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 15, 2001
Progenics Pharmaceuticals, Inc.
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(Exact name of registrant as specified in its charter)
Delaware 000-23143 13-3379479
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(State or other jurisdiction (Commission (IRS Employer
of incorporation) File Number) Indentification No.)
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
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(Former name or former address, if changed since last report.)
Item 5. Other Events.
Progenics Pharmaceuticals, Inc. reported the information contained
in the following press release:
PROGENICS REGAINS RIGHTS TO CANCER VACCINE PROGRAM;
INITIATES NEW INTERNATIONAL PHASE III CLINICAL TRIAL IN MELANOMA
Tarrytown, NY, May 15, 2001 -- Progenics Pharmaceuticals, Inc. (Nasdaq:
PGNX) announced today that it is taking over full responsibility for its GMK and
MGV cancer vaccine programs, following a joint decision by the Company and
Bristol-Myers Squibb Company (NYSE: BMY) to end their collaborative development
agreement. Progenics will receive $15.5 million and regain all rights to the
products. Progenics also announced that it has initiated a large international
Phase III clinical trial with its GMK vaccine to prevent the relapse of
malignant melanoma, the deadliest form of skin cancer. The study is being
conducted with the EORTC (European Organization for Research and Treatment of
Cancer), Europe's leading cancer cooperative group.
"Our collaboration with Bristol-Myers Squibb has been productive,
allowing us to advance GMK into two pivotal Phase III trials," said Ronald J.
Prentki, Progenics' President. "We are pleased to have reacquired all
development and marketing rights to GMK and MGV. We remain committed to the
continued development of these vaccines, and we are excited about our new
collaboration with EORTC."
Largest melanoma clinical study to date launched
The EORTC Phase III trial will be the largest randomized study ever
conducted in malignant melanoma, with an anticipated enrollment of 1,300
patients who are at intermediate risk for recurrence of the disease. The study
will recruit patients from Europe as well as Australia. EORTC will randomize
patients after surgery to receive either GMK or the current standard of care,
which is no treatment but close monitoring. Patients on the vaccine arm of the
study will receive 14 doses of GMK over three years, with an estimated two years
of additional follow-up. In addition to the EORTC study, Progenics continues to
monitor patients from an ongoing Phase III clinical trial which compared GMK to
high-dose alpha interferon in 880 melanoma patients with more extensive disease
and at high risk of relapse.
Therapeutic cancer vaccines are designed to stimulate a patient's
immune system to eradicate residual cancer cells after the tumor has been
resected. The GMK vaccine incorporates the GM2 ganglioside, a cancer antigen
present in approximately 95 percent of melanoma cells. Studies have shown that
vaccination of melanoma patients with GMK resulted in the formation of
antibodies against GM2 capable of killing melanoma cells. It has been
demonstrated that patients with high-risk melanoma who have naturally occurring
antibodies against GM2 remain disease free for significantly longer periods and
have longer overall survival.
There are an estimated 300,000 people in the United States with
malignant melanoma and over 47,000 new cases are identified each year. Patients
diagnosed with the disease undergo surgery to remove the primary lesion and are
subsequently followed to detect recurrence. For those patients in whom disease
recurs, it is often fatal, as there are few viable therapeutic options.
Currently, there is no approved therapy for patients at intermediate risk of
relapse and high-dose alpha interferon is the only approved treatment for
high-risk melanoma. While high-dose alpha interferon has been shown to improve
disease-free survival in high-risk patients, its use is limited by serious or
life-threatening side effects which afflict the majority of patients receiving
the drug.
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a
biopharmaceutical company focusing on the development and commercialization of
products for the treatment and prevention of viral, cancer,
and other life-threatening diseases. The Company applies its immunological
expertise to develop biopharmaceuticals to fight viral diseases, such as human
immunodeficiency virus (HIV) infections, and cancers, such as malignant melanoma
and prostate cancer. The Company has initiated Phase II clinical trials of its
lead HIV product, PRO 542, a viral-entry inhibitor. The Company is developing
follow-on product candidates in HIV infection: PRO 367 has completed a Phase I
study, PRO 140 is preparing to commence Phase I/II trials, and a lead
therapeutic candidate has been selected from a novel class of anti-HIV compounds
known as sulfated CCR5 peptides. The Company is also engaged in programs to
discover and develop small-molecule HIV therapeutics that target the fusion
co-receptors of the virus and other programs focusing on HIV attachment and
fusion. The Company is developing cancer immunotherapies based on PSMA (prostate
specific membrane antigen) technology. In addition to the GMK program described
above, Progenics is also developing a second cancer vaccine, MGV, with broad
application to a variety of cancers. The Company is also developing a novel
small-molecule antioxidant, dehydroascorbic acid (DHA), to treat stroke and
other disorders.
This press release contains forward-looking statements. Any statements contained
herein that are not statements of historical fact may be forward-looking
statements. When the Company uses the words `anticipates,' `plans,' `expects'
and similar expressions they are identifying forward-looking statements. Such
forward-looking statements involve risks and uncertainties which may cause the
Company's actual results, performance or achievements to be materially different
from those expressed or implied by forward-looking statements. Such factors
include, among others, the uncertainties associated with product development,
the risk that clinical trials will not commence when or proceed as planned, the
risks and uncertainties associated with dependence upon the actions of the
Company's corporate, academic and other collaborators and of government
regulatory agencies, the risk that products that appear promising in early
clinical trials do not demonstrate efficacy in larger-scale clinical trials, the
uncertainty of future profitability and other factors set forth more fully in
the Company's Annual Report on Form 10-K for the fiscal year ended December 31,
2000 and other periodic filings with the Securities and Exchange Commission to
which investors are referred for further information. In particular, the Company
cannot assure you that any of the their programs will result in a commercial
product. The Company does not have a policy of updating or revising
forward-looking statements, and thus it should not be assumed that the Company's
silence over time means that actual events are bearing out as expressed or
implied in such forward-looking statements.
SIGNATURES
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/ PHILIP K. YACHMETZ
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Philip K. Yachmetz
General Counsel and Secretary
Date May 15, 2001
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