Medexus and Ontario's Provincial Health Services Successfully Complete Agreements for Public Reimbursement of Trecondyv (treosulfan for injection) in Ontario, Canada
Medexus Pharmaceuticals (MEDXF) has successfully completed listing agreements with Ontario's Ministry of Health and Ontario Health for Trecondyv (treosulfan for injection). This enables public reimbursement through Ontario Public Drug Programs for eligible claims, marking a significant milestone following the pCPA negotiation process.
The company is now focused on securing similar reimbursement agreements with other provincial, territorial, and federal government organizations across Canada. This development follows the recent FDA approval of GRAFAPEX (treosulfan) for Injection in the US market, highlighting the expanding potential of Medexus's treosulfan products in North America.
Medexus Pharmaceuticals (MEDXF) ha completato con successo gli accordi di quotazione con il Ministero della Salute dell'Ontario e Ontario Health per Trecondyv (treosulfano per iniezione). Ciò consente il rimborso pubblico attraverso i Programmi Pubblici di Farmaci dell'Ontario per le richieste idonee, segnando un traguardo significativo dopo il processo di negoziazione pCPA.
L'azienda ora si concentra sull'ottenere accordi di rimborso simili con altre organizzazioni governative provinciali, territoriali e federali in tutto il Canada. Questo sviluppa segue l'approvazione recente da parte della FDA di GRAFAPEX (treosulfano) per Iniezione nel mercato statunitense, evidenziando il potenziale crescente dei prodotti a base di treosulfano di Medexus in Nord America.
Medexus Pharmaceuticals (MEDXF) ha completado con éxito los acuerdos de listado con el Ministerio de Salud de Ontario y Ontario Health para Trecondyv (treosulfano para inyección). Esto permite el reembolso público a través de los Programas Públicos de Medicamentos de Ontario para reclamaciones elegibles, marcando un hito significativo tras el proceso de negociación del pCPA.
La empresa ahora se centra en asegurar acuerdos de reembolso similares con otras organizaciones gubernamentales provinciales, territoriales y federales en todo Canadá. Este desarrollo sigue a la reciente aprobación de la FDA de GRAFAPEX (treosulfano) para inyección en el mercado estadounidense, destacando el potencial en expansión de los productos de treosulfano de Medexus en América del Norte.
Medexus Pharmaceuticals (MEDXF)는 온타리오 보건부와 온타리오 건강을 위한 Trecondyv (주사용 트레오설판) 관련 상장 계약을 성공적으로 완료했습니다. 이는 온타리오 공공 약제 프로그램을 통해 적격 청구의 공적 환급을 가능하게 하여, pCPA 협상 과정 이후 중요한 이정표가 됩니다.
회사는 이제 캐나다 전역의 기타 주 정부, 준주 및 연방 정부 기관과 유사한 환급 계약을 확보하는 데 주력하고 있습니다. 이 발전은 미국 시장에서 GRAFAPEX (트레오설판) 주사에 대한 최근 FDA 승인을 따른 것으 로, 북미에서 Medexus의 트레오설판 제품의 확장 가능성을 강조합니다.
Medexus Pharmaceuticals (MEDXF) a réussi à finaliser des accords de cotation avec le ministère de la Santé de l'Ontario et Ontario Health pour Trecondyv (treosulfan pour injection). Cela permet le remboursement public par le biais des programmes publics de médicaments de l'Ontario pour les demandes éligibles, marquant une étape importante après le processus de négociation pCPA.
L'entreprise se concentre désormais sur la sécurisation d'accords de remboursement similaires avec d'autres organisations gouvernementales provinciales, territoriales et fédérales à travers le Canada. Ce développement fait suite à l'approbation récente par la FDA de GRAFAPEX (treosulfan) pour injection sur le marché américain, soulignant le potentiel croissant des produits à base de treosulfan de Medexus en Amérique du Nord.
Medexus Pharmaceuticals (MEDXF) hat erfolgreich Listungsvereinbarungen mit dem Gesundheitsministerium von Ontario und Ontario Health für Trecondyv (Treosulfan zur Injektion) abgeschlossen. Dies ermöglicht die öffentliche Erstattung über die öffentlichen Arzneimittelprogramme von Ontario für anspruchsberechtigte Anträge und markiert einen bedeutenden Meilenstein nach dem pCPA-Verhandlungsprozess.
Das Unternehmen konzentriert sich nun darauf, ähnliche Erstattungsvereinbarungen mit anderen Provinzen, Territorien und bundesstaatlichen Regierungsorganisationen in ganz Kanada zu sichern. Diese Entwicklung folgt auf die jüngste FDA-Zulassung von GRAFAPEX (Treosulfan) für Injektion auf dem US-Markt, was das wachsende Potenzial von Medexus' Treosulfan-Produkten in Nordamerika unterstreicht.
- Secured public reimbursement approval for Trecondyv in Ontario, Canada's largest market
- Successfully completed pCPA negotiation process
- Recent FDA approval for GRAFAPEX in the US market expands market potential
- None.
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - February 4, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) recently completed listing agreements with Ontario's Ministry of Health (Ontario Public Drug Programs) and Ontario Health (Cancer Care Ontario) for Trecondyv® (treosulfan for injection). The Ontario Public Drug Programs will now reimburse eligible claims made for Trecondyv®, subject to satisfaction of any relevant conditions set out in the agreements.¹
"This important development is another reimbursement milestone following the successful completion of the pCPA negotiation process for Trecondyv®," said Richard Labelle, Medexus's Chief Operating Officer. "It further demonstrates our commitment to seeking and quickly achieving public reimbursement of Trecondyv® 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, which was recently approved by the FDA."²
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.
¹ Cancer Care Ontario, "Drug Formulary", available at www.cancercareontario.ca/en/search_2?field_type_of_contents=1&home_search=trecondyv (accessed February 3, 2025).
² Medexus, news release: "Medexus Announces FDA Approval of GRAFAPEX (treosulfan) for Injection and Provides Business Update", available at https://www.medexus.com/en_US/news-media/press-releases/detail/176/medexus-announces-fda-approval-of-grafapex-treosulfan-for (accessed January 30, 2025) and on SEDAR+. See "About GRAFAPEX™ (treosulfan) for Injection" below.
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
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® is appropriate for, or authorized for sale to or use by, persons who are not located in Canada. 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.
About GRAFAPEX™ (treosulfan) for Injection
On January 22, 2025, Medexus was informed that the FDA approved GRAFAPEX™ (treosulfan) for Injection, an alkylating agent, 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™ 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™ is appropriate for, or authorized for sale to or use by, persons who are not located in the United States. For more information about GRAFAPEX™, including indications and important safety information (including boxed warning), see the full prescribing information for GRAFAPEX™ (treosulfan) for Injection, which is available on the product's website at www.grafapex.com and is or will be available on the Drugs@FDA drug database at www.fda.gov.
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 Trecondyv® (treosulfan for injection), in Canada, and GRAFAPEX™, in the United States, and the product-level revenue to be generated from their commercialization); the legislative, regulatory, and policy environment in Canada; the potential benefits of Trecondyv® and GRAFAPEX™; the occurrence, timing, and expected outcome of the public reimbursement review process for Trecondyv® 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 product and anticipated trends and potential challenges in the market in which the product is expected to compete, including if approved by one or more participating jurisdictions, in the case of public reimbursement process for Trecondyv®. 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
Medexus holds exclusive commercialization rights to Trecondyv® in Canada and to GRAFAPEX™ in the United States.
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/239519
FAQ
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