May 18, 2014
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Drug companies pledge Factor VIII donation in developing countries

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Biogen Idec Inc. and their partner Swedish Orphan Biovitrum AB recently announced that they will donate one billion international units of Factor VIII therapy for humanitarian aid programs.

These clotting factor medicines would be intended for use in countries in which the existing World Federation of Hemophilia program use less than 1 international unit of Factor VIII per capita. Due to the lack of treatment, people with severe hemophilia in these countries often do not survive to adulthood.

“Our dialogue with the hemophilia community consistently highlights sustainable global equity as a major unmet need in the field,” Geoffrey McDonough, president and chief executive officer of Sobi, said in a press release. “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.”

However, the success of this humanitarian effort will depend largely on FDA approval of Eloctate – an investigational recombinant factor VIII Fc fusion protein product candidate – for hemophilia A. Under the terms of the agreement with the WFH, Eloctate is expected to account for at least 85% of the donated product.

Earlier in 2014, Biogen Idec Inc. and Sobi reported positive top-line results of the Kids A-LONG phase 3 clinical study that evaluated the safety and efficacy of Eloctate in children with severe hemophilia A. Study results demonstrated that Eloctate was generally well-tolerated and no inhibitors were detected. In addition, efficacy analyses exhibited twice-weekly prophylactic dosing with Eloctate maintained low bleeding rates in children.

“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,” Alain Weill, president of the WFH, said in a press release. “Their generosity today brings us 500 million steps closer to making the WFH vision of treatment for all a reality.”