Red blood cells illustration (geralt, Pixabay)
8 January 2018. The biopharmaceutical company Celgene Corp. is acquiring Impact Biomedicines Inc., a developer of drugs to treat a type of blood-related cancer. The agreement with Celgene, in Summit, New Jersey could bring shareholders in San Diego-based Impact Biomedicines more than $7 billion if all milestones are achieved and sales projections met.
Impact Biomedicines develops drugs to treat a type of blood-related cancers known as myeloproliferative neoplasms, where bone marrow produces too many blood cells. The company’s lead product, fedratinib, was tested in intermediate- and late-stage clinical trials as a therapy for chronic myeloproliferative neoplasm, a condition where bone marrow makes too many red blood cells, platelets, or certain white blood cells. The latest trial tested the drug in patients that do not respond to the currently approved drug, ruxolitinib, comprising 30 to 40 percent of individuals with the disease.
Fedratinib limits the actions of the Janus kinase 2, or JAK2, gene that codes for the production of a protein stimulating growth and proliferation of cells. The gene’s protein is particularly important in the production of red and white blood cells, as well as platelets, and is linked to a number of myeloproliferative neoplasms. In addition to chronic myeloproliferative neoplasm, Impact Biomed plans to test fedratinib as a treatment for myelofibrosis, a scarring of bone marrow that disrupts production of red blood cells, and polycythemia vera, a blood cancer that results in too many blood cells and a thickening of blood in the body.
Impact Biomedicines began only in October 2017, and is not your typical scientific start-up. The company was formed to acquire the rights to fedratinib from drug maker Sanofi, which sponsored clinical trials of the candidate drug. While the trials showed clinical benefits from fedratinib, several patient deaths also occurred from Wernicke’s encephalopathy, a neurological condition associated with a vitamin-B deficiency. While researchers could not link the deaths to the drug, FDA put a clinical hold on the trial, effectively stopping the study, in 2013.
Once Impact Biomed gained fedratinib, the company presented a new plan to FDA for testing the candidate drug in patients with myelofibrosis and polycythemia vera, with the agency lifting the clinical hold in August 2017. The company is co-founded by Catriona Jamieson, who studies blood-related cancers at University of California in San Diego, and is serving as the company’s interim medical director. John Hood, another company founder and CEO, is one of the inventors of fedratinib while at TargeGen Inc., which was later acquired by Sanofi.
Under the agreement, Celgene is paying an initial fee of $1.1 billion with Impact Biomed’s shareholders also eligible for further payments of $1.4 billion if all regulatory milestones of fedratinib are achieved. In addition, if sales of fedratinib exceed $5 billion, Impact Biomed’s shareholders would qualify for as much as $4.5 billion in subsequent payments.
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