Shire plc : Xiidra® Approved by Health Canada To Treat the Signs and Symptoms of Dry Eye Disease
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Shire plc

January 3, 2018

Cambridge, MA – January 3, 2018 – Shire plc (LSE: SHP, NASDAQ: SHPG) announced today that 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 adults,1 has been approved in Canada, marking the first international approval for the treatment outside of the U.S. Xiidra is the first new prescription medication for dry eye disease to be approved in Canada in seven years,2 providing patients with an effective treatment option for this common eye disease.3

Dry eye disease is one of the most prevalent conditions seen by eye care professionals and may affect up to 29 per cent of Canadians.4 The condition significantly affects vision-related quality of life and may impact activities such as reading, using computers, driving and watching television.5

“Many Canadians aren’t aware of the chronic nature of dry eye disease, and the potential impact it can have on their eye health,” says Dr. W. Bruce Jackson, an ophthalmologist specializing in cornea and external disease with a special or primary interest in ocular surface disease and dry eye disease. “The approval of Xiidra in Canada gives patients a new option to address both the signs and symptoms of dry eye disease.”

The approval of Xiidra is supported by the largest development program globally to-date for an investigational-stage dry eye disease therapy, consisting of five clinical trials with more than 2,500 patients. In four safety and efficacy studies, Xiidra 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).6

“Xiidra is Shire’s entry into the eye care market, and represents our commitment to ophthalmics,” said Howard B. Mayer, M.D., Chief Medical Officer, Research and Development, Shire. “It’s important that we successfully deliver innovative treatments for patients worldwide, so we’re pleased to now be able to make Xiidra available in Canada.”

Xiidra will be available for patients in Canada in early 2018.

Xiidra in Clinical Trials

A larger reduction in eye dryness score (EDS) favouring Xiidra was observed in all four efficacy studies at week six and week 12. In two clinical trials, symptom improvement was noted at two, six and 12 weeks. A long-term safety study randomized to either Xiidra (n=220) or placebo (n=111) over 360 days found Xiidra to be generally well-tolerated with no serious treatment-emergent ocular adverse events. 7

 

The most common ocular adverse reactions were eye irritation (18%), eye pain (13%) and instillation site reactions (12%). The majority of ocular adverse reactions were mild and transient in nature. The most common non-ocular adverse reaction was altered taste sensation (dysgeusia) (14%).8

About Dry Eye Disease

Dry eye disease affects almost one-third of the population globally9 and may significantly affect vision-related quality of life and activities such as reading and using computers.10 The symptoms of dry eye disease include scratchiness, stinging, stringy mucus in or around the eyes, blurry vision and excess tearing.11

Dry eye disease is a multifactorial disease of the ocular surface that is often chronic and may be progressive.12 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.13 Management options may include the use of non-prescription and prescription treatments.14

About Xiidra

In Canada, Xiidra (lifitegrast ophthalmic solution 5%) is a sterile, preservative-free prescription eye drop used to treat the signs and symptoms of dry eye disease.15

Xiidra works by blocking the interaction between two types of proteins that can cause inflammation in dry eye disease.16

Xiidra is currently approved in the United States. Please refer to local labelling at www.shire.com.

Important Safety Information

The most common side effects of Xiidra include irritation where the drops are applied to the eyes and altered 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.

Xiidra is contraindicated in patients who are hypersensitive to the drug or to any ingredient in the formulation or component of the container. For a complete listing, see the Dosage Forms, Composition and Packaging section of the Product Monograph.

Shire’s Commitment to Ophthalmics

Shire officially entered into ophthalmics with the acquisition of SARcode Bioscience in 2013. 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 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 ophthalmics 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 ophthalmics pipeline also includes investigational candidates in infectious conjunctivitis and glaucoma.

*Xiidra is a trademark or registered trademark of SARcode Bioscience Inc., a wholly-owned, indirect subsidiary of Shire plc.

About Shire

Shire is the global leader in serving patients with rare diseases. We strive to develop best-in-class therapies across a core of rare disease areas including hematology, immunology, genetic diseases, neuroscience, and internal medicine with growing therapeutic areas in ophthalmics and oncology. Our diversified capabilities enable us to reach patients in more than 100 countries who are struggling to live their lives to the fullest.

We feel a strong sense of urgency to address unmet medical needs and work tirelessly to improve people’s lives with medicines that have a meaningful impact on patients and all who support them on their journey.

www.shire.com

About Shire Pharma Canada ULC

Shire Pharma Canada ULC is a subsidiary of Shire. Our Canadian office is located in Toronto, Ontario. For more information, please visit: www.shirecanada.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, among other things, 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 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.

References

  1. Xiidra product monograph. December 22, 2017.
  2. Health Canada. https://health-products.canada.ca/dpd-bdpp/dispatch-repartition.do. Restasis DIN #02355655. Accessed December 15, 2017.
  3. Canadian Journal of Optometry. National Dry Eye Disease Guidelines for Canadian optometrists. Supplement. https://opto.ca/sites/default/files/resources/documents/cjo_dry_eye_supplement_2014.pdf. Accessed December 15, 2017.
  4. Canadian Journal of Optometry. National Dry Eye Disease Guidelines for Canadian optometrists. Supplement. https://opto.ca/sites/default/files/resources/documents/cjo_dry_eye_supplement_2014.pdf. Accessed December 15, 2017.
  5. Miljanovic, B. et al. (2007). “Impact of Dry Eye Syndrome on Vision-Related Quality of Life”. American Journal of Ophthalmology. 143(3): 409-415.
  6. Xiidra product monograph. December 22, 2017.
  7. Xiidra product monograph. December 22, 2017.
  8. Xiidra product monograph. December 22, 2017.
  9. Canadian Journal of Optometry. National Dry Eye Disease Guidelines for Canadian optometrists. Supplement. https://opto.ca/sites/default/files/resources/documents/cjo_dry_eye_supplement_2014.pdf. Accessed December 15, 2017.
  10. Miljanovic, B. et al. (2007). “Impact of Dry Eye Syndrome on Vision-Related Quality of Life”. American Journal of Ophthalmology. 143(3): 409-415.
  11. Canadian Ophthalmological Society. Dry eyes. http://www.cos-sco.ca/vision-health-information/conditions-disorders-treatments/corneal-diseases/dry-eyes/. Accessed December 15, 2017.
  12. Gayton JL. (2009). “Etiology, prevalence, and treatment of dry eye disease”. Clinical Ophthalmology. 3: 405-412.
  13. Gayton JL. (2009). “Etiology, prevalence, and treatment of dry eye disease”. Clinical Ophthalmology. 3: 405-412.
  14. Vickers LA, Preeya PK. The Future of Dry Eye Treatment: A Glance into the Therapeutic Pipeline Ophthalmol Ther 2015 4:69-78
  15. Xiidra product monograph. December 22, 2017.
  16. Xiidra product monograph. December 22, 2017.
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