Medexus Granted Authorization by Health Canada to Distribute Treosulfan in Canada
Commences shipments to hospitals under the Special Access Program Plans underway to apply for full registration in Canada
MONTREAL, March 6, 2019 -- Medexus Pharmaceuticals Inc. (the “Company” or “Medexus”) (TSXV: MDP, OTCQB: PDDPF) today announced that Health Canada has authorized the Company to distribute Treosulfan, a conditioning agent used prior to stem cell transplantation. Authorization was granted via the Special Access Program which allows healthcare practitioners to access non-marketed drugs to treat patients with serious or life-threatening conditions when conventional therapies have failed, are unsuitable, or unavailable. Medexus plans to file for registration of Treosulfan with Health Canada in 2019 and expects to receive full registration within 12 to 18 months following the application. Medexus acquired the rights to Treosulfan through the acquisition of Medac Pharma, Inc., in the fall of 2018.
Treosulfan is indicated as part of conditioning treatment prior to allogeneic haematopoietic stem cell transplantation in adult patients with malignant and non-malignant diseases, and in pediatric patients older than one month with malignant diseases (https://www.ema.europa.eu/en/medicines/human/summaries-opinion/trecondi). Treosulfan is a significant improvement over current products used as conditioning agents prior to bone marrow transplantation, particularly in children, due to the increased rate of event-free survival after 2 years.
Ken d’Entremont, Chief Executive Officer of Medexus, commented, “We are thrilled to have been granted authorization to distribute Treosulfan within Canada, as it demonstrates our commitment to bringing products to market with clear market demand that can help patients live better lives. We have already begun shipments to hospitals across Canada and expect to expand distribution of Treosulfan once the product has received approval as a fully registered product.” Mr. d’Entremont continued, “The launch of Treosulfan is further validation of the synergies evident from our recent transformative acquisitions, and illustrates our abilities to leverage the combined product portfolios and North American sales force.”
While not an approved product in the US, on December 13, 2018, The European Medicines Agency’s Committee for Medical Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for Treosulfan, intended as a conditioning treatment prior to allogeneic haematopoietic stem cell transplantation. In the US Treosulfan is under clinical development and is being used in clinical trials on patients who desire to try a new treatment approach.
Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform. The Company’s vision is to provide the best healthcare products to healthcare professionals and patients, through our core values of Quality, Innovation, Customer Service and Teamwork. Medexus Pharmaceuticals is focused on the therapeutic areas of auto-immune disease and pediatrics. The leading products include Rasuvo and Metoject, unique formulations of methotrexate (auto-pen and pre-filled syringe) designed to treat rheumatoid arthritis and other auto-immune diseases; and Rupall, an innovative allergy medication with a unique mode of action.
For more information, please contact:
Ken d’Entremont, Chief Executive Officer
Medexus Pharmaceuticals Inc.
Roland Boivin, Chief Financial Officer
Medexus Pharmaceuticals Inc.
Tel.: 514-762-2626 ext. 202
Investor Relations (U.S.):
Crescendo Communications, LLC
Investor Relations (Canada):
Direct Financial Strategies and Communication Inc.
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