IB1001 is an intravenous recombinant Factor IX (rFIX) being developed for the treatment and prevention of bleeding episodes in hemophilia B. The IB1001 development program includes pharmacokinetic, safety, and efficacy data from a Phase III trial in people with hemophilia B. A BLA and MAA for IB1001 are under review by the FDA and the EMA, respectively.
John A. Sedor, president and chief executive officer of Cangene, said, "The acquisition of IB1001 is consistent with our strategy of targeting late-stage products to drive growth in our commercial business. We are a patient-focused company and the addition of IB1001 to our pipeline provides an opportunity to address a significant global need for patients with hemophilia B. We will use our significant experience in developing and commercializing biological products to resolve the regulatory challenges and bring value to hemophilia B patients and to Cangene."