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

      * 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
       
    Lexington, Mass. - July 12, 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 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).

    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   

    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.

    www.shire.com

    Forward-Looking Statements

    Statements included herein that are not historical facts, including without
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    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
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      * the failure to achieve the strategic objectives with respect to the
        acquisition of Baxalta may adversely affect the company's financial
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      * 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
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        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
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        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.
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    otherwise required by applicable law, we do not undertake any obligation to
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