DEERFIELD, IL, USA I January 24, 2013 I Baxter International Inc. (NYSE:BAX) announced today that it 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 hemophilia A and congenital hemophilia A patients with inhibitors. Acquired hemophilia A is a rare, potentially life-threatening bleeding disorder, which, unlike congenital hemophilia, 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 hemophilia portfolio," said Bruce Ewenstein, M.D., Ph.D., 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 hemophilia 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 hemophilia A and those with congenital hemophilia 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 hemophilia A by the United States Food and Drug Administration (FDA).
About Acquired Hemophilia A
Acquired hemophilia 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 hemophilia A, individuals typically experience soft tissue or post-procedural bleeding, in contrast to bleeding into joints, which is more typical in congenital hemophilia.
About Baxter in Hemophilia
Baxter has more than 60 years experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia 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 hemophilia care and improving the lives of people living with hemophilia A and B worldwide.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
SOURCE: Baxter
Post Views: 136
DEERFIELD, IL, USA I January 24, 2013 I Baxter International Inc. (NYSE:BAX) announced today that it 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 hemophilia A and congenital hemophilia A patients with inhibitors. Acquired hemophilia A is a rare, potentially life-threatening bleeding disorder, which, unlike congenital hemophilia, 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 hemophilia portfolio," said Bruce Ewenstein, M.D., Ph.D., 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 hemophilia 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 hemophilia A and those with congenital hemophilia 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 hemophilia A by the United States Food and Drug Administration (FDA).
About Acquired Hemophilia A
Acquired hemophilia 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 hemophilia A, individuals typically experience soft tissue or post-procedural bleeding, in contrast to bleeding into joints, which is more typical in congenital hemophilia.
About Baxter in Hemophilia
Baxter has more than 60 years experience in hemophilia and has introduced a number of therapeutic firsts for hemophilia patients. Baxter has the broadest portfolio of hemophilia 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 hemophilia care and improving the lives of people living with hemophilia A and B worldwide.
About Baxter International Inc.
Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.
SOURCE: Baxter
Post Views: 136
