Baxter International Inc. has agreed to acquire the investigational hemophilia compound OBI-1 and related assets from Inspiration BioPharmaceuticals, Inc. as well as certain other OBI-1 related assets, including manufacturing operations, from Ipsen Pharma S.A.S. in conjunction with Inspiration's ongoing bankruptcy proceedings. The transaction is subject to bankruptcy court and regulatory approvals.
OBI-1 is a recombinant porcine factor VIII (rpFVIII) being investigated for the treatment of bleeding in people with acquired haemophilia A and congenital haemophilia A patients with inhibitors. Acquired haemophilia A is a rare, potentially life-threatening bleeding disorder, which, unlike congenital haemophilia, typically affects older adults and occurs equally in both males and females.
"OBI-1 has the potential to address existing unmet needs of hemophilia patients and is a strong strategic fit with Baxter's current haemophilia portfolio," said Bruce Ewenstein, MD, vice president of clinical affairs in Baxter's BioScience business.
Under the terms of the agreement, Baxter will make an upfront payment of $50 million for the OBI-1 assets, including the manufacturing operations. In the future, Baxter may make payments of up to $20 million in total based on regulatory approval of the acquired haemophilia A indication in the United States and first additional country. Additional amounts may be paid upon approval of additional indications, through net sales payments, and as sales milestones when sales exceed $100 million.
OBI-1 is currently in phase III clinical studies in individuals with acquired haemophilia A and those with congenital haemophilia A who have developed inhibitors against human FVIII. OBI-1 received orphan drug designation in the United States and Europe, and was recently granted fast track designation for acquired haemophilia A by the United States Food and Drug Administration (FDA).
Acquired haemophilia A is a very rare (estimated annual incidence of 1.5 cases per million lives) and potentially life-threatening acute bleeding disorder caused by the development of autoantibodies (inhibitors) against coagulation FVIII. In acquired haemophilia A, individuals typically experience soft tissue or post-procedural bleeding, in contrast to bleeding into joints, which is more typical in congenital haemophilia.
Baxter has more than 60 years experience in haemophilia and has introduced a number of therapeutic firsts for haemophilia patients. Baxter has the broadest portfolio of haemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company's work is focused on optimizing haemophilia care and improving the lives of people living with haemophilia A and B worldwide.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with haemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions.