• SKIP TO CONTENT
  • SKIP NAVIGATION
  • Patient Resources
    • COVID-19 Patient Resource Center
    • Clinical Trials
    • Search Clinical Trials
    • Patient Notification System
    • What is Clinical Research?
    • Volunteering for a Clinical Trial
    • Understanding Informed Consent
    • Useful Resources
    • FDA Approved Drugs
  • Professional Resources
    • Research Center Profiles
    • Clinical Trial Listings
    • Market Research
    • FDA Approved Drugs
    • Training Guides
    • Books
    • eLearning
    • Events
    • Newsletters
    • JobWatch
    • White Papers
    • Patient Education
    • SOPs
    • eCFR and Guidances
  • White Papers
  • Trial Listings
  • Advertise
  • COVID-19
  • iConnect
  • Sign In
  • Create Account
  • Sign Out
  • My Account
Home » Talecris Biotherapeutics receives EU orphan drug designation for Plasmin

Talecris Biotherapeutics receives EU orphan drug designation for Plasmin

March 11, 2011
CenterWatch Staff

Talecris Biotherapeutics has been granted orphan drug designation by the European Commission for the development of Plasmin (human) to treat acute peripheral arterial occlusion (aPAO). Talecris is currently investigating Plasmin in a phase II clinical trial designed to assess its ability to treat aPAO, a condition in which arterial blood flow to the extremities, usually the legs, is blocked by a clot. 

The European Medicines Agency (EMA) will provide Talecris with 10 years of market exclusivity if the product is the first to be approved in the European Union. In addition, under this designation EMA will provide Talecris with clinical development assistance and reduced regulatory fees. Talecris received orphan drug designation for Plasmin from the FDA in 2009.  

"The European Commission's orphan drug designation represents another promising development milestone for Talecris in the expansion of our product pipeline, a pursuit that reflects our ongoing commitment to offer clinical advancements for patients with chronic and acute life-threatening conditions," said Steve Petteway, executive vice president, research and development at Talecris.

By providing incentives to the pharmaceutical industry, the EU legislative framework for orphan medicines encourages the development of products intended to diagnose, prevent and treat life-threatening or chronically-debilitating conditions that impact up to five in 10,000 people in the European Union. The initiative helps improve access to quality medical care for patients who have rare diseases for which there are few, if any, approved treatments.

Upcoming Events

  • 15Apr

    Five Telltale Signs You’re Ready for an Electronic TMF System

  • 26Apr

    MAGI's Clinical Research vConference — Spring 2021

  • 06May

    The World of Post-COVID-19 Clinical Trials: How to Prepare for What’s Coming Next

Featured Products

  • Regenerative Medicine – Steps to Accelerate Development : PDF

    Regenerative Medicine: Steps to Accelerate Development

  • Clinical Trial Agreements — A Guide to Key Words and Phrases : PDF

    Clinical Trial Agreements: A Guide to Key Words and Phrases

Featured Stories

  • Clinical-Trial-Brainstorming

    FDA, Industry Tackle Problem of Including Older Adults in Trials

  • ClinicalTrialNetwork-360x240.png

    National Community-Based Research Network Would Improve Reach of Trials

  • Bottleneck-360x240.png

    Sites Face Trials Bottleneck After Pandemic, But Also Opportunities

  • AsktheExpertsBadge-360x240.png

    Ask the Experts: Genetic Research and IBC Oversight Requirements

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 My Personal Information

Footer Logo

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

Phone 617.948.5100 – Toll free 866.219.3440

Copyright © 2021. All Rights Reserved. Design, CMS, Hosting & Web Development :: ePublishing