Medexus Announces Commercial Availability of GRAFAPEX (treosulfan) for Injection
Medexus Pharmaceuticals (MEDXF) announces the commercial launch of GRAFAPEX (treosulfan) for Injection in the United States, approximately one month after FDA approval. The company has set the wholesale acquisition cost at US$3,050 per 5-gram vial and US$610 per 1-gram vial.
The company projects that GRAFAPEX's annual product-level revenue in the US market could exceed US$100 million within five years after commercial launch. The product has already received orders and positive feedback from the 2025 Tandem Meetings, with several key US institutions expressing interest. GRAFAPEX is available as treosulfan in a lyophilized powder form in single-dose vials for injection.
Medexus Pharmaceuticals (MEDXF) annuncia il lancio commerciale di GRAFAPEX (treosulfan) per iniezione negli Stati Uniti, circa un mese dopo l'approvazione della FDA. L'azienda ha fissato il prezzo di acquisto all'ingrosso a 3.050 US$ per fiala da 5 grammi e 610 US$ per fiala da 1 grammo.
L'azienda prevede che il fatturato annuale di GRAFAPEX nel mercato statunitense potrebbe superare 100 milioni di US$ entro cinque anni dal lancio commerciale. Il prodotto ha già ricevuto ordini e feedback positivi dai 2025 Tandem Meetings, con diverse importanti istituzioni statunitensi che hanno espresso interesse. GRAFAPEX è disponibile come treosulfan in forma di polvere liofilizzata in fiale monodose per iniezione.
Medexus Pharmaceuticals (MEDXF) anuncia el lanzamiento comercial de GRAFAPEX (treosulfán) para inyección en los Estados Unidos, aproximadamente un mes después de la aprobación de la FDA. La compañía ha establecido el costo de adquisición mayorista en 3,050 US$ por frasco de 5 gramos y 610 US$ por frasco de 1 gramo.
La compañía proyecta que los ingresos anuales a nivel de producto de GRAFAPEX en el mercado estadounidense podrían superar 100 millones de US$ en cinco años después del lanzamiento comercial. El producto ya ha recibido pedidos y comentarios positivos de las Reuniones Tandem 2025, con varias instituciones clave de EE. UU. expresando interés. GRAFAPEX está disponible como treosulfán en forma de polvo liofilizado en frascos de dosis única para inyección.
Medexus Pharmaceuticals (MEDXF)는 FDA 승인 약 한 달 후, 미국에서 GRAFAPEX (treosulfan) 주사제의 상업적 출시를 발표했습니다. 회사는 도매 인수 비용을 5그램 바이알당 3,050 US$ 및 1그램 바이알당 610 US$로 설정했습니다.
회사는 GRAFAPEX의 미국 시장에서의 연간 제품 수준 수익이 상업적 출시 후 5년 이내에 1억 US$를 초과할 수 있을 것으로 예상하고 있습니다. 이 제품은 이미 2025년 Tandem 회의에서 주문과 긍정적인 피드백을 받았으며, 여러 주요 미국 기관이 관심을 표명했습니다. GRAFAPEX는 주사용을 위해 단일 용량 바이알에 리오필라이즈된 분말 형태로 제공됩니다.
Medexus Pharmaceuticals (MEDXF) annonce le lancement commercial de GRAFAPEX (treosulfan) pour injection aux États-Unis, environ un mois après l'approbation de la FDA. L'entreprise a fixé le coût d'acquisition en gros à 3 050 US$ par flacon de 5 grammes et 610 US$ par flacon de 1 gramme.
L'entreprise prévoit que les revenus annuels de GRAFAPEX sur le marché américain pourraient dépasser 100 millions US$ dans les cinq ans suivant le lancement commercial. Le produit a déjà reçu des commandes et des retours positifs lors des réunions Tandem 2025, plusieurs institutions clés américaines ayant exprimé leur intérêt. GRAFAPEX est disponible sous forme de treosulfan en poudre lyophilisée dans des flacons à dose unique pour injection.
Medexus Pharmaceuticals (MEDXF) kündigt die kommerzielle Einführung von GRAFAPEX (Treosulfan) zur Injektion in den Vereinigten Staaten an, etwa einen Monat nach der Genehmigung durch die FDA. Das Unternehmen hat die Großhandelskosten auf 3.050 US$ pro 5-Gramm-Phiole und 610 US$ pro 1-Gramm-Phiole festgelegt.
Das Unternehmen prognostiziert, dass der jährliche Produktumsatz von GRAFAPEX auf dem US-Markt innerhalb von fünf Jahren nach der kommerziellen Einführung 100 Millionen US$ übersteigen könnte. Das Produkt hat bereits Bestellungen und positives Feedback von den Tandem Meetings 2025 erhalten, wobei mehrere wichtige US-Institutionen Interesse bekundet haben. GRAFAPEX ist als Treosulfan in Form eines lyophilisierten Pulvers in Einzeldosis-Phialen zur Injektion erhältlich.
- Early commercial launch achieved within one month of FDA approval
- Initial orders already received for GRAFAPEX
- Projected annual US revenue potential exceeding $100M within 5 years
- Strong interest from key US institutions
- Clear pricing structure established: $3,050 (5g) and $610 (1g) per vial
- None.
Toronto, Ontario and Chicago, Illinois--(Newsfile Corp. - February 24, 2025) - Medexus Pharmaceuticals (TSX: MDP) (OTCQX: MEDXF) is pleased to announce that GRAFAPEX™ (treosulfan) for Injection is now commercially available in the United States.
"We are pleased to report this positive development, which marks a strategically important step forward for our business and, importantly, will now benefit eligible patients across the United States," commented Ken d'Entremont, Medexus's Chief Executive Officer. "Not only will GRAFAPEX™ make a substantial contribution to alloHSCT in the United States, but it also solidifies Medexus's leadership position in this therapeutic field."
"We have achieved a commercial launch even earlier in calendar year 2025 than previously anticipated, around one month after FDA approval, with orders already received now that product is commercially available," added Richard Labelle, Medexus's Chief Operating Officer. "Given our recent experience in Canada we are very optimistic about the potential of GRAFAPEX™ in the US market. We anticipate that GRAFAPEX™ will have a meaningful impact on Medexus's total revenue and believe that annual product-level revenue in the United States has the potential to exceed US
"We were encouraged by the level of positive feedback we heard at the 2025 Tandem Meetings (Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR) earlier this month," concluded Virginie Bernier PhD, Vice President—Hemato-Oncology at Medexus. "We are already aware of requests for GRAFAPEX™ in connection with urgent patient needs, and we have begun engaging with several key US institutions interested in learning about GRAFAPEX™, so we are glad that this product is now FDA approved and available to benefit eligible patients."
Medexus has established a wholesale acquisition cost for GRAFAPEX™ in the United States of US
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™ holds Orphan Drug Designation under the Orphan Drug Act, meaning that the product will benefit from a seven-year period of regulatory exclusivity in the FDA-approved indication.
Full prescribing information for GRAFAPEX™ is available on the Drugs@FDA drug database at www.fda.gov.
Efficacy was evaluated in MC-FludT.14/L Trial II (NCT00822393), a randomized active-controlled trial comparing treosulfan to busulfan with fludarabine as a preparative regimen for allogeneic transplantation. Eligible patients included adults 18 to 70 years old with AML or MDS, Karnofsky performance status ≥
The major efficacy outcome measure was overall survival (OS), defined as the time from randomization until death from any cause. The hazard ratio for OS (stratified by donor type and risk group) compared to busulfan was 0.67 (
The most common adverse reactions (≥
The recommended treosulfan dose is 10 g/m2 daily on days -4, -3, and -2 in combination with fludarabine 30 mg/m2 daily on days -6, -5, -4, -3, and -2, and allogeneic hematopoietic stem cell infusion on day 0.
For more information about GRAFAPEX™, including important safety information, see the full prescribing information, which is available on the Drugs@FDA drug database at www.fda.gov. For more information about the pivotal phase 3 clinical trial of treosulfan conducted by medac GmbH, including its methods, results, and conclusions, and about the publication of the study in the American Journal of Hematology, including a link to the full publication, see Medexus's June 6, 2022 press release, including the section entitled "About the study", available on the Investors—News & Events section of Medexus's corporate website.
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 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 GRAFAPEX™ (treosulfan) for Injection and the product-level revenue to be generated from its commercialization in the United States); the potential benefits of GRAFAPEX™ (treosulfan) for Injection; and expectations regarding the commercial launch of GRAFAPEX™ (treosulfan) for Injection and the product's prospects and performance, including in respect of its potential adoption and use in the United States and any related product-level revenue, and including the potential competitive position of the product and anticipated trends and potential challenges in the market in which the product is expected to compete. 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. In particular, and without limiting the generality of the foregoing, Medexus's estimate of product-level revenue from commercialization of GRAFAPEX™ (treosulfan) for Injection in the United States is based on a number of such factors and assumptions, as most recently described in Medexus's most recent management's discussion and analysis, including the wholesale acquisition cost for GRAFAPEX™ (treosulfan) for Injection (which will likely change from time to time over the life cycle of the product), and including Medexus's planned commercial, market access, and medical strategies, the success of which will depend in part on the US regulatory landscape and related dynamics, including potential future changes to each, and can introduce and affect exposure to commercial, legal, and regulatory risk. 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). 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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The information in this news release is provided for informational purposes to investors in Medexus securities.
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