0000835887-14-000014.txt : 20140130 0000835887-14-000014.hdr.sgml : 20140130 20140130163606 ACCESSION NUMBER: 0000835887-14-000014 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20140130 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140130 DATE AS OF CHANGE: 20140130 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: 14561187 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_k30jan2014.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) January 30, 2014
 
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 presented a poster reporting data from the company's phase 2 trial of  its PSMA ADC antibody-drug conjugate product candidate at the American Society of Clinical Oncology's 2014 Genitourinary Cancers Symposium in San Francisco.  The trial assessed the anti-tumor activity and tolerability of the compound in patients with metastatic castrate resistant prostate cancer. Enrollment of an additional trial cohort of chemotherapy naïve patients who have progressed on hormonal therapies is ongoing.

Progenics also presented at ASCO GU a poster reporting interim data from the company's phase 2 study of its PSMA targeted imaging agent candidate, 1404, to identify and localize prostate cancer in high-risk patients undergoing radical prostatectomy and extended pelvic lymph node dissection compared to histopathology.

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

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: January 30, 2014


EX-99.2 2 ex99_230jan2014.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


PROGENICS 1404 IMAGING AGENT SHOWS HIGH ACCURACY IN
 DETECTING CANCER WITHIN THE PROSTATE GLAND IN INTERIM
 ANALYSIS OF PHASE 2 STUDY
 
1404 more accurate than MRI in detecting primary prostate cancer in this study

Tarrytown, NY, San Francisco, CA, January 30, 2014 – 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 2 study of its PSMA targeted imaging agent, 1404, entitled A Phase 2 Study of 99mTc-Trofolostat (MIP-1404) SPECT/CT to Identify and Localize Prostate Cancer in High-risk Patients Undergoing Radical Prostatectomy (RP) and Extended Pelvic Lymph Node Dissection (ePLND) Compared to Histopathology: An Interim Analysis, were presented today at the meeting of the American Society of Clinical Oncology's Genitourinary Cancers Symposium
"In this study, our imaging agent, 1404, showed 94% sensitivity and 100% specificity in detecting and imaging cancer in the prostate gland," said Hagop Youssoufian, Executive Vice President, Research and Development. "From this data we can foresee how 1404 might significantly alter the clinical course of a patient's treatment. For example, four men in our phase 2 trial might have avoided a prostatectomy and its inevitable life-changing side effects if our drug had been available to them as a diagnostic prior to that surgery. While this study tested 1404 in men undergoing prostatectomy, we believe it may have utility at other points in the treatment plan as well."
"Today's results demonstrate the potential of our PSMA targeted imaging agent, 1404, to change the course of clinical care in prostate cancer," said Mark R. Baker, CEO of Progenics. "Our imaging agent, which showed a high degree of accuracy, was tested against the gold standard of the histopathology of the patient's prostate gland and lymph nodes following surgery. In its first large scale use, 1404 showed an increased sensitivity and specificity in the detection and imaging of prostate cancer over MRI."


Page 2

A discussion with CEO Mark Baker and Senior Management of these findings will be webcast at 7:00 PM PST/10 PM EST on Thursday, January 30. The live webcast will be available in the Events section of the Progenics website, www.progenics.com. To ensure a timely connection, users should register at least 15 minutes prior to the scheduled start. An archive of the event will be available for 90 days.
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 distinct proteins by diseased 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, 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.
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.

Contact:
 
Kathleen Fredriksen
Corporate Development
(914) 789-2871
kfredriksen@progenics.com
 
(PGNX-C)
Editors Note:
For more information, please visit www.progenics.com.

EX-99.1 3 ex99_130jan2014.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


PROGENICS PHARMACEUTICALS PRESENTS POSITIVE DATA FROM A
 PHASE 2 TRIAL OF PSMA ADC IN PATIENTS WITH CHEMOTHERAPY
 EXPERIENCED METASTATIC CASTRATE RESISTANT PROSTATE CANCER

Discussion with Senior Management to be webcast from ASCO GU on January 30th
7 PM PST/10 PM EST
Tarrytown, NY, San Francisco, CA, January 30, 2014 – Progenics Pharmaceuticals, Inc., (NASDAQ: PGNX), an oncology company focused on developing innovative approaches to targeting and treating prostate cancer, today presented a poster entitled A Phase 2 trial of Prostate Specific Membrane Antigen Antibody Drug Conjugate (PSMA ADC) in Taxane-Refractory Metastatic Castration Resistant Prostate Cancer (mCRPC) at the American Society of Clinical Oncology's 2014 Genitourinary Cancers Symposium in San Francisco, CA. The Phase 2 trial assessed the anti-tumor activity and tolerability of its antibody drug conjugate, PSMA ADC, in patients with metastatic castrate resistant prostate cancer. A total of 83 patients who had progressive disease despite treatment with at least one taxane containing chemotherapy received PSMA ADC. Enrollment of a chemotherapy naïve cohort is ongoing.
"We are encouraged by the tolerability and clear activity of PSMA ADC in this heavily pre-treated population," said HagopYoussoufian, M.D., Executive Vice President, Research and Development. "For example, reductions in CTC's of more than 50% were seen in over 70% of patients treated."
Dr Youssoufian also said, "we look forward to the upcoming data in the less clinically advanced chemo naïve setting, where our ADC technology may provide an even greater clinical benefit to men with prostate cancer."
"I've been encouraged by the response seen to date in our patients," said Daniel Petrylak, M.D., Professor of Medical Oncology at Yale Cancer Center, Clinical Research Program Leader for the Prostate and Urologic Cancers Program at Smilow Cancer Hospital at Yale-New Haven, and lead investigator on the trial. "I believe that the 2.3 mg/kg dose has been well tolerated," added Dr. Petrylak.

Page 2
"We have long held the belief that PSMA expression would correlate with response, and were pleased to see that correlation in this trial. I was also pleased that another biomarker that measures low neuroendocrine disease also correlates and offers the ability to identify responders in this trial through the use of a simple blood test," said Mark R. Baker, CEO of Progenics.

An additional PSMA ADC related poster is being presented by EPIC Sciences entitled "Expression of Prostate-specific Membrane Antigen (PSMA) on Circulating Tumor Cells (CTC's) in Castration-resistant Prostate Cancer." The poster presentation is scheduled for Friday, January 31, at 11:30 AM PST.
 
A discussion with CEO Mark Baker and Senior Management of these findings will be webcast at 7:00 PM PST/10 PM EST on Thursday, January 30. . The live webcast will be available in the Events section of the Progenics website, www.progenics.com. To ensure a timely connection, users should register at least 15 minutes prior to the scheduled start. An archive of the event will be available for 90 days.
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.

Page 3

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.
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.

Contact:
 
Kathleen Fredriksen
Corporate Development
(914) 789-2871
kfredriksen@progenics.com
(PGNX-C)
Editors Note:
For more information, please visit www.progenics.com.

GRAPHIC 4 image0.jpg begin 644 image0.jpg M_]C_X``02D9)1@`!`0$`8`!@``#_VP!#``@&!@<&!0@'!P<)"0@*#!0-#`L+ M#!D2$P\4'1H?'AT:'!P@)"XG("(L(QP<*#7J#A(6&AXB)BI*3E)66EYB9FJ*CI*6FIZBIJK*SM+6VM[BYNL+#Q,7& MQ\C)RM+3U-76U]C9VN'BX^3EYN?HZ>KQ\O/T]?;W^/GZ_\0`'P$``P$!`0$! M`0$!`0````````$"`P0%!@<("0H+_\0`M1$``@$"!`0#!`<%!`0``0)W``$" M`Q$$!2$Q!A)!40=A<1,B,H$(%$*1H;'!"2,S4O`58G+1"A8D-.$E\1<8&1HF M)R@I*C4V-S@Y.D-$149'2$E*4U155E=865IC9&5F9VAI:G-T=79W>'EZ@H.$ MA8:'B(F*DI.4E9:7F)F:HJ.DI::GJ*FJLK.TM;:WN+FZPL/$Q<;'R,G*TM/4 MU=;7V-G:XN/DY>;GZ.GJ\O/T]?;W^/GZ_]H`#`,!``(1`Q$`/P#KO&_AZ/P_ MH:WEG>W>\RK'M=@P.?PJ3PSX3_MSP[:W\FK7<3RJ250*5'/TK4^*I_XI)?\` MKX2M+X?8_P"$(T[_`'#_`#-^`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`HJ.#2 MY@P"Q$92E0BGHT[VVZGP%'.C6>$JP<4U>^UK._P!QJ$9[4?A7%GQAK+V;7\7ABX-F%WAF ME`8KZX^E;NC>(;?6-(MM0CBDC6920C6C3_(Y[XJ_\ MBFO_`%\)67X4T#6[WPQ:3VOB2XM('4[840';SZUI?%*5#X555=2_VA.-P_E6 MC\/Y(QX,TY?,3=L/R[ADG&I.GE<7%?;>ZOT\RM8?#RR2]6]U6 M[N-4N%Y!G;Y?RKLE554*H``&`!VI:0D*,D@"MXQ45H>35KU*SO-W/'M5TZ+5 MOBW)8SLXAE<;]AP2`F<5ZG!HVFV[0-%8VZ/`,1LJ`%1[5YLSH/C4'W)LW8SD M8_U?K7JRE6^92"#W!S6-%*\O4]',YS4:*ZGR MC)_6O71@=*\>\5P3^&?B)!K+HWV6259%<#CD88?7K7K5G=V][:IX\TC>E0G#X.7\>IY-XYA.B>/[*_M/W;SE)3CUS@_G6E\7)IVL=, M"Y$#EF(]6QP#5?Q+'_PEOQ%L[&Q(EBLU`GD7[JC.3S^E=%\1+_3;70TL+NV$ M\URP2!2<;#TW$]@*S<=)]COA5Y:N%O'FDEJO+I^&IT/AWR1X5Y"8Q] M.?US7F/AT-'\6IEL_P#4^;*'"]-N.?UKHM,\)>*-/TV.RM/$<26K)D@Q;BA/ M7:?2MWPSX/L_#:22([W%W+_K+B0E:.,I\MU:QQQK4<-&LU/FM2G^]DF[%U8Q_ MLZE*,.9*]]]'\CAUMM4NOB/!J]MI%Y;6[RJ6\Q,8&,-FN\\(Q%'FC:UDM]D_,S/A8JCP@&V@,9WR<T\--&"($X+CTK@/&TL;_$ M71F1U908\D$8'/?>FN)&+N>IP<5L^,=+;6_"MY;6Y#2E=\>#G)7G%<;\-/$UM:VLN MBW\HMY$D+1&4XZ]5/N*6U/9J[4DWWM_D=]KVB6_B#2GL;AV2 M-V#;DZ@@UR?Q-T2\OM%LY+-'E6T8[XTZD8`SCOC%=C=ZOIUC;F>YO8(HU&23 M(*RM<\3KI4^CF-(Y+:_EV-(3C:I'!'YU=11::>AS8*I7IU82@KV;:3VVU_`Y MG0OB1IMQ8II^LQ/;.(_):4#*'C&3W%=EHNDZ=9Z1;P6,K2VR@F-]^<@DGK^- M9/B[PSHMYI%W>SP0P3QQEUN$^4Y`XSZUYOHL?B%M(MVL3-]F()3:2!U.G3PM#&TW4H2]GKJGM?R9Z?)X`\/38,EH[]/O2L?YT^W\"Z#:3)- M!;2(\;!EQ*W!^E=)171[./8\9XS$-6186R1)U)'+,?<]ZXCXF?V?? MR66FH))-79@+=(^P/9O:O1\5Y=XGT[5-&\=Q^(XK26[LP59O+7<5`&"*SJKW M;)'=EDG+$NI*7O)-K7=]%<9%\,=<,:EM>\ML?<#/\OMUK)U6T\5>!)X;G^TV MEA=L!@Y9">ZD'UKT*'Q]H$L09IYHF(_U;PL&'MTKG]?DOO'TEOI^F6,\.G)( M&EN[B,H#[`'DUDZ<.7W-ST:&,Q3J*6GD=4^NV,GAJWU*_A8VUS&N M]-FX`MQ@CZUR>H>'/!N^YN&M[VWD@`>6"(E&"G^(#T]Q6]XKM$T_P2+*`D+$ MT*(<9/##FHM?TEDT?4M4N+@373V@ACVKA57.<#UK22OI)7//P\O9VE3DXJ4F MM'Z?YFKHWA;1='`GLK-1*P!\V3YG/ODT:EX3T?6+MKF]@>21@`?WA`('MTK% MFN9-(O+J-M1O'M38)*#-%TJ[CNK.W:.6,Y7]X61R9>_!!'%4K*\N[>'1;V;4K MIOM4T51W?KY_P"3-7_A7_AT#'V1P/:5O\:0 M_#SPV3DV;$^ID)-89UV^A6\>TFN)$-DDR&1][#+`,^!T..2.U:6IW$EE#:-9 M:E-/:W,R)/(TNX1#!.YM#',>LD+;"Q]_6L])M0L-2TH7>IM);27$J%@^4V;,J M&;N0:J03SW;Z2\]]<;5U"XC,OF[?E^;:"?7&,4W*+5FC*G"M"?M(S:?=7\_\ MC0T;P;X:@NYC':S7$UL^TFZ)<`XS\N>#6WK'A_3==MXX+^WWK$X2T7[/!J5Y*SQRS1;9@%& M`/X^^#T%"<;6L5*.(G.,W)WZ;E>+P?X?76QI:[>" M"*WA2&*-4C0855&`!7"&[NKJXL[E;M(KMM(_US#(#[N].CUR6V3R;A-869"0 9X@(E3.?X6[BE%Q6Q5:A6JM*4KO\`X<__V3\_ ` end