[{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable ","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Announces Issuance of U.S. Patent for Use of PEDMARK\u2122","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Pharmaceuticals Announces FDA Filing Acceptance and Priority Review of New Drug Application for PEDMARK\u2122","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Pharmaceuticals Receives Complete Response Letter from the FDA for its New Drug Application for PEDMARK\u2122","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2020","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Pharma Resubmits NDA For Pedmark","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"May 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Pharmaceuticals Expects To Receive Complete Response Letter From The Fda For Its New Drug Application For Pedmark\u2122 To Prevent Ototoxicity Associated With Cisplatin In Pediatric Patients With Localized, Non-Metastatic, Solid Tumors","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"November 2021","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Pharmaceuticals Resubmits New Drug Application to U.S. Food and Drug Administration for Pedmark","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Pharmaceuticals Announces FDA Acceptance for Filing of New Drug Application Resubmission for Pedmark\u2122","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"April 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Petrichor Healthcare Capital Management","pharmaFlowCategory":"D","amount":"$45.0 million","upfrontCash":"Undisclosed","newsHeadline":"Fennec Pharmaceuticals Announces Up to $45 Million Investment From Petrichor","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Petrichor Healthcare","pharmaFlowCategory":"D","amount":"$25.0 million","upfrontCash":"Undisclosed","newsHeadline":"Fennec Pharmaceuticals Closes First $5 Million Investment From Petrichor","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"August 2022","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Pharmaceuticals Announces Updated Nccn Clinical Practice Guidelines Recommend Pedmark\u00ae (sodium thiosulfate injection) to Reduce the Risk of Cisplatin-Induced Hearing Loss in Pediatric Patients","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Phase III","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Phase III"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Pharmaceuticals Announces Pedmark\u00ae (sodium thiosulfate injection) Receives Orphan Drug Exclusivity from U.S. FDA","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"January 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Not Applicable","pharmaFlowCategory":"DU","amount":"Not Applicable","upfrontCash":"Not Applicable","newsHeadline":"Fennec Pharmaceuticals Receives Positive CHMP Opinion for Pedmarqsi\u2122 (sodium thiosulfate) to Reduce the Risk of Hearing Loss in Pediatric Oncology Patients","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Petrichor","pharmaFlowCategory":"D","amount":"$20.0 million","upfrontCash":"Undisclosed","newsHeadline":"Fennec Announces Incremental $5 Million Investment from Petrichor","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"December 2023","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"},{"orgOrder":0,"company":"Fennec Pharmaceuticals","sponsor":"Norgine","pharmaFlowCategory":"D","amount":"$271.6 million","upfrontCash":"$43.4 million","newsHeadline":"Fennec Pharmaceuticals and Norgine Enter into Exclusive Licensing Agreement to Commercialize PEDMARQSI in Europe, Australia, and New Zealand","therapeuticArea":"Otolaryngology (Ear, Nose, Throat)","highestDevelopmentStatus":"Approved","country":"U.S.A","productType":"Small molecule","productStatus":"Approved","date":"March 2024","url1":"","url2":"","graph1":"Otolaryngology (Ear, Nose, Throat)","graph2":"Approved"}]
Find Clinical Drug Pipeline Developments & Deals by Fennec Pharmaceuticals
Norgine will commercialize Pedmarqsi (sodium thiosulfate) in Europe, Australia and New Zealand. Pedmarqsi is the first and only approved therapy in the EU and U.K. for the prevention of ototoxicity induced by cisplatin chemotherapy in patients with localized, non-metastatic solid tumors.
The net proceeds will be used by the company for the commercialization of Pedmark (sodium thiosulfate), the only approved therapy for reducing the risk of hearing loss in pediatric cancer patients who receive treatment with platinum-based chemotherapy.
Pedmarqsi™ (sodium thiosulfate) is the only FDA approved intravenous therapy, to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors.
Pedmark® (sodium thiosulfate) is the only FDA approved intravenous therapy, to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors.
Pedmark® (sodium thiosulfate) is the only FDA approved intravenous therapy, to reduce the risk of ototoxicity associated with cisplatin treatment in pediatric patients with localized, non-metastatic, solid tumors.
Under the terms of the agreement, an additional is to be funded upon the potential U.S. Food and Drug Administration approval of PEDMARK (sodium thiosulfate) by September 30, 2022 and satisfaction of other closing conditions.
PEDMARK (sodium thiosulfate), has been studied by cooperative groups in two Phase 3 clinical studies of survival and reduction of ototoxicity, the clinical Oncology Group Protocol ACCL0431 and SIOPEL 6. Both studies have been completed.
PEDMARK is a small molecule, unique formulation of STS, is administered 6 hours post completion of cisplatin infusion in an intravenous bolus dose over 15 minutes, has potential to reduce the incidence of chemotherapy-induced hearing loss.
PEDMARK™ (a unique formulation of sodium thiosulfate), is currently under evaluation by EMA, as an essential chemotherapeutic agent for many pediatric malignancies also has received breakthrough therapy and fast track designation.
The COG ACCL0431 protocol enrolled one of five childhood cancers typically treated with intensive cisplatin therapy for localized and disseminated disease, including newly diagnosed hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma.
Market Place
Upload your Marketing & Sales content on your company Virtual Booth, click HERE
