Medexus Strengthens Medical Affairs Team in Preparation for Planned Treosulfan Launch.
ENPNewswire-June 11, 2021--Medexus Strengthens Medical Affairs Team in Preparation for Planned Treosulfan Launch
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Release date- 10062021 - TORONTO, CHICAGO and MONTREAL - Medexus Pharmaceuticals Inc. (the 'Company' or 'Medexus') (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) announced that it has expanded its medical affairs team in preparation for the planned launch of treosulfan, a bifunctional alkylating agent, in the United States.
Treosulfan is an innovative, orphan-designated agent developed for use as part of a conditioning treatment for patients undergoing allogeneic hematopoietic stem cell transplantation ('allo-HSCT'). With more than 100 publications supporting its safety and efficacy, management believes treosulfan is ideally positioned to become the new standard of care in the U.S. As such, pro-actively putting in place the right people and resources ahead of the scheduled Prescription Drug User Fee Act ('PDUFA') date, which is set for August 2021, is critical to both the successful and timely launch of this innovative product for the benefit of patients and maximizing the value of the seven and a half years of exclusivity the Company expects to receive upon FDA approval. The hires announced today of Keith Steward, MD, MBA, Senior Vice President of Medical Affairs, J. Lynn Bass, B.S, PharmD, Senior Director of Medical Sciences and Mark Fosdal, DHSc, PA-C, Director, Scientific Communications are all part of that pro-active plan.
Ken d'Entremont, CEO, commented, 'We expect the launch of treosulfan to be a major milestone for Medexus as it is a truly innovative, best-in-class product that addresses a substantial and underserved market. Before it was genericized in 2016, the current market leading product reached peak annual sales of U.S.$126 million in the United States despite lacking indications for use in patients with AML or MDS.1 Treosulfan is expected to be approved for these indications. For treosulfan, the confirmatory interim analysis of the Phase III Study achieved two-year event-free survival of 64.0% (95% CI 56.0-70.9). This was a marked and statistically significant improvement compared to the busulfan group survival rate of 50.4% (95% CI 42.8-57.5) (HR 0.65 [95% CI 0.47-0.90]); p=0.0000164 (adjusted p-value for testing non-inferiority of treosulfan compared to busulfan)2. To support our expected launch later in 2021, we have put together an exceptional team in all...
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