-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, PvYserSnRQK+BCPQcJoZ+35OqbyB20BObBYvDM+rphXIdsqtWASJulceE+k8qOBa 7MkCiuviCkf+JFvIjJLydQ== 0000835887-08-000025.txt : 20080425 0000835887-08-000025.hdr.sgml : 20080425 20080425140544 ACCESSION NUMBER: 0000835887-08-000025 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 6 CONFORMED PERIOD OF REPORT: 20080424 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20080425 DATE AS OF CHANGE: 20080425 FILER: COMPANY DATA: COMPANY CONFORMED NAME: PROGENICS PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000835887 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 133379479 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23143 FILM NUMBER: 08777053 BUSINESS ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 BUSINESS PHONE: 9147892800 MAIL ADDRESS: STREET 1: 777 OLD SAW MILL RIVER ROAD CITY: TARRYTOWN STATE: NY ZIP: 10591 8-K 1 form8k04242008.htm FORM 8-K APRIL 24, 2008 form8k04242008.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) April 24, 2008
 
Progenics Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)
 
Delaware
 
000-23143
 
13-3379479
(State or other jurisdiction
of incorporation)
 
(Commission
File Number)
 
(IRS Employer
Identification No.)
         
777 Old Saw Mill River Road, Tarrytown, New York
 
10591
(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))
 
 
 


 

 
 

 

Section 8 – Other Events
 
Item 8.01. Other Events.
 
Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), yesterday announced that the U.S. Food and Drug Administration (FDA) has approved RELISTOR™ (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid-induced constipation in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. The companies also announced that they have received a Positive Opinion for RELISTOR subcutaneous injection from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA).
 
Copies of these Progenics/Wyeth press releases are attached hereto as Exhibits 99.1 and 99.2 and the information contained therein is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
 
Progenics also yesterday announced that its Board of Directors has approved a share repurchase program to acquire up to $15 million of its outstanding common shares, funding for which will come from the $15 million milestone payment Progenics will receive from Wyeth for receiving FDA marketing approval for RELISTOR for subcutaneous use. Purchases under the program will be made at the company’s discretion and may be discontinued at any time. A copy of this Progenics press release is attached hereto as Exhibit 99.3 and the information contained therein is incorporated by reference into this Item 8.01 of this Current Report on Form 8-K.
 
 
Item 9.01   Financial Statements and Exhibits.
 
(d) Exhibits
  
Exhibit No.            Description
 
99.1  
Press Release dated April 24, 2008
99.2  
Press Release dated April 24, 2008
99.3  
Press Release dated April 24, 2008
 

 
 

 

 
 
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: April 25, 2008 




EX-99.1 2 ex99_142408.htm EXHIBIT 99.1 ex99_142408.htm

 Progenics Logo                Wyeth Logo

 

Contacts:
Progenics Pharmaceuticals, Inc.:
 
Investor Contacts:
Richard W. Krawiec, Ph.D.
Vice President
Corporate Affairs
(914) 789-2814
rkrawiec@progenics.com
 
Dory A. Lombardo
Senior Manager
Corporate Affairs
(914) 789-2818
dlombardo@progenics.com
 
Media Contacts:
Aline Schimmel
WeissComm Partners
(312) 284-4706
aschimmel@wcpglobal.com
 
Julie Normart
WeissComm Partners
(415) 946-1087
Wyeth:
 
Media Contacts:
Sal Foti
Wyeth Pharmaceuticals
(484) 865-3490
 
Douglas Petkus
Wyeth
(973) 660-5218
 
Investor Contact:
Justin Victoria
Wyeth
(973) 660-5340


PROGENICS AND WYETH ANNOUNCE
FDA HAS APPROVED RELISTOR

First Drug for Opioid-Induced Constipation to Launch in United States


Tarrytown, N.Y. and Collegeville, Pa., April 25, 2008 – Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced that the U.S. Food and Drug Administration (FDA) has approved RELISTOR™ (methylnaltrexone bromide) subcutaneous injection for the treatment of opioid-induced constipation (OIC) in patients with advanced illness who are receiving palliative care, when response to laxative therapy has not been sufficient. In clinical studies, RELISTOR significantly decreased the constipating effects of opioids without interfering with pain relief. Wyeth expects to make RELISTOR available in the United States in early June.

 
 

 


“The approval of RELISTOR is a transformative event for Progenics Pharmaceuticals,” says Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc. “This is our first U.S. product approval. I am proud of what our Company has achieved and especially want to thank our patients and investigators who participated in the RELISTOR development program. This program has greatly benefited from our collaboration with Wyeth to develop and commercialize the RELISTOR platform of products.”

Each year, more than 1.5 million Americans receive palliative care due to an advanced illness, such as incurable cancer, end-stage heart and lung disease, or AIDS. Many of these patients are prescribed opioids to manage their pain, and experts have stated that constipation that can be debilitating occurs in practically all of them.

“We are pleased to make RELISTOR available to patients to address this serious unmet medical need,” says Bernard Poussot, President and Chief Executive Officer, Wyeth. “As Wyeth’s third new medicine to receive FDA approval in 2008, RELISTOR is an excellent example of Wyeth’s continuing commitment to develop and deliver medicines that work in novel ways and provide important new treatment options for patients.”

 Jay Thomas, M.D., Ph.D., an investigator in the subcutaneous RELISTOR clinical trial program and Clinical Medical Director of San Diego Hospice and the Institute of Palliative Medicine, says: “Opioid analgesics are the mainstay therapy for pain management in advanced-illness patients receiving palliative care. Side effects associated with opioids, such as constipation, can be severe enough to limit pain management. I am pleased that we now have a new treatment option to provide relief to advanced-illness patients with OIC.”

About RELISTOR and Opioids

RELISTOR, administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that counteracts the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain.

Opioids provide pain relief by specifically interacting with mu-opioid receptors within the central nervous system (CNS) – the brain and spinal cord. However, opioids also interact with mu-opioid receptors found outside the CNS, such as those within the gastrointestinal tract, resulting in constipation that can be debilitating. RELISTOR selectively displaces opioids from the mu-opioid receptors outside the CNS, including those located in the gastrointestinal tract, thereby decreasing their constipating effects. Because of its chemical structure, RELISTOR does not affect the opioid-mediated analgesic effects on the CNS. The efficacy and safety profile of RELISTOR was established in two phase 3 clinical trials. Use of RELISTOR beyond four months has not been studied.

Important Safety Information for RELISTOR

·  
RELISTOR is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
 
·  
If severe or persistent diarrhea occurs during treatment, advise patients to discontinue therapy with RELISTOR and consult their physician.
 
·  
Use of RELISTOR has not been studied in patients with peritoneal catheters.
 
·  
The most common adverse reactions with RELISTOR in clinical trials were abdominal pain, flatulence, and nausea.

 
 

 

 
RELISTOR Prescribing Information will be available at www.relistor.com.

About the Collaboration

In December 2005, Wyeth and Progenics Pharmaceuticals entered into an exclusive, worldwide agreement for the joint development and commercialization of methylnaltrexone for the treatment of opioid-induced side effects.  In accordance with the terms of the collaboration, this U.S. marketing approval triggers a $15 million milestone payment to Progenics from Wyeth.

(PGNX-G)

About the Companies

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products. Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies.  It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide.  The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

WYETH DISCLOSURE NOTICE: The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, there can be no assurance that RELISTOR will be commercially successful or that RELISTOR will be approved in the future in other formulations or indications and/or in other countries.  Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward-looking statements include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data  on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, RISK FACTORS” in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008.  The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

 
 

 

 
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer. The Company, in collaboration with Wyeth, is developing RELISTOR for the treatment of opioid-induced side effects, including constipation (oral and subcutaneous formulations) and postoperative ileus (intravenous formulation).  In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV entry co-receptor CCR5, which has completed phase 1b clinical studies with positive results. In the area of prostate cancer, the Company is developing a human monoclonal antibody drug conjugate – a selectively targeted cytotoxic antibody directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA.

PROGENICS DISCLOSURE NOTICE: The information contained in this document is current as of April 25, 2008. 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, it is 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 or proceed as planned, the risks and uncertainties associated with dependence upon the actions of our corporate, academic and other collaborators and of government regulatory agencies, the risk that our licenses to intellectual property may be terminated because of our failure to have satisfied performance milestones, the risk that products that appear promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that we may not be able to manufacture commercial quantities of our products, 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, 2007, and other reports filed with the Securities and Exchange Commission, to which investors are referred for further information. In particular, the Company cannot assure you that any of its programs will result in a commercial product. Progenics does not have a policy of updating or revising forward-looking statements and assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments. 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.

Editor’s Note:
Additional information on Progenics available at http://www.progenics.com
Additional information on Wyeth available at http://www.wyeth.com








EX-99.2 3 ex99_242408.htm EXHIBIT 99.2 ex99_242408.htm

Wyeth Logo                    Progenics Logo


Contacts:
Wyeth:
 
Media Contacts:
Sal Foti
Wyeth Pharmaceuticals
(484) 865-3490
 
Douglas Petkus
Wyeth
(484) 865-5140
 
Investor Contact:
Justin Victoria
Wyeth
(973) 660-5340
Progenics Pharmaceuticals, Inc.:
 
Investor Contacts:
Richard W. Krawiec, Ph.D.
Vice President
Corporate Affairs
(914) 789-2814
rkrawiec@progenics.com
 
Dory A. Lombardo
Senior Manager
Corporate Affairs
(914) 789-2818
dlombardo@progenics.com
 
Media Contacts:
Aline Schimmel
WeissComm Partners
(312) 284-4706
 
    Julie Normart
    WeissComm Partners
    (415) 946-1087
 

WYETH AND PROGENICS RECEIVE POSITIVE OPINION FROM EUROPEAN COMMITTEE FOR RELISTOR FOR THE TREATMENT OF OPIOID-INDUCED CONSTIPATION IN ADVANCED-ILLNESS PATIENTS

Final Decision from European Commission Expected by Mid-2008
 
 
Collegeville, Pa., and Tarrytown, N.Y., April 24, 2008 – Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), and Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX), today announced that the companies have received a Positive Opinion for RELISTOR™ (methylnaltrexone bromide) subcutaneous injection from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA). The companies are seeking the approval of RELISTOR in Europe for the treatment of opioid-induced constipation in advanced-illness patients who are receiving palliative care when response to usual laxative therapy has not been sufficient.
 
The CHMP is responsible for reviewing medicinal product applications for safety, quality and efficacy. The CHMP’s Positive Opinion for RELISTOR will now be forwarded to the European Commission for a final decision, which is anticipated by mid-year.

 
 

 

 
RELISTOR, administered via subcutaneous injection, is a peripherally acting mu-opioid receptor antagonist that decreases the constipating effects of opioid pain medications in the gastrointestinal tract without affecting their ability to relieve pain.

About the Subcutaneous RELISTOR Clinical Investigational Program

In March 2007, Progenics submitted a New Drug Application for subcutaneous RELISTOR for the treatment of opioid-induced constipation (OIC) in patients receiving palliative care to the U.S. Food and Drug Administration. This application has a Prescription Drug User Fee Act (PDUFA) date of April 30, 2008. Additionally, in May 2007, Wyeth submitted a Marketing Authorization Application (MAA) in Europe to the European Medicines Agency (EMEA) for subcutaneous RELISTOR. The MAA has been validated, and the EMEA review is ongoing. Similarly, in August 2007, Wyeth submitted a marketing application to the Therapeutic Goods Administration division of the Australian government for subcutaneous RELISTOR. On March 28, 2008, RELISTOR received Canadian marketing approval.

About the Companies

Wyeth Pharmaceuticals, a division of Wyeth, has leading products in the areas of women’s health care, infectious disease, gastrointestinal health, central nervous system, inflammation, transplantation, hemophilia, oncology, vaccines and nutritional products.  Wyeth is one of the world’s largest research-driven pharmaceutical and health care products companies.  It is a leader in the discovery, development, manufacturing and marketing of pharmaceuticals, vaccines, biotechnology products, nutritionals and non-prescription medicines that improve the quality of life for people worldwide.  The Company’s major divisions include Wyeth Pharmaceuticals, Wyeth Consumer Healthcare and Fort Dodge Animal Health.

WYETH DISCLOSURE NOTICE: The statements in this press release that are not historical facts are forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. In particular, there can be no assurance that RELISTOR will be commercially successful or that RELISTOR will be approved in the future in other formulations or indications and/or in other countries.  Other risks and uncertainties that could cause actual results to differ materially from those expressed or implied by forward-looking statements include, without limitation, the inherent uncertainty of the timing and success of, and expense associated with, research, development, regulatory approval and commercialization of our products and pipeline products; government cost-containment initiatives; restrictions on third-party payments for our products; substantial competition in our industry, including from branded and generic products; emerging data  on our products and pipeline products; the importance of strong performance from our principal products and our anticipated new product introductions; the highly regulated nature of our business; product liability, intellectual property and other litigation risks and environmental liabilities; uncertainty regarding our intellectual property rights and those of others; difficulties associated with, and regulatory compliance with respect to, manufacturing of our products; risks associated with our strategic relationships; economic conditions including interest and currency exchange rate fluctuations; changes in generally accepted accounting principles; trade buying patterns; the impact of legislation and regulatory compliance; risks and uncertainties associated with global operations and sales; and other risks and uncertainties, including those detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including our current reports on Form 8-K, quarterly reports on Form 10-Q and annual report on Form 10-K, particularly the discussion under the caption “Item 1A, RISK FACTORS” in our Annual Report on Form 10-K for the year ended December 31, 2007, which was filed with the Securities and Exchange Commission on February 29, 2008.  The forward-looking statements in this press release are qualified by these risk factors. We assume no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

 
 

 

Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer. The Company, in collaboration with Wyeth, is developing methylnaltrexone for the treatment of opioid-induced side effects, including constipation (oral and subcutaneous formulations) and postoperative ileus (intravenous formulation). In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV entry co-receptor CCR5, which has completed phase 1b clinical studies with positive results. In the area of prostate cancer, the Company is developing a human monoclonal antibody drug conjugate – a selectively targeted cytotoxic antibody directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA.

PROGENICS DISCLOSURE NOTICE: The information contained in this document is current as of April 24, 2008. 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, it is 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 or proceed as planned, the risks and uncertainties associated with dependence upon the actions of our corporate, academic and other collaborators and of government regulatory agencies, the risk that our licenses to intellectual property may be terminated because of our failure to have satisfied performance milestones, the risk that products that appear promising in early clinical trials do not demonstrate efficacy in larger-scale clinical trials, the risk that we may not be able to manufacture commercial quantities of our products, 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, 2007, and other reports filed with the Securities and Exchange Commission, to which investors are referred for further information. In particular, the Company cannot assure you that any of its programs will result in a commercial product. Progenics does not have a policy of updating or revising forward-looking statements and assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments. 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.


Editor’s Note:
Additional information on Wyeth is available at http://www.wyeth.com
Additional information on Progenics is available at http://www.progenics.com

 
EX-99.3 4 ex99_342408.htm EXHIBIT 99.3 ex99_342408.htm
 
 
 
Progenics Logo
 
Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown , New York   10591
Fax: (914) 789-2817
(914) 789-2800 
 
www.progenics.com

 
Contact:
Investors:
 
Progenics Pharmaceuticals, Inc.
Richard W. Krawiec, Ph.D.
Vice President
Corporate Affairs
(914) 789-2814
rkrawiec@progenics.com
 
Progenics Pharmaceuticals, Inc.
Dory A. Lombardo
Senior Manager
Corporate Affairs
(914) 789-2818
dlombardo@progenics.com
 
Media:
 
WeissComm Partners
Aline Schimmel
(312) 284-4706
aschimmel@wcpglobal.com
 

 
PROGENICS BOARD APPROVES $15 MILLION SHARE REPURCHASE PROGRAM
 
Tarrytown, NY, April 24, 2008 – Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced that its Board of Directors has approved a share repurchase program to acquire up to $15 million of its outstanding common shares.

Funding for the repurchase program will come from the $15 million milestone payment Progenics will receive from Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), for receiving U.S. marketing approval for RELISTOR™ (methylnaltrexone bromide injection) for subcutaneous use.

Purchases under the program will be made at the Company’s discretion subject to market conditions in the open-market or otherwise, and will be made in accordance with the regulations of the U.S. Securities and Exchange Commission, including Rule 10b-18. The Company has made no commitment to purchase any shares and purchases may be discontinued at any time.  Reacquired shares will be held in treasury until redeployed or retired.

“This repurchase program demonstrates our commitment to enhancing value for the shareholders of Progenics and underscores the Board’s belief that Progenics’ stock represents an attractive opportunity,” said Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer, Progenics Pharmaceuticals, Inc.
 

 

 
About the Company
 
Progenics Pharmaceuticals, Inc., of Tarrytown, NY, is a biopharmaceutical company focusing on the development and commercialization of innovative therapeutic products to treat the unmet medical needs of patients with debilitating conditions and life-threatening diseases. Principal programs are directed toward gastroenterology as well as the treatment of HIV infection and cancer. The Company, in collaboration with Wyeth, is developing RELISTOR for the treatment of opioid-induced side effects, including constipation (oral and subcutaneous formulations) and postoperative ileus (intravenous formulation).  In the area of HIV infection, the Company is developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody targeting the HIV entry co-receptor CCR5, which has completed phase 1b clinical studies with positive results. In the area of prostate cancer, the Company is developing a human monoclonal antibody drug conjugate – a selectively targeted cytotoxic antibody directed against prostate-specific membrane antigen (PSMA), a protein found on the surface of prostate cancer cells. Progenics is also developing vaccines designed to stimulate an immune response to PSMA.
 
DISCLOSURE NOTICE: The information contained in this document is current as of April 24, 2008. 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, it is identifying forward-looking statements. Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the Company's actual results, performance or achievements, or industry results, to be materially different from any expected future results, performance or achievements expressed or implied by forward-looking statements. Such factors include, among others, the risks associated with our dependence on Wyeth to fund and to conduct clinical testing, to make certain regulatory filings and to manufacture and market products containing methylnaltrexone, the uncertainties associated with product development, the risk that clinical trials will not commence, proceed or be completed as planned, the risk that our product candidates will not receive marketing approval from regulators, the risks and uncertainties associated with dependence upon the actions of our corporate, academic and other collaborators and of government regulatory agencies, the risk that our licenses to intellectual property may be terminated because of our failure to have satisfied performance milestones, the risk that product candidates that appear promising in early clinical trials are later found not to work effectively or are not safe, the risk that we may not be able to manufacture commercial quantities of our products, the risk that our products, if approved for marketing, do not gain sufficient market acceptance to justify development and commercialization costs, the risk that we will not be able to obtain funding necessary to conduct our operations, 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, 2007, and other reports filed with the Securities and Exchange Commission, to which investors are referred for further information. In particular, the Company cannot assure you that any of its programs will result in a successful commercial product. Progenics does not have a policy of updating or revising forward-looking statements and assumes no obligation to update any forward-looking statements contained in this document as a result of new information or future events or developments. 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.


Editor's Note:
Additional information on Progenics is available at http://www.progenics.com

 
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