form8_k100109.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date of
Report (Date of earliest event reported) October 1, 2009
Progenics
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
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|
000-23143
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13-3379479
|
|
(State
or other jurisdiction
of
incorporation)
|
|
(Commission
File
Number)
|
|
(IRS
Employer
Identification
No.)
|
|
|
|
|
|
|
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777
Old Saw Mill River Road, Tarrytown, New York
|
|
10591
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|
(Address
of principal executive offices)
|
|
(Zip
Code)
|
|
Registrant's
telephone number, including area code (914)
789-2800
|
Check the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions (see General
Instruction A.2. below):
o Written communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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.
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
PROGENICS
PHARMACEUTICALS, INC.
By: /s/ ROBERT A.
MCKINNEY
Robert A. McKinney
Chief Financial Officer, Senior
Vice President,
Finance & Operations and
Treasurer
Date: October
1, 2009