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GmbH enter into Licensing Agreement for First-in-Class Conditioning Agent, Treosulfan, in Canada","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"July 2021","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Medexus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Medexus Pharmaceuticals Announces Resubmission of Treosulfan NDA","therapeuticArea":"Oncology","highestDevelopmentStatus":"Approved","country":"CANADA","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Oncology","graph2":"Approved"},{"orgOrder":0,"company":"Medexus Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Medexus Pharmaceuticals Provides 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Find Clinical Drug Pipeline Developments & Deals by Medexus Pharmaceuticals
Trecondyv (treosulfan) is used to prepare patients for blood stem cell transplant. Trecondyv destroys bone marrow cells. This allows for the transplant of new blood stem cells from a donor which leads to the production of healthy blood cells.
Study found event-free survival and overall survival superior after Trecondyv (treosulfan) compared to RIC busulfan, also found non-relapse mortality lower in treosulfan arm than busulfan arm.
Trecondyv (treosulfan), preparative regimen for allogeneic hematopoietic stem cell transplantation to be used in combination with fludarabine, is medication given to people before they have bone marrow transplant from a donor allogeneic hematopoietic stem cell transplantation
The resubmission includes additional clinical data and statistical analysis relating to previously-completed phase 3 clinical trial of Treosulfan as well as an update of integrated summary of safety, which FDA had requested in their July 2021 Complete Response Letter to medac.
Treosulfan will be marketed in Canada under the brand name Trecondyv® and indicated in combination with fludarabine as part of a conditioning treatment prior to allogeneic hematopoietic stem cell transplantation (“allo-HSCT”).
Medac intends to leverage its strong, existing commercial infrastructure in the United States to address the underserved allo-HSCT market through its commercialization of treosulfan.
Triamcinolone Hexacetonide is a longest-acting corticosteroid for intra articular injection. The companies have agreed to a small upfront fee along with milestone payments at the time of FDA approval, at commercial product launch, and upon certain sales milestones.
Medexus reached the 50% enrollment target in its Phase 4 clinical trial investigating IXINITY® as a prophylactic treatment for pediatric patients under 12 years of age with hemophilia B.
Lead Product(s):
Recombinant coagulation factor IX
Triamcinolone Hexacetonide Injectable Suspension 20 mg/mL (TH) has been approved for inclusion as a general benefit (open listing) on the List of Medications- Institutions administered by the Régie de l’assurance maladie du Québec (RAMQ), effective August 19, 2020.
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