Portola Pharmaceuticals Announces Acceptance of Late-Breaker Abstract Highlighting New Data for Andexanet Alfa at ACC.18
January 22 2018 - 9:33PM
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 RyanW2O
Grouppryan@w2ogroup.com
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