Mr. Ken d'Entremont reports
MEDEXUS SUCCESSFULLY COMPLETES AGREEMENT FOR PUBLIC REIMBURSEMENT OF TRECONDYV (TREOSULFAN FOR INJECTION) IN QUEBEC, CANADA
Medexus Pharmaceuticals Inc. recently completed a listing agreement with the provincial government of Quebec for Trecondyv (treosulfan for injection). The public prescription drug insurance plan of the Regie de l'Assurance Maladie du Quebec, or RAMQ, will now reimburse eligible claims made for Trecondyv.
"This development is another important reimbursement milestone for Trecondyv because we have now achieved public reimbursement of Trecondyv in Canada's three most populous provinces, representing around three quarters of Canadians," said Richard Labelle, Medexus's chief operating officer. "It further demonstrates our commitment to seeking and quickly achieving public reimbursement across Canada, and is yet another important indicator of the prospects and potential of our treosulfan products -- both Trecondyv in the Canadian market and, in the U.S. market, Grafapex (treosulfan) for injection."
The next step in the Trecondyv public reimbursement process will be for other remaining government organizations to make their respective final decisions on public reimbursement for their regions or jurisdictions. Medexus is committed to continuing to work with these other participating provincial, territorial and federal government organizations to make Trecondyv available as soon as possible through public drug plans for the patients who need it.
About Trecondyv (treosulfan for injection)
Trecondyv (treosulfan for injection) is part of a preparative regimen for allogeneic hematopoietic stem cell transplantation, to be used in combination with fludarabine, used in treating eligible patients with acute myeloid leukemia and myelodysplastic syndromes.
Final study results and analysis of the pivotal phase 3 clinical trial of treosulfan conducted by medac GmbH, which was published in the American Journal of Hematology, concluded that the study demonstrates clinically relevant superiority of treosulfan over a widely applied "reduced-intensity conditioning" busulfan regimen with regard to its primary end point, event-free survival. The publication also includes favourable conclusions on two key secondary end points, finding that overall survival with treosulfan was superior compared with busulfan and that non-relapse mortality for patients in the treosulfan arm was lower than for patients in the busulfan arm. For more information about the study and the publication, including a link to the full publication, see Medexus's June 6, 2022, press release, available via the investors section of Medexus's corporate website.
During the phase 3 clinical trial of treosulfan, treatment emergent adverse events (TEAEs) were most commonly reported in the system organ classes, or SOCs, of gastrointestinal disorders, general disorders and administration site conditions and musculoskeletal and connective tissue disorders. TEAEs of at least CTCAE Grade III were reported by 54.8 per cent of patients in the treosulfan treatment group. Severe adverse events were reported by 8.5 per cent of patients in the treosulfan treatment group. Over all, TEAEs were reported by 92.6 per cent of patients in the treosulfan treatment group.
Trecondyv (treosulfan for injection) is approved by Health Canada for sale and use in Canada only and is not intended for export outside Canada. Medexus makes no representation that Trecondyv (treosulfan for injection) is appropriate for, or authorized for sale to or use by, persons who are not located in Canada.
Medexus Pharmaceuticals Inc. holds exclusive commercial rights to Trecondyv in Canada under a July, 2021, exclusive licence agreement with medac GmbH.
About Grafapex (treosulfan) for injection
Grafapex (treosulfan) for injection, an alkylating agent, is indicated in combination with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (alloHSCT) in adult and pediatric patients one year of age and older with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS).
Grafapex (treosulfan) for injection is approved by the Food and Drug Administration for sale and use in the United States only and is not intended for export outside the United States. Medexus makes no representation that Grafapex (treosulfan) for injection is appropriate for, or authorized for sale to or use by, persons who are not located in the United States.
Medexus Pharma Inc. holds exclusive commercial rights to Grafapex in the United States under a February, 2021, exclusive licence agreement with medac GmbH.
About Medexus Pharmaceuticals Inc.
Medexus is a leading specialty pharmaceutical company with a strong North American commercial platform and a growing portfolio of innovative and rare disease treatment solutions. Medexus's current focus is on the therapeutic areas of hematology-oncology and allergy, dermatology, and rheumatology.
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