Puma Biotechnology, Inc.

pumabiotechnology,biotechnology,nerlynx,neratinib,neratinibtablets,breastcancer,earlystage,metastatic,drugdevelopment,pb,clinicaltrials,oncology,her+,biopharmaceutical,in-licensing,cancertreatment,oncology,extendedadjuvanttherapy,non-smallcelllungcancer,biliarycancer,extenet,summit,fb-,control,nala,tyrosinekinaseinhibitor,tbcrc-,her-mutated,egfr,egfrexon,egfrexon-mutant,her-seq,alisertib,aurorakinasea,adenosinetriphosphate–competitiveandreversibleinhibitorofaurorakinasea,inhibitorofaurorakinasea,disruptionofmitosis,apoptosisofrapidlyproliferatingtumorcells,apoptosisoftumorcells,breastcancer,smallcelllungcancer,headandneckcancer,ovariancancer,peripheraltcelllymphoma,acutemyeloidleukemia,metastaticestrogenreceptor-positive(er-positive)her-negativebreastcancer,triple-negativebreastcancer,her-negativebreastcancer,er-positivebreastcancer

pumabiotechnology,inc.isabiopharmaceuticalcompanywithafocusonthedevelopmentandcommercializationofinnovativeproductstoenhancecancercare.pumain-licensedtheglobaldevelopmentandcommercializationrightstopb(neratinib,oral),pb(neratinib,intravenous),andpbin.in,pumain-licensedglobalresearchanddevelopmentandcommercialrightstoalisertib,aselective,smallmolecule,orallyadministeredinhibitorofaurorakinasea. neratinibisapotentirreversibletyrosinekinaseinhibitorthatblockssignaltransductionthroughtheepidermalgrowthfactorreceptors,her,herandher.pumahasbeenfocusedondevelopingtheoralversionofneratinib,anditsmostadvanceddrugcandidatesaredirectedatthetreatmentofher-positivebreastcancer.pumabelievesthatneratinibhasclinicalapplicationsinthetreatmentofseveralothercancersaswell,includingnon-smallcelllungcancerandothersolidtumortypesthatover-expressorhaveamutationinher. neratinib,oralwasapprovedbytheu.s.foodanddrugadministrationinfortheextendedadjuvanttreatmentofadultpatientswithearlystageher-overexpressed/amplifiedbreastcancer,followingadjuvanttrastuzumab-basedtherapy.pumacommencedcommercialsalesofthedruginanditismarketedintheunitedstatesasnerlynx®tablets.infebruary,nerlynxwasalsoapprovedbythefdaincombinationwithcapecitabineforthetreatmentofadultpatientswithadvancedormetastaticher-positivebreastcancerwhohavereceivedtwoormoreprioranti-her-basedregimensinthemetastaticsetting. nerlynxwasgrantedmarketingauthorizationbytheeuropeancommissioninfortheextendedadjuvanttreatmentofadultpatientswithearlystagehormonereceptor-positiveher-overexpressed/amplifiedbreastcancerandwhoarelessthanoneyearfromcompletionofprioradjuvanttrastuzumab-basedtherapy.commercialsalescommencedintheeuropeanunionin. pumahasenteredintoadditionalexclusivelicenseagreementswithvariouspartiestocommercializenerlynxinregionsoutsidetheunitedstates,includingtheeuropeanunion,canada,latinamerica,greaterchina,israel,southeastasia,australia,newzealand,southkorea,themiddleeast,andpartsofafrica.pumaplanstocontinuetopursuethecommercializationofnerlynxoutsidetheunitedstates. alisertibisanadenosinetriphosphate–competitiveandreversibleinhibitorofaurorakinaseaandresultsindisruptionofmitosisleadingtoapoptosisofrapidlyproliferatingtumorcellsthataredependentonaurorakinasea.alisertibhasbeentestedinclinicaltrialsinpatientswithmetastaticcancersincludingbreastcancer,smallcelllungcancer,headandneckcancer,ovariancancer,peripheraltcelllymphomaandacutemyeloidleukemia.pumainitiallyintendstofocusthedevelopmentofalisertibonthetreatmentofpatientswithmetastaticestrogenreceptor-positive(er-positive)her-negativebreastcancer,triple-negativebreastcancerandsmallcelllungcancer. alanh.auerbachhasservedaschairmanoftheboard,ceoandpresidentofpumabiotechnology,inc.sincehefoundedthecompanyin.priortopuma,mr.auerbachservedasceo,presidentandamemberoftheboardofdirectorsofcougarbiotechnology,inc.,fromitsinceptioninuntilitsacquisitionbyjohnson&johnsoninjuly. fromjulyuntiljanuary,mr.auerbachservedasco-chairmanoftheintegrationsteeringcommitteeatcougar(aspartofj&j),providingleadershipandoversightforthedevelopmentandglobalcommercializationofcougar&#;sleadproductcandidate,abirateroneacetate.abiraterone(zytiga)wasapprovedforthetreatmentofmetastaticprostatecancerintheu.s.inaprilandintheeuinseptember. priortofoundingcougar,fromjunetoaprilmr.auerbachwasvicepresident,seniorresearchanalystatwellsfargosecurities,wherehewasresponsibleforresearchcoverageofsmall-andmid-capbiotechnologycompanies,withafocusononcology.hehadprimaryresponsibilityfortechnical,scientificandclinicalduediligence,andselectedbiotechnologycompaniesfollowedbythecompany.in,mr.auerbachrankedsecondinthenasdaq/starminesurveyofanalystperformanceforstockpickinginbiotechnology.fromaugusttomay,mr.auerbachwasvicepresident,researchanalystattheseidlercompanies,inc.,wherehewasresponsibleforresearchcoverageofsmall-capbiotechnologycompanies.priortohisworkasasecuritiesanalyst,mr.auerbachworkedfordiagnosticproductscorporation,wherehedesignedandimplementedclinicaltrialsinthefieldofoncology. mr.auerbachreceivedab.s.inbiomedicalengineeringfrombostonuniversityandanm.s.inbiomedicalengineeringfromtheuniversityofsoutherncalifornia. pumabiotechnology,inc.,foundedin,isheadquarteredinlosangeles,california.additionalinformationmaybefoundathttps://www.pumabiotechnology.com. nerlynx®isaregisteredtrademarkofpumabiotechnology,inc.