Portola Pharmaceuticals Announces Upcoming Data Presentations on Betrixaban and Andexanet Alfa at the European Society of Car...
August 21 2017 - 8:00AM
Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced
that data on betrixaban and andexanet alfa, as well as
presentations on disease awareness and risk, will be presented at
the European Society of Cardiology (ESC) Congress, which is taking
place from August 26-30 in Barcelona, Spain.
Details regarding the presentations follow.
Poster Presentation Details:
- Poster Title: D-dimer concentration is
associated with increased risk for VTE and greater absolute benefit
of extended prophylaxis with betrixaban in acutely ill medical
patients: insights from the APEX trial
- Poster #: P1551
- Poster Session: Session 2, Adverse outcome in
patients with cardiometabolic disorders
- Presenter: Rim Halaby, M.D., Beth Israel
Deaconess Medical Center, Boston
- Presentation Date and Time: August 27, 2017
from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: Extended duration betrixaban in
acutely ill medical patients is associated with reduction in fatal
or irreversible ischemic or bleeding events compared with standard
dose enoxaparin: an APEX substudy
- Poster #: P1732
- Poster Session: Session 2, Coronary artery
disease: from bench to bedside
- Presenter: Tarek Nafee, M.D., Beth Israel
Deaconess Medical Center, Boston
- Presentation Date and Time: August 27, 2017
from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: Apixaban anticoagulation can be
reversed using andexanet alfa in a polytrauma model
- Poster #: P4490
- Poster Session: Session 5, Cardiovascular care
– Biology II
- Presenter: Pamela B. Conley, Ph.D., Portola
Pharmaceuticals
- Presentation Date and Time: August 28, 2017
from 2:00 p.m. - 6:00 p.m. UTC
- Poster Title: N-Terminal pro-B–type
Natriuretic Peptide (NT-proBNP) is associated with stroke among
hospitalized medical patients: an APEX trial substudy
- Poster #: P4316
- Poster Session: Session 5, Stroke and Carotid
disease
- Presenter: Gerald Chi, M.D., Beth Israel
Deaconess Medical Center, Boston
- Presentation Date and Time: August 28, 2017
from 2:00 p.m. - 6:00 p.m. UTC
- Poster Title: Analysis of patient
characteristics as covariates potentially affecting
pharmacokinetics, efficacy, or safety of betrixaban in the APEX
study
- Poster #: P5136
- Poster Session: Sessions 6, Best posters in
prevention, interventions and outcomes
- Presenter: Janet Leeds, Ph.D., Portola
Pharmaceuticals
- Presentation Date and Time: August 29, 2017
from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: Effect of extended-duration
thromboprophylaxis on venous thromboembolism and major bleeding
among acutely ill hospitalized medical patients: a bivariate
analysis
- Poster #: P5599
- Poster Session: Session 6, Latest on
STEMI
- Presenter: Gerald Chi, M.D., Beth Israel
Deaconess Medical Center, Boston
- Presentation Date and Time: August 29, 2017
from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: History of venous
thromboembolism is associated with higher risk for recurrent venous
thromboembolism: insights from the APEX trial
- Poster #: P5600
- Poster Session: Session 6, Latest on
STEMI
- Presenter: Megan K. Yee, Mercy Health, Grand
Rapids
- Presentation Date and Time: August 29, 2017
from 8:30 a.m. - 12:30 p.m. UTC
- Poster Title: Andexanet alfa reduces
betrixaban-induced blood loss in a rabbit liver laceration model of
acute bleeding
- Poster #: P6208
- Poster Session: Session 7, Prevention
general
- Presenter: Pamela B. Conley, Ph.D., Portola
Pharmaceuticals
- Presentation Date and Time: August 29, 2017
from 2:00 p.m. - 6:00 p.m. UTC
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 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.
U.S. Important Safety Information for Bevyxxa (betrixaban)
INDICATION
BEVYXXA is indicated for the prophylaxis of venous
thromboembolism (VTE) in adult patients hospitalized for an acute
medical illness who are at risk for thromboembolic complications
due to moderate or severe restricted mobility and other risk
factors for VTE.
Limitations of Use:
The safety and effectiveness of BEVYXXA have not been
established in patients with prosthetic heart valves because this
population has not been studied.
WARNING: SPINAL/EPIDURAL
HEMATOMA
EPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN
PATIENTS TREATED WITH BETRIXABAN WHO ARE RECEIVING NEURAXIAL
ANESTHESIA OR UNDERGOING SPINAL PUNCTURE. THE RISK OF THESE
EVENTS MAY BE INCREASED BY THE USE OF IN‑DWELLING EPIDURAL
CATHETERS OR THE CONCOMITANT USE OF MEDICAL PRODUCTS AFFECTING
HEMOSTASIS. THESE HEMATOMAS MAY RESULT IN LONG -TERM OR
PERMANENT PARALYSIS. CONSIDER THESE RISKS WHEN SCHEDULING
PATIENTS FOR SPINAL PROCEDURES.
CONTRAINDICATIONSActive pathological
bleedingSevere hypersensitivity reaction to BEVYXXA
WARNINGS AND PRECAUTIONS
- Risk of Bleeding
- BEVYXXA increases the risk of bleeding and can cause serious
and potentially fatal bleeding.
- Concomitant use of drugs affecting hemostasis increases the
risk of bleeding. These include aspirin and other
antiplatelet agents, other anticoagulants, heparin, thrombolytic
agents, selective serotonin reuptake inhibitors, serotonin
norepinephrine reuptake inhibitors, and nonsteroidal
anti-inflammatory drugs (NSAIDs).
- Advise patients of signs and symptoms of blood loss and to
report them immediately or go to an emergency room.
- Promptly evaluate any signs or symptoms of blood loss and
consider the need for blood replacement.
- Discontinue BEVYXXA in patients with active pathological
bleeding.
- There is no established way to reverse the anticoagulant effect
of Bevyxxa, which can be expected to persist for at least
72 hours after the last dose.
- Spinal/Epidural Anesthesia or Puncture
- When neuraxial anesthesia (spinal/epidural anesthesia) or
spinal/epidural puncture is employed, patients treated with
antithrombotic agents for prevention of thromboembolic
complications are at risk of developing an epidural or spinal
hematoma which can result in long-term or permanent paralysis.
- An epidural catheter should not be removed earlier than
72 hours after the last administration of BEVYXXA. The
next BEVYXXA dose is not to be administered earlier than
5 hours after the removal of the catheter. If traumatic
puncture occurs, delay the administration of BEVYXXA for
72 hours.
- Monitor patients frequently for signs and symptoms of
neurological impairment (e.g., numbness or weakness of the
legs, bowel, or bladder dysfunction). If neurological
compromise is noted, urgent diagnosis and treatment is
necessary.
- Use in Patients with Severe Renal Impairment
- Patients with severe renal impairment (CrCl ≥ 15 to < 30
mL/min computed by Cockcroft-Gault) taking BEVYXXA may have
an increased risk of bleeding events
- Reduce dose of BEVYXXA, monitor patients closely, and promptly
evaluate any signs or symptoms of blood loss in these
patients.
- Use in Patients on Concomitant P-glycoprotein (P-gp)
Inhibitors
- Patients on concomitant P-gp inhibitors with BEVYXXA may have
an increased risk of bleeding.
- Reduce dose of BEVYXXA, monitor patients closely, and promptly
evaluate any signs or symptoms of blood loss in these
patients.
- Avoid use of BEVYXXA in patients with severe renal impairment
receiving concomitant P‑gp inhibitors.
ADVERSE REACTIONS
- The most common adverse reactions with BEVYXXA were related to
bleeding (> 5%).
USE IN SPECIFIC POPULATIONS
- Hepatic Impairment
- BEVYXXA has not been evaluated in patients with hepatic
impairment, because these patients may have intrinsic coagulation
abnormalities.
- BEVYXXA is not recommended in patients with hepatic
impairment.
Please see full U.S. Prescribing Information and Medication
Guide at Bevyxxa.com
Investor Contact:
Michele Mantynen
Portola Pharmaceuticals
ir@portola.com
Media Contact:
Julie Normart
Pure Communications
jnormart@purecommunications.com
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