MONTRÉAL, Feb. 14, 2017 /CNW Telbec/ - Shire Pharma Canada ULC (Shire) today announced that the company has filed a New Drug Submission (NDS) with Health Canada for the marketing authorization of lifitegrast for the treatment of dry eye disease in adults in Canada.
"Dry eye disease is a chronic inflammatory condition which affects millions of people worldwide," said Eric Tse, General Manager of Shire in Canada. "We look forward to the possibility of helping Canadians living with the condition by offering them a new treatment option to manage their symptoms. This constitutes an important milestone for Shire and our commitment to help more Canadians living with rare diseases and other specialized conditions such as dry eye disease."
The lifitegrast submission is supported by five clinical trials with more than 2,500 patients. These included one Phase 2 study, three Phase 3 efficacy and safety studies, and one long-term Phase 3 safety study. The file is currently under review with Health Canada. If approved, Canada will be the first country to receive marketing authorization for lifitegrast after the United States.
NOTES TO EDITORS
About Lifitegrast
Lifitegrast is a novel small-molecule integrin antagonist. It inhibits the interaction between the integrin LFA-1 (lymphocyte function-associated antigen-1), a cell surface protein found on leukocytes with its cognate ligand ICAM-1 (intercellular adhesion molecule-1). ICAM-1 may be over-expressed in corneal and conjunctival tissues in dry eye disease. LFA-1/ICAM-1 interaction can contribute 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 medical need.
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.
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. Shire currently has an ophthalmics pipeline of investigational candidates in infectious conjunctivitis, the prevention of retinopathy of prematurity, autosomal dominant retinitis pigmentosa, and glaucoma.
About Shire Pharma Canada ULC
Shire Pharma Canada ULC is a subsidiary of Shire. Our Canadian offices are located in Montréal (Saint-Laurent), Québec and Mississauga, Ontario. For more information, please visit: www.shirecanada.com.
SOURCE Shire Pharma Canada ULC
Brigitte Viel, [email protected], +1 514 787 5114
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