Overview

Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation, is pioneering the development of life-changing treatments for patients with myeloproliferative neoplasms and other cancers. Led by a highly skilled and devoted team, Impact is advancing a late-stage pipeline centered around fedratinib, a potent and highly selective oral small molecule JAK2 kinase inhibitor, which is being developed initially for the treatment of myelofibrosis (MF) and polycythemia vera (PV). Impact was formed in 2016 after acquisition of Sanofi’s full rights for the global development and commercialization of fedratinib. The Impact team intends to pursue multiple clinical indications for fedratinib to maximize its potential as a best-in-class therapy for JAK2-dependent diseases.

The clinical package for fedratinib includes data from a total of 18 studies completed in 877 subjects. In a completed Phase 3 trial for the treatment of myelofibrosis, fedratinib met its primary and secondary endpoints by achieving a significant reduction in spleen size and a significant improvement in disease symptoms. In a separate study, fedratinib was active in patients who were unresponsive to all other available therapies, including rescuing patients who were either ruxolitinib-resistant or intolerant. The most common adverse events for fedratinib were hematological (anemia, thrombocytopenia) and gastrointestinal (nausea, diarrhea and vomiting). The results of these trials have been published in leading peer reviewed journals and can be accessed here.

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Overview

Impact Biomedicines, Inc., a wholly owned subsidiary of Celgene Corporation, is pioneering the development of life-changing treatments for patients with myeloproliferative neoplasms and other cancers. Led by a highly skilled and devoted team, Impact is advancing a late-stage pipeline centered around fedratinib, a potent and highly selective oral small molecule JAK2 kinase inhibitor, which is being developed initially for the treatment of myelofibrosis (MF) and polycythemia vera (PV). Impact was formed in 2016 after acquisition of Sanofi’s full rights for the global development and commercialization of fedratinib. The Impact team intends to pursue multiple clinical indications for fedratinib to maximize its potential as a best-in-class therapy for JAK2-dependent diseases.

The clinical package for fedratinib includes data from a total of 18 studies completed in 877 subjects. In a completed Phase 3 trial for the treatment of myelofibrosis, fedratinib met its primary and secondary endpoints by achieving a significant reduction in spleen size and a significant improvement in disease symptoms. In a separate study, fedratinib was active in patients who were unresponsive to all other available therapies, including rescuing patients who were either ruxolitinib-resistant or intolerant. The most common adverse events for fedratinib were hematological (anemia, thrombocytopenia) and gastrointestinal (nausea, diarrhea and vomiting). The results of these trials have been published in leading peer reviewed journals and can be accessed here.

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