經(jīng)常頭暈，未必是腦供血不足、頸椎病，警惕前庭神經(jīng)炎
關(guān)鍵詞：頸椎
正當(dāng)
Celgene
公司雄心勃勃要增強公司市場地位的時候,
Celgene
公司研制的治療牛皮癬新藥
apremalist
三期試驗卻傳出不利消息。這無疑為公司的發(fā)展雪上加霜。
Apremalist
在三期實驗中僅有三分之一的患者牛皮癬獲得很大程度抑制,而在二期實驗中,這個數(shù)目達到了
41%
。因此,一些人不看好
apremalist
能取代現(xiàn)有治療牛皮癬藥物。
此前
Celgene
公司對
Apremalist
寄予厚望,相信它將取代現(xiàn)在在售的
Amgen
的
Enbrel
和
AbbVieHumira
等藥物。
詳細(xì)英文報道：
Inmappingoutanaggressiveplanforgrowth,Celgene($CELG)executiveshavehighlightedablockbusterfuturefortheoralpsoriasisdrugapremalist.ButonSaturdayinvestigatorsrattledthecompany'sdie-hardenthusiasts,notingthatPhaseIIIdatafortheanti-inflammatorytreatmentfellshortofanearlierroundofmid-stageefficacydatawhichhadhelpedwhipuphighhopes.Nevertheless,Celgeneisonitswaytofilingforanapprovallaterthisyear,withgoododdsofwinningagreenlightfromtheFDA.
Apremalisteasilybestedtheplacebointhestudy.AthirdofthepatientsinthePhaseIIIhada75%reductioninpsoriasis,comparedtoonly5.3%inthecontrolarm.But41%ofthepatientsintheearlierPhaseIIstudyhadreachedthesamemark,leavingsomeanalystsshakingtheirheadsovertheoraldrug'siffyfuturecompetingwithestablishedbiologics.
"Overall,theefficacywasabitbelowwhatwasseeninthePhaseIItrialandappeartoplaceapremilastbelowtheinjectablebiologics,"ISI'sMarkSchoenebaumsaidinanotetoinvestorstoday."Earlyphysicianfeedbackonefficacymatchesourview,andeventhepresenterremarkedtheefficacywas'modest'duringtheofficialpresentation.However,webelievethedrugisclearlyapprovableandcouldbeadoptedbyameaningfulnumberofdermatologistsasa'bridge'betweenmethotrexate(genericpill)andbiologics.RecallthatthemajorityofdermatologistsdoNOTusebiologics--thus,eventhoughapremilast'sefficacyisbelowbiologics,webelieveitsgoodsafetyprofileandtheeaseoforaladministrationcoulddrivesignificantuse."
ButCelgene'sestimateof$1.1billionto$1.75billioninpeaksales,Schoenebaumcautioned,is"aggressive,"withmostStreetprojectionscominginwellbelowthat.
It'shardtooverestimatetheimportanceofapremalisttoCelgene.Thecompanyseesitasoneofthreelikelynewblockbusterstoinjectbillionsofnewdollarsintothecompany.Anditrepresentsakeyefforttodiversifyitsproductbase.ButthedrugwillhavetocompeteagainstAmgen's($AMGN)EnbrelandAbbVie's($ABBV)megablockbusterHumira,biologicswithapowerfulimpact.
Celgenedoeshaveashotatprovidingatherapywithanimprovedsafetyprofile,withinvestigatorsnotinga3.6%rateofseriousadverseeventscomparedto3.2%intheplacebogroup.AndwithnocasesofTBandlymphoma,athreatpresentedbythebiologics,somedoctorscouldpreferit.
"Dermatologistswantsafety.Theydon'twantlong-termmonitoringofserioussideeffectsfortheirpatients,"CelgenespokesmanBrianGilltoldTheWallStreetJournal.
"Iseethisasaprimecandidateforfuturemanagementofpsoriasisthatallowsustotreatarangeofpatients,includingmoremoderatecasesearlieron,"saidKristianReich,aninvestigatorforthecompany.