LEXINGTON, Mass., Aug. 29, 2016 /PRNewswire/ -- Shire plc
(LSE: SHP, NASDAQ: SHPG) today announced that Xiidra™ (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.
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"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™ (lifitegrast ophthalmic solution) 5%
Xiidra™ (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 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.
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.
S14190 08/16
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SOURCE Shire plc