead to damage to
the surface of the eye. Dry eye may be progressive and is a common
patient complaint to eye care professionals.

Shire's Commitment to Ophthalmics

In May 2014, Shire entered into ophthalmics, solidifying its
commitment to growing in this emerging therapeutic area. Shire's
multi-faceted approach to discovery, development, and delivery in
both rare diseases and specialty conditions includes our efforts to
address unmet needs in eye care.

Shire's ophthalmics business has been driven by a combination of
strategic acquisitions and organic growth. Committed to growing its
reputation as a leading biotech company, Shire is focused on
continuing to expand its ophthalmics portfolio to include treatment
options for rare diseases and those for anterior and posterior
segment eye conditions. In just three years, acquisitions include
Foresight Biotherapeutics, SARcode Bioscience, Premacure AB, and
BIKAM Pharmaceuticals, which have helped bolster Shire's early-, mid-
and late-stage ophthalmics pipeline. The Company currently has an
ophthalmics pipeline of investigational candidates in infectious
conjunctivitis, retinopathy of prematurity, autosomal dominant
retinitis pigmentosa, and glaucoma.

Stephen Williams, Deputy Company Secretary (responsible for
arranging the release of this announcement).

NOTES TO EDITORS

Inside Information

This announcement contains inside information.

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:

- 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.

S11858 07/16

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
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Clotilde Houze
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