Biogen Idec and Swedish Orphan Biovitrum AB (Sobi) today announced their intent to produce one billion international units (IUs) of clotting factor therapy for humanitarian aid programs in the developing world at the World Federation of Hemophilia (WFH) 2014 World Congress. Initially, the companies have committed to donating up to 500 million IUs to the World Federation of Hemophilia over five years to support its efforts to raise the standard of care for people with hemophilia in the developing world. The remaining 5000 million IUs of clotting factor will be made available for future distribution.
This donation is expected to enable a predictable, sustained humanitarian supply of factor therapy and improve the quality of patient care and outcomes in the developing world. Hemophilia is a rare, chronic, inherited disorder in which the ability of a person’s blood to clot is impaired. This can lead to recurrent and extended bleeding episodes. According to the WFH, an estimated 400,000 people worldwide are living with hemophilia and of these, more than 300,000 individuals live in areas where there is limited access to diagnosis and treatment. The commitment of one billion IUs of factor is intended to enable physicians to treat more than 75,000 joint bleeding episodes, more than 2,000 life threatening bleeding episodes as well as conduct thousands of elective surgical procedures that would not be possible without access to clotting factor.
“All of us at Biogen Idec are dedicated to making life better for people living with hemophilia,” said George A. Scangos, Ph.D., chief executive officer of Biogen Idec. “Hemophilia occurs all over the world, and this donation will provide some level of care to thousands of people who otherwise would not have access to treatment.”
“Our dialogue with the hemophilia community consistently highlights sustainable global equity as a major unmet need in the field,” said Geoffrey McDonough, president and chief executive officer of Sobi. “This donation is consistent with our patient-centered approach, and has the potential to transform the treatment model for people with hemophilia in developing countries. We are proud to partner with the WFH in their work.”
“The WFH humanitarian aid program would exist in name only if not for the generous donations we receive from companies such as Biogen Idec and Sobi,” said WFH President Alain Weill. “Their generosity today brings us 500 million steps closer to making the WFH vision of treatment for all a reality.”
Biogen Idec and Sobi are partners in the development and commercialization of treatments for hemophilia. Biogen Idec, which is responsible for product supply under the collaboration, will designate one billion IUs of clotting factor therapy for use in humanitarian programs over the next decade.
Under the terms of the agreement with WFH, at least 85 percent of donated factor will be Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein for the treatment of hemophilia A, with the remainder comprised of Coagulation Factor IX (Recombinant), Fc Fusion Protein for the treatment of hemophilia B. The donation of Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein is contingent upon approval of a Biologics License Application currently under review by the U.S. Food and Drug Administration (FDA). Shipments for humanitarian programs are expected to begin in the second half of 2015.
Countries eligible for the WFH program use less than 1 IU of FVIII per capita. Due to the lack of treatment, people with severe hemophilia in these countries often do not survive to adulthood.