Portola Pharmaceuticals Announces New APEX Study Sub-Analyses Data on Betrixaban to be Presented at the America Heart Associa...
November 07 2017 - 8:00AM
Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced
that results of new sub-analyses of the APEX Study of betrixaban
will be presented in oral and poster sessions at the upcoming
American Heart Association (AHA) Scientific Sessions 2017, which is
taking place from November 11-15 in Anaheim, California.
Details regarding the presentations follow.
Oral Presentations:
- Presentation Title: Extended-Duration
Betrixaban Reduces The Risk of Venous Thromboembolism-Related
Rehospitalization Among Acutely Ill Hospitalized Medical Patients:
An APEX Trial Substudy
- Session Number: VA.AOS.829
- Session Title: Best in Show Vascular Disease
and Thrombosis Science
- Presenter: Gerald Chi, M.D., PERFUSE Study
Group, Beth Israel Deaconess Medical Center, Boston
- Presentation Date and Time: November 14, 2017
from 2:00 p.m. – 3:15 p.m. PT
- Presentation Number: 364
- Location: 201AB (Main Building)
- Presentation Title: Full-Dose Betrixaban
Reduces Venous Thromboembolism-Related Mortality: An APEX Trial
Substudy
- Session Number: VA.AOS.796
- Session Title: Emerging Science and Discovery
in Vascular Disease and Thrombosis
- Presenter: Gerald Chi, M.D., PERFUSE Study
Group, Beth Israel Deaconess Medical Center, Boston
- Presentation Date and Time: November 14, 2017
from 3:45 p.m. – 5:00 p.m. PT
- Presentation Number: 387
- Location: 210C (Main Building)
Poster
Presentation:
- Poster Title: Betrixaban Reduces Not Only The
Presence of Thrombus But Also Extent of Thrombus: An APEX Trial
Substudy
- Session Number: VA.APS.07
- Session Title: Horizons in Venous
Thromboembolism: Emerging Science in Pathophysiology, Treatment,
and Prevention
- Presenter: Gerald Chi, M.D., PERFUSE Study
Group, Beth Israel Deaconess Medical Center, Boston
- Presentation Date and Time: November 12, 2017
from 3:15 p.m. – 4:30 p.m. PT
- Presentation Number: S5173
- Location: Science and Technology Hall-Clinical
Science III Section
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
HEMATOMAEPIDURAL 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
Forward-Looking
Statements
This announcement contains forward-looking
statements, including statements relating to Portola
Pharmaceuticals’ expectations regarding the completion, timing and
size of the proposed public offering. 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 market conditions and satisfaction of
customary closing conditions related to the public offering. There
can be no assurance that Portola Pharmaceuticals will be able to
complete the public offering on the anticipated terms, or at all.
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 second
quarter of 2017, which was filed on August 9, 2017, and in the
prospectus supplement related to the proposed offering filed with
the SEC. 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:Michele MantynenPortola
Pharmaceuticalsir@portola.com
Media Contact:Patrick RyanW2O
Grouppryan@w2ogroup.com
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