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August 21, 2014
15:37 EDTNKTR, BAXNektar: 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
News For NKTR;BAX From The Last 14 Days
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September 1, 2015
17:29 EDTBAXBaxalta files to sell $1.45B of common stock for holders
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08:33 EDTNKTRNektar receives $40M milestone payment from first commercial sale of Moventig
Nektar (NKTR) announced that it has received a $40M cash payment under a license agreement with AstraZeneca (AZN). The payment was triggered by the first commercial sale of MOVENTIG (naloxegol) in Germany. MOVENTIG is the first once-daily, oral peripherally-acting mu-opioid receptor antagonist (PAMORA) medication approved in the European Union for the treatment of opioid-induced constipation (OIC) in adult patients who have had an inadequate response to laxatives. MOVENTIG is marketed in the U.S. by AstraZeneca as MOVANTIK and is the first once-daily oral PAMORA medication indicated for the treatment of OIC in adult patients with chronic, non-cancer pain. MOVENTIG/MOVANTIK is part of the exclusive worldwide license agreement announced on September 21, 2009 between AstraZeneca and Nektar Therapeutics. Under the terms of the agreement, in addition to the $40 million milestone payment announced today, Nektar received a $100 million milestone payment upon first commercial sale of MOVANTIK in the U.S. in March of 2015. Nektar is also entitled to royalties on worldwide net product sales and up to $375 million in sales milestones. The royalty rate in the U.S. starts at 20% and escalates. The royalty rate in Europe and the rest of the world starts at 18% and escalates. Under the agreement, AstraZeneca is responsible for all sales and marketing activities for MOVANTIK worldwide.
August 27, 2015
10:06 EDTBAXHigh option volume stocks
High option volume stocks: GLOG ACI NGD BEAT BAX TTPH STJ FNF SSTK

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