-----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, ElLSAgLZxBujizCcihf5ddFMVkGc89lalrVqLr1W/6Y8stCuwwfC390Q/Jnw0Web H5EfX+60t/LjFQRCG4vsrA== 0000835887-10-000052.txt : 20101006 0000835887-10-000052.hdr.sgml : 20101006 20101006105735 ACCESSION NUMBER: 0000835887-10-000052 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20101006 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101006 DATE AS OF CHANGE: 20101006 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: 101111045 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 form8_koct62010.htm PROGENICS FORM 8-K OCT 6, 2010 form8_koct62010.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 6, 2010
 
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))
 
 
 

 

Item 8.01.  Other Events.

Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) today announced the award of a $4.1 million grant from the U.S. National Institutes of Health for the company’s program to develop novel monoclonal antibodies to treat Clostridium difficile infection.

A copy of Progenics’ press release is included in this Report as Exhibit 99.1 and the information contained therein is incorporated into this Item 8.01 by this reference.
 
Item 9.01.  Financial Statements and Exhibits.
 
(d) Exhibits
  
Exhibit No.     Description
 
99.1  
 Press Release dated October 6, 2010.
 
 




 
 

 

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/ ROBERT A. MCKINNEY                            
Robert A. McKinney
Chief Financial Officer, Senior Vice President,
Finance & Operations and Treasurer
 
 
 
Date:  October 6, 2010




EX-99.1 2 ex99_1oct62010.htm PROGENICS EXHIBIT 99.1 OCT 6, 2010 ex99_1oct62010.htm

Progenics logo



Contact:
 
Investors:
 
Dory A. Kurowski
Director, Corporate Affairs
(914) 789-2818
dkurowski@progenics.com
 
 
Media:
 
Aline Schimmel
Scienta Communications
(312) 238-8957
aschimmel@scientapr.com

Progenics Awarded $4.1 Million NIH Grant to Advance Novel C. Difficile Antibody Therapy

Tarrytown, NY -- October 6, 2010 -- Progenics Pharmaceuticals, Inc. (Nasdaq: PGNX) today announced the award of a grant totaling $4,143,652 from the National Institutes of Health (NIH) for Progenics’ program to develop novel monoclonal antibodies to treat Clostridium difficile (C. difficile) infection.  C. difficile is a bacterium that represents the leading cause of hospital-acquired diarrhea in the United States and a serious global public health challenge.  Progenics’ monoclonal antibodies constitute a non-antibiotic treatment strategy that is designed to block the harmful effects of the disease-causing toxins produced by C. difficile.

“We are honored to receive this competitive NIH award and are gratified that NIH elected to support our program based on its scientific merit, innovation and therapeutic potential,” said Paul J. Maddon, M.D., Ph.D., Founder, Chief Executive Officer and Chief Science Officer of Progenics Pharmaceuticals, Inc.  “The award acknowledges the growing burden of C. difficile infection and the need for innovative therapies that go beyond standard antibiotic approaches.”

About the NIH Grant

The three-year award supports research and preclinical development of Progenics’ humanized monoclonal antibodies against C. difficile toxins.  The award was made under the American Recovery & Reinvestment Act of 2009 through the “NIH Director’s Opportunity for Research in Five Thematic Areas” program.  NIH established this program to support projects that address research endeavors that have high short-term impact, and a high likelihood of enabling growth and investment in biomedical research and development, public health, and health care delivery.

About Clostridium difficile

C. difficile is an anaerobic, spore-forming bacterium that represents the leading cause of hospital-acquired diarrhea and life-threatening pseudomembranous colitis. C. difficile-associated disease (CDAD) affects an estimated 750,000 individuals each year in the U.S. and is responsible for more deaths than all other intestinal infections combined. Recent outbreaks of hypervirulent strains have been reported globally, significantly increasing the economic burden of CDAD and requiring new treatment strategies to combat this worldwide public health challenge. Upon infection, C. difficile produces two protein toxins (toxin s A and B) that can damage the cells that line the colon, leading to CDAD. CDAD encompasses a spectrum of diseases ranging from mild-to-severe diarrhea to potentially life-threatening complications such as toxic megacolon and sepsis. CDAD often occurs when an individual is exposed to C. difficile while taking antibiotics, since a course of antibiotic treatment can disrupt the normal (beneficial) intestinal bacteria, providing opportunities for C. difficile to become established. Current treatments for CDAD consist of narrow-spectrum antibiotics, such as vancomycin or metronidazole that may impede regrowth of the normal colonic bacteria. Although current therapies are generally effective in treating CDAD, the disease frequently relapses after antibiotic treatment ceases.

 
 

 
About Progenics’ C. difficile antibodies

Progenics' humanized monoclonal antibodies are designed to block the cytotoxic effects of C. difficile toxins and enable the normal bacteria in the colon to become reestablished.  In laboratory studies, the humanized monoclonal antibodies potently neutralized the cell-killing activities of the toxins produced by both conventional and hypervirulent strains of C. difficile.  In a preclinical efficacy study conducted in a stringent hamster model of CDAD, treatment with a combination of humanized monoclonal antibodies (one against toxin A and the other against toxin B) provided a highly statistically significant (P<0.0001) survival advantage rela tive both to no treatment and to treatment with vancomycin, a current standard antibiotic therapy.

(PGNX-G)

About Progenics
 
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 supportive care, oncology and infectious diseases. Progenics is developing RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced constipation. RELISTOR is now approved in over 50 countries, including the U.S., E.U., Canada, Australia and Brazil. Progenics is pursuing strategic alternatives for RELISTOR, including licensing, collaboration, strategic alliances and U.S. commercialization or co-promotion, following termination of its 2005 collaboration with Wyeth, now part of Pfizer Inc., which is continuing manufacturing, sales, marketing, clinical, and certain development and regulatory activities for RELISTOR during the transition. Ono Pharmaceutical Co., Ltd. has an exclusive license from Progenics for development and commercialization of subcutaneous RELISTOR in Japan. In oncology, the Company is conducting a phase 1 clinical trial of PSMA ADC, a human monoclonal antibody-drug conjugate for the treatment of prostate cancer. PSMA is a protein found on the surface of prostate cancer cells as well as in blood vessels supplying other solid tumors. In virology, Progenics is also developing the viral-entry inhibitor PRO 140, a humanized monoclonal antibody which binds to co-receptor CCR5 to inhibit human immunodeficiency virus (HIV) infection. PRO 140 is currently in phase 2 clinical testing. In e arly development, Progenics is evaluating novel antibodies to toxins produced by the bacteria C. difficile, as well as single-agent multiplex PI3-Kinase inhibitors as a potential strategy to combat some of the most aggressive forms of cancer, and is also seeking to identify novel entry-inhibitors of HCV infection.
 
 
PROGENICS DISCLOSURE NOTICE: 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 in herent 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; competing products currently on the market or in development might reduce the commercial potential of our products; 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 o rganizations 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; potential product liability; intellectual property, litigation, environmental and other risks; the risk that we may not be able to enter into favorable collaboration or other relationships or that existing or future relationships may not proceed as planned; the risk that current and pending patent protection for our products may be invalid, unenforceable or challenged, or fail to provide adequate market exclusivity, or that our rights to in-licensed intellectual property may be terminated for our failure to satisfy performance milestones; the risk of difficulties in, and regulatory c ompliance 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 our Annual Report on Form 10-K and other reports filed with the U.S. Securities and Exchange Commission. 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 ou r 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.

Editors Note:
 
For more information, please visit www.progenics.com.
 



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-----END PRIVACY-ENHANCED MESSAGE-----