-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, T+iLanizMHLC4QRVIW2MPa5fpjodNgvszizcEO9V4msVD3UB58uWrRnPowAY0ygs 2OMhLbi6Sftii/RE+uwrfQ== 0000950137-06-002363.txt : 20060228 0000950137-06-002363.hdr.sgml : 20060228 20060228170432 ACCESSION NUMBER: 0000950137-06-002363 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060222 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060228 DATE AS OF CHANGE: 20060228 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SPECTRUM PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000831547 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 930979187 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-28782 FILM NUMBER: 06651925 BUSINESS ADDRESS: STREET 1: 157 TECHNOLOGY DR CITY: IRVINE STATE: CA ZIP: 92618 BUSINESS PHONE: 9497886700 MAIL ADDRESS: STREET 1: 157 TECHNOLOGY DR CITY: IRVINE STATE: CA ZIP: 92618 FORMER COMPANY: FORMER CONFORMED NAME: NEOTHERAPEUTICS INC DATE OF NAME CHANGE: 19960819 FORMER COMPANY: FORMER CONFORMED NAME: AMERICUS FUNDING CORP DATE OF NAME CHANGE: 19920703 8-K 1 a17775e8vk.htm FORM 8-K e8vk
Table of Contents

 
 
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 AND EXCHANGE ACT OF 1934
Date of Report (Date of earliest event reported): February 22, 2006
 
SPECTRUM PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other Jurisdiction
of Incorporation)
  000-28782
(Commission File Number)
  93-0979187
(IRS Employer
Identification Number)
         
157 Technology Drive
Irvine, California

(Address of principal executive offices)
     
92618

(Zip Code)
(949) 788-6700
(Registrant’s telephone number, including area code)
N/A
(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))
 
 

 


TABLE OF CONTENTS

Item 1.01 Entry Into Material Definitive Agreement.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
EXHIBIT INDEX
EXHIBIT 99.1


Table of Contents

Item 1.01 Entry Into Material Definitive Agreement.
     On February 22, 2006, Spectrum Pharmaceuticals, Inc. (the “Company”) entered into a Development and Marketing Agreement (the “Agreement”) with PAR Pharmaceutical Companies, Inc. (“PAR”) whereby PAR agreed, and obtained an exclusive license, to market, sell and distribute all of the Company’s current as well as certain future generic drugs in the United States. Pursuant to the terms of the Agreement, the Company is responsible for the development of and regulatory filings for the generic drugs and the Company will receive payments upon regulatory approval of each abbreviated new drug application. The Agreement also provides for a share of the profits from the sale by PAR of the Company’s generic products. The term of the Agreement is determined on a product by product basis from the effective date of the Agreement until the date that is ten years following the commercial launch of the relevant product. In addition, PAR shall provide financial and legal support, including the payment of all legal expenses going forward, for the ongoing patent challenge for sumatriptan injection. Within twenty-four months of the effective date of the Agreement, the Company has the right to request PAR to make an equity investment in the Company which is subject to due diligence and the negotiation of definitive documents at that time. The Company could receive an aggregate of over $10 million under the Agreement if the equity investment is made and all the regulatory approvals are obtained.
     On February 28, 2006, the Company and Cura Pharmaceutical Co., Inc. (“Cura”) entered into a First Amendment to the Distribution and Supply Agreement dated April 12, 2005 (the “Supply Agreement”). The Supply Agreement was amended to modify Cura’s right to distribute, promote and sell the Company’s generic carboplatin injection in the United States from an exclusive right to a semi-exclusive right, which gives the Company the ability to grant a similar semi-exclusive right to another third party. No other terms were modified.
Item 9.01 Financial Statements and Exhibits.
     (c) Exhibits
     
Exhibits   Description of Document
99.1
  Press Release dated February 23, 2006.

 


Table of Contents

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.
         
  SPECTRUM PHARMACEUTICALS, INC.
 
 
Date: February 28, 2006  By:   /s/ Shyam Kumaria    
    Name:   Shyam Kumaria   
    Title:   V.P. Finance   

 


Table of Contents

         
EXHIBIT INDEX
     
Exhibits   Description of Document
99.1
  Press Release dated February 23, 2006.

 

EX-99.1 2 a17775exv99w1.htm EXHIBIT 99.1 exv99w1
 

Exhibit 99.1
(Spectrum Logo)
Contact:
Dr. Rajesh C. Shrotriya
Chairman, President and CEO
(949) 743-9295
Spectrum Announces Strategic Alliance with Par
Pharmaceutical Companies, Inc. for Sales and
Distribution of Spectrum’s Generic Product Line
    Spectrum to receive over $10 million in milestone payments on achievement of specified regulatory approvals and equity investment
 
    Agreement covers both current and future generic drugs, including sumatriptan injection filed with Paragraph IV certification
 
    PAR will assume all financial responsibility for litigation with GSK related to the sumatriptan injection paragraph IV filing
 
    Spectrum and PAR will share profits from the sale of Spectrum’s generic drugs
     IRVINE, Calif., February 23, 2006 — Spectrum Pharmaceuticals, Inc. (Nasdaq: SPPI) today announced that it has entered into a strategic alliance with Par Pharmaceutical Companies, Inc. (NYSE: PRX) for the sale and distribution of Spectrum’s generic drugs. As of the date of signing the agreement, Spectrum had three Abbreviated New Drug Applications (ANDAs) approved, and nine under review by the United States Food and Drug Administration (FDA). The agreement also covers additional ANDAs currently being developed by Spectrum. Spectrum will receive certain milestone payments on achievement of specified regulatory approvals and the parties shall share the profits from the sale of Spectrum’s generic products. In addition, Par shall provide financial and legal support for the ongoing patent challenge for sumatriptan injection. Par also has agreed to make an equity investment in Spectrum during the next 24 months, at Spectrum’s request. Additional financial terms of the agreement were not disclosed.
     “Our alliance with Par represents an important strategic step in the implementation of our strategic plan,” stated Rajesh C. Shrotriya, M.D., Chairman, Chief Executive Officer and President of Spectrum Pharmaceuticals, Inc. “We are very pleased to have Par as our partner as they have the expertise in the field of generics, financial strength and drug distribution skills. I believe our complementary skills and experience will enhance and expedite the development of our generics program, including what we hope will be a successful paragraph IV challenge for sumatriptan injection. Their knowledge and experience in the pharmaceutical marketplace will be a key factor in the future success for our current and future generic drugs.”

 


 

     “We are very pleased to begin working with the team at Spectrum,” said Scott Tarriff, President and Chief Executive Officer of Par. “Par is very impressed by the progress Spectrum has achieved in both the generic and proprietary arenas. Our collaboration provides Par access to injectable and ophthalmic pharmaceuticals, including sumatriptan injection, a very promising first-to-file opportunity.”
About Spectrum Pharmaceuticals
     Spectrum Pharmaceuticals is a specialty pharmaceutical company engaged in the business of acquiring, developing and commercializing prescription drug products for the treatment of cancer and other unmet medical needs. By leveraging its operational flexibility and regulatory proficiency, and using the extensive research and development capabilities of its strategic alliance partners, Spectrum has built a diversified portfolio of proprietary and generic drug products in various stages of development and regulatory approval. For more information, please visit our website at www.spectrumpharm.com.
About Par Pharmaceutical
     Par Pharmaceutical Companies, Inc. develops, manufactures and markets generic drugs and innovative branded pharmaceuticals for specialty markets. In 2005, Par received approval for and introduced Megace® ES, its first branded pharmaceutical product, and expects to launch its second in 2006. Par’s Generic Products Division is committed to providing high-quality pharmaceuticals that are affordable and accessible to patients. Par manufactures, markets or licenses more than 100 generic drugs. For press release and other company information, visit www.parpharm.com.
     Forward-looking statements
     This press release may contain forward-looking statements regarding future events and the future performance of Spectrum Pharmaceuticals that involve risks and uncertainties that could cause actual results to differ materially. These statements include but are not limited to statements that relate to our business and its future, the Company’s operational flexibility and regulatory proficiency, the extensive research and development capabilities of the Company’s strategic alliance partners, that Spectrum will receive over $10 million in milestone payments on achievement of specified regulatory approvals and an equity investment from Par, that PAR will generate profits from the sale of Spectrum’s generic drugs, that the parties complementary skills and experience will enhance and expedite the development of Spectrum’s generics program, a successful paragraph IV challenge for sumatriptan injection, that Par’s knowledge and experience in the pharmaceutical marketplace will be a key factor in the future success for Spectrum’s current and future generic drugs and any statements that relate to the intent, belief, plans or expectations of Spectrum or its management, or that are not a statement of historical fact. Risks that could cause actual results to differ include the possibility that our existing and new drug candidates, may not prove safe or effective, the possibility that our existing and new drug candidates may not receive approval from the FDA, and other regulatory agencies in a timely manner or at all, the possibility that our existing and new drug candidates, if approved, may not be more effective, safer or more cost efficient than competing drugs, the possibility that price and other competitive pressures may make the marketing and sale of our generic drugs not commercially feasible, the uncertainties involved in and unpredictability of litigation, the possibility that our efforts

 


 

to acquire or in-license and develop additional drug candidates may fail, our lack of revenues, our limited experience in establishing strategic alliances, our limited marketing experience, our limited experience with the generic drug industry, our dependence on third parties for clinical trials, manufacturing, distribution and quality control and other risks that are described in further detail in the Company’s reports filed with the Securities and Exchange Commission. Representatives of Par provided the information under “About Par Pharmaceutical” to Spectrum and therefore, Spectrum has not verified the accuracy of those statements.
###

 

GRAPHIC 3 a17775a1777501.gif GRAPHIC begin 644 a17775a1777501.gif M1TE&.#EAYP)6`+,``/_____,S/^9S/^9F?]FF?]F9O\S9LS,S)F9F69F9C,S M,P```````````````````"'Y!```````+`````#G`E8```3_$,A)ZSP8::14 M^M^B+&1IGFBJDEZ"6'!L91IHWWBN[YN&';*@<`C[]7;(Y`UQ>!&?0N-&245N M9,VJ=LNE,H'0(`W1+2\WOS"T2<[YU/!BULV,V[$U'/HNUW1L>WQW&0D=*X>( MB8HG'W!L"8N1DHHM8()#CY.:BQV6EP"$(INC*PI@'*2IJI$M<&TCJ[$H?QB# MD)(?GI\5!R&XNKM!?IR-=KV%G`O`P7@LILR$ MWM^<8`>BY>J19*Z^ZZ2TVD2]DQ[SGP<>DPGXVQ(:)+4S1D92N'\PAL$KYV1( MP(7E^@5C0PZBI$O.+&HRA4ZCQQ0-_V6@^BBKGS\*[S858Y92DP:$,&YM?!FF M(CN8$V22A!8RILZ=T#KP40A4TLDB-HL>>JA48P*1Z9JN4D!/5D]!'5<=Y=-2 MY9.NDYK@_"EUT]4*+LK&$GJ'J-H56WDE?5N"*=V((N?>3405DZRX56,!CI-6 MU5,BR%+5V89.[]X4*Y$^U@K8[603?:$@B'JY1%_'GJSH%H+6NF1(E@L'JL3=K'$R(_&@@TZ?/KWS\> MSG1-]Z''W_^`^JU'`0;?&0C`?X?DTA\?%,4"E6HL6840$WC)`-8FG5Q"6BKG M?9&>@K0QN())@_'6!#3TF1B);O@1*..#-44$HX@S$D@B*+>1,AM.)7VQ"QMK M3;A*=F%L-PF2U&080W-3I33N&)A6ZU$X0X]K"6DE%A^"^,:7C''I%4X( M8@FD5F=Y1PJ37UG(&#S@4>!B*8*XN5%F9$*AI%%9'CE#?:E(U"=]T)AT*$)I M&K;>AJ*MB5V;FK,9$JJ6(6H(I9E<02RJ'_,L26F>!8 MERHB)12JX2IH,-4J`BLFZB'R+*$F^7A"K;''4&^F]:!EKZ[:HQ0OQI*C)!@%:0L[[TVWZQQ'/GZN*_) M*OA+VY'+."Q0A>_RD;)G_("9J,A">/QL"S?V8+75(\(F,TM`IW#@PD=CDN/8 M68L!\,[Y@/WBHUVC(+2&$L9@-*:Z)AT'N?P\96*=],[]L7:A@2`6X#2+G6,; MB:+D]W-B?+!T*30=-Q7:&Z\"]2[\IK(5_]D%E62DJ=R23#C'"^X--S2#C]I9 M(2ZDV+;;])`-I:.H+8Y(XZ]S$CG&JU`^I-J+7`Y;[B5L?G@]GLLM^AW$UU5R MXA.<62Q/*<;WV\M,-D^"-HX7Q=8$F:ML@=37#)NR\+ZO`;PBZ`L2_BC6X0V/ MSB/;S=7RP=G^W+#ZY/VD-=?*R&_XEI.MU4\I\B)?(DX#%%TT#V;IVQ+I_J%` M=EE`?^7XGO+LQSS\"0&#A]"9/DP'`_D91$K(P0T!):`]:/T*@25\8`P:&#'0 M17`0ZTM$^Y2F/6#D-!L[%H7+(:W^-$T*X(E>8@TZM5]+RW&[0T M#VH5!%8-]75#'/].?03X#KJ=,4N>M%R/RL<2G;B1\T4<70V?$(;K76E%T'- MA)R@GVWX<[4\\)$%"30@`#ZI@GO`R2ZDH(<=S7`&9E6L=X;DV215L$/F]3`A M*?Q&![P4AC."!&EK!!?J3FD6.0)4U M\(`V6;?-;G*3=3!R);Q@&4LUP%%Z"&FF)I91&"#Z,476/$$:_S=$R5@E+K-< MP%EZHT6T88"/>Q3E!3QIAEV.Z0Y?O%<^4;"[:&K M9[*@U\M)KJ9_YM$DL1;*T/$)E')+$^>K'O>VG9TSB>F4:-3<.9B+DF">TGS3 M$S#)OEKF5(Q&Y*A+2:;'*K#IVZ1DDX3ZL[N^,NO:JZ<397G4->BTJ7R"**8B^H0IKJLK5P5IR;5J`2. MF:=<,J*M]$HK(R@GV)OF58I=+"P)97^!TVF@XE:PA3%ZU/-A2R+VW:K.2Z!JZB>08"685)=F"T_Y4D&2$35&U$ MMV$25H8V5A0-!Q>"PCFXK[5&K-CM=;&S"RA@B#6BLZ(VE\$-_J8W=ZSC"Q%CV6G"5[YKH]:2^TI&Y@KQP$$3QEWQ2B85KR"])/D#8LX;RPS8F89K M:"\C-_SR9JJXLR0YE*75H\5G+=;B+G0M-`/_L$<`2IKZ5 M\]&EDT0[JW*:D8Z>*8A@>VH?3/H>E<;.J".(/$V;Z]1XA&_SCOQ6$,TZ3ES\ M"JX_TB'5S<>M.-XOC\H=$]N]N_P:-=%^BV?;;=M%_T9IL2J2:&^*-M[SC73:8.+&4W@8SA-I@;AK?X\S'Z/=' M\FV@5S3HH/&=0RG.PVMH"YP1",<*C.HO9M:K<<+R>]A]5!2^`@YS`*FJX`]/U7K)Y&ZV_WN>,^[WO?.][[[_>^`#[S@!T_X MPAO^\(A/O.(7S_C&._[QD(^\Y"=/^A'3_K2 MF_[TJ$^]ZE?/^M:[OL_SOAI@>_!ZP']7PVBS6F-[8/;:^_[-'-KG;7[_=MX; M:87SZM'%,+-MXCL_Z?'`,B^&__RT&W^#Q&F^J)0/,>97__OKN(#_<(`*&`#;$``"\(`/R(`-"($#$(',8(`#D($9:(`7F($$4``#4``"<($! M,``$\($$L($.80+/EG_G5P+\!UG^IR*UT'O&<$W=YQGS!UD+&`#%U8,<>($0 M:($3^(`5*``2N`L8J($#$(1*F($@6``$,((MA8$G*(4J^$$L&!`D"<(1#.(1JN(9,&(=-*`@"((51F()8*((C>`()^F(*"$``%4``&<(B(F(@$P`<&F(B.F(A)>$%;6$TLB&1?&'2Y<7.\D7.7 MQ3=SX`*H41Y"T1L@L&SUL?]+R^%7/_=Q1L<"K*4B1B%Q"6$#1``= M8D&*+7$#EL!OKZ4PG"@"2+>)K4@.B.=]B.[3B04%"/2GF/]:@&&1B0 M`8G_DS(`D%"YCQDHB<7#A3IQD+?1+:`80T;1$PW9&-+P%`@ID:65*G)DD46` MD:Z2DGRAB6'FD3<%DCGTBYU8DI3PEL.%"#ZTC!<@6[L0C5[(77=V&A-Y,@EX MDV@8!CK)DSO)EY@`E#\IE5.YCD:)F42I@6K`E$J)@DKIE%19E8YHF3`PFJ2) MB%<)8/=G5=+@A:"D8ZY_YB,"810`)D`NH=$ M0)E`28Z%N)F9:90?:)H4X(&!6(B?R90@B)1"$`"(:(@&@*%560!/T(BIN8_C M>!T"LA\;4!'"28;)\@PAD2]OU)&I*$^GD2_T8Y]!L'XKFIY821P;Y1EOI%;< M8*,'0QP_XJ)#4Y>L@E%O%AVB^&Z!Z51-VIJ?`YYP(&=J*8D:5>"@25*!+45SOR!#4R MNE7>6:-U\2,HRIH)LYOY*:4-HK`J;8(I^P7"`$4BF"$@$WWBFX+JG1`"HB2BNCBBH0D"HA>J(AZJJ'$(C+/I'2(J= M_M"%+QJO$B22$P5*K+JBVAD#S^`KMP%8M]<0,E%+U8&H=)FH1VI8V!<9`9L= MMW>B@!6F+Z2K>^6=%NXFD%`I]S*K4PI!`]8M/M8H9C[B$YX'1E;M7GKKTX[`]BH M7A1KJ;BI=E:+2U6ZK]*("!CGM:L+!Y#VM16)ML6IMB,9&;8K2\;J[AZ M(*6;*DA%F)8XO"49$F7;)R3;C14ZN#N9IH9[N$(@IR#XN)YYH.TXJ#&+L_-X ML_0H!%+HLSU[OC]+KHAXO9OKB)#KN6^S?_"ZM_KY)W`;NIFF_[P_VKJPN6?T MV[QD\KPEFY/2^ZR%6[UQR*"9B8=Y2*=8N+B">*[?.X\VZZUU&KGIB[Z'>,,! MB0^HV;[O.XF7(+];-;K8AAGXL;_#RQ3H(\17J\&WJ["(B@U8MYU'ZSZ7M77V MI[]IB[L4P,!K.Z2S:T[,%UH5*[>Q4PWD\+DSM+$;/%?Q.EB+`L*!*\(CW(:3 M:<)Q**`QX(Z.>X]\K*!];(+>.[EZ:H_7.YI"FZ[LV[ZJB93PFS9A;$7QZ@V: MQ,1]T[>J6\'URK9KS,5W&T4$O#W9,?_`!92Z#G%]9EM=K:J[V^G`+#C*_[JK M"!8%LTN&`(BH[I>PT6')RQNKLTS+MCJ(!R4,6"4BINX@*B9 M$VJR>3K#,?R9AVR^&)K-YAN0ELO(C8RH:KRT6FPG1.R2N_E!MMM.2URI3X*U MZ`/`Z@FLH%RQN)>BF!S!IHS.@9#*M_J5N4N_H.JIZW<2I+Q7OJJ%!6S+4PQ\ MN7RV6MK&JN:E[>%9`?LVPTS,EFO,$'@2R2JPP:@N37=N4`,'Y%,SI.,L<()%E.[6$$=V0#ASJXKRZC("ZUQ M*CH8G2DQUD[UBO_TRL4YGHTT4*2QRJY8;^T'L`RF'`$,K-YY%;U0$5]MSK'I MKM&V.V[R!,A[UN.\2`"-S['I79Q!FUT=`V@(N/U)!.%XL@%*W7=MTG`=`*") MF>_XS,\%\KV@MR?0K_Q^RZ0*\ MO1P%F]F:C!JWP,D)O#O2H-MDP3^4;);UJ1/^;-P[IS`8F]4LT!/FN7X+S*.R M?5F?(JDZ6$6I?5DAX9W):6"]O2!&#-Q;Z0G#K>)Q>M@KQB*[?$5`2*-I>@0S2XW8&';Y@X( M:C#,86#,DIZ3R>R8E5Z/#AK>:G"SY$WI!/#N,O#D.,S>B8CI,*"^4#FT8'CP M^H:UC"?'<("RROP$1FBX<,#=CCNY[LCO.2G8A/W7Z1CJ4"ZT-1P&F(OP)`]F M"K]X#*\&#H_7[0Z'*SOQKQ.)S#(0\%F&N#)1_T?=6Q M*#_==_"8:,KH.\N'ICC?H11_I_`X`.E"V.![WDIO`?JX\^@K\.1+\(HH]&!_ M0QTQG8\'O9_@Z.*8#XUNCE7XIO7.\H/(K5SO]'Z8PX;HWD?_@89*\V'?]^\7 MVY%W`&9_"6@/@5
-----END PRIVACY-ENHANCED MESSAGE-----