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 9, 2012
MEDIVATION, INC.
(Exact name of registrant as specified in its charter)
Delaware | 001-32836 | 13-3863260 | ||
(State or other jurisdiction of incorporation) |
(Commission File No.) |
(IRS Employer Identification No.) |
201 Spear Street, 3rd Floor
San Francisco, California 94105
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (415) 543-3470
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:
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 8.01. | Other Events. |
On January 9, 2012, Medivation, Inc. and Astellas Pharma Inc. issued a joint press release entitled Data from Phase 3 AFFIRM Trial of MDV3100 in Advanced Prostate Cancer to be Highlighted in Late-Breaking Presentation at ASCO GU. A copy of the joint press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01. | Financial Statements and Exhibits. |
(d) | Exhibits. |
99.1 | Press release, dated January 9, 2012, entitled Data from Phase 3 AFFIRM Trial of MDV3100 in Advanced Prostate Cancer to be Highlighted in Late-Breaking Presentation at ASCO GU. |
-1-
SIGNATURE
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.
MEDIVATION, INC. | ||||||
Dated: January 9, 2012 | By: | /s/ C. Patrick Machado | ||||
C. Patrick Machado | ||||||
Chief Business Officer and Chief Financial Officer |
EXHIBIT INDEX
99.1 | Press release, dated January 9, 2012, entitled Data from Phase 3 AFFIRM Trial of MDV3100 in Advanced Prostate Cancer to be Highlighted in Late-Breaking Presentation at ASCO GU. |
Exhibit 99.1
![]() |
![]() | |
Medivation Contacts: | Astellas Contacts: | |
Patrick Machado | Jenny Kite | |
Chief Business & Financial Officer | Corporate Communications | |
(415) 829-4101 | (847) 317-5405 | |
Anne Bowdidge | Mike Beyer | |
Investor Relations | Sam Brown, Inc (media for both companies) | |
(650) 218-6900 | (773) 463-4211 |
Data from Phase 3 AFFIRM Trial of MDV3100 in Advanced Prostate Cancer to
be Highlighted in Late-Breaking Presentation at ASCO GU
SAN FRANCISCO, CA and TOKYO January 9, 2012 Medivation, Inc. (NASDAQ: MDVN) and Astellas Pharma Inc. today announced that data from the Phase 3 AFFIRM trial, evaluating MDV3100 in men with advanced prostate cancer, will be highlighted in a late-breaking oral presentation at the upcoming American Society of Clinical Oncology 2012 Genitourinary Cancers Symposium in San Francisco, CA.
Details of the oral presentation are as follows:
Title: Effect of MDV3100, an androgen receptor signaling inhibitor (ARSI), on overall survival in patients with prostate cancer postdocetaxel: Results from the phase III AFFIRM study
Presenter: Howard I. Scher, M.D., chief, Genitourinary Oncology Service at Memorial-Sloan Kettering Cancer Center, and the co-principal investigator of the AFFIRM study
| Thursday, February 2 from 10:15-11:45am PT |
| General Session II: Castration-Resistant Prostate Cancer Treatment Sequencing and Implementation |
About the AFFIRM Trial
The Phase 3 AFFIRM trial is a randomized, double-blind, placebo-controlled, multinational trial evaluating MDV3100 (160 mg/day) versus placebo in 1,199 men with advanced prostate cancer who were previously treated with docetaxel-based chemotherapy. In November 2011, the Independent Data Monitoring Committee overseeing the AFFIRM trial informed the companies of positive overall survival results from the planned interim analysis and recommended that the study be stopped early and that all patients who received placebo be offered MDV3100. MDV3100 has been granted Fast Track designation by the FDA for the post-chemotherapy indication.
About Medivation
Medivation, Inc. is a biopharmaceutical company focused on the rapid development of novel small molecule drugs to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their caregivers. Together with its corporate partners Astellas and Pfizer, Medivation currently has investigational drugs in Phase 3 development to treat advanced prostate cancer and mild-to-moderate Alzheimers disease. For more information, please visit us at www.medivation.com.
About Astellas Pharma Inc.
Astellas Pharma Inc. is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. The organization is committed to becoming a global category leader in Oncology, and has several oncology compounds in development in addition to MDV3100. For more information on Astellas Pharma Inc., please visit our website at www.astellas.com/en.
'H7%J_:D MY\/5[)A+]NKW'O(:D6VX5)O+Q]]@!X*Q-[V/UST0@])5!(F8NOJ_.1Q"LZ29 M82[-UBN3PV=$S)'BF*$,RPZTI$E`GP`U4L1LZ\``BR::9UR+.,QQ?;E_SL:L M["+FC`RD2\0(QQ/F/E=M"0NJ\3P,Q90M>,'Y=M2;(L(Q`#/D2G\),P:668'& M]FH\ZV3E^GT0O>#R#9F!)71;+Z=;E#B9*V),QI6E:\#5]['M`AF$_E[^FB_Q5J3/LD9ZUG++*G!C9EBSY>DZ$#3FE&9"(!H,AS\<9X1,M95[TY3E7K[LM2S8-`:A; M$3.Y+[,DTF:VV$)FZ0K$:!A7BD9A^6P2-Y6.* ['"+`(=H M=>7.T(32J"Y:[4VS9$`(M2`5T&3(`3*95PJ2J5Q$UC;`8("UVC@T:(XWW)6! M`P`H6<_XYX1;%=5R0>AZZ>[)GZU0G96HUL;6]M;DXET@ELJD#BE9(E!HDTEB M">]RZ92%>G;FU(7GN.5*`XSD(,#&$BTD-U1.J* M,0QE=;;TY2 MYJ*@M1.BX]J+!"W61#/`B2#CN'9$B-./],Q6J-P?V`">`&")<,^7[Q;8+R;G M?W53!6,]N3?O'$/3P/X?I[_F';W?'\.O7A$P(=S]41L5&2@&PM1CCFS;T7'- M>GL,V:,M]SOIRPEO`TUNH":($J7Y6J"R_32]^>X8-Z>2DW3H:-,G-"7G.,"SC.>$66 MU\VKUNVPBZF:ZUW?6=W19`>0E=':NI:U2/#,K5%>ND2/:)$>-Q9E2HG]0"U1 M1(Q!QG.,9Z9X1>VM=F=>KCG=E5?55T5M8-C4XYF,UJ0>)RUH>I17[H2XK6@Y M%*F9&H,6M!Y3JW'IQX,!C`3BA`SGNX18\G:[6Q3;CE0B>[ZT.NAFD#'$W:KR MY4VCFS=)Y+$Y#.X_'UC#@W*LAW>8;$W-T3$"Q@PU"@/.#C("Q9P1+)Y!K>GL M9BL ;T5BV/0<@:RCV;+^1''9N?,V5`J[/),3'8P0H=FH M"<\TU,<$1QB?%\30A=WD85J-M<5C)Q2KN*-5L=LB#$C'$8AR`%\W%"G &Y<5D9"A*K:$^1EC#U[L# MQ^?PYQVI:W5C6G:W@,:\)$$2!$@1F""M,JT)V]>5.J"*HP+X:K\\K5ZRGC36 MQ](?._>X9/\`3.WVUF^X;K&S(%#RZ#@,J959<&2MK4(Y,2H4*Y`B?L)@C,!@ M)2(H77M#W!JI+'!6Y7+=VUI@=;-I[:8#X1NIY5+DBVI^E55J%O^"-*9D], M#E8\D9TZDL.3=A;2B*U(H?'D1)9Z3*M(2`91:3*84%> H/F9)3H;V&FB1C. M[<"%\.2K1+*QCQTUA;])-=]V#L+JYXT]<%"9E93&)R\?S,H2'2./1]'('V1) MK1=U\;CYV"&HP*8QL3E^H7_L4P'/;UA4.:H]\/=(>/RP_%ELSMKOO7>NL@ M2W?L#M59 "/JIE<_F; %;\7U*YOSR1\>F%O>*+R40I`,ANU)NUCH"T M%2$`L&'4I.6TDDQN/+(Q@X23#.U/J4L/7(?6<0!QCN%\2KH5*\7W9B.SD[>O M*';S#:1WCQUAGJFKM$:]@M6S6Q9E?MX.*A;$IUMXOK:+-*^0.+9&4ABUBAWK MI\%-:7+DO'DE7G],*@S2T>)K:RI+(\CWDETGE$=F$GH7;::+-VJ$A.T-42&, MN[D^NJ=E% >0\5M5,ZYZ[V MW_)!VWB95#TF=46K^C];1OZ%35-"0P/[@3]QASZ)R71D#)B.&2,I!(5H,*!) M_7R2'`>[H7CD+S4C^0.*1N7^;;P K[D2-$A*JC7>.'OS?'G.N(5*@K&_VJ\A,D]= 22`LP"P!^ M^.[70=#:MP^6X:];]EI/_()UN,2R_+4JRX_8*":A;5LZ_P!-D[?F&'7Z*L5, M2-/T[LJ>T/3IC...BC1NB_0LSG/473.7I7-)-]N%@_/@OJNU7 MMCC^OVHNNLGG,4:_9``C'84[KF%.*^>+$9)0U#[82DB9#868H@)BD)!^4Z0& M3UIN#?:6[V3DS^M<:N>YKRM\V(\7 XY1#.<&"E?5&1N MNI>Q$ZTRFL5E,*9+_= '@] ML3!4'IVPX>#%BG/>=GSEN;\LM-P1]KE9C@J]YP7+U^"K[HT;N0K6SY`DO*.G MF`=]<#@F/LWP>>.FV[+D]KR.H7II?IFL,='QGADXD4-B&7=2+!BQU11AD5)D M#8N<#NIBCV_IDF'#&9V8$,6<]$XWYO?,#B[&GQEE=S%I2BP?$L.NK?W==UM. M\NX;&WC:T:WD$6\2Z<&,Z2Z^1K5M=ICF-/4BUT :5RW+W?.\A/E.0(E?U#YI,SY M8GK@,>BP-W>UKZL:]QC6D<3XK%NOC[TT?J3I77%\U_@SQ1^NTIC$UIJMW(ER M5Q^$R>'J'!4P.J4!SB)6YF)CW92(TM<:I*69/'[@)O=GF.7RK?[.U0U^N>VZ M/O6T*Y;IA:NMSD]O-(RMP<7LDR`.TC(3)GIP:VM$YI654J7$(B0Y&J3GY!@H M/9VY#C/"*.]L/'QIYO(J@RS:NE&:X#ZU+?"X,)X?9 #%+B_OKJ\)\K(^G`F_T*"\`QCN#C`\Y%DB4"/^!?Q#QI M@:.;W)HJNT0N#ZV2**,[OE?ER9P?*'5`A=VE7AT4X$G7DJBL84FX"'& M#!=2+VUSJCK]4MSW3L/7];MD>NC8<<>% WD M-2 C'AB@ M+F X%@\6/4Z9Z8(EFVL\2'CZW3FQ%G[`Z]LL M@M$E$F;#[,BTBE];SIW;$9/MDR"12&OGZ-K)(G(2]"2_?94"*)Q@`,A#C&,$ M4WZVZ,:FZ@UJ_5+K=2$/JF$RP"D,O3L!2XY^F!BM">W'*I9,G1:OE\B6X2*3 M0%FJUQHR,&"]/(,BSGA%M=+:HZ]Z\44FUFIVKX]#J)2MTI:"ZV+PN>F`ULFR MAQ52Q"NQ(5KLM GTX16/B_'/]<_C M^'">A _Y[^I?D_V0^9?96"]OL^S][]U^_P#\ MGYC^U]7I[+]YZ7/23;_,V[:/L^]<0M_XE_ZE7^)^(_D?EV[FV[F#= M^X7T#[G][[WZ)]7YCZ'Q]G_E\ M.G*!V77K[]-^-M/B]OQN^7NG_P`MIW-UV_1U-/(611PB.$1PB.$1PB.$1PB. 3$1PB.$1PB.$1PB.$1PB.$7__V3\_ ` end