Portola Pharma (PTLA) to Present Results from Betrixaban Phase 3 APEX Study at AHA Scientific Sessions

November 7, 2016 8:05 AM EST

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Portola Pharmaceuticals Inc.® (Nasdaq: PTLA) announced that results of new sub-analyses of the Phase 3 APEX Study of betrixaban, conducted by Dr. C. Michael Gibson and the PERFUSE Study Group, will be presented in oral and poster sessions at the upcoming American Heart Association (AHA) Scientific Sessions 2016, which is taking place from November 12-16 in New Orleans.

Betrixaban, a U.S. Food and Drug Administration (FDA) Fast Track-designated investigational drug, is an oral, once-daily Factor Xa inhibitor anticoagulant in development for the prevention of venous thromboembolism (VTE) in acute medically ill patients. Portola submitted a New Drug Application to the FDA in October 2016 seeking approval to market betrixaban for extended-duration prophylaxis of VTE in acute medically ill patients with risk factors for VTE. Portola expects a response from the FDA within 60 days as to whether the NDA is complete and acceptable for filing.

Following are details of the oral and poster presentations, which will include additional data not available in the abstracts. AHA will post the abstracts on Friday, November 11, at 4:00 p.m. ET at http://www.abstractsonline.com/pp8/#!/4096.

Oral Presentations

  • Abstract Title: Betrixaban reduces the burden of multiple symptomatic venous thromboembolic events in the APEX trial

Abstract #: 640Presenting Author: Purva Jain, M.P.H., biostatistician, PERFUSE Study Group, Beth Israel Deaconess Medical Center, BostonSession Title: Hemostasis, Thrombosis and FibrinolysisPresentation Date and Time: Monday, November 14, 10:30 -10:35 a.m. CT Presentation Location: Science and Technology Hall, Basic Science Theater

  • Abstract Title: Extended duration betrixaban reduces the risk of stroke vs standard dose enoxaparin among hospitalized medically ill patients: An APEX substudy

Abstract #: 277Presenting Author: C. Michael Gibson, M.S., M.D., APEX Executive Committee Member and Steering Committee Chairman; professor, Harvard Medical School; chairman, PERFUSE Study Group, Beth Israel Deaconess Medical Center, BostonSession Title: Sol Sherry Distinguished Lecture in ThrombosisPresentation Date and Time: Monday, November 14, 3:15-3:25 p.m. CTPresentation Location: Room 217

Poster Presentation

  • Abstract Title: IMPROVEDD Score: Addition of D-dimer to the IMPROVE score improves venous thromboembolism risk stratification: An APEX trial substudy

Abstract #: T1201/1201Presenting Author: Gerald Chi, M.D., PERFUSE Study Group, Beth Israel Deaconess Medical Center, BostonSession Title: Hemostasis, Thrombosis and FibrinolysisPresentation Date and Time: Tuesday, November 15, 12:45-2:00 p.m. CTPresentation Location: Science and Technology Hall, Basic Science Section

About the APEX Study

The pivotal Phase 3 APEX Study enrolled 7,513 patients at more than 450 clinical sites worldwide and assessed the superiority of extended-duration anticoagulation with oral betrixaban for 35-42 days compared with standard-duration injectable enoxaparin for 10+4 days in preventing VTE in high-risk acute medically ill patients. Full study results were presented at the 62nd Annual International Society on Thrombosis and Haemostasis (ISTH) Scientific and Standardization Committee (SSC) Meeting in May 2016 and published simultaneously online in The New England Journal of Medicine.

About BetrixabanBetrixaban, an investigational drug, directly inhibits the activity of Factor Xa, an important validated target in the blood coagulation pathway, to prevent life-threatening thrombosis. Betrixaban has distinct properties that may allow it to demonstrate clinical benefit without the significant imbalance in the risk of major bleeding seen with other agents in the class. These include a 19-25-hour half-life for once-daily dosing; a low peak-to-trough drug concentration ratio that minimizes anticoagulant variability; low renal clearance; and no significant CYP3A4 metabolism, which may reduce the risk of drug-drug interactions.



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