0000835887-15-000093.txt : 20151013 0000835887-15-000093.hdr.sgml : 20151012 20151013164610 ACCESSION NUMBER: 0000835887-15-000093 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20151012 ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20151013 DATE AS OF CHANGE: 20151013 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: 151156478 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_k12oct2015.htm FORM 8-K
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 12, 2015
 
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 7.01.
Regulation FD Disclosure.
 
Progenics Pharmaceuticals, Inc., ("Progenics") yesterday issued a press release announcing the presentation of additional data from a Phase 2 trial of its PSMA-targeted imaging agent candidate, 1404, at the 28th Annual European Association of Nuclear Medicine (EANM) Congress being held in Hamburg, Germany. 1404 is a prostate specific membrane antigen (PSMA) targeted small molecule labeled with technetium-99m designed to "visualize" prostate cancer.
 
A copy of Progenics' press release is included in this Report as Exhibit 99.1.
 
The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Exchange Act of 1934, as amended (the "Exchange Act"), or as otherwise subject to liability of that section, nor shall such information be deemed to be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933, as amended or the Exchange Act.
 
  
Item 9.01.
Financial Statements and Exhibits.
 
(d) Exhibits
 
Exhibit No.
Description
 
 


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/ ANGELO W. LOVALLO, JR.
   
Angelo W. Lovallo, Jr.
   
Vice President - Finance & Treasurer
   
(Principal Financial and Accounting Officer)

 
 
Date: October 13, 2015


EX-99.1 2 ex99_112oct2015.htm EXHIBIT 99.1
Exhibit 99.1

 
 
Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
Fax: (914) 789-2817
(914) 789-2800
www.progenics.com
 
Data from Phase 2 Study of Progenics' 1404 Imaging Agent Presented
at EANM Congress 2015

- Uptake Associated with Gleason Score Upgrade/Downgrade Following Radical Prostatectomy -

Tarrytown, N.Y., October 12, 2015 – Progenics Pharmaceuticals, Inc., (Nasdaq: PGNX) today announced the presentation of additional data from a Phase 2 trial of its PSMA-targeted imaging agent candidate, 1404, at the 28th Annual European Association of Nuclear Medicine (EANM) Congress being held in Hamburg, Germany. 1404 is a prostate specific membrane antigen (PSMA) targeted small molecule labeled with technetium-99m designed to "visualize" prostate cancer.

Results from the Phase 2 trial in high-risk patients undergoing radical prostatectomy were presented by Professor Karolien Goffin, M.D., Ph.D., University Hospitals Leuven, and included previously reported sensitivity and accuracy data for 1404 and data related to the uptake of 1404 in the lobes of the prostate gland. New data presented at the meeting demonstrate that 1404 uptake in the prostate gland is significantly higher in prostate cancer patients with upgraded Gleason scores at radical prostatectomy from those who are downgraded at radical prostatectomy.

"The data presented demonstrate the potential of 1404 to better assess the stage and extent of a patient's prostate cancer versus biopsy, as confirmed by comparison with histopathology, the truth standard, obtained from radical prostatectomy," stated Dr. Goffin.

In the Phase 2 study, 31% (25/81) of evaluable patients had their biopsy Gleason score upgraded to >7 or downgraded to 7 by histopathologic assessment of the prostatectomy specimen. Of patients upgraded to a Gleason score >7, 79% (11/14) demonstrated high lesion uptake of 1404 with a mean tumor to background ratio (TBR) of 47:1. Of patients downgraded to Gleason score 7, 91% (10/11) had significantly (p<0.001) lower lesion uptake of 1404 with a mean TBR of 16:1.

About 1404, an Imaging Compound Targeting Prostate Specific Membrane Antigen

Progenics' molecular imaging radiopharmaceutical product candidate 1404 targets the extracellular domain of prostate specific membrane antigen (PSMA), a protein amplified on the surface of > 95% of prostate cancer cells and a validated target for the detection of primary and metastatic prostate cancer. 1404 is labeled with technetium-99m, a gamma-emitting isotope that is widely available, is easy to prepare, and is attractive for nuclear medicine imaging applications. The image created provides the opportunity to visualize cancer, potentially allowing for improved detection and staging, more precise biopsies, and a targeted treatment plan including active surveillance as a disease management tool.

About Prostate Cancer

Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in seven men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 220,800 new cases of prostate cancer will be diagnosed and about 27,540 men will die of the disease, and that approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.
 

Page 2
About Progenics
Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in later-stage clinical development. Progenics' first-in-class PSMA-targeted technology platform for prostate cancer includes a small molecule imaging agent that has completed a phase 2 trial and an antibody drug conjugate therapeutic which has also completed a two-cohort phase 2 clinical trial. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is AZEDRA, an ultra-orphan radiotherapy candidate currently in a phase 2 study under an SPA. Progenics' first commercial product, RELISTOR® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Valeant Pharmaceuticals International, Inc. For additional information, please visit www.progenics.com.
This press release may contain projections and other "forward-looking statements" regarding future events. Statements contained in this communication that refer to Progenics' estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics' current perspective of existing trends and information as of the date of this communication. Forward looking statements generally will be accompanied by words such as "anticipate," "believe," "plan," "could," "should," "estimate," "expect," "forecast," "outlook," "guidance," "intend," "may," "might," "will," "possible," "potential," "predict," "project," or other similar words, phrases or expressions. Such statements are predictions only, and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others, the cost, timing and unpredictability of results of clinical trials and other development activities and collaborations, such as the Phase 3 clinical program for 1404; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; the sales of products by our partners and the royalty revenue generated thereby; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; possible product safety or efficacy concerns, general business, financial and accounting matters, litigation and other risks. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the U.S. Securities and Exchange Commission. Progenics is providing the information in this press release as of its date and, except as expressly required by law, Progenics' disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release. For more information, please visit www.progenics.com. Please follow us on LinkedIn®.
Information on or accessed through our website or social media sites is not included in the company's SEC filings.

 
(PGNX-F)
Progenics Contact:
Melissa Downs
Investor Relations
(914) 789-2801
mdowns@progenics.com
 
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