Baxter International, Inc., announced the results of a Phase III study evaluating FEIBA NF, the company’s plasma-derived activated prothrombin complex concentrate (aPCC) for use in patients with inhibitors to infused factor VIII or IX. aPCCs are called bypassing agents because bypass the need for the deficient clotting factor proteins (VIII or IX) in the clotting cascade. The study was designed to measure the efficacy and safety of routine prophylaxis compared to on-demand treatment of FEIBA NF in patients with hemophilia A or B and inhibitors.
Study results from the 36 patients showed a reduced median annual bleed rate from 28.7 during FEIBA NF on-demand treatment to 7.9 during FEIBA NF prophylactic treatment, representing a 72.5% reduction. According to the Baxter press release, the Phase III study will form the basis of a biologics license application to be filed with the U.S. Food and Drug Administration (FDA) in the first quarter of 2013.
“One of the greatest remaining challenges in the management of hemophilia is the development of inhibitors, which can lead to more difficult-to-control and sometimes life-threatening bleeding. The FEIBA NF prophylaxis study demonstrates Baxter’s dedication to providing treatment options to the hemophilia community, including effective inhibitor management,” said Hartmut J. Ehrlich, MD, vice president of global research and development in Baxter’s BioScience business.
Inspiration Biopharmaceuticals Acquisition
In a separate press release, Baxter announced that the company has agreed to acquire the investigational hemophilia compound OBI-1 and related assets from Inspiration BioPharmaceuticals, Inc. According to the release, Baxter also acquires “certain other OBI-1 related assets, including manufacturing operations, from Ipsen Pharma S.A.S. in conjunction with Inspiration’s ongoing bankruptcy proceedings.”
OBI-1 is an intravenous recombinant porcine (pig) factor VIII (rpFVIII) product designed for the treatment of bleeding in people with hemophilia A and inhibitors, and in those with acquired hemophilia.
OBI-1 received Fast Track status from the FDA in late 2012 for use in patients with acquired hemophilia A, a rare condition that results when the body produces antibodies to clotting factors proteins such as factor V, VIII and IX. The disorder has been associated with allergic drug reactions, pregnancy and immune system disorders such as rheumatoid arthritis. In approximately half of cases, the cause is unknown.
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 factor VIII.
“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, MD, PhD, vice president of clinical affairs in Baxter’s BioScience business.
Source: Baxter press releases dated January 8 and 24, 2013