May 26, 2015

Bristol-Myers Squibb Receives Positive CHMP Opinion in the European Union for Nivolumab (Opdivo, Nivolumab BMS) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer in Previously-Treated Patients

(PRINCETON, NJ, May 22, 2015) - Bristol-Myers Squibb Company (NYSE: BMY) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending that nivolumab, a PD-1 immune checkpoint inhibitor, be granted approval for the treatment of locally advanced or metastatic squamous non-small cell lung
cancer (NSCLC) after prior chemotherapy in adults. The CHMP positive opinion will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union (EU).
Through the collaboration agreement entered into in September 2011 between ONO and BMS, ONO granted BMS exclusive rights to develop and commercialize Opdivo in the rest of the world, except in Japan, Korea and Taiwan where ONO had retained all rights to develop and commercialize the compound. In July 2014, ONO and BMS signed a new collaboration agreement in which the companies agreed to jointly develop and commercialize Opdivo, ipilimumab and three early-stage immunotherapies in Japan, South Korea and Taiwan.
In USA, Opdivo was approved under accelerated approval for the treatment of unresectable or
metastatic melanoma and disease progression following Yervoy and, if BRAF V600 mutation positive, a BRAF inhibitor in December 2014 and approved for the treatment of metastatic squamous NSCLC with progression on or after platinum-based chemotherapy in March 2015. Also, BMS has a robust clinical development program in a variety of tumor types overseas, including: Renal Cell Carcinoma (RCC), Head and Neck Cancer, Blood Cancer, Glioblastoma, Colorectal Cancer, Pancreatic Cancer, Gastric Cancer, Hepatocellular Carcinoma, Triple-Negative Breast Cancer, Small-Cell Lung Cancer, Bladder
Cancer. In Japan, ONO launched it for the treatment of unresectable melanoma in September 2014. Also, ONO is conducting clinical development programs including RCC, NSCLC, Head and Neck Cancer, Gastric Cancer, Esophageal Cancer, Hepatocellular Carcinoma and Hodgkin Lymphoma.
Attached from the following page is the press release made by BMS for your information.
Contact
ONO PHARMACEUTICAL CO., LTD. Corporate Communications public_relations@ono.co.jp

Bristol-Myers Squibb Receives Positive CHMP Opinion in the European Union for Nivolumab (Opdivo, Nivolumab BMS) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer in Previously-Treated Patients

 Nivolumab is the first PD-1 immune checkpoint inhibitor to receive a positive opinion from the CHMP in advanced non-small cell lung cancer
 Opinion based on overall survival benefit demonstrated in CheckMate -017
 CHMP positive opinion marks the second for nivolumab; positive opinion for advanced melanoma was received in April 2015
(PRINCETONN, JM, a2y22,015) - Bristol-MyerSsquibCbompany (NYSEB: MYt)odayannounced thatthCe ommittefeoMr edicinaPlroductfsoHr umanUs(eCHMPo)tfhEe uropeanMedicineAs gency (EMAh)aasdoptepdaositivoepinionrecommendintghantivolumab , PaD-1immunceheckpoint inhibitorb,geranteadpprovaflotrhtereatmenotlfocallyadvancedomr etastatiscquamounson-small celllungcance(rNSCLCa)fteprriocrhemotherapyinadultsT. hCe HMPpositivoepinionwilnlowbe reviewedbythEe uropeanCommissionw, hichatshaeuthoritytoapprovme edicinefsotrhEe uropean
Union(EU).
"Waerme ovingagatround-breakingpacteodeliveormna issionthaltooktsotransformcancer treatmenotptionfsopratients,s"aidMichaeGl iordanos,eniovricperesidentH, eadoDf evelopment, Oncology".Lasmt onthw, reeceiveCad HMPpos itivoepinionfonrivolumabfotrhtereatmenotf advancedmelanomaT. oday'asnnouncemenotpafositivoepinionfonrivolumabiNSCLCbringuss closetrodeliverinognouprromisoecfhangingthsetandardocfarfeolrungcancer."

Positive Opinion based on CheckMate -017 and -063

ThCe HMPpositivoepinioinbsaseodndatfaromCheckMat-e017anCd heckMat-e063t,wo
trialtshadtemonstratedthefficacyandsafetyonfivolumaibpnatientws itah
dvancedomr etastatic
squamouNs SCLCwhhoapdrogressefdollowingprevioucshemotherapytreatmentC. heckMat-e017 waPashasIeIIr,andomizedo,pen-labetlriatlhaitncludedpatientws hohadexperiencedisease progressiondurinoarfteornperioprlatinumdoublet-basedchemotherapyregimen.
Resultfsromparespecifiedinterimanalysis oCf heckMat-e017d,emonstratedsignificantly superioorveralslurviva(lOSw) ithnivolumavbsd.ocetaxelw, it4ha1%reductioninthreiskodfeath
(hazarrdatio0:.5[995%CI0:.440,.79p;=0.00025])T. hibsenefiwt aosbservedregardlesosPfD-L1
expressionstatusT. hestimatedone-yeasrurvivarla twe ansearldyoubledwithnivolumab(42%[95% CI3:45,0]c)omparedtdoocetaxe(l24%[95%CI1:73,1])T. hme edianOSwa9s.m2 onthistnhe
nivolumab arm(95%CI7:.31,3.3a)nd6monthisnthdeocetaxealrm(95%CI5:.17,.3).
AsecondstudyC, heckMat-e063w, aPashasIesIi ngle-armm, ultinationalm, ulticentetrriatlhat includedpatientws ithmetastat iscquamouNs SCLCwhohadprogre ssedaftereceivinpgalatinum- basetdherapayndalteasotnaedditionaslystemic treatmenrtegime(n65%opfatienthsardeceived ≥3 priotrherapies)I.nCheckMat-e063c,onfirmedobjectivreesponsreatet,hsetudy'psrimaryendpoint, wa1s4.5%(17/117()95%C=8I.72,2.2w) ithanestimatedone-yeasrurvivarlatoe4f0.8%(95%CI:
31.64,9.7a)ndmedianoveralslurvivaol8f.2month(s95%CI6:.11,0.9).
Ibn
othCheckMat-e017and-063t,herwe acsonsistenntivolumabdosingo3mf g/kgeverytwo
weeksT. hseafetyprofiloenfivolumahbabseenevaluatedinthousandospfatientesnrolleidnthe broadecrlinicaplrogramandtreatment-relatedadversevent(sAEsw) ergeenerallymanageudsing
establishesdafetyalgorithmsI.Cn heckMat-e017t,hseafetpy
rofiloenfivolumawacsonsistenwt ith
priosrtudieasndfavorablveersudsocetaxelT. reatm ent-relatedadverseventosccurreldesfsrequently withnivolumabthandocetaxe(lgrad3e-46,.9%vs5.5%r,espectively).

About Nivolumab

Bristol-MyerSsquibhbabasroadg,lobadlevelopmenptrogramtostudynivolumabimn ultiple
tumotrypecsonsistingomf ortehan50trial-asms onotherapoyirncombinatiown
ithothetrherapie-s
iwn
hichmortehan8,00patienthsavbeeenenrolledworldwide.
NivolumabecamtehfeirsPtD-1immunceheckpo initnhibitotroreceivreegulatoryapproval
anywherienthwe orldonJuly42,014whenOnoPharmaceuticaCl oa.nnouncedthairtteceived
manufacturinganmd
arketingapprovailnJapanfotrhtereatmenotpfatientws ithunresectable
melanomaI.nthUe .S.t,hUe .SF.oodanDd rugAdministratio(nFDAg)ranteidtfsirsatpprovaflor nivolumabfotrhtereatmenotpfatientws ithunresectabloemr etastatimc elanomandisease
progressionfollowing Yervo(yipilimumaba)ndiB,f RAFV600muta tiopnositiveBa, RAFinhibitorO. n
March42,015n,ivolumarbeceiveditssecondFDAapprovaflotrhtereatmenotpfatientws ith
metastatiscquamounson-smalclellluncgance(rNSC LCw) itphrogressioonn oarfteprlatinum-based chemotherapy.
Ian
dditionn,ivolumabibseininvestigatedinpatientws ithadvancednon-squamouNs SCLC.
OnApri1l72,015a,nopen-label, randomizedPhasIeIsItudy(Check Mat0e57e)valuatingnivolumab versudsocetaxeilpnreviouslytreatepdatientws ithadvancednon-squamouNs SCLCwastoppedearly becausaenassessmenctonductedbythiendepend enDt atMa onitoringCommitte(eDMCc)oncluded
thatthsetudymeitesndpointd,emonstratingsuperior overalslurvivailpnati entrseceivingnivolumab comparedtodocetaxelT. hceompanyplantso shartehesdeatwa ithealthauthorities.

About Lung Cancer

Lungcanceitrshleeadincausoecfancedreathgsloballyr,esultinginmortehan1.m5 illion
deathesacyheara,ccordingtothWe
orldHealthOrganizationN. SCLCiosnoetfhme osctommontypes
otfhdeiseasaenadccountfsoarpproximately85percenotcfasesS.urvivarlatevsardyependinognthe
stagaendtypoetfhceancewr heinidtsiagnosed
G. loballyt,hfeive-yeasrurvivarlatfeoSrtagIe
NSCLCibsetwee4n7and50percentf;oSrtagIeVNSCLCt,hfeive-yeasrurvivarlatderoptsotwo percent.

IMPORTANT SAFETY INFORMATION Immune-Mediated Pneumonitis

 Severpeneumonitiosirnterstitiallundgisease, includingfataclaseso,ccurredwithOPDIVO
treatmentA. crostshcelinicatlriaelxperiencien 691patientws itsholidtumorsf,atailmmune- mediatedpneumonitiosccurredi0n.7%(5/691o)pfatientrseceivingOPDIVOn;ocases
occurrediTn
ria1olTr ria3lI.nTria1lp,neumonitisi,ncludinginterstitiallundgiseaseo,ccurred
i3.4%(9/268o)pfatientrseceivinOg PDIVOanndonoetfh1e02patientrseceiving chemotherapyI.mmune-mediatedpneumonitiosccurredin2.2%(6/268o)pfatientrseceiving OPDIVOo;nwe ithGrad3aendfivwe ithGrad2eI.nTria3li,mmune-mediatepdneumonitis occurredin6%(7/117o)pfatientrseceivingOPDIVOi,ncludingf,ivGe rad3aendtwoGrad2e caseMs.onitopratientfsosrignasndsymptoms opfneumonitisA. dministecrorticosteroidfsor Grado2egrreateprneumonitisP.ermanently discontinuOe PDIVOfoGr rado3ea4rnd withholdOPDIVOuntirlesolutionfoGr rad2e.

Immune-Mediated Colitis

 InTria1ld,iarrheoacrolitiosccurreidn21%(57/268o)pfatientrseceivingOPDIVOand18% (18/102o)pfatientrseceivingchemotherapyI.m mune-mediatedcolitiosccurredi2n.2%(6/268)
opfatientrseceivinOPDIVOf;ivwe itGrad3aenod
nwe ithGrad2eI.nTria3ld,iarrhea
occurredi2n
1%(24/117o)pfatientrseceivinOg PDIVOG. rad3iemmune-mediatedcolitis
occurredin0.9%(1/117o)pfatientsM. onitopratientfsoirmmune-mediatedcolitisA. dminister
corticosteroidfsoGr rad2(eomf ortehand5aydsuration)3o,,c4rolitisW.
ithholdOPDIVOfor
Grado2e3rP.ermanentlydiscontinuOe PDIVO foGr rad4ceolitiosrrecurrenctolitiuspon restartingOPDIVO.

Immune-Mediated Hepatitis

 InTria1lt,herwe aasinncreasedincidencoef livetresatbnormalitie
istnhOe PDIVO-treated
groupacsomparedtothcehemotherapy-treategdroupw, ithincreaseisnAST(28%v1s2%), alkalinpehosphatas(e22%v1s3%)A, LT(16%v5s%)a,ntdotablilirubin(9%v0s)I.mmune- mediatedhepatitiosccurredin1.1%(3/268o)f patientrseceivingOPDIVOt;wwo itGh rad3e anodnwe ithGrad2eI.nTria3lt,hiencidenceosifncreaseldivetresvtaluews erAe ST(16%), alkalinpehosphatas(e14%)A, LT(12%)a,ndtotablilirubin(2.7%)M. onitopratientfsor
abnormallivetrestpsriotroanpderiodicallyduringtreatmentA. dministecrorticosteroidfsor
Grado2egrreatetrransaminaselevationsW.
ithholdOPDIVOfoGr rad2aenpdermanently
discontinuOe PDIVOfoGr rad3oe4irmmune-mediatehdepatitis.

Immune-Mediated Nephritis and Renal Dysfunction

 InTria1lt,herwe aasinncreasedincidencoeeflevatedcreatininietnhOe PDIVO-treategdroup acsomparedtthcehemotherapy-treategdrou(p13%v9s%)G. rado2e3irmmune-mediated nephritiosrrenadlysfunctiooccurreidn0.7%(2/268o)pfatientsI.nTria3lt,hiencidencoef elevatedcreatininwe a2s2%I.mmune-mediatedrenadlysfunction(Grad2eo)ccurredin0.9% (1/117o)pfatientsM. onitopratientfsoerlevat edserumcreatininperiotraonpderiodically duringtreatmentF.oGr rad2oe3srerumcreatininelevationw, ithholdOPDIVOandadminister corticosteroidsiw;f orseninognroimprovemenotccursp,ermanentldyiscontinuOe PDIVO. AdministecrorticosteroidfsoGr rad4seerumcreatininelevationanpdermanentldyiscontinue OPDIVO.

Immune-Mediated Hypothyroidism and Hyperthyroidism

 InTria1lG, rad1oe2hrypothyroidismoccurredi8%(21/268o)pfatientrseceivinOg PDIVO
anndonoetfh1e02patientrseceivingchemotherapyG. rad1oe2hryperthyroidismoccurredin
3%(8/268o)pfatientrseceivingOPDIVOand1%(1/102o)pfatientrseceivingchemotherapy. InTria3lh,ypothyroidismoccurredi4n.3%(5/117o)pfatientrseceivinOg PDIVO. Hyperthyroidismoccurredin1.7%(2/117o)pfatientsi,ncludingonGe rad2ceaseM. onitor
thyroifdunctiopnriotroanpderiodicallydurintreatmentA. dministehrormonreplacement therapyfohrypothyroidismI.nitiatme edicaml a nagemenftocrontroolhfyperthyroidism.

Other Immune-Mediated Adverse Reactions

 InTria1alnd3(n=385)t,hfeollowingclinical lysignificanitmmune-mediateaddversreeactions occurredin
anad
bducennservpearesisd,emyeliniationa,utoimmunneeuropathym, otodrysfunctiona,nd
vasculitisA. croscslinicatlrialosOf PDIVOadministeredadtose3ms g/kgan1d0mg/kg, additionacllinicallysignificanti,mmune-med iatedadversreeactionws eriedentified: hypophysitisd,iabetikcetoacidosish,ypopituitarismG, uillain-Barrséyndromea,ndmyasthenic syndromBea. seodnthseeveritoyafdversree actionw, ithholdOPDIVOa,dministehrigh-dose corticosteroidsa,ndia,fppropriatei,nitiatheormoner-eplacementtherapy.

Embryofetal Toxicity

 Basedonitms echanismoafctionO, PDIVOcancausfeetahlarmwhenadministeredtoa pregnanwt omanA. dvisperegnanwt omeontfhpeotentiarlisktfoaetusA. dvisfeemaleosf reproductivpeotentiatlouseffectivceontrace ptiodnuringtreatmenwt itOh PDIVOandfoart leas5mt onthasftetrhleasdtosoeOf PDIVO.

Lactation

 IintsoktnownwhetheOr PDIVOipsresenitnhumanmilkB. ecausme anydrugsi,ncluding antibodiesa,rexcretedinhumanmilkandbecausoetfhpeotentiaflosreriouasdversreeactions
inursinginfantfsromOPDIVOa,
dviswe omentodiscontinuberea stfeedindguringtreatment.

Serious Adverse Reactions

 InTria1ls,eriouasdversreeactionosccurredi4n1%opfatientrseceivinOg PDIVOG. rada3end
4adversreeactionosccurredin42%opfatientrseceivingOPDIVOT. hme osftrequenGt rad3e an4dadversderugreactionrseportedin2% t
 InTria3ls,eriouasdversreeactionosccurredi5n9%opfatientrseceivinOg PDIVOT. hme ost frequensteriouasdversderurgeactionrseportedin ≥2%opfatientws erdeyspneap,neumonia, chroniocbstructivpeulmonarydiseasexacerbationp,neumonitish,ypercalcemiap,leural effusionh,emoptysisa,npdain.

Common Adverse Reactions

 Thme osctommonadversreaction(s
≥20%r)eportewd ithOPDIVOinTria1wl erreash(21%)
anidnTriaw3l erfeatigu(e50%)d,yspne(a38%m),usculoskeletaplai(36%)d,ecreased appetit(e35%)c,ough(32%)n,ause(a29%)a,ndconstipation(24%).
Pleasseee USFulPlrescribinIgnformation foOr PDIVO.

Immuno-Oncology at Bristol-Myers Squibb

Surgeryr,adiationc,ytotoxioctrargetedtherapiehsavreepresentedthme ainstaoycfancer
treatmenotvetrhleassteveradle cadesb,ultong-termsurvivaalnd remainedelusivfeomr anypatientws itahdvancedisease.
paositivqeualitoylfifheave
Toaddrestshiusnmemt edicanleedB, ristol-Myers Squibbilseadingresearchinaninnovative fielodcfancerresearchandtreatmenktnownaismmuno-oncologyw, hicihnvolveasgentws hose primarymechanismitsoworkdirectlywiththbeody'ismmunseystemtofighctancerT. hceompanyis explorinvgaarietoycfompoundasndimmunotherapeutiacpproachefsopratientws itdifferenttypeosf canceri,ncludinrgesearchingthpeotentiaolcfombininigmmuno-oncologyagenttshattargedtifferent
pathwayistnhtereatmenotcfancer.
Bristol-MyerSsquibbicsommittedtoadvancintgh
seciencoeifmmuno-oncologyw, iththgeoal
ocfhangingsurvivaelxpectationasnd thwe apyatientlsivwe ithcancer.

About Bristol-Myers Squibb

Bristol-MyerSsquibbigaslobaplharmaceuticaclo mpanywhosme issionitsdoiscoverd,evelop andeliveirnnovativme edicinetshahtelpatientpsrevaiolvesrerioudsiseasesF.omr orienformation
abouBt ristol-MyerSsquibbv,isitwww.bms.como,frollowuosnTwitteart http://twitter.com/bmsnews.

Bristol-Myers Squibb Forward-Looking Statement

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. 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. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that nivolumab will receive regulatory approval in the European Union or, if approved, that it will become a commercially successful product. Forward-looking statements in this

press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb's business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb's Annual Report on

Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current

Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

###

Contacts: MediaC: arriFeernandez2,15-859-2605, carrie.fernandez@bms.com InvestorsR: anyDa ajani6,09-252-5330, ranya.dajani@bms.com
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