ONO PHARMACEUTICAL : European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab), the First and Only PD-1 Checkpoint Inhibitor Approved in Europe, for Both First-Line and Previously-Treated Advanced Melanoma Patients(164KB)

June 22, 2015

European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab), the First and Only PD-1 Checkpoint Inhibitor Approved in Europe,

for Both First-Line and Previously-Treated Advanced Melanoma Patients

(PRINCETON, NJ, June 19, 2015 - Bristol-Myers Squibb Company (NYSE: BMY) announced that the European Commission has approved Opdivo, a PD-1 immune checkpoint inhibitor, for the treatment of advanced (unresectable or metastatic) melanoma in adults, regardless of BRAF status. This approval allows for the marketing of Opdivo in all 28 Member States of the EU. It follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), which was announced on April 24, 2015.
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

European Commission Approves Bristol-Myers Squibb's Opdivo (nivolumab), the First and Only PD-1 Checkpoint Inhibitor Approved in Europe, for Both First-Line and Previously-Treated Advanced Melanoma Patients

Opdivo safety profile is consistent with previously-reported trials

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About CheckMate -066, -037

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thfeirsPthast3eriaolPafD-i1mmunceheckpoinitnhibitotrdoemonstratseuperioorveralslurvival
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mosctommon Opdivo treatment-relateAd Ews erfeatigu(e20%), pruritu(s17%)a,nndause(a16.5%). CommoandverseventistnhDe TICarmwerceonsistenwt itthhosiepnreviourseportasnidncluded nause(a41.5%)v,omitin(g21%)f,atigu(e15%)d,iarrhe(a15%a)nhdematologicatloxicitiesN. doeaths weraettributetdsotuddyrutgoxicitiyenithearrm.
CheckMat-e037iPashas3reandomize dc,ontrolledopen-labesltudyof Opdivo (n=272v)ersus investigator'cshoiccehemotherapy(ICC()n=133-)e-ithesringle-agendtacarbazinoecrarboplatinplus
paclitaxe-il-pnatientws itahdvancemd elanomwa hwo erpereviousltyreatewd ith

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metastatimc elanomaw, hicdhemonstratetdhfeirsctharacterizatioonf Opdivo benefit/risikandvanced melanomaO.tfh3e0p6reviously-treatepdatientesnrolleidtnhsetudy1,0h7amd elanomanrdeceived

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wa3s.m7 onth(s95%CI1:.99,.3)T. hme ediaOn Swa1s7.3month(s95%CI1:2.53,6.7)a,ntdhe estimateOd Sratews er6e3%(95%CI5:37,1a)otnyeear4,8%(95%CI3:85,7a)ttwoyearsa,nd41% (95%CI3:15,1a)tthreyeears.

About Opdivo

Bristol-MyerSsquibhbabasroadg,lobadlevelopmenptrogramtsotudy Opdivo imn ultiple tumotrypecsonsistinogmf orteha5nt0riala-sms onotherapoyircnombinatiown itohthetrherapie-s
iwn hicmh orteha8n,00p0atienthsavbeeeennrollewd orldwide.

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approvaflor Opdivo fotrhtereatmenotpfatientws ituhnresectabloemr etastatimc elanomandisease
progressiofnollowing Yervoy (ipilimumaba)ndiBf, RAFV60m0 uta tiopnositiveBa, RAFinhibitoOr. n
Marc4h2,015, Opdivo receiveidtsseconFdDAapprovaflotrh
tereatmenotpfatientws itmh etastatic
squamounson-smalcleluncgance(rNSCLCw) itphrogressioononarfteprlatinum-based chemotherapy.

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1p,neumonitisi,ncludinignterstitiallundgiseaseo,ccurredi3n.4%(9/268o)pfatientrseceiving OPDIVOanndonoetfh1e0p2atientrseceivincghemotherapyI.mmune-mediatepdneumonitiosccurred in2.2%(6/268o)pfatientrseceivinOg PDIVOo;nwe itGh rad3aenfdivwe itGh rad2eI.Tn ria3l,

immune-mediatepdneumonitiosccurredi6n%(7/117o)pfatientrseceivinOg PDIVOi,ncludingf,ive

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onitopratientfsosrignasndsymptomospfneumonitisA. dminister

corticosteroidfsoGr rado2egrreateprneumonitisP.ermanentldyiscontinuOe PDIVOfoGr rad3oe4r anwd ithholOd PDIVOuntirlesolutiofnoGr rad2e.

 ITn ria1ld,iarrheoacrolitiosccurredi2n1%(57/268o)pfatientrseceivinOg PDIVOan1d8%(18/102) opfatientrseceivincghemotherapyI.mmune-mediatecdolitiosccurreidn2.2%(6/268o)pfatients receivinOg PDIVOf;ivwe itGh rad3aendonwe ithGrad2eI.Tn ria3ld,iarrheoaccurreidn21% (24/117o)pfatientrseceivinOg PDIVOG. rad3iemmune-mediatecdolitiosccurreidn0.9%(1/117o)f

patientsM. onitopratientfsoirmmune-mediatedcolitis

A. dministecrorticosteroidfsoGr rad2(eomf ore

thadn5aydsuration)3,o,4crolitisW. ithholOd PDIVOfoGr rado2e3rP.ermanentldyiscontinue

OPDIVOfoGr rad4ceolitiosrrecurrenctolitiuspornestartinOg PDIVO.

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 ITn ria1lt,herwe aasnincreaseidncidencoeeflevatecdreatininietnhOe PDIVO-treatedgroupas comparedttohcehemotherapy-treatedgroup(13%v9s%)G. rad2oe3irmmune-mediatendephritiosr renadlysfunctionoccurreidn0.7%(2/268o)pfatientsI.Tn ria3lt,hiencidencoeeflevatedcreatininwe as

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 ITn ria1lG, rado1e2hrypothyroidismoccurreidn8%(21/268o)pfatientrseceivinOg PDIVOandnone otfh1e0p2atientrseceivincghemotherapyG. rado1e2hryperthyroidismoccurreidn3%(8/268o)f patientrseceivinOg PDIVOand1%(1/102o)pfatientrseceivincghemotherapyI.Tn ria3l, hypothyroidismoccurredi4n.3%(5/117o)pfatientrseceivinOg PDIVOH. yperthyroidismoccurreidn

1.7%(2/117o)pfatientsi,ncludinognGe radc2easeM. onitotrhyroidfunctiopnriotroanpderiodically durintgreatmentA. dministehrormonreeplacementtherapfyohrypothyroidismI.nitiatme edical managemenftocrontroolhfyperthyroidism.

 ITn ria1alnd3(n=385)t,hfeollowincglinicallsyignificanitmmune-mediateaddversreactionosccurred in

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oOf PDIVO.

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 ITn ria3ls,eriouasdversreeactionosccurreidn59%opfatientrseceivinOg PDIVOT. hme osftrequent seriouasdversderurgeactionrseporteidn ≥2%opfatientws erdeyspneap,neumoniac,hroniocbstructive pulmonardyiseasexacerbationp,neumonitish,ypercalcemiap,leuraelffusionh,emoptysisa,ndpain.

 Thme osctommonadversreeaction(s

≥20%r)eportewd ithOPDIVOiTn ria1wl erreas(h21%a)nidn

Tria3wl erfeatigu(e50%)d,yspne(a38%),musculoskeletaplai(n36%)d,ecreaseadppetit(e35%), coug(h32%)n,ause(a29%)a,ndconstipatio(n24%).

Please e U.SF.ulPlrescribinIgnformation foOr PDIVO.

About Advanced Melanoma

Melanomiafasormosfkicnancecrharacterizebdtyhuencontrollegdrowtohpfigment- producincgell(smelanocytesl)ocateidtnhsekinM. etastatimc elanomiatshdeeadliesftormotfhe diseasea,nodccurws hecnancesrpreadbseyontdhseurfacoetfhsekitntohoetheorrgan s,ucahtshe lympnhodesl,ungsb,raionorthearreaostfhbeodyM. elanomiatshneintmh osctommocnanceirn Europew, itahenstimate1d00,00n0ewcasedsiagnoseadnnuallaynmd orteha2n0,00d0eaths.

Immuno-Oncology at Bristol-Myers Squibb

Surgeryr,adiationc,ytotoxioctrargetetdherapiehsavreepresentetdhme ainstaoycfancer treatmenotvetrhleassteveradlecadesb,ultong-termsurvivaalnpadositivqeualitoylfifheave
remaineedlusivfeomr anpyatientws itahdvancedisease.
Taoddrestshiusnmemt edicanleedB, ristol-Myer
Ssquibiblseadinrgesearcihaninnnovative
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Bristol-MyerSsquibibcsommittetdaodvancintghseciencoeIfmmuno-Oncologyw, itthhgeoal ocfhanginsgurvivaelxpectationasntdhwe apyatientlsivwe itchancer.

About the Bristol-Myers Squibb and Ono Pharmaceutical Collaboration

I2n011t,hrougcahollaboratioangreemenwt itOh nPoharmaceuticalB, ristol-MyerSsquibb expandeidttserritoriarlights tdoeveloapncdommercialize Opdivo globalleyxcepitJnapanS,outh KoreanTd aiwanw, herOe nhoardetaineadlrlighttstohceompounadtthteimeO. Jnul2y32,014,
Bristol-MyerSsquibabnOd nPoharmaceuticaflurtheerxpandetdhceompaniess'trategiccollaboration agreementtjoointldyeveloapncdommercializme ultipliemmunotherapiea-sssinglaegentasnd combinatiornegimenf-sopratientws itchanceirJnapanS,outKh oreanTd aiwan.

About Bristol-Myers Squibb

Bristol-MyerSsquibibgaslobaplharmaceuticaclompanwy hosme issiointsdoiscoverd,evelop andeliveirnnovativme edicinetshahtelpatientpsrevaiolvesrerioudsiseasesF.omr orienformation
abouBt ristol-MyerSsquibbv,isit www.bms.como,frollowuosTn witteart 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 Opdivo will be 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:

###

Media: CarriFeernandez2,15-859-2605, carrie.fernandez@bms.com

Investors: RanyDa ajan6i,09-252-5330, ranya.dajani@bms.com

BilSlzablewsk6i,09-252-5864, william.szablewski@bms.com

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