Yahoo! Finance Search - Finance Home - Yahoo! - Help
EDGAR
Online

Quotes & Info
Enter Symbol(s):
e.g. YHOO, ^DJI
Symbol Lookup | Financial Search
PGNX > SEC Filings for PGNX > Form 8-K on 1-Oct-2009All Recent SEC Filings

Show all filings for PROGENICS PHARMACEUTICALS INC | Request a Trial to NEW EDGAR Online Pro

Form 8-K for PROGENICS PHARMACEUTICALS INC


1-Oct-2009

Other Events


Item 8.01. Other Events.

Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) has been informed by Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), with which Progenics collaborates in the development and commercialization of RELISTOR®, that it has completed enrollment in a phase 3 one-year, open-label safety study of subcutaneous RELISTOR in over 1,000 chronic, non-cancer pain patients. The study enrolled ahead of anticipated schedule.

This study, initiated in December 2008, is designed to support planned supplemental regulatory filings in the U.S., Europe and elsewhere for approval of RELISTOR to treat opioid-induced constipation in the chronic-pain setting, an additional indication beyond than that for which the drug is currently approved.

In December 2008, Progenics and Wyeth initiated this safety study in accordance with U.S. Food and Drug Administration International Conference on Harmonization (ICH) Guidance, available at
http://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM129517.pdf.

Progenics and Wyeth expect to present a consolidated safety database from this study and a 470-patient efficacy study in chronic, non-cancer pain patients, the results of which were announced in May, as part of supplemental regulatory filings which are planned for by the end of 2010.

RELISTOR is currently approved over 30 countries for the treatment of OIC in patients with advanced illness receiving palliative care.


  Add PGNX to Portfolio     Set Alert         Email to a Friend  
Get SEC Filings for Another Symbol: Symbol Lookup
Quotes & Info for PGNX - All Recent SEC Filings
Sign Up for a Free Trial to the NEW EDGAR Online Pro
Detailed SEC, Financial, Ownership and Offering Data on over 12,000 U.S. Public Companies.
Actionable and easy-to-use with searching, alerting, downloading and more.
Request a Trial      Sign Up Now


Copyright © 2010 Yahoo! Inc. All rights reserved. Privacy Policy - Terms of Service
SEC Filing data and information provided by EDGAR Online, Inc. (1-800-416-6651). All information provided "as is" for informational purposes only, not intended for trading purposes or advice. Neither Yahoo! nor any of independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. By accessing the Yahoo! site, you agree not to redistribute the information found therein.