丙肝领域，Achillion能否撼动吉利德霸主地位？

2015年4月3日讯/生物谷BIOON/--目前，生物技术巨头吉利德（Gilead）已奠定了自身在丙肝治疗领域的统治地位，这得益于该公司成功商业化推出的丙肝明星药物Sovaldi及新一代全口服丙肝鸡尾酒Harvoni，这2个药物在2014年带来了124亿美元的销售额，使其成功实现“鲤鱼跳龙门”跻身《2014年全球制药巨头收入排行Top15》榜单前10。然而，有分析师表示，吉利德的统治地位不会立刻面临威胁，然而该公司仍需要保持警觉。
最近，有传言称，吉利德在丙肝市场的份额可能会受到新的竞争对手Achillion制药公司的冲击。Achillion是美国的一家小型生物技术公司，目前也正在开发一种丙肝治疗药物，其优势在于能够以更短的治疗疗程治愈丙肝。据估计，目前全球丙肝感染者已达1.5亿人，患者群体如此庞大也难怪所有制药公司均想涉足。而吉利德可能面临的挑战还不仅仅来自Achillion，美国制药巨头默沙东（Merck&Co）也在开发另一种全口服丙肝鸡尾酒疗法。
据了解，Achillion公司在临床上推进最快的是丙肝药物ACH-3102，目前正处于II期临床。根据已发布的数据，ACH-3102/Sovaldi组合疗法8周和6周疗程，均实现了100%的治愈率，目前正在调查4周疗程的疗效。如果成功，ACH-3102/Sovaldi组合疗法将成为丙肝治疗领域疗程最短的全口服鸡尾酒。
此外，Achillion也正在尝试调查ACH-3102与其他丙肝药物的组合疗法，包括其内部在研的ACH-3422。业界目前正拭目以待Achillion能否带来同样强劲的疗效数据，以及如果成功，是否会对吉利德的霸主地位构成严重威胁。
不过，业界认为，Achillion可能需要数年的时间才能将其丙肝药物推向市场，同时也存在根本无法上市的可能性。因为Achillion开展的相关临床试验中，患者仅十多个。而根据大多数专家的意见，这些研究患者数量太少，还不足以得出药物疗效的结论。同时，还没有数据证明ACH-3422/ACH-3102组合能带来ACH-3102/Sovaldi组合的强劲疗效。有分析认为，Achillion意图超越吉利德的野心也很可能挫败，因为吉利德也正在开发一款疗程更短的丙肝药物GS5816/Sovaldi，该药预计将在2016年登陆市场。
近日，巴克莱（Barclay）分析师就在一份报告中指出，Achillion在丙肝市场实现有意义的差异化的机会很少。换句话说，巴克莱认为，Achillion的投资者在作一个危险的赌注。不过，投资者可不这么认为，在过去的12个月里，受投资者追捧Achillion公司的股价已上涨214.7%。
英文原文：DoesGileadSciences,Inc.FaceImminentThreatFromAchillionPharmaceuticals,Inc.?
Gilead’sdominanceinthehepatitisCmarketmaynotbeinanyimmediatedanger.Thecompany,nonetheless,willneedtobeonitstoeswhenitcomestothwartingcompetitioninthehepatitisCspace
GileadSciences,Inc.(NASDAQ:GILD)hasestablisheditselfasaleaderinthehepatitisCmarket,thankstothesuccessfullaunchofitshepatitisCdrugSovaldi,whichcanbeusedtotreatdifferentgenotypesofthevirus.Sovaldi’slaunchwaslaterfollowedbyanewer,moreadvancedversionofthedrugnamedHarvoni.
Thecompanyrakedinsalesof$12.4billionlastyear;however,thereisspeculationthatGileadsrevenueshareinthehepatitisCmarketmaybethreatenedbyarelativelynewentrantinthemarketbythenameofAchillionPharmaceuticals,Inc.(NASDAQ:ACHN).ItisasmallbiotechcompanythatisalsoworkingonahepatitisCdrug,whichcouldreducethetimetakenforpatientstorecoverfromthedisease.
HepatitisCimpactsover150millionpeopleacrosstheworld,andbecauseofthesheersizeofthepatientpopulationandthefactthatthisdiseasecancausefatalityinpatients,itisnosurprisethatacureforthisdiseaseissomethingthatalldrug-makerswanttolaytheirhandson.GileadmayfacecompetitionnotonlyfromAchillion,butalsofromcompaniessuchasMerck&Co.,Inc.(NYSE:MRK),whichisalsoworkingonitsownversionofahepatitisCdrug.
AchillionsmostadvancedhepatitisCdrugisACH-3102,whichiscurrentlyundergoingPhaseIItrials.Thecompanyreportedlastyearthatitwasabletoseea100%curerateinthepatientswhotookthepillincombinationwithSovaldi,inamatterofeightweeks.Thedrug-makerreportedpastFebruarythatSovaldiandACH-3102combinationcured100%ofpatientsuponsixweeksoftherapy.Thecompanyisnowstudyingtheeffectivenessofthedrugwhenitistakenforfourweeks.Thetrial,ifsuccessful,wouldmeanthatthecompanysdrugcouldbetheshortesttreatmentplantocurehepatitisCinpatients.
Moreover,AchillionisalsotryingtotesttheefficacyofACH-3102whenusedwithpotentialalternativesforSovaldi,includinganin-houseoptionbythenameofACH-3422.InvestorswillcertainlyhavetowaititouttoseewhetherAchillionisabletodeliverthesameresults,and,ifso,whetheritwillposeaseriousthreattoGileadsdominance.
However,itcouldtakeyearsforAchilliontolaunchatherapyintothemarket.Thereisalsothepossibilityofthedrugneverreachingthemarketingstageasupuntilnow,thecompanyhasonlyruntrialsinvolvingadozenpatients.Aspermostexperts,thenumberistoosmallforaconclusiononthedrugsefficacy.TheresalsolittledataprovingthatACH-3422couldyieldresultsaspotentastheACH-3102andSovaldicombination.Furthermore,Achillion’seffortstobeatGileadmaybethwartedbythefactthatGileadisalsodevelopingcutting-edgefollow-uphepatitisCtherapies.ThecompanyisexpectedtolaunchanewdrugforhepatitisC,onethatwillutilizeGS5816alongsidesofosbuvirby2016.
BarclaysanalystswroteinareportonMarch5,2015thattheyseelittleopportunityforAchilliontomeaningfullydifferentiateitselfinthehepatitisCmarket.Inotherwords,BarclaysviewsinvestmentinAchillionasariskybet.Thecompany,nonetheless,hasseenitsstockpriceincrease214.7%inthepast12months.Thestockpricegains,however,havebeeninthenegativesofarthisyear,withAchillionlosing18.5%ofitsvaluetonowbeworth$10.01apiece.
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