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May 12, 2014

Biogen Idec, Sobi Donate Clotting Factor

  • Biogen Idec and Swedish Orphan Biovitrum (Sobi) said today they will donate 1 billion units of clotting factor to developing nations over the next decade, a philanthropic action that also highlights the companies’ expansion into hemophilia products they have co-developed and are co-commercializing. 

    The companies have committed to donating an initial 500 million units of clotting factor to the World Federation of Hemophilia (WFH) over five years in support of its efforts to care people with hemophilia in Africa, Asia, and Latin America, with the remaining 500 million units to be made available for future distribution.

    The companies said their billion-unit commitment would enable physicians to treat more than 75,000 joint bleeding episodes, and more than 2,000 life threatening bleeding episodes, as well as carry out thousands of elective surgical procedures that would not be possible without access to clotting factor. Biogen Idec and Sobi announced their donation at the WFH meeting in Melbourne, Australia.

    “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,” Biogen Idec CEO George A. Scangos, Ph.D., said in a statement.

    Added Geoffrey McDonough, Sobi’s president and CEO: “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 clotting factor donation coincides with the launch of the companies’ first product for people with hemophilia, a combination of the coagulation Factor IX (Recombinant) molecule combined via fusion with the protein fragment Fc. Alprolix is designed to treat adults and children with the rare disease hemophilia B, which is estimated to affect about 3,300 Americans, primarily males. Alprolix won marketing approval from the FDA in March, enabling Biogen Idec and Sobi to enter a market whose largest players to date have included pharma giants like Pfizer and Baxter International.

    “It gives Biogen a big blazing sign that, ‘We make [clotting] factor,’ ” David Kuter, M.D., D.Phil., director, clinical hematology at Massachusetts General Hospital, told the Boston Globe, which also reported him as  observing that the donation will help the company make a “big splash.”

    While acknowledging the coincidental timing, Biogen Idec said it was responding to WFH’s global plea for help from drug developers, and rejected the argument that its donation was primarily promotionally motivated: ““Giving away a free product that can help thousands of patients is more than a marketing tactic,” Biogen Idec spokeswoman Kate Niazi-Sai told the newspaper.

    Biogen Idec and Sobi are awaiting an FDA decision on a second hemophilia treatment, Eloctate, which is indicated for hemophilia A. 

    In December 2013, Biogen Idec and Sobi announced Phase III interim results showing that the mean half-life – the time a therapy circulates in the bloodstream -- of children treated with Eloctate was approximately one and a half times that of existing factor VIII therapies, while kids treated with Aprolix saw mean half-lives that were more than three times longer than currently available factor IX therapies.

    For their WFH donation, Biogen Idec and Sobi have agreed with the federation that at least 85% 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. However, the donation of the hemophilia A factor is contingent upon approval of the companies’ Biologics License Application for Eloctate.

    Shipments for humanitarian programs are expected to begin in the second half of 2015.


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