form8_k5709.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) May 7,
2009
Progenics
Pharmaceuticals, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-23143
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13-3379479
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(State
or other jurisdiction
of
incorporation)
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(Commission
File
Number)
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(IRS
Employer
Identification
No.)
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777 Old Saw Mill River Road, Tarrytown, New
York
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10591
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(Address
of principal executive offices)
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(Zip
Code)
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Registrant's telephone number,
including area code (914)
789-2800
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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.
Today,
Progenics reported key results, shown below, from the open-label portion of the
pivotal phase 3 clinical study of subcutaneous RELISTOR in 303 chronic,
non-cancer pain patients for the treatment of opioid-induced constipation
(OIC).
Data from the blinded portion of
this study is scheduled to be presented tomorrow at the annual meeting of the
American Pain Society (APS). Today, Wyeth and Progenics issued a
press release with respect to the data scheduled to be presented from the
double-blind portion of this study: “Phase 3 Clinical Study of
RELISTOR Presented at American Pain Society Meeting Showed Positive Activity For
the Treatment of Opioid-Induced Constipation in Chronic, Non-cancer Pain
Patients.” (A copy of
the release can be found at www.progenics.com).
Preliminary
results of open-label portion of the pivotal phase 3 study of RELISTOR in
chronic, non-cancer pain patients
Patients
who completed the four-week, double-blind, placebo-controlled portion of the
trial were eligible to continue in the subsequent eight-week, open-label
portion. During the open-label portion, patients were permitted to take RELISTOR
on an as-needed basis, but no more than once daily. Of the 460 chronic,
non-cancer pain patients who participated in the blinded portion of the study,
364 entered into the open-label portion of the study. Of these, 303 patients
completed the open-label portion of the study. An inclusion criterion
of the study was that patients had <3 rescue-free bowel movements (RFBMs) per
week during the baseline screening period.
The
preliminary top-line results from the eight-week, open-label period were as
follows:
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§
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Patients
chose to self-administer RELISTOR on average 4.5 times per week throughout
the open-label period.
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§
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The
percentage of patients with ≥3 RFBMs per week was 59.8% over the
open-label period.
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o
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During
the double-blind portion of the study, the percentage of patients with ≥3
RFBMs per week was 38.3% while on placebo compared to 58.7% and 45.3%
while receiving RELISTOR daily or every other day,
respectively.
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·
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On
average, the percent of injections resulting in any RFBM within four hours
during the open-label portion was
34.4%.
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o
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This
result was similar to that observed in the active treatment groups in the
double-blind portion.
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Consistent
with the double-blind portion of the study and previous studies, RELISTOR was
generally well tolerated. The most common adverse events reported in the
open-label portion of the study were abdominal pain, nausea, urinary tract
infection, diarrhea, and hyperhidrosis.
Results
from this phase 3 study would be included in a planned supplemental New Drug
Application to the U.S. Food and Drug Administration, and if approved, would add
a new indication for RELISTOR for chronic pain patients with OIC in the United
States. Currently, RELISTOR is approved for the treatment of OIC in patients
with advanced illness who are receiving palliative care, when response to
laxative therapy has not been sufficient.
Special
Note Regarding Forward-Looking Statements
This document contains statements
that do not relate strictly to historical fact, any of which may be forward-looking statements within
the meaning of the U.S. Private Securities Litigation Reform Act of 1995.
When we use the words
“anticipates,” “plans,” “expects” and similar expressions, we are identifying
forward-looking statements. Forward-looking statements involve known and unknown
risks and uncertainties which may cause our actual results, performance or
achievements to be materially different from those expressed or implied by
forward-looking statements. While it is impossible to identify
or predict all such matters, these differences may result from, among other
things, the inherent uncertainty of the timing and success of, and expense
associated with, research, development, regulatory approval and
commercialization of our products and product candidates, including the risks
that clinical trials will not commence or proceed as planned; products appearing
promising in early trials will not demonstrate efficacy or safety in
larger-scale trials; clinical trial data on our products and product candidates
will be unfavorable; our products will not receive marketing approval from
regulators or, if approved, do not gain sufficient market acceptance to justify
development and commercialization costs; we, our collaborators or others might
identify side effects after the product is on the market; or efficacy or safety
concerns regarding marketed products, whether or not originating from subsequent
testing or other activities by us, governmental regulators, other entities or
organizations or otherwise, and whether or not scientifically justified, may
lead to product recalls, withdrawals of marketing approval, reformulation of the
product, additional pre-clinical testing or clinical trials, changes in labeling
of the product, the need for additional marketing applications, declining sales
or other adverse events.
We
are also subject to risks and uncertainties associated with the actions of our
corporate, academic and other collaborators and government regulatory agencies,
including risks from market forces and trends, such as those relating to the
recently-announced acquisition of our RELISTOR®
collaborator, Wyeth Pharmaceuticals, by Pfizer Inc.; potential product
liability; intellectual property, litigation, environmental and other risks; the
risk that licenses to intellectual property may be terminated for our failure to
satisfy performance milestones; the risk of difficulties in, and regulatory
compliance relating to, manufacturing products; and the uncertainty of our
future profitability.
Risks
and uncertainties also include general economic conditions, including interest-
and currency exchange-rate fluctuations and the availability of capital; changes
in generally accepted accounting principles; the impact of legislation and
regulatory compliance; the highly regulated nature of our business, including
government cost-containment initiatives and restrictions on third-party payments
for our products; trade buying patterns; the competitive climate of our
industry; and other factors set forth in this document and other reports filed
with the U.S. Securities and Exchange Commission (SEC). In particular, we cannot
assure you that RELISTOR will be commercially successful or be approved in the
future in other formulations, indications or jurisdictions, or that any of our
other programs will result in a commercial product.
We
do not have a policy of updating or revising forward-looking statements, and we
assume no obligation to update any statements as a result of new information or
future events or developments. It should not be assumed that our silence over
time means that actual events are bearing out as expressed or implied in
forward-looking statements.
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: May
7, 2009