baxter international inc (BAX) Key Developments
Baxter International Inc. Amends and Restates its Bylaws
Mar 25 15
On March 24, 2015, the Bylaws of Baxter International Inc. were amended and restated to remove the mandatory director retirement age from Section 2 Article II. The foregoing description of the amendment and restatement of the Bylaws is qualified in its entirety by reference to the text of the Bylaws, as amended and restated on March 24, 2015.
Baxter Bioscience Announces Positive Phase III Results for BAX 817
Mar 13 15
Baxter International Inc. announced positive results from its Phase III clinical trial evaluating the safety and efficacy of BAX 817, an investigational recombinant factor VIIa (rFVIIa) treatment for people with hemophilia A or B who develop inhibitors. The prospective, open-label, randomized, multicenter trial was designed to assess the safety and efficacy of BAX 817 in male patients ages 12 to 65 with hemophilia A or B with inhibitors over a 6-month period using on-demand therapy. The trial met its primary endpoint of successful resolution of acute bleeding episodes at 12 hours with both on-demand treatment regimens, dosing either 3x90 Âµg/kg or 1x270 Âµg/kg, with an overall success rate of 92% (98% and 85% in each dosing group, respectively). Further, 89% of patients in the trial achieved sustained bleeding control for all acute bleeding episodes 24 hours after infusion.
Baxter International Inc. Presents at 12th Annual BIO Asia International Conference, Mar-25-2015 01:00 PM
Mar 12 15
Baxter International Inc. Presents at 12th Annual BIO Asia International Conference, Mar-25-2015 01:00 PM. Venue: Grand Hyatt Hotel, Tokyo, Japan.
CTI BioPharma Corp. and Baxter International Inc. Announce Positive Top-Line Results from Phase 3 Persist-1 Trial of Pacritinib for Patients with Myelofibrosis
Mar 9 15
CTI BioPharma Corp. and Baxter International Inc. announced positive top-line results for the primary endpoint from PERSIST-1, the randomized, controlled Phase 3 registration clinical trial examining pacritinib, a next generation oral JAK2/FLT3 multikinase inhibitor, for the treatment of patients with primary or secondary myelofibrosis. The PERSIST-1 trial met its primary endpoint in the intent-to-treat population with statistically significant activity observed in patients irrespective of their initial platelet count, including patients with very low platelet counts at study entry, a condition known as severe or life-threatening thrombocytopenia. The primary endpoint of the trial was the proportion of patients achieving a 35% or greater reduction in spleen volume from baseline to Week 24 as measured by magnetic resonance imaging (MRI) or computerized tomography (CT) when compared with physician-specified best available therapy (BAT), excluding treatment with JAK2 inhibitors. The PERSIST-1 trial demonstrated that pacritinib treatment provided a clinically and statistically significant response rate (p = 0.0003) in spleen volume reduction in patients with myelofibrosis when compared to BAT. Importantly, the trial results also demonstrated a significant difference among patients with platelet counts of less than 100,000 per microliter and less than 50,000 per microliter, both subgroups that were stratified at randomization. The magnitude of treatment effect was consistent with previously reported Phase 2 results, with the great reduction observed among the sickest patients (platelet counts <50,000 per microliter). Among 50 patients who were red blood cell (RBC) transfusion dependent at study entry (= 6 units of RBC over 90 days pre entry), pacritinib therapy resulted in a clinically meaningful percentage of patients becoming transfusion independent compared to BAT. 79% of patients in the BAT arm of the study crossed over to pacritinib therapy. The safety profile in the PERSIST-1 trial was consistent with prior Phase 2 trials. While the most common treatment emergent adverse events were diarrhea, nausea and vomiting, the incidence of grade 3 events was lower than observed in Phase 2 trials. No grade 4 gastrointestinal adverse events were reported. Three patients discontinued therapy and nine patients required dose reduction for diarrhea. Preliminary analysis suggests that very few patients discontinued treatment while on pacritinib or required a dose reduction due to treatment-related anemia or thrombocytopenia. Additional data from ongoing analyses along with top-line results from PERSIST-1 will be submitted for presentation at an upcoming scientific meeting. Pacritinib is currently being evaluated in two Phase 3 clinical trials, known as the PERSIST program, for patients with myelofibrosis. The PERSIST clinical trials are intended to support a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA). In August 2014, pacritinib was granted Fast Track designation by the FDA for the treatment of intermediate and high risk myelofibrosis, including but not limited to patients with disease related thrombocytopenia, patients experiencing treatment emergent thrombocytopenia on other JAK2 therapy or patients who are intolerant to or whose symptoms are sub-optimally managed on other JAK2 therapy. The FDA's Fast Track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
Baxter International Inc. Presents at Barclays Global Healthcare Conference, Mar-10-2015 through Mar-12-2015
Feb 19 15
Baxter International Inc. Presents at Barclays Global Healthcare Conference, Mar-10-2015 through Mar-12-2015. Venue: Loews Miami Beach Hotel, 1601 Collins Avenue, Miami, Florida, United States. Presentation Date & Speakers: Mar-10-2015, Robert J. Hombach, Chief Financial Officer and Corporate Vice President.