Portola Pharmaceuticals to Present New Data on Betrixaban, Andexanet Alfa and Cerdulatinib at the 59th American Society of He...
November 30 2017 - 8:00AM
Portola Pharmaceuticals, Inc.® (Nasdaq:PTLA) today announced
that new data on the Company’s first FDA-approved anticoagulant,
betrixaban, and its two investigational hematologic compounds – the
anticoagulant reversal agent andexanet alfa and the oral, dual
Syk/JAK kinase inhibitor cerdulatinib – will be presented at the
59th American Society of Hematology (ASH) Annual Meeting taking
place December 9-12 in Atlanta, Georgia. The Company also will
present outcomes-based research on prophylaxis of venous
thromboembolism in two real-world settings.
Oral Presentation
Details:• Presentation Title:
Effect of Andexanet-TFPI Interaction on in Vitro Thrombin Formation
and Coagulation Markers in the TF-Pathway
- Session: 332 (Antithrombotic Therapy:
Anticoagulation in Cancer and Beyond)
- Presenter: Genmin Lu, Ph.D., Portola
Pharmaceuticals
- Presentation Date and Time:
Monday, Dec. 11, 2017 at 11:30 a.m. ET
- Location: Building B, Level 2, B207-B208
(Georgia World Congress Center)
Poster Presentation
Details:
• Poster Title:
Physiologically-Based Pharmacokinetic (PBPK) Modeling for
Betrixaban and the Impact of P-glycoprotein Inhibition on
Betrixaban Pharmacokinetics
- Poster Session: 321 (Blood Coagulation and
Fibrinolytic Factors: Poster III)
- Presenter: Janet M. Leeds, Ph.D., Portola
Pharmaceuticals
- Presentation Date and Time: Monday, Dec. 11,
2017 from 6:00 p.m. – 8:00 p.m. ET
- Location: Building A, Level 1, Hall A2
(Georgia World Congress Center)
• Poster Title: Impact of D-Dimer Assays
Performed at Local Labs vs. Central Laboratory in the Evaluation of
APEX Trial Outcomes
- Poster Session: 332 (Antithrombotic Therapy:
Poster II)
- Presenter: Lisa Jennings, Ph.D., CirQuest
Labs, Memphis, Tennessee
- Presentation Date and Time: Sunday, Dec. 10,
2017 from 6:00 p.m. – 8:00 p.m. ET
- Location: Building A, Level 1, Hall A2
(Georgia World Congress Center)
• Poster Title: Did Patients with Renal Disease
Receive Sufficient Prophylaxis for Venous Thromboembolism in the
Real-World Settings?: A Study Among Hospitalized Acutely Medically
Ill Patients
- Poster Session: 903 (Outcomes
Research—Non-Malignant Conditions: Poster II)
- Presenter: Donna Hesari, R.N., Portola
Pharmaceuticals
- Presentation Date and Time: Sunday, Dec. 10,
2017 from 6:00 p.m. – 8:00 p.m. ET
- Location: Building A, Level 1, Hall A2
(Georgia World Congress Center)
• Poster Title: The Frequency of Venous
Thromboembolism (VTE) Prophylaxis Among Patients Hospitalized for
Cancer in the US
- Poster Session: 903 (Outcomes
Research—Non-Malignant Conditions: Poster III)
- Presenter: Andrea Hafeman, Ph.D., Portola
Pharmaceuticals
- Presentation Date and Time: Monday, Dec. 11,
2017 from 6:00 p.m. – 8:00 p.m. ET
- Location: Building A, Level 1, Hall A2
(Georgia World Congress Center)
• Poster Title: Cerdulatinib Pharmacodynamics
and Relationships to Tumor Response Following Oral Dosing in
Patients with Relapsed/Refractory B Cell Malignancies: Results from
a Phase I Dose Escalation Study
- Poster Session: 623 (Mantle Cell, Follicular,
and Other Indolent B-Cell Lymphoma—Clinical Studies: Poster
II)
- Presenter: Greg Coffey, Ph.D., Portola
Pharmaceuticals
- Presentation Date and Time: Sunday, Dec. 10,
2017 from 6:00 p.m. – 8:00 p.m. ET
- Location: Building A, Level 1, Hall A2
(Georgia World Congress Center)
Important
U.S. Safety Information for Bevyxxa (betrixaban)
capsulesINDICATION 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. SELECT IMPORTANT SAFETY
INFORMATION ___________________________________________________________________________________________________________________________________________________
WARNING: SPINAL/EPIDURAL
HEMATOMAEPIDURAL OR SPINAL HEMATOMAS MAY OCCUR IN
PATIENTS TREATED WITH BEVYXXA 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.
___________________________________________________________________________________________________________________________________________________
CONTRAINDICATIONS
- Active pathological bleeding
- Severe 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
- It is unknown whether hemodialysis removes Bevyxxa
- Protamine sulfate, vitamin K, and tranexamic acid are not
expected to reverse the anticoagulant activity of Bevyxxa
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
- Do not remove an epidural catheter 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
- Prior to neuraxial intervention, consider the potential benefit
versus the risk in anticoagulated patients or in patients to be
anticoagulated for thromboprophylaxis
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 in patients receiving or starting
concomitant P-gp inhibitors, 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 additional Important
Safety Information and full Prescribing Information, including the
Boxed Warning at Bevyxxa.com 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. Forward-Looking
StatementsThis announcement contains
forward-looking statements, including statements relating to
Portola Pharmaceuticals’ expectations regarding the anticipated
product availability of Bevyxxa. 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
regulatory review and our manufacturing and distribution strategy.
There can be no assurance that Portola Pharmaceuticals will be able
to make Bevyxxa commercially available on our anticipated timeline.
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: |
Media
Contact: |
Michele Mantynen |
Patrick Ryan |
Portola
Pharmaceuticals |
W2O Group |
ir@portola.com |
pryan@w2ogroup.com |
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