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June 1, 2014
16:17 EDTNKTRNektar announces new data from Phase 2 study of NKTR-102
Nektar Therapeutics announced new data from an investigator-sponsored Phase 2 study of NKTR-102, etirinotecan pegol, in patients with Avastin-refractory high-grade glioma conducted at Stanford Cancer Institute under the direction of Lawrence Recht, M.D., Professor of Neurology and Neurosurgery, with co-investigator Seema Nagpal, M.D., Clinical Assistant Professor of Neurology and Neurological Sciences, Stanford School of Medicine. The primary endpoint was met and exceeded with fifty-five percent of patients in the study achieving six-week progression-free survival. Response and disease progression were assessed by RANO criteria in the trial. Three patients, or 15%, achieved partial responses with NKTR-102 monotherapy with maximum percent reductions in tumor area of 86%, 72%, and 59%. An additional eight patients, or 40%, achieved stable disease as best response. Two of the three patients with RANO responses experienced a long duration of response of 14 and 20 months. Secondary endpoints include median progression-free survival, median survival from time of first NKTR-102 infusion and median overall survival from date of pathologic diagnosis or confirmation of high-grade glioma. NKTR-102 monotherapy was well-tolerated in patients with Avastin-refractory high-grade glioma with low toxicity in spite of being heavily pre-treated and neurologically symptomatic. Only one patient had Grade 3 toxicity attributable to NKTR-102 as a result of not taking anti-diarrheal medication. Hematologic toxicity was mild. As of May 31, there is one patient in the study who is continuing on NKTR-102 monotherapy.
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August 27, 2014
09:08 EDTNKTRNektar could see $100M in revenue from Baxter drug, says Roth Capital
Roth Capital believes that Baxter's (BAX) BAX-855 drug delivered compelling Phase III data, and the firm expects the drug to compete effectively against Biogen's (BIIB) Eloctate. Roth expects BAX-855 to launch in 1Q16 and believes it could generate up to $100M in annual revenue for Nektar. The firm keeps a $21 price target and Buy rating on Nektar.
August 21, 2014
15:37 EDTNKTRNektar: 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

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