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April 10, 2014
07:04 EDTBMYBristol-Myers presents Phase III data on all-oral Daclatasvir and Asunaprevir
Bristol-Myers Squibb Company announced Phase III results from the global HALLMARK-Dual study investigating the all-oral, interferon- and ribavirin-free regimen of daclatasvir, a NS5A inhibitor, and asunaprevir, a NS3 inhibitor, among genotype 1b hepatitis C virus infected patients. Results showed that the 24-week regimen achieved an overall sustained virologic response 12 weeks after the end of treatment among treatment-naïve, peginterferon/ribavirin non-responder and peginterferon/ribavirin ineligible/intolerant patients, including cirrhotic and non-cirrhotic patients. In the study the DCV+ASV regimen was generally well tolerated. These data will be presented this week at the 49th annual meeting of the European Association for the Study of the Liver The International Liver Congress in London, April 9-13. These data were part of the company’s recent DCV and ASV new drug application submissions to the U.S. Food and Drug Administration, and helped support the validated marketing authorization application to the European Medicines Agency for the use of DCV in combination with other agents for the treatment of adults with HCV with compensated liver disease, including genotypes 1, 2, 3, and 4. These data are comparable to a similar Phase III study of this regimen in Japanese patients, which led to the submission of a New Drug Application with Japan’s Pharmaceutical and Medical Devices Agency.
News For BMY From The Last 14 Days
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December 16, 2014
08:47 EDTBMYHemispherx Ampligen provides anti-tumor activity
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December 10, 2014
06:08 EDTBMYBristol-Myers partners with Ono Pharma and Kyowa Hakko Kirin for oncology trial
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December 9, 2014
16:35 EDTBMYBristol-Myers raises dividend to 37c per share from 36c per share
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08:25 EDTBMYBristol-Myers data positive, says BMO Capital
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December 8, 2014
13:32 EDTBMYPfizer, Bristol-Myers announce results of human study on Eliquis
Bristol-Myers Squibb Company (BMY) and Pfizer (PFE) announced results of the first human study evaluating the reversal of the anticoagulant effect of Eliquis by 4-factor prothrombin complex concentrates in healthy subjects. The study results demonstrated that both PCCs, Sanquin’s Cofact and CSL Behring’s Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis in several coagulation assessments, including endogenous thrombin potential. The full data will be presented today during the Antithrombotic Therapy: Anticoagulant Therapy session at the 56th annual meeting of the American Society of Hematology in San Francisco, CA. The study was an open label, randomized, placebo-controlled, three-period crossover study in 15 healthy, adult subjects. Within each period, subjects received Eliquis 10 mg twice daily. On day four, three hours after Eliquis administration, subjects received a 30-minute infusion of 4-factor PCCs, either 50 IU/kg Cofact or Beriplex P/N, or an equivalent volume of saline solution. The effect of Cofact and Beriplex P/N on the pharmacodynamics of Eliquis was based upon changes in endogenous thrombin potential, a measure of thrombin-mediated coagulation. Treatment periods were separated by an 11-day washout, after which the alternate treatment was administered. In this study, no serious adverse events, bleeding-related events or signs of thrombosis were reported with Eliquis administration with or without PCC treatment. Overall, these data demonstrate that Cofact and Beriplex P/N reversed the steady-state pharmacodynamic effects of Eliquis as measured by ETP and support further evaluation of PCCs in the management of patients treated with Eliquis who require reversal of its anticoagulant effect.
05:53 EDTBMYStocks with implied volatility movement; BSX BMY
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