-----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, HFmAql5+Fz0IfSIfJu1sZBeMrLCoC0XMP/JY9DI2ETCYyu5d2oOA/dLRtbezllbV lMnipPNcPfZvSGSouATWVQ== 0001047469-04-010210.txt : 20040331 0001047469-04-010210.hdr.sgml : 20040331 20040331123632 ACCESSION NUMBER: 0001047469-04-010210 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20040331 ITEM INFORMATION: Other events ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040331 FILER: COMPANY DATA: COMPANY CONFORMED NAME: BRISTOL MYERS SQUIBB CO CENTRAL INDEX KEY: 0000014272 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 220790350 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-01136 FILM NUMBER: 04704595 BUSINESS ADDRESS: STREET 1: 345 PARK AVE CITY: NEW YORK STATE: NY ZIP: 10154 BUSINESS PHONE: 2125464000 MAIL ADDRESS: STREET 1: 345 PARK AVE CITY: NEW YORK STATE: NY ZIP: 10154 FORMER COMPANY: FORMER CONFORMED NAME: BRISTOL MYERS CO DATE OF NAME CHANGE: 19891012 8-K 1 a2132646z8-k.htm 8-K
QuickLinks -- Click here to rapidly navigate through this document



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): March 31, 2004

BRISTOL-MYERS SQUIBB COMPANY
(Exact name of registrant as specified in its charter)

Delaware
(State or other jurisdiction
of incorporation)
  1-1136
(Commission file number)
  2-079-0359
(IRS employer
identification number)

345 Park Avenue
New York, NY 10154
(Address of Principal Executive Office)

Registrant's telephone number, including area code: (212) 546-4000




Item 5.    OTHER EVENTS

        Incorporated by reference in its entirety is a press release issued by the registrant on March 31, 2004, attached as exhibit 99, concerning the registrant's statement regarding Paraplatin® pediatric submission and federal appeals court reversal on patent.

Item 7.    FINANCIAL STATEMENTS AND EXHIBITS

        (a)    Financial Statements

            Inapplicable.

        (b)    Pro Forma Financial Information

            Inapplicable.

        (c)    Exhibit.

            99    Press Release dated March 31, 2004.

2



SIGNATURE

        Pursuant to the requirements of the Securities and Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.


 

 

BRISTOL-MYERS SQUIBB COMPANY

 

 

By:

 

/s/  
SANDRA LEUNG      
Name:    Sandra Leung
Title:    Corporate Secretary

3



EXHIBIT INDEX

Exhibit No.

  Description of the Exhibit

99

 

Press Release dated March 31, 2004



QuickLinks

SIGNATURE
EXHIBIT INDEX
EX-99 3 a2132646zex-99.htm EXHIBIT 99

Exhibit 99

GRAPHIC

Media and Investor Contacts:   Tracy Furey
Corporate Affairs
Bristol-Myers Squibb
Tel: (609) 252-3208
  John Elicker
Investor Relations
Bristol-Myers Squibb
Tel: (212) 546-3775

 

 

Kathy Baum
Corporate Affairs
Bristol-Myers Squibb
Tel: (212) 546-4631

 

Susan Walser
Investor Relations
Bristol-Myers Squibb
Tel: (609) 252-4227

        Bristol-Myers Squibb Statement Regarding Paraplatin Pediatric Submission and Federal Appeals Court Reversal on Patent

        (NEW YORK, NY, March 31, 2004)—Bristol-Myers Squibb Company (NYSE: BMY) reported today that it has submitted to the Food and Drug Administration (FDA) data from two clinical studies evaluating the potential health benefits for pediatric patients of Paraplatin® (carboplatin), a widely-used chemotherapeutic agent. If the FDA finds that these studies meet its requirements, the Company would be entitled to a six-month extension of marketing exclusivity for Paraplatin after the expiration of the patent on April 14, 2004.

        The Company was awarded summary judgment in 2002 by the New Jersey U.S. District Court in a patent infringement lawsuit brought by the Company and Research Corporation Technologies, Inc., holder of the patent for Paraplatin, against Pharmachemie based on its Abbreviated New Drug Application ("ANDA"), seeking FDA approval of a generic version of Paraplatin. On March 17, 2004, the U.S. Court of Appeals for the Federal Circuit, in a 2-to-1 decision, reversed the District Court's summary judgment in favor of the Company, and directed that the case be returned to the District Court for further proceedings. The Company has filed a request that the full Federal Circuit Court rehear its decision.

        The Company believes its submission to the FDA should meet the FDA's standards for pediatric extension, and six months of pediatric exclusivity is included in the Company's plan for 2004, contributing approximately $.10 per share. However, there is no guarantee that the Company will have all or part of the benefit of a pediatric extension as generic competition for Paraplatin could develop before its previously anticipated loss of exclusivity on October 14, 2004. If multiple generic competitors were FDA-approved and could legally launch and commence sales on April 14, the Company would lose all the benefit of the additional exclusivity. In such an event, the Company intends to pursue offsetting cost-reductions.

        Bristol-Myers Squibb is a global pharmaceutical and related health care products company whose mission is to extend and enhance human life.

        ###

        This press release contains certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to plans and projections. These statements may be identified by the fact that they use words such as "anticipate", "estimate","believe" and other words and terms of similar meaning in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. These factors include, among other things, patent positions and litigation. For further details and a discussion of these and other risks and uncertainties, see the Company's Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.



GRAPHIC 4 g761343.jpg G761343.JPG begin 644 g761343.jpg M_]C_X``02D9)1@`!`0$!+@$N``#__@`\35),3%]'4D%02$E#4SI;0E))4U1/ M3"U-64524UU"4DE35$],35E%4E-3455)0D)?2U],3T=/+D504__;`$,`!P4& M!@8%!P8&!@@(!PD+$@P+"@H+%Q`1#1(;%QP<&A<:&1TA*B0='R@@&1HE,B4H M+"TO,"\=(S0X-"XW*BXO+O_```L(`!T!-0$!$0#_Q``<```"`P$``P`````` M````````!@0%!P,!`@C_Q``X$``!!`(!`P,$`@$`"`'P_]H`"`$!```_`-JSRZDU51_& MJ^U5S8%4>"A7LE7:5*<5_NH2%*/^`/GF"0:-O(+"DN[T,IMI$:*Q*?D1Q(9= M+J08LAQM7W)<&V5$%)2XD$'R=^9N.T%M"KK*=55T)L=\E^#41O3[&6G2UI2S MM3CCSB0VA([0.Y1T2G?-1Z:7]XW:3Z+*%M*>?E/JA*:^QLM]OJ1A_P``4"G\ MIW^.:AQ)RSJ/1XS=Q:!Z-93K>4$EF)"C=ZE[.AHJ(3\'Y_SSKCF?U%U>NXZ[ M$L*JZ;;]7^%8LAM:T?\`J202E7CSX/\`\'C@I02DJ40$@;)/QRLQZ_I\DKS8 MTDYN9$#BFBXV"!W)]QY`_7_?D^3(8BLEZ2^VRT-`K<4$I&SH>3^^=>+V:Y;4 MX93*M[@22P%=B4QV2X5*/L/PG_*B!R^9=2\RV\C?:M(4-^^B-\4*SJ%1S\RD MX`%:)^T^=`>VM\]_UQEY59)?U.-5+UO=3$18;6@5JV22?9(`\D MG\#B4>KM,VB)(E8_DD.!+=;:9G28'IL*[R`%=Q5X'G?['MOFE<.'#APX<.', M$RJZNY.=VCKQCQJQILP6'(UI!$E+6]N!(==`:+BM;44E0"4@`$$\IE/RE6%3 M"B1X\BB:1_!<9F7$`OMQ%Z!:2MMX]X20A:.X!25('U'?.LRHN\+F5U2S(A3% MLN*FRY\B;&0LN%2@R4-.NHV&TJ4H!7T^HLJ\ZYSLY]DW&WCSRURA*$[_`,TN M:US4D$;>2MMX%!(VE2-%!2H@!/OSZ&IIBK&IA3EM):7(90XIM+B7`DD;("DD MI4/V#H\R'J2I]OK=@3D9A+[Z8\E3;2E]@6H)7H%6CK9^='7*B)8SW.ND>=F% M8JKN4UZFJ6&RX%L2/I7]SX^25+'V_C?MY9\%Z@9KEZ%3HF'P4UC"P[&!C%75?R[EV!V@E,6+[*+CA0G9/GSH# M>B?UR'U>M\HL\%CKM(%4VPBY8#4F')4XU)24=R%MG7E))4#O1&AX/'HYME%C ME$G$J"HJG+.N9#EE*D27!&94H_2A&D=RB01YT/._QQ0Z@9DYD_2?-:ZPKC77 M5.^PQ-C!SU$;+Z>U25>-@Z/_`/'FV09<5J#%0[(:0KT4'2E@'[1SY\ZB4TZ5 MU#S'):5:Q<8ZS7SXX3Y"T!!]0$?/TC?^`1\\K>J-X>HF(3\J9;=9IZAF,Q&0 MH$!M$>?.N6P,2C9/ M8XM!C5\X1TQ'C+4I(4YO:W$I!*4:23^?('D[YH&$75Y<":JVB5PC(#2HDVN? M+K$M*DDJ4DGSX(UKXW\^_%'JMAV2/7]=GN%O(-Y6L^DN(X!J0UM1T-^"?J4" M/&P?!!'GA1=6,=DXW=Y384YA7]0PAB=%4@!U6UZ0A*B-]O>3X/E))V/D^D_/ ML[KW<8-G14\2/D$UAED-R'''8Z5*25!:2`"HI5X(/@^_+.NZB74FGS2P>QUA M$C'7U-F()?W)2G:R7-:\:)\#S[?OE>YG,FP;Z<3YN+US_P#=R$=LIQ048;A) M!]-)&PKMT>[?(=$[DC74KJ6O&HM<_(#\-3B9SJT#M#*M!/:#LD^/)`'[Y097 MF!S2NZ<7<.$EBDA*F)`( M_P!4/'G8.PKP!L;'QR2SGV?+RR9AAQ6I5=H93*;<1.7_`!VVC\K)3LG9`\:\ MG\<@N=8[889"N&\8:78.VBZE]LRNUIEX`%/QW$*!/^-'9]N,5?G.10ITA2G)4U121Y(^U/DK&M#QK MSL\BP^K5O*@8G9_T,)FOO9'\-!]`(.DD%.MG0\\5,3QS-:+&/Z"TP M>-;5LJ?(>GQ%2F5%;:TI["A16`%)4D^_OL:(]Q5JZ:9BCI[95D6O6A!O&YL" MH>F(6MAA/<""O?9L]P.M_!/N>-=159EC^9VF71<35*C9`TE4JN;G,^O#=1O7 MU*(0H'W\'QW?KS0VW3_,IN,YA)74L+OXKD;<:UR7%FO[9;#:'DN/$J24I"0"4*[3X'N.0,9J<@C=2\BM)F/!BG MLF&8[;O\IM?:EE)2"4`[TL'V^/GD/J;A$A?3?_0S"*%OT77TK[1(2A+("^\D ME9VHD^/_`,'*?J+73F^E./293*JK**9^*W7(2XEU2WP4MA*2GP>\#NU_NC?L M>=\KZ9V;=%B#U`E$RQQ_O]>.M\LF8'-%XI<_V5E7<0?'W;WL#G1^HR9S![;' M*/`(U+`?A+C(C+FM*?=>7H>H5`]O:D;V5$J4=:URU$7*XO3_`!NH5B,>Q#*$ M0K6L>?:5ZC*6RD+0LJ[?N2DZ/YUX]^>O1O%;3&WA/U=/-E)?&:3 M\BE6'3>/D&.*J7H]U&05F4VZEY8[0HI""=)\`^?S^N6?U59C<>?# MR9UQQB>9R&TL!:""%(/U$Z/Q\_KD=&,9LU2=/(2<7*W<6-=&Z@X]FV8W$?#$SF[M31C*9L&@EM3:2E)65$'1!V?'CV\^_%U[IM MF-#0X@U7UK%M+@6QMYZ6I26R7"4_ZM/<`".U('=OW^-<>,>Q_(;KJ6K.\@K$ MU#$6#_#@PE/(==.]DK64[`^Y7C>_/Z\S>J^#S,JCUEI1RD1,AIW_`%X3CGA" MO()0HCV\I!!_6OGG!J[ZI649%>G#(=/-4`EVRD3T/,-_E2&D[4H_A).OR>56 M-U.9=/I5_7UN._W];/EJFPWVI;3*FUJ'E+H60=>!Y3OV_?A<;Z=Y=44V.,,5 MB+*>U>B^L5M26VT!0T/11W$$G0WO6M[XW1*C)V>L5CEBL><-6_6_PD$2F>\J M3VJ"NWN]B4]O_/?MS+;ZCR''<+C0[VJ$1R3F#,YDB0AP*"T*';]).B.WW]O/ M-#NLE(<<M*MA0.]^V_*C\C7@>'/&*G+*O.\UR-_&7#'MVD* MBMB8SW%3:=!*OJ\=V_?V'SR@;Q236]!;>AS",FL7^0U,2]I9M1 M.051Y+90K7ND_"A^"#H@_D#GS#DMDYA&2_Z/Q"\N!21$L%3#OH/2%N=BW7/4 MT2@K)2D]OU!*0D*'G=2[GRD-,+H*O^J8A2$2$Q%2E26>[ZNXI"QW([DE25`* M[5!1VDGSSZ4Z=XA68O$FR(!<6JR=$C;AV6FR-H9!^4H!('YXY<.'#APX<.'# MARCN<:K+BXJ+2>'W'JMPO1FPX0V'"/N*?DCX/QR\X<.'#AQ5R["JK*9D"792 M;!MR`KU(PC22V&W-["QH?=^_UQI0GM2E.R=#6S[GGGAPX<.'#APXKYIAM3E[ M<-JW>G);BN>JVB-(+0[_`(6=>Y'G1^-GC)':]&.TSZBW.Q(3WN':E:'N3\GG B3ARCRK&JO*(L6';AY<9B0B1Z2'"E+BD^P6!]R?UR\Y__V3\_ ` end
-----END PRIVACY-ENHANCED MESSAGE-----