0000835887-14-000039.txt : 20140424 0000835887-14-000039.hdr.sgml : 20140424 20140424144831 ACCESSION NUMBER: 0000835887-14-000039 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20140424 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20140424 DATE AS OF CHANGE: 20140424 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: 14781397 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_k04242014.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) April 24, 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 announced completion of enrollment in a cohort of chemotherapy-naïve patients who have progressed on hormonal therapies in the company's phase 2 trial to assess anti-tumor activity and tolerability of its antibody drug conjugate candidate, PSMA ADC, in patients with metastatic castration-resistant prostate cancer.   A copy of its release is included in this Report as Exhibit 99.1.

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: April 24, 2014


EX-99.1 2 ex99_104242014.htm EXHIBIT 99.1

Exhibit 99.1

Progenics Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, New York 10591
(914) 789-2800
www.progenics.com
 

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

Progenics Pharmaceuticals Announces the Completion of Enrollment
of Chemotherapy Naive Cohort in Phase II Trial of PSMA ADC

TARRYTOWN, N.Y., April 24, 2014 - Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) an oncology company focused on the development of innovative approaches to targeting and treating prostate cancer, announced today the completion of enrollment in the chemotherapy naïve cohort in its Phase II trial of PSMA ADC. This cohort of 36 chemotherapy naïve prostate cancer patients, all of whom progressed on hormonal therapies, was added to the Phase II trial following positive response to PSMA ADC in patients in the chemotherapy experienced setting.

"We look forward to seeing the response to PSMA ADC in the chemo naive patients, as this compound may be of benefit to men earlier in their treatment cycle," 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 Phase II trial.
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.
1

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 in a phase 2 trial, and a small molecule targeted imaging agent that just completed a phase 2 trial. Among other assets in its pipeline of targeted radiotherapy and molecular imaging compounds is Azedra™, an ultra-orphan radiotherapy candidate also 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 Salix Pharmaceuticals, Inc. 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.
(PGNX-C)
Editors Note:
For more information, please visit www.progenics.com.
2
GRAPHIC 3 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