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Portola Pharmaceuticals to Present New Data on Betrixaban, Andexanet Alfa and Cerdulatinib at the 59th American Society of Hematology (ASH) Annual Meeting


Posted on: 30 Nov 17

SOUTH SAN FRANCISCO, Calif., Nov. 30, 2017 (GLOBE NEWSWIRE) -- 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) capsules

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.  

SELECT IMPORTANT SAFETY INFORMATION 

___________________________________________________________________________________________________________________________________________________

WARNING: SPINAL/EPIDURAL HEMATOMA
EPIDURAL 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 INDWELLING 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 Statements
This 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 MantynenPatrick Ryan
Portola PharmaceuticalsW2O Group
ir@portola.compryan@w2ogroup.com
GlobeNewswire
globenewswire.com

Last updated on: 01/12/2017

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