Press Release
www.shire.com
U.S. FDA Grants Priority Review to Lifitegrast NDA for the Treatment of Dry Eye
Disease in Adults
Lexington, Mass. - April 9, 2015 - Shire plc (LSE: SHP, NASDAQ: SHPG) today
announced that the United States Food and Drug Administration (FDA) has
accepted for filing the New Drug Application (NDA) for lifitegrast and granted
a Priority Review designation. Lifitegrast is an investigational treatment for
dry eye disease in adults and, if approved, has the potential to be the first
treatment indicated to address both signs and symptoms of the disease. The FDA
is expected to provide a decision on October 25, 2015, based on the
Prescription Drug User Fee Act V action date.
The FDA grants Priority Review designation to drugs that have the potential to
provide significant improvements in the safety or effectiveness for the
treatment, diagnosis or prevention of a serious disease. Drugs with Priority
Review designation have an accelerated review target of eight months, instead
of the standard of 12 months.
"Our NDA filing for lifitegrast represents an important regulatory milestone,
exemplifying Shire's ability to forge new paths in therapeutic areas aligned
with our focus in rare and specialty conditions," said Philip J. Vickers,
Ph.D., Head of Research and Development, Shire. "Our commitment to moving
lifitegrast forward reflects our intent to grow in the Ophthalmics therapeutic
category in areas of unmet patient need. We look forward to working closely
with the FDA throughout the review process."
The NDA filing is supported by the totality of evidence from four clinical
trials with more than 1,800 patients. These include one Phase 2 study, two
Phase 3 efficacy and safety studies, and one long-term Phase 3 safety study.
"The symptoms of dry eye are one of the most common complaints from patients,
yet there remains a tremendous unmet need," said Stephen C. Pflugfelder, M.D.,
Professor of Ophthalmology at Baylor College of Medicine, Houston, Texas. "It's
encouraging to see Shire moving the program for lifitegrast forward."
About Lifitegrast
Lifitegrast is a novel small-molecule integrin inhibitor. It binds to the
integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface
protein found on leukocytes, and blocks the interaction of LFA-1 with its
cognate ligand ICAM-1 (intercellular adhesion molecule-1). ICAM-1 is
over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/
ICAM-1 interaction contributes to the formation of immunological synapses
resulting in T-cell activation and migration to target tissues.
About Dry Eye Disease
As defined by the 2007 Dry Eye WorkShop ("DEWS"), sponsored by the Tear Film &
Ocular Surface Society (TFOS), dry eye is a multifactorial disease of the tears
and ocular surface that results in symptoms of discomfort, visual disturbance,
and tear film instability with potential damage to the ocular surface. It is
accompanied by increased osmolarity of the tear film and inflammation of the
ocular surface. Dry eye, an often chronic and progressive ocular disease, is
one of the most common complaints to eye care professionals, and represents a
significant unmet need.
About Shire
Shire enables people with life-altering conditions to lead better lives.
Our strategy is to focus on developing and marketing innovative specialty
medicines to meet significant unmet patient needs.
We focus on providing treatments in Rare Diseases, Neuroscience,
Gastrointestinal and Internal Medicine and are developing treatments for
symptomatic conditions treated by specialist physicians in other targeted
therapeutic areas, such as Ophthalmics.
www.shire.com
For further information please contact:
Investor Relations
Sarah Elton-Farr
Seltonfarr@shire.com
+44 1256 894157
Media
Gwen Fisher
gfisher@shire.com
+1 484 595 9836
THE "SAFE HARBOR" STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT
OF 1995
Statements included in this announcement that are not historical facts 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, that:
* Shire's products may not be a 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 Shire's
products may affect 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 the Shire's products or ingredients are only available from a
single approved source for manufacture. Any disruption to the supply chain
for any of the 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;
* 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;
* 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;
* adverse outcomes in legal matters 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
Shire's revenues, financial condition or results of operations;
* Shire faces intense competition for highly qualified personnel from other
companies and organizations. Shire is undergoing a corporate reorganization
and was the subject of an unsuccessful acquisition proposal and the
consequent uncertainty could adversely affect Shire's ability to attract
and/or retain the highly skilled personnel needed for Shire to meet its
strategic objectives;
* failure to achieve Shire's strategic objectives with respect to the
acquisition of NPS Pharmaceuticals, Inc. may adversely affect Shire's
financial condition and results of operations;
and other risks and uncertainties detailed from time to time in Shire's filings
with the US Securities and Exchange Commission, including its most recent
Annual Report on Form 10-K.
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