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July 9, 2014
09:02 EDTBAXBaxter acquires AesRx, specific terms not disclosed
Baxter announced the acquisition of AesRx, including the development and commercialization of Aes-103. The Aes-103 program is currently in a Phase 2 clinical trial as part of an ongoing collaboration with the NIH’s National Center for Advancing Translational Sciences through its Therapeutics for Rare and Neglected Diseases program. Data has previously been presented from an escalating dose Phase I/2a safety study involving administration of a single dose among stable SCD patients. The compound was developed by a team from the VCU Institute for Structural Biology and Drug Discovery. Baxter made an initial payment to acquire the company and may make additional future payments based on specified development, regulatory and commercial milestones. The specific terms of the agreement were not disclosed.
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August 21, 2014
15:37 EDTBAXNektar: Baxter announces positive results from Phase 3 study of BAX 855
Nektar Therapeutics (NKTR) reports Baxter International (BAX) announced positive results from its Phase 3 pivotal clinical trial of BAX 855, an investigational, extended half-life recombinant factor VIII treatment for hemophilia A based on ADVATE, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95 percent reduction in median ABR as compared to those in the on-demand arm (1.9 vs. 41.5, respectively). BAX 855 was also effective in treating bleeding episodes, 96 percent of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 - 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study
09:02 EDTBAXBaxter announces BAX 855 met primary endpoint in Phase 3 study
Baxter announced "positive" results from its Phase 3 pivotal clinical trial of BAX 855, which met its primary endpoint in reducing annualized bleed rates in the prophylaxis arm compared to the on-demand arm. Top-line results from the prospective, global, multi-center Phase 3 study demonstrated that BAX 855 met its primary endpoint in the control and prevention of bleeding, routine prophylaxis and perioperative management for patients who were 12 years or older. Patients in a twice-weekly prophylaxis arm experienced a 95% reduction in median ABR as compared to those in the on-demand arm. BAX 855 was also effective in treating bleeding episodes, 96% of which were controlled with one or two infusions. The half-life of BAX 855 was 1.4 – 1.5 times that of ADVATE, consistent with the findings from the Phase 1 study. No patients developed inhibitors to BAX 855 and no treatment-related serious adverse events, including hypersensitivity, were reported. The most common product-related adverse event was headache. Baxter expects to submit a Biologics License Application for BAX 855 to the U.S. Food and Drug Administration before the end of 2014 and will present additional data in the coming months. In addition to an ongoing continuation study for patients who have completed the pivotal trial, the company is initiating a Phase 3, prospective, open-label, multi-center study to evaluate the safety and efficacy of BAX 855 among 60 previously treated patients under the age of 12 with severe hemophilia A. Consistent with guidelines published by the European Medicines Agency that require a study in children less than 12 years of age prior to filing, Baxter expects to file a Marketing Authorization Application with the EMA upon the completion of the pediatric study.
August 19, 2014
16:33 EDTBAXBaxter to expand Alabama facility to increase dialyzers production
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August 14, 2014
08:07 EDTBAXKamada sees FY14 revenue $70M-$72M, consensus $75.4M
Kamada (KMDA) expects FY14 revenue $70M-$72M, with revenue from its Distribution Segment projected to be between $25M-$26M and revenue from its Proprietary Products Segment to be between $45M-$47M. The company notes that U.S. revenues from the agreement with Baxter (BAX) remain on track.

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