Portola Pharmaceuticals   Print Page    Close Window

Portola Pharmaceuticals Announces Acceptance of Late-Breaker Abstract Highlighting New Data for Andexanet Alfa at ACC.18

SOUTH SAN FRANCISCO, Calif., Jan. 22, 2018 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced that an abstract detailing interim results from the Company’s ongoing Phase 3b/4 trial of its investigational Factor Xa reversal agent, andexanet alfa, has been accepted for oral presentation during a late-breaking clinical trial session at the American College of Cardiology’s 67th Annual Scientific Session & Expo (ACC.18). The data will be presented on Monday, March 12, 2018 at 11:30 a.m. ET.    

“Factor Xa inhibitor-related bleeding leading to hospital admission and death is increasing because the adoption of these agents is growing significantly, and there is currently no approved reversal agent for patients,” said Jack Lawrence, M.D., chief medical officer of Portola. “We are excited to share new analyses from the ANNEXA-4 trial that will add to the understanding of the potential role of andexanet alfa as an antidote to reverse anticoagulation in Factor Xa-associated bleeding.”

Portola is developing andexanet alfa as a universal antidote for patients anticoagulated with an oral or injectable Factor Xa inhibitor who experience a serious uncontrolled or life-threatening bleeding event or who require urgent or emergency surgery. Andexanet alfa is currently under review by the U.S. Food and Drug Administration (FDA), with an assigned action date of May 4, 2018, and by the European Medicines Agency (EMA), with an expected decision in the first half of 2018.

ACC also has accepted two poster presentations regarding the unmet medical need for anticoagulant prophylaxis of venous thromboembolism in acute medically ill patients.

Late-Breaking Clinical Trial Session Details:

  • Presentation Title: Interim Report on the ANNEXA-4 Study: Andexanet for Reversal of Anticoagulation in Factor Xa-Associated Acute Major Bleeding
    • Session Number: 409
    • Presenter: Stuart J. Connolly, M.D., Professor Emeritus of Medicine, McMaster University, Hamilton Health Sciences
    • Presentation Date and Time: Monday, March 12, 2018 from
      11:30-11:40 a.m. ET
    • Location: Main Tent, Hall C

Poster Presentation Details:

  • Poster Title: Prophylaxis for Venous Thromboembolism in the Continuum of Care Among Patients With Acute Heart Failure in the United States
    • Poster Number: 376
    • Presenter: Alpesh Amin, M.D., M.B.A., F.A.C.P., University of California, Irvine School of Medicine
    • Presentation Date and Time: Monday, March 12, 2018 from
      9:30 a.m.-12:30 p.m. ET
    • Location: Poster Hall A/B

  • Poster Title: Does Age Matter?  Evaluation of Prophylaxis for Venous Thromboembolism in the Real-World Settings Among Hospitalized Acutely Medically Ill Patients of Different Age Groups
    • Poster Number: 389
    • Presenter: Alpesh Amin, M.D., M.B.A., F.A.C.P., University of California, Irvine School of Medicine
    • Presentation Date and Time: Monday, March 12, 2018 from
      9:30 a.m.-12:30 p.m. ET
    • Location: Poster Hall A/B

About Portola Pharmaceuticals, Inc.
Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company’s first medicine Bevyxxa® (betrixaban), an oral, once-daily Factor Xa inhibitor, was approved by the U.S. Food and Drug Administration in June 2017. The company is also working to advance two clinical programs for AndexXa® (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a SYK/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective SYK inhibitors for inflammatory conditions. For more information, visit http://www.portola.com and follow the Company on Twitter @Portola_Pharma.

Forward-Looking Statements

This announcement contains forward-looking statements, including statements relating to Portola Pharmaceuticals’ expectations regarding the anticipated regulatory review timeline for andexanet alfa. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. Portola Pharmaceuticals cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to the timing of regulatory approvals for andexanet alfa.   Risks and uncertainties relating to Portola Pharmaceuticals and its business can be found in the “Risk Factors” section of Portola Pharmaceuticals’ Quarterly Report on Form 10-Q for the third quarter of 2017, which was filed with the SEC on November 9, 2017. Portola Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in Portola Pharmaceuticals’ expectations. 

Investor Contact:                                                
Cara Miller                                                                                                   
Portola Pharmaceuticals                                                                             
ir@portola.com                                                                   

Media Contact:
Patrick Ryan
W2O Group
pryan@w2ogroup.com          

Primary Logo

Portola Pharmaceuticals, Inc.