Baxter's BioScience Unit Announces Positive Phase III Results for BAX 817

Baxter International Inc. (NYSE: BAX) today announced positive results from itsPhase III clinical trial evaluating the safety and efficacy of BAX 817, aninvestigational recombinant factor VIIa (rFVIIa) treatment for people withhemophilia A or B who develop inhibitors.The prospective, open-label, randomized, multicenter trial was designed toassess the safety and efficacy of BAX 817 in male patients ages 12 to 65 withhemophilia A or B with inhibitors over a 6-month period using on-demandtherapy. The trial met its primary endpoint of successful resolution of acutebleeding episodes at 12 hours with both on-demand treatment regimens, dosingeither 3x90 µg/kg or 1x270 µg/kg, with an overall success rate of 92 percent(98 percent and 85 percent in each dosing group, respectively). Further, 89percent of patients in the trial achieved sustained bleeding control for allacute bleeding episodes 24 hours after infusion.''The development of inhibitors remains one of the most significant challengesin treating hemophilia, as it may place patients at increased risk forlife-threatening complications resulting from difficult-to-treat bleedingepisodes,'' said John Orloff, M.D., vice president and global head of researchand development at Baxter BioScience. ''These positive results reflect ourcommitment to addressing the complex treatment of hemophilia patients withinhibitors, and reinforce our legacy of advancing hemophilia care worldwide.''No patients developed inhibitors or binding antibodies to BAX 817, and nonediscontinued treatment due to an adverse event (AE). One patient washospitalized following a traumatic muscle bleed that did not respond to BAX817. Non-serious AEs observed in the trial were generally consistent with theunderlying disease or other etiology, and were all deemed to be unrelated totreatment.Full data from the trial, including additional efficacy and safety outcomes,will be presented at a medical meeting later in 2015. The company plans toinitiate regulatory submissions aligned to manufacturing expansions currentlyunderway. Baxter remains committed to advancing our portfolio in inhibitormanagement. If approved, BAX 817 would broaden the existing portfolio ofhemophilia and inhibitor treatments within Baxter's biopharmaceuticalbusiness, including FEIBA [Anti-Inhibitor Coagulant Complex] and the recentlyapproved OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] foracquired hemophilia A.