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

LEXINGTON, Massachusetts, August 29, 2016 /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™ (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™ (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.

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;
• 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.

For further information 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