Celgene and Impact Biomedicines accede to collaborate

Celgene and Impact biomedicines signed an agreement that enumerates acquisition of Impact Biomedicines by Celgene to develop fedratinib for myelofibrosis and Polycythemia Vera. As per the terms of the agreement, Celgene will pay approximately $1.1 billion upfront and up to $1.25 billion.

877 patients were assessed across 18 clinical trials of Fedratinib, a highly selective JAK2 kinase inhibitor. Phase III trial witnessed positive results exhibited by fedratinib regardless of the baseline platelet count of a patient.  Single-arm phase II trial (JAKARTA-2) evaluated fedratinib in myelofibrosis patients who were found to be resistant or intolerant to ruxolitinib (Jakafi), a JAK1/JAK2 inhibitor, therefore, suggesting improvements in splenic response and total symptom scores. The U.S FDA had moved for a clinical hold on the JAKARTA-2 owing to its premature termination after cases of Wernicke’s encephalopathy (WE) being reported in eight out of 877 patients receiving one or more doses. The clinical hold was revoked however in August 2017.

Dr. John Hood, Chief Executive Officer of Impact, stated, “We launched Impact Biomedicines and based on our thorough review of the data, fedratinib presents a compelling risk-benefit profile in both treatment-naïve patients and patients who are resistant or intolerant to other JAK2 therapies.”