药业新观察第1季度英文_精品文档资料下载.pdf

药业新观察第1季度英文_精品文档资料下载.pdf

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AWARDEDTOTHOMSONSCIENTFICLIMITED（THESCIENTIFICBUSNESSOFTHOMSONREUTERS）ExpertreviewfromThomsonReutersofthemostpromisingdrugschangingclinicalphase,receivingapprovalandlaunchedthisquarter,basedonthestrategicdataandinsightofThomsonReutersPharma,theworldsleadingpharmaceuticalcompetitiveintelligencesolution.THEONESTOWATCHAPHARMAMATTERSREPORT.AREviEwofJAnuARy-MARch2011.PublishEdJunE2011.ImageCopyrIght:

@#@AlessandrobianchiPHARMAMATTERS|THEONESTOWATCHFormoreinformationonThomsonReutersPharmavisitoremailPHARMAMATTERS|THEONESTOWATCHInthefaceofexternalpressuressuchasacontinuingpooreconomy,theimpendingpatentcliff,andanincreasinglytoughregulatoryenvironment,Pharmacompaniesareseekingmorepartnershipopportunitiesthaneverbefore,especiallyatanR&@#@Dlevel.Bysharingtherisks,businessesarehopingtoavoidthecostsofearlyorlatestagefailure.Partneringcanalsoallowcompaniestoaccessinnovativenewtechnologies,andthepharmaindustryisincreasinglyrecognizinghowimportantinnovationisinallareas,notjustR&@#@D.However,whilepartneringcertainlycanbearewardingmethodofusheringaproductthroughthepipeline,dueconsiderationshouldgointoeverydeal.Overall,theindustryisexpectinggrowthduetotheincreasinghealthcareneedsofanagingpopulationandhigherincidenceofchronicdisease.ThiseditionofTheOnestoWatchcontainsexamplesofcompaniesjoiningforcestoadvancetheirproductsthroughtheR&@#@Dprocess,includingHologicandKVPharmaceuticalsMakena,BaxterandDynPortsPerFluCelandGlaxoSmithKlineandChemoCentryxsCCX-832.Anti-canceragentsalsofeatureheavilyinthisissue,asinpreviousquarters,withthemostsignificantbeingYervoy,thefirsttherapyapprovedintheU.S.forunresectableormetastaticmelanomainover10years.LorusTherapeuticsLOR-253andBioMarinPharmaceuticalsBMN-110bothenteredphaseItrialsthisquarterandofferinterestinginnovativeapproachesintacklingcancer.Partneringisoneofthemajorinitiativesdrugdevelopersareutilizingtochangethewayresourcesareallocatedforportfoliomanagementandbusinessgrowth,andinthisissueweexaminesomeofthosepartneringsuccessstories.Letstakeacloserlookatthefivemostpromisingdrugslaunchedorreceivingapproval,andthenmovethrougheachclinicalphase,betweenJanuaryandMarch2011.PHARMAMATTERS|THEONESTOWATCHThEfivEMosTPRoMisingdRugslAunchEdoRREcEivingAPPRovAlDRUGDISEASECOMPANYMakenaPrematurelaborHologic/KVPharmaceuticalGraliseNeuralgiaDepomedYervoyMelanomaMedarexPREFLUCELInfluenzavirusinfectionBaxter/DynPortEdirolOsteoporosisChugai/TaishoWebeginthiseditionofTheOnestoWatchwithHologicandKVPharmaceuticalsmakena,whichinFebruary2011becamethefirstandonlyFDA-approvedtherapydesignedtoreducetheriskofprematurelabor（pretermbirth）inwomenwithahistoryofsingletonspontaneouspretermbirth.ThedrugwaslaunchedinMarch2011.Makena（formerlyknownasGestiva）isalong-actinginjectableformofthenaturally-occurringprogesterone17alpha-hydroxyprogesteronecaproate（17P）andaccordingtoitsmakersandhealthcareproviders,offersabreakthroughinthefightagainstpretermbirth,givinghopetothousandsofwomenaffectedbypretermbirth.USstatisticsforpretermbirth,definedasabirthatlessthan37completedweeksofpregnancy,revealthatoneineightbabiesisbornprematurelyandcostthecountry$26billionperyear.Furthermore,thelastquarterofacenturyhasseena35percentincreaseintherateofprematurebirths.Whilethecauseofprematurelaborisasyetunknown,recentresearchshowedthatsupplementingprogesteronelevelsinpregnantwomenwithahistoryofspontaneouspretermbirthenabledthemtoprolongtheirgestationperiodandreducecomplicationsforthemselvesandtheirbabies.Makenasapprovalwasbasedonamulticenter,double-blind,placebo-controlledNIH-fundedstudyinwhich463womenbetweenweek16and21ofpregnancyandwithahistoryofpretermbirthreceivedweeklyinjectionsofthedrugorplacebountildeliveryor37weeksgestation.A34percentreductioninpretermbirthratewasseeninMakena-treatedwomen,withresultingchildrenhavingsignificantlylowerratesofnecrotizingenterocolitis,intraventricularhemorrhage,useofsupplementaloxygenandmeannumberofdaysofrespiratorytherapy.Thedrugiscurrentlyindicatedonlyinwomenwithapriorspontaneoussingletonpretermbirthandnotintendedforuseinwomenwithmultiplegestationsorotherriskfactorsforpretermbirth.gralise,acontrolled-releasetabletformulationoftheanticonvulsantanalgesicgabapentin（Neurontin）isthesecondapproved/launcheddrugofinterestinthisissueofTheOnestoWatch.DepomeduseditsAcuFormgastricretentiondeliverytechnologytodevelopGraliseforthetreatmentofpostherpeticneuralgia（PHN）,apersistentneuropathicpai