Medexus Successfully Completes Agreement for Public Reimbursement of Trecondyv (treosulfan for injection) in Quebec, Canada
Medexus Pharmaceuticals (MEDXF) has secured a significant reimbursement agreement with Quebec's Public Prescription Drug Insurance Plan (RAMQ) for Trecondyv® (treosulfan for injection). This achievement marks public reimbursement coverage in Canada's three most populous provinces, reaching approximately 75% of the Canadian population.
The company is actively pursuing reimbursement approvals from remaining provincial, territorial, and federal government organizations to expand Trecondyv® accessibility through public drug plans. This development also signals positive prospects for both Trecondyv® in Canada and GRAFAPEX™ (treosulfan) for Injection in the US market.
Medexus Pharmaceuticals (MEDXF) ha ottenuto un importante accordo di rimborso con il Piano Pubblico di Assicurazione per Farmaci Prescritti del Québec (RAMQ) per Trecondyv® (treosulfano per iniezione). Questo traguardo garantisce la copertura del rimborso pubblico nelle tre province più popolose del Canada, raggiungendo circa il 75% della popolazione canadese.
L'azienda sta attivamente lavorando per ottenere approvazioni di rimborso dagli enti governativi provinciali, territoriali e federali rimanenti, con l'obiettivo di ampliare l'accessibilità di Trecondyv® attraverso i piani pubblici di farmaci. Questo sviluppo rappresenta inoltre prospettive positive sia per Trecondyv® in Canada sia per GRAFAPEX™ (treosulfano) per iniezione nel mercato statunitense.
Medexus Pharmaceuticals (MEDXF) ha asegurado un acuerdo significativo de reembolso con el Plan Público de Seguro de Medicamentos Recetados de Quebec (RAMQ) para Trecondyv® (treosulfano para inyección). Este logro marca la cobertura de reembolso público en las tres provincias más pobladas de Canadá, alcanzando aproximadamente al 75% de la población canadiense.
La empresa está buscando activamente aprobaciones de reembolso de los organismos gubernamentales provinciales, territoriales y federales restantes para ampliar la accesibilidad de Trecondyv® a través de los planes públicos de medicamentos. Este desarrollo también indica perspectivas positivas tanto para Trecondyv® en Canadá como para GRAFAPEX™ (treosulfano) para inyección en el mercado estadounidense.
Medexus Pharmaceuticals (MEDXF)는 퀘벡 공공 처방약 보험 계획(RAMQ)과 Trecondyv®(주사용 트레오술판)에 대한 중요한 보험급여 계약을 체결했습니다. 이번 성과로 캐나다에서 인구가 가장 많은 세 개 주에서 공공 보험급여 적용이 이루어져 캐나다 인구의 약 75%에 도달하게 되었습니다.
회사는 남은 주정부, 준주정부 및 연방 정부 기관으로부터 보험급여 승인을 적극적으로 추진하여 공공 약제 계획을 통한 Trecondyv® 접근성을 확대할 계획입니다. 이 개발은 캐나다 내 Trecondyv®와 미국 시장의 GRAFAPEX™(트레오술판 주사제) 모두에 긍정적인 전망을 시사합니다.
Medexus Pharmaceuticals (MEDXF) a conclu un accord de remboursement important avec le régime public d'assurance médicaments sur ordonnance du Québec (RAMQ) pour Trecondyv® (tréosulfane pour injection). Cette réussite marque la couverture par remboursement public dans les trois provinces les plus peuplées du Canada, atteignant environ 75 % de la population canadienne.
L'entreprise cherche activement à obtenir des approbations de remboursement auprès des organismes gouvernementaux provinciaux, territoriaux et fédéraux restants afin d'élargir l'accès à Trecondyv® via les régimes publics de médicaments. Ce développement annonce également des perspectives positives tant pour Trecondyv® au Canada que pour GRAFAPEX™ (tréosulfane) pour injection sur le marché américain.
Medexus Pharmaceuticals (MEDXF) hat eine bedeutende Erstattungsvereinbarung mit dem öffentlichen Verschreibungsmedikamentenversicherungssystem von Quebec (RAMQ) für Trecondyv® (Treosulfan zur Injektion) abgeschlossen. Dieser Erfolg sichert die öffentliche Erstattungsdeckung in den drei bevölkerungsreichsten Provinzen Kanadas und erreicht damit etwa 75 % der kanadischen Bevölkerung.
Das Unternehmen verfolgt aktiv Erstattungszulassungen von den verbleibenden provinziellen, territorialen und bundesstaatlichen Behörden, um die Zugänglichkeit von Trecondyv® durch öffentliche Arzneimittelpläne zu erweitern. Diese Entwicklung signalisiert zudem positive Aussichten sowohl für Trecondyv® in Kanada als auch für GRAFAPEX™ (Treosulfan) zur Injektion auf dem US-Markt.
- Secured reimbursement coverage in Quebec, expanding market access
- Achieved coverage in Canada's three largest provinces, reaching 75% of population
- Potential market expansion through pending approvals in remaining jurisdictions
- None.
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - April 17, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) recently completed a listing agreement with the provincial government of Quebec for Trecondyv® (treosulfan for injection). The Public Prescription Drug Insurance Plan of the Régie de l'Assurance Maladie du Québec, 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 US 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.
* RAMQ, "Liste des médicaments fournis en établissement, 10 avril 2024", available at www.ramq.gouv.qc.ca/fr/media/20936 (accessed April 16, 2025).
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 endpoint, event-free survival. The publication also includes favorable conclusions on two key secondary endpoints, finding that overall survival with treosulfan was superior compared to 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
For more information about Trecondyv®, including important safety information, see the product monograph, which is available on Health Canada's website at health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100678.
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 license 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). For more information about GRAFAPEX™, including important safety information (including boxed warning), see the full prescribing information, which is available on the Drugs@FDA drug database at www.fda.gov.
GRAFAPEX™ (treosulfan) for Injection is approved by the FDA 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 license agreement with medac GmbH.
About Medexus
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. For more information about Medexus and its product portfolio, please see the company's corporate website at www.medexus.com and its filings on SEDAR+ at www.sedarplus.ca.
Contacts
Ken d'Entremont | CEO, Medexus Pharmaceuticals
Tel: 905-676-0003 | Email: ken.dentremont@medexus.com
Brendon Buschman | CFO, Medexus Pharmaceuticals
Tel: 416-577-6216 | Email: brendon.buschman@medexus.com
Victoria Rutherford | Adelaide Capital
Tel: 480-625-5772 | Email: victoria@adcap.ca
Forward-looking statements
Certain statements in this news release contain forward-looking information within the meaning of applicable securities laws, also known and/or referred to as "forward-looking information" or "forward-looking statements". The words "anticipates", "believes", "budget", "potential", "targets", "could", "estimates", "expects", "forecasts", "goals", "intends", "may", "might", "objective", "outlook", "plans", "projects", "schedule", "should", "will", "would", "prospects", and "vision", or similar words, phrases, or expressions, are often intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words, phrases, or expressions. Specific forward-looking statements in this news release include, but are not limited to, information contained in statements regarding any of the following: Medexus's expectations and plans regarding future growth, revenues, and expenses (including in respect of the commercialization of Trecondyv® (treosulfan for injection), in Canada, and GRAFAPEX™ (treosulfan) for Injection, in the United States, and the product-level revenue to be generated from their commercialization); the legislative, regulatory, and policy environment in Canada and the United States; the potential benefits of Trecondyv® (treosulfan for injection) and GRAFAPEX™ (treosulfan) for Injection; the occurrence, timing, and expected outcome of the public reimbursement review process for Trecondyv® (treosulfan for injection) by one or more remaining participating jurisdictions; and expectations regarding the product's prospects and performance, its potential adoption and use, and the potential competitive position of the products and anticipated trends and potential challenges in the markets in which the products are expected to compete, including if approved by one or more participating jurisdictions, in the case of public reimbursement process for Trecondyv® (treosulfan for injection). The forward-looking statements and information included in this news release are based on Medexus's current expectations and assumptions, including factors or assumptions that were applied in drawing a conclusion or making a forecast or projection, and including assumptions based on regulatory guidelines, historical trends, current conditions, and expected future developments. Since forward-looking statements relate to future events and conditions, by their very nature they require making assumptions and involve inherent risks and uncertainties. Medexus cautions that, although the assumptions are believed to be reasonable in the circumstances, these risks and uncertainties mean that actual results could differ, and could differ materially, from the expectations contemplated by the forward-looking statements. Material risk factors include, but are not limited to, those set out in Medexus's materials filed with the Canadian securities regulatory authorities from time to time, including Medexus's most recent annual information form and management's discussion and analysis. In addition, specific risks and uncertainties relevant to the content of this news release include, among other things: the uncertainties inherent in research initiatives (including the possibility of unfavorable new data and further analyses of existing data); the risk that data are subject to differing interpretations and assessments by relevant third parties; and whether relevant third parties will be satisfied with the design and methodology of and results from the relevant study, which will depend on many factors, including determinations as to whether the product's benefits outweigh its known risks and determinations of the product's efficacy and cost-effectiveness in the context of a given facility (which varies by facility type). Further such risks and uncertainties include, among other things, risks and uncertainties associated with the legislative, regulatory, and policy environment in the markets and jurisdictions in which the company does business, and, in general, the evolving international trade situation in respect of tariffs or restrictions on or otherwise affecting pharmaceutical or biologic products, including the company's products or components of those products. Accordingly, undue reliance should not be placed on these forward-looking statements, which are made only as of the date of this news release. Other than as specifically required by law, Medexus undertakes no obligation to update any forward-looking statements to reflect new information, subsequent or otherwise.
Additional notes
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FAQ
What is the significance of Medexus (MEDXF) securing RAMQ reimbursement for Trecondyv?
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