人社部：十年来就业局势总体稳定 失业水平保持低位

正当

Celgene

公司雄心勃勃要增强公司市场地位的时候,

Celgene

公司研制的治疗牛皮癣新药

apremalist

三期试验却传出不利消息。这无疑为公司的发展雪上加霜。

Apremalist

在三期实验中仅有三分之一的患者牛皮癣获得很大程度抑制,而在二期实验中,这个数目达到了

41%

。因此,一些人不看好

apremalist

能取代现有治疗牛皮癣药物。

此前

Celgene

公司对

Apremalist

寄予厚望,相信它将取代现在在售的

Amgen

的

Enbrel

和

AbbVieHumira

等药物。

详细英文报道：

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.