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 QLT091001 – Synthetic Retinoid Program The company is developing QLT091001, a synthetic retinoid compound for the potential treatment of certain age-related and inherited retinal degenerative diseases. The company is developing QLT091001 for the treatment of leber congenital amaurosis (LCA) and retinitis pigmentosa (RP). In 2014, the company met with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), including an end-of-phase II meeting with the FDA, to progress QLT091001 for the treatment of certain inherited retinal diseases toward pivotal trials. The company also conducted a Phase IIa trial of QLT091001 for the treatment of impaired dark adaptation to investigate the safety and efficacy of the drug in a larger patient population. The company has also conducted a Phase 1b study in five RP patients with autosomal dominant mutation in retinal pigment epithelium protein 65 (RPE65). QLT091001 has received orphan drug designations from the FDA and the EMA for the treatment of certain indications under evaluation. The company has a co-development agreement with Retinagenix LLC (Retinagenix), pursuant to which the company 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, and are responsible for using commercially reasonable and diligent efforts to develop and commercialize, in certain major markets and other markets as the company 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. QLT091001 has also been granted two Fast Track designations by the FDA for the treatment of the lecithin:retinol acyltransferase and RPE65 genetic mutations in both LCA and autosomal recessive RP. Government Regulation The company and its contract manufacturers are subject to the FDA’s current Good Manufacturing Practices regulations and other rules and regulations prescribed by regulatory authorities outside the U.S. The research and development, preclinical studies and clinical trials, and the manufacturing, marketing and labeling of the company’s products, are subject to extensive regulation by the FDA and other regulatory authorities in the U.S. and other countries. The U.S. Food, Drug and Cosmetic Act and its regulations govern, among other things, the testing, manufacturing, safety, efficacy, labeling, packaging, storage, record keeping, approval, distribution, export and import, advertising and promotion of the company’s products. Research and Development During the year ended December 31, 2014, the company’s total company-sponsored research and development expenses were $13.8 million. History QLT Inc. was formed in 1981 under the laws of the province of British Columbia.
qlt inc (QLT:Toronto)
887 Great Northern Way
Vancouver, BC V5T 4T5
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