QLT Inc., a biotechnology company, engages in the development and commercialization of ocular products that address the unmet medical needs of patients and clinicians worldwide. Products in Development The company is developing QLT091001 for the treatment of inherited retinal disease (IRD) caused by retinal pigment epithelium protein 65 (RPE65) and lecithin: retinol acyltransferase (LRAT) gene mutations (IRD), which indication includes Leber Congenital Amaurosis (LCA) and Retinitis Pigmentosa (RP). The company’s research and development efforts focus on QLT091001. QLT091001 is an orally administered synthetic retinoid replacement for 11-cis-retinal, which is a key biochemical component of the visual retinoid cycle. QLT091001 has received orphan drug designations for the treatment of LCA (due to inherited mutations in the LRAT and RPE65 genes) and RP (all mutations) by the U.S. Food and Drug Administration (FDA), and for the treatment of LCA and RP (all mutations) by the European Medicines Agency. LCA and RP Phase Ib Single Course of Treatment Study: The company completed a Phase Ib multi-center, open-label clinical proof-of-concept trial to evaluate the safety profile and effects of a single seven-day course of treatment with QLT091001 on various parameters of retinal function and quality of life in patients with LCA and autosomal recessive RP due to inherited mutations in RPE65 or LRAT. LCA and RP Phase Ib Retreatment Study: The company completed a Phase Ib multi-center, open-label clinical trial of repeated treatments of QLT091001 in patients with LCA and autosomal recessive RP due to inherited mutations in RPE65 or LRAT. During 2015, the company initiated a retrospective, uncontrolled, multicenter, case history study to determine the natural history of visual function in subjects with IRD phenotypically diagnosed as LCA or RP caused by autosomal recessive mutations in RPE65 or LRAT. The goal of the natural history study is to assess and compare visual outcomes in patients treated with QLT091001, relative to the treatment of naïve patients, in order to assess the extent to which QLT091001 might improve or prolong visual function. Compassionate Use Program In addition, the company had begun a compassionate use program for QLT091001 on a named-patient basis. Under the compassionate use program, QLT091001 might be made available to patients who participated in its completed Phase Ib clinical trial of QLT091001 for the treatment of LCA and RP. The program commenced in Ireland and participation for other patients would be determined on a case-by-case basis in accordance with applicable regulatory laws. Licensing Retinagenix Co-Development Agreement: Under the terms of a co-development agreement (the ‘Retinagenix Agreement’), the company entered into with Retinagenix LLC (Retinagenix) in April 2006, it obtained an exclusive, worldwide license and sub-license under certain intellectual property rights owned by Retinagenix or licensed to Retinagenix by the University of Washington, related to the synthetic retinoid compound under development. The company is responsible for using commercially reasonable and diligent efforts to develop and commercialize, in certain major markets and other markets as it reasonably determines, one or more products covered by the licensed rights or developed using such licensed rights for use in diagnosing, treating or preventing certain human diseases and conditions. The company is also responsible for committing certain annual funding to support research and development of such products. Patents, Trademarks and Proprietary Rights Pursuant to the company’s co-development agreement with Retinagenix, it has an exclusive, worldwide sub-license to patents and patent applications relating to various synthetic retinoids and uses thereof, including in the treatment of LCA and RP. These patents and patent applications are owned by the University of Washington, which has licensed the patents and patent applications to Retinagenix, and is sub-licensed to the company by Retinagenix. On May 31, 2011, the United States Patent and Trademark Office (‘the USPTO’) issued Paten
qlt inc (QLT:Toronto Stock Exchange)
887 Great Northern Way
Vancouver, BC V5T 4T5
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