OBI-1 and IB1001
OBI-1 and IB1001 phase III clinical trials of the two lead product candidates was initiated in 2010, including Ipsen's recombinant porcine factor vIII, OBI-1, and Inspiration Biopharmaceuticals Inc.'s recombinant factor IX, IB1001 (for the treatment and prevention of bleeding in patients with hemophilia B).
In February 2011, Inspiration Biopharmaceuticals Inc. announced that IB1001 had demonstrated non-inferiority in achieving overall levels of replacement factor compared to BeneFIX®, the only approved recombinant factor IX product currently on the market.
In October 2011, Ipsen and Inspiration Biopharmaceuticals Inc. announced acceptance of European Marketing Application for IB1001 for the treatment of hemophilia B. The biologics license application was filed with the Food and Drug Administration in the US in April 2012. A phase III clinical study of OBI-1 in acquired hemophilia was launched in 2010 and is in progress. In November 2011, Inspiration Biopharmaceuticals Inc. initiated a second pivotal study of patients with congenital hemophilia A who had developed human factor VIII antibodies.