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Shire announces submission of lifitegrast Marketing Authorization Application for treatment of dry eye disease in Europe

Lifitegrast, if approved, would be the first and only new class treatment to address
the signs and symptoms of dry eye disease
in adults in Europe

Zug, Switzerland – 15 August – Shire plc (LSE: SHP, NASDAQ: SHPG) announces that the Marketing Authorization Application (MAA) for lifitegrast, submitted on 07 August 2017, has been validated by the UK as the Reference Member State involved in the Decentralized Procedure (DCP). If approved, lifitegrast would be the first and only treatment in a new class of drugs (LFA-1 antagonist) to address the signs and symptoms of dry eye disease in adults in Europe. The disease is most commonly associated with eye dryness and overall eye discomfort, as well as stinging, burning, and fluctuating blurry vision1. Dry eye disease may significantly affect quality of life and may impact activities such as reading and using computers2. It is one of the most common conditions seen by ophthalmologists and eye care practitioners worldwide.3

“This submission is another important milestone for lifitegrast and the millions of patients living with dry eye disease, which can impact a person’s vision-related quality of life, affecting daily activities such as reading and using computers,” said Howard Mayer, M.D., Head of Clinical Development, R&D. “Shire is committed to continued innovation in ophthalmics, where there are opportunities to address unmet need and improve the lives of patients.”

Shire’s MAA for lifitegrast is supported by the largest development program to date for an investigational-stage dry eye disease candidate, consisting of five clinical trials with more than 2,500 patients.4,5,6,7,8 In these studies, the signs of dry eye disease were measured using corneal staining and the symptoms by using patient reported eye dryness score (EDS).4-8

About the lifitegrast Marketing Authorization Application

The lifitegrast MAA was submitted via the Decentralized Procedure (DCP) to Denmark, Norway, Sweden, Finland, the UK, Germany, the Netherlands, France, Italy, Portugal, Spain and Greece. The UK is the Reference Member State.

About Dry Eye Disease

The prevalence of dry eye disease, with and without symptoms, ranges from 5 to 50% in adults globally9. 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. Dry eye disease is a multifactorial disease of the ocular surface that is often chronic and may be progressive1. The disease is most commonly associated with eye dryness and overall eye discomfort, as well as stinging, burning, or fluctuating blurry vision.1 Dry eye disease may significantly affect quality of life and may impact activities such as reading and using computers.2

Ophthalmologists and eye care professionals can diagnose dry eye disease based on patient reported symptoms as well as signs which can be objectively evaluated through various tests.9

Management options may include the use of non-prescription and prescription treatments.10

Aging and gender are recognized as traditional risk factors of chronic dry eye disease, while modern risk factors include prolonged digital/computer screen time, contact lens wear and cataract or refractive surgery.11,12 Dry eye is a common complaint to ophthalmologists and eye care professionals.3

About lifitegrast

Lifitegrast is a lymphocyte function-associated antigen-1 (LFA-1) antagonist, the first medication in a new class of drugs. Lifitegrast binds to the integrin 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), which plays a prominent role in ocular surface inflammation.6 ICAM-1 may be over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can contribute to formation of an immunological synapse resulting in T-cell activation and migration to target tissues. 13 In vitro studies have shown that lifitegrast may inhibit the recruitment of previously activated T cells, the activation of newly recruited T cells, and the release of pro-inflammatory cytokines—interrupting the perpetual cycle of inflammation.14,15

About lifitegrast in the U.S.A.

The U.S. Food and Drug Administration approved lifitegrast under the brand name Xiidra®(lifitegrast ophthalmic solution) 5% for the treatment of signs and symptoms of dry eye disease in July 2016.16 For more information on the U.S. prescribing information, click here.

About lifitegrast clinical studies

Shire’s MAA for lifitegrast is supported by the largest development program to date for an investigational-stage dry eye disease candidate, consisting of five clinical trials with more than 2,500 patients.4-8 In four safety and efficacy studies, lifitegrast improved symptoms as measured by patient reported eye dryness score (EDS), and in three of the four studies improved the objective signs of dry eye disease (measured using corneal staining). A statistically significant reduction in EDS favoring lifitegrast was seen in all four studies at week six and week 12 (the week six analysis was a post-hoc analysis in three studies). In two clinical trials, symptom improvement was noted at two, six and 12 weeks.4-8 A long-term safety study randomized to either lifitegrast (n=220) or placebo (n=111) over 360 days found lifitegrast to be generally well-tolerated with no serious treatment-emergent ocular adverse events.

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.4-8

Shire's commitment to ophthalmology

Shire officially entered into ophthalmology with the acquisition of SARcode Bioscience in 2013. Shire's multi-faceted approach to discovery, development, and delivery in rare diseases and specialty conditions includes our efforts to address unmet needs in eye care.

Shire's ophthalmology franchise has been driven by a combination of strategic acquisitions and organic growth, and is focused on continuing to expand the portfolio to include treatment options for anterior and posterior segment eye conditions. In close to four years, acquisitions including SARcode followed by Foresight Biotherapeutics helped bolster Shire's early-, mid- and late-stage ophthalmology pipeline. As a result of a collaborative license agreement with Parion Sciences Inc., Shire is developing SHP-659 (formerly P-321), another investigational candidate for the treatment of dry eye disease in adults. Shire’s ophthalmology pipeline also includes investigational candidates in infectious conjunctivitis and glaucoma.

For further information please contact:

Investor Relations  
Ian Karpikarp@shire.com+1 781 482 9018
Robert Coates rcoates@shire.com+44 1256 894874
Media  
Gwen Fishergfisher@shire.com+1 781 482 9649
Clotilde Houzéchouze0@shire.com+1 781 266 3567

NOTES TO EDITORS

About Shire

Shire is the leading global biotechnology company focused on serving people with rare diseases. 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

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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;
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  • 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 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, including expected operating efficiencies, cost savings, revenue enhancements, synergies or other benefits at the time anticipated or at all with respect to Shire’s acquisitions, including NPS Pharmaceuticals Inc., Dyax Corp. or Baxalta Incorporated 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 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 has increased its borrowing costs may decrease its business flexibility; and a further list and description of risks, uncertainties and other matters can be found in Shire’s most recent Annual Report on Form 10-K and in Shire’s subsequent Quarterly Reports on Form 10-Q, in each case including those risks outlined in “ITEM 1A: Risk Factors”, and in Shire’s subsequent reports on Form 8-K and other Securities and Exchange Commission filings, all of which are available on Shire’s website.

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.

  1. Gayton, J. (2009). “Etiology, prevalence, and treatment of dry eye disease”. Clinical Ophthalmology. 3: 405–412.
  2. Miljanovic, B. et al. (2007). “Impact of Dry Eye Syndrome on Vision-Related Quality of Life”. American Journal of Ophthalmology. 143(3): 409-415.
  3. O’Brien PD, Collum LM. (2004). “Dry eye: diagnosis and current treatment strategies”. Curr Allergy Asthma Rep. 4:314-319. Available at: https://www.ncbi.nlm.nih.gov/pubmed/15175147 [Last accessed August 2017]
  4. Holland E J, Whitely WO, Sall Ke et al. (2016). “Lifitegrast clinical efficacy for treatment of signs and symptoms of dry eye disease across three randomized controlled trials”. Current Medical Research and Opinion. 32(10): 1759-1765.
  5. Sheppard JD, Torkildsen GL, Lonsdale JD et al. (2014). “Lifitegrast ophthalmic solution 5.0% for treatment of dry eye disease: results of the OPUS-1 phase 3 study”. Ophthalmology. 121(2): 475-83.
  6. Tauber J, Karpecki P, Latkany R et al. (2015). “Lifitegrast Ophthalmic Solution 5.0% versus Placebo for Treatment of Dry Eye Disease: Results of the Randomized Phase III OPUS-2 Study”. Ophthalmology. 122(12): 2423–2431.
  7. Holland E, Luchs J, Karpecki P et al. (2017). “Lifitegrast for the Treatment of Dry Eye Disease Results of a Phase III, Randomized, Double-Masked, Placebo-Controlled Trial (OPUS-3)”. Ophthalmology. 124(1): 53-60.
  8. Donnenfeld E, Karpecki PM, Majmudar PA et al. (2016). “Safety of Lifitegrast Ophthalmic Solution 5.0% in Patients with Dry Eye Disease: A 1-Year, Multicenter, Randomized, Placebo-Controlled Study”. Cornea. 35: 741–748.
  9. Nelson, J. Daniel et al. (2017). “TFOS DEWS II Introduction”. The Ocular Surface. 15(3): 269-275.
  10. Vickers LA, Preeya PK. The Future of Dry Eye Treatment: A Glance into the Therapeutic Pipeline Ophthalmol Ther 2015 4:69–78
  11. Uchino M et al. (2013). “Dry Eye Disease: Impact on Quality of Life and Vision”. Curr Ophthalmol Rep. June; 1(2):51-57.
  12. Hovanesian JA, Shah SS, et al. (2001). “Symptoms of dry eye and recurrent erosion syndrome after refractive surgery”. J Cataract Refract Surg. 27:577-84.
  13. Pflugfelder, S. et al. (2017). “LFA-1/ICAM-1 Interaction as a Therapeutic Target in Dry Eye Disease”. Available at: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5240001/. [Last accessed July 2017].
  14. Shire. (2016). “HIGHLIGHTS OF PRESCRIBING INFORMATION”. Available at: http://www.shirecontent.com/PI/PDFs/Xiidra_USA_ENG.pdf.[Last accessed July 2017].
  15. DEWS Research Subcommittee. Research in dry eye: report of the Research Subcommittee of the International Dry Eye WorkShop (2007). Ocul Surf. 2007;5(2):179-193.
  16. U.S. Food & Drug Administration. (2016). “FDA approves new medication for dry eye disease”. Available at: https://www.fda.gov/newsevents/newsroom/pressannouncements/ucm510720.htm. [Last accessed July 2017].

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