• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trial Listings
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • White Papers
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Clinical Trial Listings
  • Advertise
  • COVID-19
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Janssen, Bayer, Portola form clinical collaboration

Janssen, Bayer, Portola form clinical collaboration

February 8, 2013
CenterWatch Staff

Janssen Pharmaceuticals has signed a clinical collaboration agreement with Portola Pharmaceuticals and Bayer HealthCare to evaluate the safety of PRT4445—an investigational-stage antidote for Factor Xa inhibitors—in healthy volunteers who have been administered the oral anticoagulant Xarelto (rivaroxaban). The study will evaluate several dosage strengths of PRT4445 and its ability to reverse the anticoagulant activity of Xarelto in emergency situations.

As part of the agreement, Janssen and Bayer will make an upfront payment to Portola and will provide development and regulatory guidance for the study. Portola retains full global development and commercialization rights for PRT4445.

Xarelto is approved by the FDA for six distinct uses. This proof-of-concept study is scheduled to complete in the second half of 2013. A phase III trial will be required prior to submitting PRT4445 to the FDA for approval in this setting. Standard clinical measures are currently employed to manage these patients and events.

"Xarelto has the broadest indication profile of any of the new oral anticoagulants in the U.S. market, and is being used by a wide array of patients in many different settings," said Larry E. Fields, M.D., senior director, clinical development, medical affairs, Janssen. "We are committed to exploring ways to expedite reversal of the drug's effects when necessary, which could provide physicians with an additional treatment option during emergency situations."

Upcoming Events

  • 25Apr

    Effective Root Cause Analysis and CAPA Investigations for Drugs, Devices and Clinical Trials

  • 26Apr

    FDA’s New Laws and Regulations: What Drug and Biologics Manufacturers Need to Know

  • 27Apr

    Califf’s FDA, 2023 and Beyond: Key Developments, Insights and Analysis

  • 17May

    2023 WCG Avoca Quality Consortium Summit

  • 21May

    WCG MAGI Clinical Research Conference – 2023 East

Featured Products

  • Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

    Spreadsheet Validation: Tools and Techniques to Make Data in Excel Compliant

  • Surviving an FDA GCP Inspection

    Surviving an FDA GCP Inspection: Resources for Investigators, Sponsors, CROs and IRBs

Featured Stories

  • Five Ws

    Consider the Five ‘W’s to Understand Potential Participants

  • QandA-360x240.png

    Perspectives from Smaller-Sized CROs: Q&A with Cheryle Evans

  • White House

    Trial Stakeholders Advise White House on Emergency Research Infrastructure

  • SurveywBlueBackground-360x240.png

    Stress Levels Continue to Climb in Healthcare Workforce, Survey Finds

Standard Operating Procedures for Risk-Based Monitoring of Clinical Trials

The information you need to adapt your monitoring plan to changing times.

Learn More Here
  • About Us
  • Contact Us
  • Privacy Policy
  • Do Not Sell or Share My Data

Footer Logo

300 N. Washington St., Suite 200, Falls Church, VA 22046, USA

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2023. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing