Shire's First Prescription Eye Drop, Xiidra(TM) (lifitegrast ophthalmic solution) 5% is Now Available in the U.S.

Lexington, Massachusetts (ots/PRNewswire) -

- Xiidra is the only prescription eye drop approved by the U.S. FDA
for the treatment of both signs and symptoms of dry eye disease
- Resources are available to support patients seeking information
regarding coverage and savings offers
- Xiidra is the first medication in a new class of drugs - a
lymphocyte function-associated antigen 1 (LFA-1) antagonist -
approved by the FDA for dry eye disease

Shire plc (LSE: SHP, NASDAQ: SHPG) today announced that Xiidra(TM)
(lifitegrast ophthalmic solution) 5%, a twice-daily prescription eye
drop indicated for the treatment of both the signs and symptoms of
dry eye disease, is now available by prescription in the United
States. An estimated 16 million adults in the U.S. are diagnosed with
dry eye, a disease 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 U.S. Food and Drug Administration (FDA)
approved Xiidra on July 11, 2016.

"Shire worked rapidly to bring Xiidra to market following the
approval of this new treatment - a first-in-its-class medication and
the first prescription treatment to be approved for both the signs
and symptoms of dry eye disease," said Perry Sternberg, Head, U.S.
Commercial. "We have a full range of modern, educational access
programs to support the millions of patients across the U.S. living
with dry eye disease. This delivers on our commitment to showing up
differently in ophthalmics."

"As the number of people presenting with the signs and symptoms of
dry eye disease increases, the availability of a new prescription
treatment option for this condition is an exciting development," Eric
D. Donnenfeld, M.D., FAAO, National Medical Director, TLC Laser Eye
Centers. "We now have a new prescription eye drop that is
specifically indicated for the signs and symptoms of dry eye disease,
an often common eye condition that may be progressive."

With the availability of Xiidra, Shire has patient-focused
resources to share information about prescription coverage and
savings (subject to eligibility):

- ask iiris, a phone service offering live-person responses to
questions regarding information about insurance coverage, benefits,
co-pays and availability in pharmacies. To ask iiris, please call
1-844-my-iiris.
- Xiidra iinsider, an optional program that patients can sign up for
to receive information and special offers, either via text or
email.

About Xiidra(TM) (lifitegrast ophthalmic solution) 5%

Xiidra(TM) (lifitegrast ophthalmic solution) 5% is a prescription
eye drop indicated for the treatment of signs and symptoms of dry eye
disease. It is dosed twice per day, approximately 12 hours apart, in
each eye. The active ingredient in Xiidra, lifitegrast, 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). ICAM-1 may be overexpressed in corneal and conjunctival
tissues in patients with dry eye disease. This 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
cytokines in human peripheral blood mononuclear cells. The exact
mechanism of action of lifitegrast in dry eye disease is not known.
Xiidra is packaged in a foil pouch containing five low density
polyethylene 0.2 mL single-use containers, and is supplied in a
carton of 60 single use containers.

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. Aging and gender 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 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, the prevention of retinopathy of prematurity,
autosomal dominant retinitis pigmentosa, and glaucoma.

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.

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;
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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.

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
Clotilde Houze
chouze0@shire.com
+1-781-266-3567

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