0001008848-15-000063.txt : 20151221 0001008848-15-000063.hdr.sgml : 20151221 20151221072107 ACCESSION NUMBER: 0001008848-15-000063 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20151221 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20151221 DATE AS OF CHANGE: 20151221 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ACORDA THERAPEUTICS INC CENTRAL INDEX KEY: 0001008848 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 000000000 FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-50513 FILM NUMBER: 151298213 BUSINESS ADDRESS: STREET 1: 420 SAW MILL RIVER ROAD CITY: ARDSLEY STATE: NY ZIP: 10502 BUSINESS PHONE: 914-347-4300 MAIL ADDRESS: STREET 1: 420 SAW MILL RIVER ROAD CITY: ARDSLEY STATE: NY ZIP: 10502 8-K 1 report_cmo-122115.htm 8-K report_cmo-122115.htm
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 21, 2015
 
Acorda Therapeutics, Inc.
(Exact name of registrant as specified in its charter)
 
 
Delaware
 
000-50513
 
13-3831168
(State or other jurisdiction
 
(Commission
 
(I.R.S. Employer
of incorporation)
 
File Number)
 
Identification No.)
         
   
420 Saw Mill River Road,
Ardsley, NY
 
10502
   
(Address of principal executive offices)
 
(Zip Code)
         
Registrant’s telephone number, including area code:  (914) 347-4300

Not Applicable
Former name or former address, if changed since last report
 
 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:
 
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 5.02
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers

(b)  On December 21, 2015, Acorda Therapeutics, Inc. (the “Company”) announced that Enrique Carrazana, M.D., the Company’s Chief Medical Officer (CMO) and one of its named executive officers, is leaving the Company effective January 4, 2016.  Dr. Carrazana is expected to serve as a consultant to the Company for at least six (6) months following his departure.

The Company has engaged Burkhard Blank, M.D., to assume the responsibilities of CMO on an interim basis upon Dr. Carrazana’s departure. Dr. Blank has more than 25 years of industry experience, holding senior leadership positions with responsibility for managing international clinical trial programs, as well as heading regulatory affairs, statistics, drug safety and related departments. As CMO of Boehringer Ingelheim Pharmaceuticals, Inc., Dr. Blank oversaw the submission of five New Drug Applications (NDAs) and had direct responsibility for all aspects of presenting at two U.S. Food and Drug Administration (FDA) Advisory Committee Meetings; all five NDAs received FDA approval. Dr. Blank has also served as a strategic advisor to several biotechnology companies, leading the submission process for multiple Investigational Drug Applications (INDs), successfully developing protocols for clinical trial programs, and overseeing communications with regulatory agencies.  Dr. Blank is a Board-certified internist and received his medical degree from Universitaet Marburg, Germany.

A copy of the press release announcing Dr. Carrazana’s departure and the Company's engagement of Dr. Blank on an interim basis is attached as Exhibit 99.1 to this Current Report on Form 8-K, and incorporated by reference into this Item.

(e)  The Company intends to enter into a consulting agreement with Dr. Carrazana, effective as of his departure and subject to negotiation with Dr. Carrazana, pursuant to which he will provide certain consulting services to the Company during the consulting period in exchange for, among other things, the Company’s agreement to modify Dr. Carrazana’s outstanding stock options to extend vesting and exercise rights based on the consulting period.  Dr. Carrazana will also receive compensation and benefits to which he is entitled pursuant to his existing employment agreement with the Company.

Item 9.01                      Financial Statements and Exhibits

(d) Exhibits

Exhibit No.
 
Description
 
99.1
Press Release dated December 21, 2015

 
 

 

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.
 
 
Acorda Therapeutics, Inc.
 
 
 
December 21, 2015
By:
/s/ Michael Rogers
 
 
Name: Michael Rogers
 
 
Title: Chief Financial Officer


 
 

 

EXHIBIT INDEX

Exhibit No.
 
Description
 
99.1
Press Release dated December 21, 2015
 
EX-99.1 2 release_cmo-122115.htm PRESS RELEASE release_cmo-122115.htm
EXHIBIT 99.1
 
 
CONTACT:

Jeff Macdonald
Acorda Therapeutics
(914) 326-5232
jmacdonald@acorda.com

FOR IMMEDIATE RELEASE


Acorda Announces Departure of Chief Medical Officer (CMO); Company Appoints Burkhard Blank, M.D. as Interim CMO


ARDSLEY, N.Y. – December 21, 2015 – Acorda Therapeutics, Inc. (Nasdaq: ACOR) today announced that Chief Medical Officer (CMO) Enrique Carrazana, M.D. is leaving the Company effective January 4, 2016. Burkhard Blank, M.D., who has served as CMO for several biopharmaceutical companies including Boehringer Ingelheim, will assume the responsibilities of CMO on an interim basis. Dr. Carrazana is expected to serve as a consultant to the Company following his departure.

“We thank Enrique for his significant contributions to Acorda during the last four years, as we grew from having a single product to a robust pipeline of six clinical-stage compounds, including three Phase 3 programs,” said Ron Cohen, M.D., President and CEO of Acorda Therapeutics. “We anticipate that Burkhard, who has led multiple clinical programs successfully to FDA approval, will contribute substantially to Acorda's programs going forward."

Dr. Blank has more than 25 years of industry experience, holding senior leadership positions with responsibility for managing international clinical trial programs, as well as heading regulatory affairs, statistics, drug safety and related departments. As CMO of Boehringer Ingelheim Pharmaceuticals, Inc., Dr. Blank oversaw the submission of five New Drug Applications (NDAs) and had direct responsibility for all aspects of presenting at two U.S. Food and Drug Administration (FDA) Advisory Committee Meetings; all five NDAs received FDA approval.

Dr. Blank has also served as a strategic advisor to several biotechnology companies, leading the submission process for multiple Investigational Drug Applications (INDs), successfully developing protocols for clinical trial programs, and overseeing communications with regulatory agencies. Dr. Blank is a Board-certified internist and received his medical degree from Universitaet Marburg, Germany.

Prior to his appointment as interim CMO, Dr. Blank served as a consultant to the Company’s commercial and business development departments.
 
 
 

 

About Acorda Therapeutics           
Founded in 1995, Acorda Therapeutics is a biotechnology company focused on developing therapies that restore function and improve the lives of people with neurological disorders.

Acorda markets three FDA-approved therapies, including AMPYRA® (dalfampridine) Extended Release Tablets, 10 mg. The Company has one of the leading pipelines in the industry of novel neurological therapies. Acorda is currently developing a number of clinical and preclinical stage therapies. This pipeline addresses a range of disorders including post-stroke walking deficits, Parkinson’s disease, epilepsy, heart failure, MS and spinal cord injury.

For more information, please visit the Company’s website at: www.acorda.com.

Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, regarding management's expectations, beliefs, goals, plans or prospects should be considered forward-looking. These statements are subject to risks and uncertainties that could cause actual results to differ materially, including the ability to realize the benefits anticipated from the Civitas transaction and to successfully integrate Civitas' operations into our operations; our ability to successfully market and sell Ampyra in the U.S.; third party payers (including governmental agencies) may not reimburse for the use of Ampyra or our other products at acceptable rates or at all and may impose restrictive prior authorization requirements that limit or block prescriptions; the risk of unfavorable results from future studies of Ampyra or from our other research and development programs, including CVT-301, Plumiaz (diazepam) Nasal Spray, or any other acquired or in-licensed programs; we may not be able to complete development of, obtain regulatory approval for, or successfully market CVT-301, Plumiaz, or any other products under development; we may need to raise additional funds to finance our expanded operations and may not be able to do so on acceptable terms; the occurrence of adverse safety events with our products; delays in obtaining or failure to obtain regulatory approval of or to successfully market Fampyra outside of the U.S. and our dependence on our collaboration partner Biogen International GmbH in connection therewith; competition; failure to protect our intellectual property, to defend against the intellectual property claims of others or to obtain third party intellectual property licenses needed for the commercialization of our products; and, failure to comply with regulatory requirements could result in adverse action by regulatory agencies.

These and other risks are described in greater detail in Acorda Therapeutics' filings with the Securities and Exchange Commission. Acorda may not actually achieve the goals or plans described in its forward-looking statements, and investors should not place undue reliance on these statements. Forward-looking statements made in this release are made only as of the date hereof, and Acorda disclaims any intent or obligation to update any forward-looking statements as a result of developments occurring after the date of this release.

###



 
 

 

GRAPHIC 3 acorda_logobw.jpg begin 644 acorda_logobw.jpg M_]C_X 02D9)1@ ! 0$ 8 !@ #_X0!X17AI9@ 24DJ @ & #$! @ 1 M 5@ $#!0 ! : ,# 0 ! +(D Q!1 0 ! 0 !%1 M! ! Q X !)1! ! Q X !-:6-R;W-O9G0@3V9F:6-E -Z@ MA@$ C[$ /_; $, " 8&!P8%" <'!PD)" H,% T,"PL,&1(3#Q0=&A\>'1H< M'" D+B<@(BPC'!PH-RDL,#$T-#0?)SD].#(\+C,T,O_; $,!"0D)# L,& T- M&#(A'"$R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R,C(R M,C(R,C(R,C(R,O_ !$( $4 V ,!(@ "$0$#$0'_Q ? !!0$! 0$! 0 M 0(#! 4&!P@)"@O_Q "U$ " 0,# @0#!04$! 7T! @, !!$% M$B$Q008346$'(G$4,H&1H0@C0K'!%5+1\"0S8G*""0H6%Q@9&B4F)R@I*C0U M-CH.$A8:'B(F* MDI.4E9:7F)F:HJ.DI::GJ*FJLK.TM;:WN+FZPL/$Q<;'R,G*TM/4U=;7V-G: MX>+CY.7FY^CIZO'R\_3U]O?X^?K_Q ? 0 # 0$! 0$! 0$! 0(# M! 4&!P@)"@O_Q "U$0 " 0($! ,$!P4$! ! G< 0(#$00%(3$&$D%1!V%Q M$R(R@0@40I&AL<$)(S-2\!5B7J"@X2%AH>(B8J2DY25EI>8 MF9JBHZ2EIJ>HJ:JRL[2UMK>XN;K"P\3%QL?(RKR\_3U]O?X^?K_V@ , P$ A$#$0 _ /?J**\N^-OC2Y\*>'K.#2[Z6VU: MZGS$8L<1K]XD$'(Y ^OTH ]1HKP;X1_$'7KGQQ=^'O%]_=/=R1E;>.=50)(O M+*0 .2.GT]Z]YH ***\?\:_&&\BU]O"_@BP&I:J&,;S[2ZJXZJJCJ1W)X'O0 M![!17AZ>%?C;J*_:;CQ3;64C<^1YH&WVPB$?J:SK_P 5_%WX=!;C7[>#5M-# M8:8J&49_VT *_P# A0!] T5FZ!?7VI:%9WVHV0L;JXC$CVP??Y8/(!.!SC&> M.M4_&'B[3?!6@2ZMJ3$J#LBA3[\SGHH_Q[ 4 ;U%> 6'B3XM?$HO=Z (-&TG M<0DN JG_ (&P+,?=0!3KR7XC^!8H=8U?Q?;ZC:.WEP6L+^:UU,>$0 H.,\D@ M] >^* /<+?48[O4KNUA&Y;3:LKCH)",[/J%()_WA5VO+_A[XTTNVUJ?P-=._ M]LP.SS74AR+RY/S38]"&+ #N%XKU"@ HKP[XV>*?$OAGQ-I4.A:U<6J7T)W1 M80H&#!01E21UYIW_ BOQP_Z&NR_[^#_ .-4 >WT5X)JNGZHS!(K@+L5V/0,.G/9AP: /8:*** "BOFKX@_$OQ0WCG6+ M?PIJEXNG:>O[X1JCJI7"NXRO"[B!^O>O8/A5XJ7Q;X%M+N2X>:_@S#>&0@MY M@YSP!P001^7:@#M:*** $=UC1G=@J*,LQ. !ZU\[:$K?%OXW3ZQ*I?0])(:, M$?*40_NU_P"!-EB/3-=S\<_%Y\/>##IEM)MOM6S",'E8A]\_CD+_ ,"/I7(> M$?A3XYTO0XGLM2TRR^UJLTD;R3K("1PK;"!D?XT 2?'?PQ<:3JUAX[T@&*:. M1$N70?=D4_NY/TVGZ#UKU[P9XGM_%_A2QUF# ,R8FC'_ "SD'#+^?Z8KS._^ M&/C_ %.PFLKO7=(E@F7:Z/+=,#^!)''6N=^$6KWO@'XAW_@?6V"1W4NQ#GY1 M.!\K#V=Y>+[^;2_!NM7]L<3V]E-)&1V8(<&O*OV<='MAH>JZXZA[V M6Y^S>8>65%56(_$MS]!7L]_9PZCI]S8W S#<1-%(/56!!_G7SEX,\177P7\9 M:AX<\1Q2?V5]MVM[J%)H7QNCD7* MG!R,CZBJ6F^(M%UBU6YT[5;.YA89W1S*F74/&GAW1#(5MS$&]MTDFTG\E%>T^# M?$\7B[PS:ZM'!);O(N)89%(*/CD#/4*-/C=VT\&. MXV#)1,[E?Z YS]10!VWCW7;;X>?#>9K!5A>.);.PC7C#D8!_ M^%>/?"6/4 M?'?BO1AJ)WZ7X8MMT:=C(6)4G_:)Y^B"NANF?XK>+]'AULQV.C:1!&U]')(% M$UXZAFB4GJ< CJ &]:['P1I>A_##PM=_P!IZG8VSSW,D\KM,OW-Q$:CG)^4 M#@=R: /-OC= GAWXI:'KM@/*N9ECGDV<;GC?&?Q&!^%?1P.Y0?49KYGNKF;X MT?&*T>P@E&BV&P&1UQB%6W%CZ%SD ?3T-?3- 'SO^T7*(/%'AR5@2$A=B!WP MX-=!_P -(^'O^@+JG_D/_P"*K"_:%_Y&_P ,?]WLYN&A/6-< *#[\9_&O/?'>FW?PE^)=IXPT:(_V3?2'SH5X4$_ZR/V!^\O MH1[5[[I6IVFM:5:ZE82B6UN8Q)&X[@_U[$4 (/^O8?^A+7/_L__ M /),5_Z_9O\ V6N@^+'_ "2SQ!_U[#_T):Y?X"7UI;_#14FNH(G^V2G:\@![ M>M 'K5>&?M(:;"NF:)K,8V7D=PUOYB\$J06'/L5./J:]F?6-,C0N^I6:H!DL MTZ@#]:\ ^*_B2/XD^*M'\(^&'%ZD4Q,D\?*-(W&0>ZJN23TY/I0![SX9(3Y88R6^A%<5X0NI_A%\ M8+GP]?R,-)OW$0D?H58_NI/PSM/U;TKL(_AW\1(HTCCU_24C10JJL]V H' M&[I7(_$'X6^,6T.76]1OM/OCI\98K \S2F//.-^>!RO>O0NWK7+;?'_\ SV\,_P#?J?\ ^*HV^/\ _GMX9_[] M3_\ Q5 '4UY_XL^$FD>+_$8UR]U+4;>[146/[,T:!-O((.TDG/.2:U]OC_\ MY[>&?^_4_P#\51M\?_\ /;PS_P!^I_\ XJ@#HK."2VLXH9;F2YD1<--*%#/[ MG: ,_05G>(O"VB^*['['K6GQ740Y0MPZ'U5AR/PK.V^/_P#GMX9_[]3_ /Q5 M&WQ__P ]O#/_ 'ZG_P#BJ .&NOVWU/5+=#_!N1L?B5S6WX>^"'@W0 M+A+E[:;49T.5:]<.H/KL "G\0:WMOC__ )[>&?\ OU/_ /%4;?'_ /SV\,_] M^I__ (J@#J H X ':J6KS7$.ES_8XEENW7RX48?*7;@%O]D=3[ UB;?' M_P#SV\,_]^I__BJ-OC__ )[>&?\ OU/_ /%4 <_JOP7T'6=$L-/NKW4$DM0S MM-%(!YTKG,DC*0068_H .U8]G^SIX6AG#W6HZI=(/^69=$!^I"YKN-OC_P#Y M[>&?^_4__P 51M\?_P#/;PS_ -^I_P#XJ@#6T+P[I'AG3Q8Z/8Q6EN#DA!RQ M]6)Y)]S6G7+;?'__ #V\,_\ ?J?_ .*HV^/_ /GMX9_[]3__ !5 &=XR^%VF M^-]7M]1U'4]0B>V0)#' 8PJWAG_ +]3_P#Q5 %WQ;X7L_&/A^71KZ66 M.WE969H@NX;3D8+ X^M4_!?@F#P/826%CJE_WAG_OU/_\ %4;?'_\ SV\,_P#?J?\ ^*H T?%'AZ+Q5H%QHUQ=W%M; MW&!*T&WWAG_OU/\ _%4 <0O[.7A,,"VI:NP[CS(QG_QRN[\*> O#O@R- MQHU@(YG&)+B1M\K#TW'H/88%1[?'_P#SV\,_]^I__BJ-OC__ )[>&?\ OU/_ M /%4 =#?VTEY836T5U-:/(I43PXWI[C((S^%!-1N[W3KV]N)+J/ MRY!&?^_4__P 50!U- M0W4'VJTFM]Y3S49-P .,C&<$$'\:YS;X_P#^>WAG_OU/_P#%4;?'_P#SV\,_ M]^I__BJ ,WP7\+=.\"ZE+=Z3JVI,LZA9X)FC,:(8Y@^W/.W+8SCUHH Z"=I5MY6@17F"$QHS;0S8X!/89[US7A M/Q'K&OW6H)?:1;64-E.]JSQ79E+2IC(QL7Y<'K^E=35#3-(M=(-[]E#_ .F7 M3W,A&R3N_2NNK#UWPO9Z]=V=W-=7]M<6BNL4EG<&%@'QN&1USM% & MS"9&AC,R*DI4%U4Y ..0#WK$\8>(F\+>'GU1;>.;$\>YEW*5W*<$9]#ZT NGK T;P9HGA^\ANM,MC;RQVHM"5./-0$'+_ M -YLC[QYY-;] '!M\19$\>2^&_[,CD5+Q+3?'<$R_-&'\SR]N-@S@G=7>50L M-'M--OM1O+,[G0O$>G:-:V5I-+?1,\; MW-TT(W!U4(,(V2=P].]=>N2HW !L<@'H:PM:\)V>MZE#J$EYJ-I=0PM LEE< MF$[&()!QUY _*MR-/+B1 S-M4#+')./4^M &3KVMMHK:4!;B;[=?QV9R^W9O M!.[ISC'2GZ#K#:S!>R- (3;7L]I@-NW>6Q7=T&,XZ4_6]#L]?L5M;SSE$DVND1W*6N_%SU %ZL;0M<;6;C6(FMQ"-.OF MLP0^[S,*K;NG'WNGM6S6?IFCVNDRW\EMYFZ^N6NIM[9^<@ X]!A1Q0!?) !) MZ#FN<\,^(M1\1*E]_8Z6^CW",]K\5<.(K9KEV@A#G