Medexus and British Columbia's Provincial Health Services Authority (PHSA) Successfully Complete Agreement for Public Reimbursement of Trecondyv (treosulfan for injection) in British Columbia, Canada
Medexus Pharmaceuticals (MEDXF) has secured a listing agreement with British Columbia's Provincial Health Services Authority for Trecondyv (treosulfan for injection) to be included on the BC Cancer Benefit Drug List. This agreement enables public reimbursement for eligible patients using Trecondyv in combination with fludarabine as conditioning treatment before allogeneic hematopoietic stem cell transplantation in adult patients with acute myeloid leukemia or myelodysplastic syndromes who are at increased risk for standard conditioning therapies.
This marks the first reimbursement milestone following the successful completion of the pCPA negotiation process. Medexus is actively working with other provincial, territorial, and federal government organizations to expand public reimbursement coverage across Canada. The company views this development as an important indicator of the product's potential in both the Canadian market and potentially the US market, pending FDA approval.
Medexus Pharmaceuticals (MEDXF) ha ottenuto un accordo per la quotazione con l'Autorità dei Servizi Sanitari della Columbia Britannica per Trecondyv (treosulfan per iniezione), che sarà incluso nella Lista dei Farmaci a Beneficio del Cancro della BC. Questo accordo consente il rimborso pubblico per i pazienti idonei che utilizzano Trecondyv in combinazione con fludarabina come trattamento di condizionamento prima del trapianto allogenico di cellule staminali ematopoietiche in pazienti adulti con leucemia mieloide acuta o sindromi mielodisplastiche che presentano un rischio maggiore per le terapie di condizionamento standard.
Questo segna il primo traguardo di rimborso dopo il completamento con successo del processo di negoziazione con il pCPA. Medexus sta lavorando attivamente con altre organizzazioni governative provinciali, territoriali e federali per espandere la copertura del rimborso pubblico in tutto il Canada. L'azienda considera questo sviluppo un indicatore importante del potenziale del prodotto sia nel mercato canadese che, potenzialmente, nel mercato statunitense, in attesa dell'approvazione della FDA.
Medexus Pharmaceuticals (MEDXF) ha conseguido un acuerdo de listado con la Autoridad de Servicios de Salud de Columbia Británica para Trecondyv (treosulfan para inyección), que se incluirá en la Lista de Medicamentos Beneficiosa del Cáncer de BC. Este acuerdo permite el reembolso público para pacientes elegibles que utilizan Trecondyv en combinación con fludarabina como tratamiento de acondicionamiento antes del trasplante de células madre hematopoyéticas alogénicas en pacientes adultos con leucemia mieloide aguda o síndromes mielodisplásicos que están en mayor riesgo para las terapias de acondicionamiento estándar.
Este es el primer hito de reembolso tras la exitosa finalización del proceso de negociación con el pCPA. Medexus está trabajando activamente con otras organizaciones gubernamentales provinciales, territoriales y federales para expandir la cobertura de reembolso público en todo Canadá. La empresa ve este desarrollo como un indicador importante del potencial del producto tanto en el mercado canadiense como, potencialmente, en el mercado estadounidense, a la espera de la aprobación de la FDA.
Medexus Pharmaceuticals (MEDXF)는 브리티시컬럼비아 주 보건 서비스 당국과 Trecondyv (주사용 treosulfan)의 상장 계약을 체결하여 BC 암 치료 약품 목록에 포함될 수 있게 되었습니다. 이 계약은 조건 치료로 Trecondyv와 fludarabine을 사용하기 위해 자격이 있는 환자에 대한 공적 환급을 가능하게 합니다. 이는 표준 조건 요법에 대해 더 높은 위험을 가진 성인 급성 골수성 백혈병 또는 골수형성이상증후군 환자에게 적용됩니다.
이는 pCPA 협상 과정의 성공적인 완료 후 첫 번째 환급 이정표를 의미합니다. Medexus는 캐나다 전역의 공적 환급 범위를 확장하기 위해 다른 주, 준주 및 연방 정부 기관과 적극적으로 협력하고 있습니다. 이 회사는 이 발전을 캐나다 시장에서의 제품 잠재력과 FDA 승인을 기다리는 미국 시장에서도 중요한 지표로 보고 있습니다.
Medexus Pharmaceuticals (MEDXF) a conclu un accord de listing avec l'Autorité des Services de Santé de Colombie-Britannique pour Trecondyv (treosulfane injectable), qui sera inclus sur la Liste des Médicaments Bénéfiques pour le Cancer de la BC. Cet accord permet le remboursement public pour les patients éligibles utilisant Trecondyv en combinaison avec fludarabine comme traitement de conditionnement avant une transplantation de cellules souches hématopoïétiques allogéniques chez des patients adultes atteints de leucémie myéloïde aiguë ou de syndromes myélodysplasiques présentant un risque accru pour les thérapies de conditionnement standard.
Ceci marque la première étape de remboursement après l'achèvement réussi du processus de négociation avec le pCPA. Medexus travaille activement avec d'autres organisations gouvernementales provinciales, territoriales et fédérales pour étendre la couverture du remboursement public à travers le Canada. L'entreprise considère ce développement comme un indicateur important du potentiel du produit tant sur le marché canadien que potentiellement sur le marché américain, en attente de l'approbation de la FDA.
Medexus Pharmaceuticals (MEDXF) hat eine Listungsvereinbarung mit der Gesundheitsbehörde der Provinz British Columbia für Trecondyv (Treosulfan zur Injektion) gesichert, die in die BC Krebs-Benefit-Arzneimittelliste aufgenommen wird. Diese Vereinbarung ermöglicht die öffentliche Erstattung für berechtigte Patienten, die Trecondyv in Kombination mit Fludarabin als Konditionierungstherapie vor einer allogenen hämatopoetischen Stammzellentransplantation bei erwachsenen Patienten mit akuter myeloischer Leukämie oder myelodysplastischen Syndromen verwenden, die ein erhöhtes Risiko für Standardkonditionierungstherapien aufweisen.
Dies markiert den ersten Erstattungsmeilenstein nach dem erfolgreichen Abschluss des pCPA-Verhandlungsprozesses. Medexus arbeitet aktiv mit anderen provinzialen, territorialen und bundesstaatlichen Regierungsorganisationen zusammen, um die öffentliche Erstattung in ganz Kanada auszuweiten. Das Unternehmen betrachtet diese Entwicklung als einen wichtigen Indikator für das Potenzial des Produkts sowohl im kanadischen Markt als auch möglicherweise im US-Markt, abhängig von der FDA-Zulassung.
- Secured public reimbursement approval for Trecondyv in British Columbia
- First successful regional reimbursement following pCPA negotiation completion
- Potential for expanded market access across other Canadian provinces
- FDA approval for US market still pending
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - January 15, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) recently completed a listing agreement with British Columbia's Provincial Health Services Authority (PHSA), a publicly funded health service provider in the Canadian province, for a new approved indication for Trecondyv® (treosulfan for injection) to be listed on the BC Cancer Benefit Drug List and funded through BC Cancer, a part of PHSA that provides a province-wide population-based cancer control program for the residents of British Columbia. BC Cancer will now reimburse eligible claims made for Trecondyv® for eligible patients in combination with fludarabine as part of conditioning treatment prior to allogeneic hematopoietic stem cell transplantation in adult patients with acute myeloid leukemia or myelodysplastic syndromes at increased risk for standard conditioning therapies.*
"This important reimbursement milestone is the first of several we expect following the successful completion of the pCPA negotiation process for Trecondyv®," said Richard Labelle, Medexus's Chief Operating Officer. "It demonstrates our commitment to seeking and quickly achieving public reimbursement of Trecondyv® across Canada, and is yet another important indicator of this product's prospects and potential, both in the Canadian market and, if and when approved by the FDA, the US market as well."
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.
* BC Cancer, "BC Cancer Benefit Drug List: January 2025," available at www.bccancer.bc.ca/systemic-therapy-site/documents/policy%20and%20forms/benefit%20drug%20list.pdf (HTTPS version not available) (accessed January 14, 2025).
About Trecondyv® (treosulfan for injection)
Treosulfan 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® (treosulfan for injection), including important safety information, see the product monograph, which is available on Health Canada's website at https://health-products.canada.ca/dpd-bdpp/info?lang=eng&code=100678.
Treosulfan 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 treosulfan is appropriate for, or authorized for sale to or use by, persons who are not located in Canada. Treosulfan is currently the subject of a regulatory review process with the US Food and Drug Administration. Medexus holds exclusive commercialization rights to treosulfan in Canada and the United States.
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 oncology, hematology, rheumatology, auto-immune diseases, allergy, and dermatology. 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", "expects", "will", "plans", "potential", "prospects", and 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 treosulfan (including under the brand name Trecondyv®) and the product-level revenue to be generated from its commercialization in Canada and the United States); the legislative, regulatory, and policy environment in Canada; the potential benefits of treosulfan (including under the brand name Trecondyv®); the occurrence, timing, and expected outcome of the public reimbursement review process for Trecondyv® by one or more remaining participating jurisdictions and the FDA review process for treosulfan; and, if approved by one or more participating jurisdictions (in the case of public reimbursement process for Trecondyv®) and the FDA (in the case of commercialization of treosulfan in the United States), expectations regarding the product's prospects and performance, its potential adoption and use, and the potential competitive position of the product and anticipated trends and potential challenges in the market in which the product is expected to compete. These statements and information 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. 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
Trecondyv® (treosulfan for injection), as discussed in this news release, is a Canadian trademark of medac GmbH. Solely for convenience, trademarks and other protected names and marks referred to in this news release may appear without the "®", "™", or other similar symbols. Each such reference should be read as though it appears with the relevant symbol. Any such references are not intended to indicate, in any way, that the holder or holders will not assert those rights to the fullest extent under applicable law.
The information in this news release is provided for informational purposes to investors in Medexus securities.
Uniform resource locators, or website addresses, that appear in this news release are intended to be provided as inactive textual references only. Information contained on or accessible through these website addresses is not a part of this news release and is not incorporated by reference into this news release or any of Medexus's public filings.
To view the source version of this press release, please visit https://www.newsfilecorp.com/release/237176
FAQ
What is the new reimbursement status for Medexus's (MEDXF) Trecondyv in British Columbia?
What medical conditions is MEDXF's Trecondyv approved for reimbursement in British Columbia?
What are the next steps for MEDXF's Trecondyv reimbursement in Canada?
How does the BC reimbursement approval impact MEDXF's market potential?
