0000835887-13-000121.txt : 20131209 0000835887-13-000121.hdr.sgml : 20131209 20131206173116 ACCESSION NUMBER: 0000835887-13-000121 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20131206 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20131209 DATE AS OF CHANGE: 20131206 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: 131264044 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_k6dec2013.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) December 6, 2013
 
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 that it has completed enrollment of chemotherapy experienced patients in its Phase II trial to assess the anti-tumor activity and tolerability of its antibody drug conjugate candidate, PSMA ADC, in patients with metastatic castrate resistant prostate cancer.  The company has also initiated treatment in an additional trial cohort, now enrolling, of chemotherapy naive patients who have progressed on hormonal therapies.

Progenics separately announced that findings from a Phase I study of its Molecular Insight subsidiary's imaging agent candidate, 1404, were presented today at the 14th Annual Meeting of the Society of Urologic Oncology being held in Rockville, Maryland.

Copies of the company's press releases are included in this Report as Exhibits 99.1 and 2, 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

 
 






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: December 6, 2013


EX-99.1 2 ex99_16dec2013.htm EXHIBIT 99.1
EXHIBIT 99.1
 
 
Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591
 914-789-2800
www.progenics.com


Contact:
 
Kathleen Fredriksen
Corporate Development
(914) 789-2871
kfredriksen@progenics.com


PROGENICS PHARMACEUTICALS ANNOUNCES COMPLETION OF
ENROLLMENT OF CHEMOTHERAPY EXPERIENCED COHORT IN PHASE
II PSMA ADC CLINICAL TRIAL IN PROSTATE CANCER

 – Top-line Data in Chemotherapy Experienced Patients to be presented at Oncology Meeting in January 2014
– Additional Cohort in Chemotherapy Naive Patients has been added to the Trial
Tarrytown, NY, December 6, 2013 – Progenics Pharmaceuticals, Inc., (NASDAQ: PGNX) an oncology company focused on developing innovative approaches to targeting and treating prostate cancer, today announced that it has completed enrollment of chemotherapy experienced patients in a Phase II trial to assess the anti-tumor activity and tolerability of its antibody drug conjugate, PSMA ADC in patients with metastatic castrate resistant prostate cancer (mCRPC).  A total of 83 patients who had progressive disease despite treatment with at least one taxane containing chemotherapy received PSMA ADC.
Based on the observations following treatment of the patients in the chemotherapy experienced cohort, Progenics has initiated treatment of a cohort of chemotherapy naive patients who have progressed on hormonal therapies.  This cohort is now enrolling.  Progenics expects that an additional 35 patients will be included in this chemotherapy naïve group.
"PSMA ADC is the most advanced antibody drug conjugate in clinical development to treat prostate cancer," said Robert J. Israel, M.D., Executive Vice President, Medical Affairs.  "Based on the data seen with PSMA ADC in chemotherapy experienced patients, we have decided to explore whether this compound can also benefit men in the less clinically advanced chemotherapy naïve setting."
Topline data on the chemotherapy experienced cohort of the Phase II PSMA ADC trial will be presented at the American Society of Clinical Oncology's 2014 Genitourinary Cancers Symposium Meeting in San Francisco in January 2014.


Page 2
About PSMA ADC
Prostate Specific Membrane Antigen, PSMA, a protein that is a validated biomarker of prostate cancer, is expressed on the surface of prostate cancer cells as well as on blood vessels supplying other solid tumors.  PSMA ADC comprises a fully human monoclonal antibody selectively targeting PSMA linked to a chemotherapeutic drug.  Using technology licensed from Seattle Genetics, Inc., the PSMA antibody is linked to monomethyl auristatin E, a compound that inhibits cell proliferation by disrupting the cellular "backbone" (i.e. microtubules) required for replication.  The resultant antibody-drug conjugate attaches to the PSMA protein on the surface of prostate cancer cells and is designed to internalize into the cancer cell, release active anti-cancer drug, and destroy the malignant cell.
Unlike traditional chemotherapy, PSMA ADC is designed to deliver the drug selectively to prostate cancer cells by targeting PSMA.
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in six will be diagnosed with prostate cancer in his lifetime.  The American Cancer Society estimates that approximately 240,000 new cases of prostate cancer will be diagnosed and about 30,000 men will die of the disease this year, and that approximately 2 million men in the U.S. currently count themselves among prostate cancer survivors.
About Progenics
Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in late-stage clinical development. Progenics' first-in-class PSMA targeted technology platform includes an antibody drug conjugate therapeutic and a small molecule targeted imaging agent, both completing phase 2 clinical trials. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra, an ultra-orphan radiotherapy candidate in a registrational phase 2 study under an SPA with the FDA. Progenics' first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. Ono Pharmaceutical Co. has licensed subcutaneous Relistor in Japan. For additional information, please visit www.progenics.com.

Page 3
This press release may contain projections and other forward-looking statements regarding future events. 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 results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible 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 does not undertake any obligation to update or revise it, 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.
Information on or accessed through our website is not included in the company's SEC filings.
(PGNX-C)
Editors Note:
For more information, please visit www.progenics.com.
EX-99.2 3 ex99_26dec2013.htm EXHIBIT 99.2
EXHIBIT 99.2
 
 
Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591
914-789-2800
www.progenics.com


Contact:
 
Kathleen Fredriksen
Corporate Development
(914) 789-2871
kfredriksen@progenics.com


PROGENICS PHARMACEUTICALS ANNOUNCES THAT DATA FROM A
PHASE I STUDY OF ITS 1404 IMAGING AGENT HAS BEEN PRESENTED AT
THE SOCIETY FOR UROLOGIC ONCOLOGY MEETING

– Progenics' Imaging Agent Correctly Identified the Presence of Primary Prostate Cancer in 100% of Phase I Study Subjects
 – Progenics Also Announces that Topline Data from a Recently Completed Phase II Trial of 1404 will be presented at ASCO GU in January 2014

Tarrytown, NY, December 6, 2013 – Progenics Pharmaceuticals, Inc. (NASDAQ: PGNX) an oncology company focused on the development of innovative approaches to targeting and treating prostate cancer, announced that findings from a Phase I study of its Imaging Agent, 1404, were presented today at the meeting of the Society for Urologic Oncology in Rockville, Maryland.
The poster, entitled A Phase I Study of TC-99-M-MIP-1404 SPECT/CT to Identify and Localize High Grade Cancer in the Prostate Gland, was presented by Kevin Slawin, M.D., Director, Vanguard Urologic Institute, Memorial Hermann-TMC. "In this study, the presence of primary prostate cancer was correctly identified in eight of eight patients by SPECT/CT imaging with 1404," said Dr. Slawin. "An imaging agent with this high degree of accuracy has the potential to allow doctors and their patients to focus on the treatment of aggressive cancers while more conservatively managing low grade cancers."
"The successful development of an initial and ongoing treatment plan for the management of prostate cancer is often handicapped by the inability to accurately assess the presence, location, grade and extent of the disease," said Hagop Youssoufian, M.Sc., M.D., Executive Vice President, Research & Development at Progenics. "Accurate diagnosis and staging is imperative to avoid overtreatment of indolent disease, with its potential life changing side effects, including incontinence and impotence, and the underestimation of aggressive disease.  In this Phase I trial our imaging agent identified primary prostate cancer with a high degree of accuracy and, in addition, may have the ability to discriminate high grade prostate cancer from moderate and low grade disease.  We believe this is the kind of information men suffering from prostate cancer and their doctors need in order to best manage their disease."

Page 2
About 1404, an Imaging Compound targeting Prostate Specific Membrane Antigen
1404 is a developmental stage radiopharmaceutical imaging agent that is designed to highlight the expression of a distinct protein by cancerous cells.  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 six will be diagnosed with prostate cancer in his lifetime.  The American Cancer Society estimates that approximately 240,000 new cases of prostate cancer will be diagnosed and about 30,000 men will die of the disease this year.  Approximately 2 million men in the U.S. currently count themselves among prostate cancer survivors.
About Progenics
Progenics Pharmaceuticals, Inc. is developing innovative medicines for oncology, with a pipeline that includes several product candidates in late-stage clinical development. Progenics' first-in-class PSMA targeted technology platform includes an antibody drug conjugate therapeutic and a small molecule targeted imaging agent, both completing phase 2 clinical trials. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra, an ultra-orphan radiotherapy candidate also in a registrational phase 2 study under a SPA with the FDA. Progenics' first commercial product, Relistor® (methylnaltrexone bromide) for opioid-induced constipation, is partnered with and marketed by Salix Pharmaceuticals, Inc. Ono Pharmaceutical Co. has licensed subcutaneous Relistor in Japan. For additional information, please visit www.progenics.com.
This press release may contain projections and other forward-looking statements regarding future events. 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 results of clinical trials and other development activities; the unpredictability of the duration and results of regulatory review of New Drug Applications and Investigational NDAs; market acceptance for approved products; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; and possible 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 does not undertake any obligation to update or revise it, whether as a result of new information, future events or circumstances or otherwise.


Page 3
Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this release.
Information on or accessed through our website is not included in the company's SEC filings.
(PGNX-C)
Editors Note:
For more information, please visit www.progenics.com.
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