The Sage Group Announces $100M+ Transaction between medac GmbH and Medexus Pharma for Treosulfan in
The Sage Group Inc. served as exclusive advisor to medac GmbH on this $100M+ transaction.
Medexus Pharmaceuticals and medac GmbH enter into a License Agreement for First-in-Class Conditioning Agent for Hematopoietic Stem Cell Transplantation, Treosulfan, in the United States
TORONTO and CHICAGO and MONTREAL and WEDEL, Germany, Feb. 02, 2021 (GLOBE NEWSWIRE) -- Medexus Pharmaceuticals Inc. (“Medexus”) (TSXV: MDP) (OTCQX: MEDXF) (Frankfurt: P731) is pleased to announce that it and its wholly-owned United States-based subsidiary, Medexus Pharma, Inc. (“Medexus Pharma” and together with Medexus, the “Company”) entered into a Commercialization and Supply Agreement with medac Gesellschaft für klinische Spezialpräparate m.b.H. (“medac”), pursuant to which medac has granted Medexus Pharma an exclusive license to commercialize treosulfan, a bifunctional alkylating agent, in the United States (the “License Agreement”).
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”). If approved by the U.S. Food and Drug Administration (“FDA”), the Company expects that a treosulfan-based regimen will be the first in a new conditioning treatment class, Reduced Toxicity Conditioning, resulting in a unique combination of improved survival outcomes compared to reduced-intensity regimens and decreased toxicity compared to standard myeloablative regimens. A Prescription Drug User Free Act (“PDUFA”) date to review the New Drug Application (“NDA”) in respect of treosulfan by the FDA has been scheduled for August 2021.
The Company intends to leverage its strong, existing commercial infrastructure in the United States to address the underserved allo-HSCT market through its commercialization of treosulfan. medac conducted a phase III randomized study (the “Phase III Study”) comparing the results of treosulfan-based therapy with busulfan-based reduced intensity conditioning in advance of allo-HSCT for adult patients with acute myeloid leukemia (“AML”) and myelodysplastic syndrome (“MDS”) who were considered ineligible for standard myeloablative conditioning regimens. The planned confirmatory interim analysis of the Phase III Study demonstrated that non-inferiority was achieved in the treosulfan group compared to the busulfan group in two-year event-free survival. *FDA granted medac Orphan Drug Designation for Treosulfan for conditioning treatment prior to allo-HSCT in malignant and non-malignant disease in adults and pediatric patients. FDA approval is anticipated in 2021 For additional information about this transaction, please contact:
Wayne Pambianchi +1-908-2306170 firstname.lastname@example.org
Dr. Bill Mason +44 (0)7785 950134 email@example.com
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