Treosulfan is an innovative, orphan-designated agent developed for use as part of a conditioning treatment for patients undergoing allogeneic hematopoietic stem cell transplantation, or allo-HSCT.
The commercialization and supply agreement with Germany’s medac Gesellschaft für klinische Spezialpräparate mbH grants Medexus’ US subsidiary Medexus Pharma Inc the exclusive license to commercialize the drug.
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Medexus told shareholders it expects that, if approved by the US FDA, a treosulfan-based regimen will be the first in a new conditioning treatment class, Reduced Toxicity Conditioning, that will lead to improved survival outcomes and decreased toxicity compared to standard treatment regiments. A Prescription Drug User Free date to review the New Drug Application for treosulfan by the FDA is scheduled for August 2021.
In a statement, Medexus said it plans to leverage its existing commercial infrastructure in the US to address the underserved allo-HSCT market through its commercialization of treosulfan. medac conducted a phase III randomized study that compared results of treosulfan-based therapy with busulfan-based reduced intensity conditioning in advance of allo-HSCT for adult patients with acute myeloid leukemia and myelodysplastic syndrome who were considered ineligible for standard myeloablative conditioning regimens. Interim analysis of the data demonstrated that non-inferiority was achieved in the 64% of the treosulfan group compared to the 50.4% of the busulfan group in two-year event-free survival.
Busulfan, the current market leading alkylating agent for allo-HSCT, reached peak annual sales of US$126 million in the US before a generic version was developed.
Long time collaborators
The license agreement builds on Mexedus’ existing relationship with medac, which was established in 2018 when Medexus acquired the latter’s US affiliate.
At the time, the company anticipated that treosulfan could be a significant advancement in HSCT, according to Medexus CEO Ken d’Entremont.
“This transaction marks another major milestone for Medexus and is indicative of our continued effort to further expand into the US through what we believe will be a highly accretive transaction for the company,” d’Entremont told investors in a statement.
Medexus believes that treosulfan could exceed busulfan’s US $126 million in sales from use in allo-HSCT alone – a belief re-enforced by the fact that busulfan is currently being used off-label for the indications for which treosulfan has Orphan Drug Designation.
“Importantly, we believe there is a large unmet need as the current standard of care is not suitable for numerous at-risk groups, due to the high toxicity effects,” d’Entremont said. “Treosulfan has demonstrated excellent event-free survival and overall survival among such groups and as a result, should be well positioned to become the new standard of care in the US, with more than 100 publications supporting the safety and efficacy of treosulfan. We are proud to be working towards providing patients with a new solution that could have a very meaningful impact on their lives.”
Terms of licensing
Under the terms of the deal, Medexus Pharma paid medac an upfront payment of US$5 million, and must pay up to an aggregate of $55 million in milestone payments tied to the FDA’s review process as well as US$40 million in sales-related milestone payments. Medexus Pharma will also pay a royalty – said to be in “low single digits” on net sales of treosulfan in the US.
The agreement extends until the tenth anniversary of FDA approval of the initial New Drug Application, unless terminated by either company.
Headquartered in Montreal with offices in Toronto and Chicago, Medexus is a leading specialty pharmaceutical company focused on the therapeutic areas of auto-immune disease, hematology and allergy. Shares of Medexus were up 4.1% in Toronto at C$8.15 on Tuesday afternoon.
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