Cangene closes acquisition of investigational hemophilia B product
IB1001 is an intravenous recombinant Factor IX that is being developed for the prevention and treatment of bleeding episodes in people with hemophilia B. Hemophilia B is a rare, inherited disorder caused by a congenital FIX deficiency that leads to poor coagulation of the blood and possibly life-threatening hemorrhages.
Cangene acquired IB1001 and other assets in connection with Inspiration's bankruptcy proceedings.
"With the closing of the acquisition behind us, we will focus on integrating the development of IB1001 into our pipeline as we drive hard towards licensure," John Sedor, the president and CEO of Cangene, said. "We will use our significant experience in developing and commercializing biological products to respond to the additional regulatory requirements as we seek to address a significant global need for hemophilia B patients."
IB1001 is under regulatory review by the U.S. Food and Drug Administration and the European Medicines Agency in Europe. The FDA recently issued a complete response letter connected to the biologics license application for IB1001. The letter defined a clear path to approval which includes the provision of additional development and manufacturing information.
Under the terms of the agreement, Cangene paid approximately $5.9 million upfront for IB1001 and the other assets. The company will pay tiered royalties on net sales and pay more if certain sales milestones are achieved.