最新爆料！武田将支付$22亿和解糖尿病药物艾可拓（Actos）致癌风波

2015年4月1日讯/生物谷BIOON/--上周，日本制药巨头武田（Takeda）在糖尿病市场投下了一枚重磅炸弹，该公司研发的全球首个每周口服一次的降糖药Zafatek（trelagliptinsuccinate，曲格列汀琥珀酸盐）获批，给广大2型糖尿病患者群体带来了福音。然而不幸的是，同样在糖尿病市场，武田目前正深陷于另一种糖尿病畅销药艾可拓（Actos）的致癌风波。（相关阅读：糖尿病重磅消息！全球首个每周一次口服降糖药Zafatek获批！）
本周一彭博社最新报道，据3位知情人士爆料，武田将支付超过22亿美元，用于解决因隐瞒旗下糖尿病药物艾可拓（Actos，通用名：吡格列酮）致癌风险的相关指控。据爆料，武田此次将解决在美国联邦及州立法院超过8000例法律诉讼，每个案子将支付27.5万美元，合计支付金额超过22亿美元，这也将是美国制药历史上最大的罚单之一。
知情人士透露，武田提供的解决方案是，只有那些已经提起诉讼或已经聘请律师即将提交诉讼的服用过Actos的糖尿病患者才有资格参与赔偿，这一限制条件意图帮助该公司避免支付新一波的法律诉讼。该人士透露，目前武田与联邦及州立法院尚未达成最终协议，仍有谈判失败的可能性；武田也可能选择解决其中一些诉讼，并继续在其他诉讼上进行协商。不过，也有一些律师表达了强烈的反对，认为22亿美元的赔偿金不足以支付所有已患膀胱癌的糖尿病患者。
据了解，自2013年以来，武田被指控至少在9个临床试验中隐瞒Actos的致癌风险。去年，美国联邦法院陪审团对武田及合作伙伴礼来分别处于60亿美元和30亿美元（合并90亿美元）的罚款，成为美国制药领域的最大一笔罚单。不过去年10月，这一罚单被戏剧性地降至3680万美元，降低幅度高达99%。而就在业界认为武田和礼来会松一口气，结束这场惊心动魄的诉讼攻守战时，武田和礼来的律师却表示：还要再次上诉！
武田与合作伙伴礼来自1999年开始在美国联合销售糖尿病药物艾可拓（Actos），直至2006年结束合作。之后，礼来保留Actos在亚洲及欧洲一些国家、加拿大、墨西哥的销售权。根据彭博社汇总的数据，艾可拓（Actos）在截止2011年3月的年销售额峰值高达45亿美元，约占武田当时收入的27%。另外，根据法庭文件，艾可拓（Actos）自1999年上市以来，合计销售额已超过160亿美元。目前，该药正面临着来自兰伯西（Ranbaxy）的仿制药的竞争。
英文原文：TakedaOffers$2.2BilliontoSettleActosDrugCases
(Bloomberg)--TakedaPharmaceuticalCo.hasofferedtopaymorethan$2.2billiontoresolveclaimsofhidingitsActosdiabetesmedicine’scancerrisksinwhatwouldbeoneofthelargestU.S.settlementsofpatientlawsuitstargetingdrugsordevices,threepeoplefamiliarwiththemattersaid.
OfficialsatAsia’slargestdrugmakerproposetosettlemorethan8,000lawsuitsinfederalandstatecourtsintheU.S.,saidthepeople,whoaskednottobeidentifiedbecausetheyweren’tauthorizedtospeakpubliclyabouttheoffer.
Suchadealwouldamounttoapaymentofabout$275,000foreachcase.Anysettlementwouldbethefirstinthethree-yearlitigationoverthediabetesdrug.
AfederaljuryinLouisianalastyearorderedTakedaandEliLilly&Co.topayacombined$9billionindamagestoashopkeeperwhoblamedActosforcausinghisbladdercancer.Thataward,theseventh-largestinU.S.historybasedondatacompiledbyBloomberg,waslaterreducedbymorethan99percentto$36.8millionbyajudge.
“ThisisastrongsignalthatTakedareallywantstosettlethesecasessoitcanavoidanymorehugeverdicts,”CarlTobias,whoteachesproduct-liabilitylawattheUniversityofRichmondinVirginia.“Buttheper-casenumberindicatestheydon’twanttohavetopayapremiumtosettletheseclaims.”
TeaganKnapp,anoutsidespokeswomanforOsaka,Japan-basedTakeda,didn’timmediatelyrespondtophoneande-mailmessagesafterregularbusinesshoursTuesdayseekingcommentonthesettlementofferintheActoslitigation.KazumiKobayashi,aTakedaspokesmaninTokyo,wasn’timmediatelyabletorespondtoarequestforcomment.
ProposalCritics
Afinaldealhasn’tbeenreachedandthetalkscouldstillfallapart,thepeoplesaid.Takedaalsocouldchoosetosettlesomelawyers’inventoriesofcasesunderthe$2.2billionproposalandcontinuenegotiationsonothers,thepeopleadded.
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There’soppositiontoTakeda’ssettlementofferfromsomelawyerswhohavesuedthedrugmakeroverActos,thepeoplefamiliarwithitsaid.Someattorneyscontend$2.2billionisn’tenoughcompensationforallpatientswhodevelopedbladdercanceraftertakingthedrug,thepeoplesaid.
ActossalespeakedintheyearendedMarch2011at$4.5billionandaccountedfor27percentofTakeda’srevenueatthetime,accordingtodatacompiledbyBloomberg.Actoshasgeneratedmorethan$16billioninsalessinceits1999release,accordingtocourtfilings.TakedanowfacesgenericcompetitionoverthedrugfromRanbaxyLaboratoriesLtd.
ConsolidatedLawsuits
Morethan3,500ActossuitshavebeenconsolidatedbeforeU.S.DistrictJudgeRebeccaDohertyinLafayette,Louisiana,forpretrialinformationexchanges,accordingtocourtdockets.Thecompanyfacesanother4,500casesinstatecourtsinIllinois,WestVirginia,CaliforniaandPennsylvania,accordingtocourtrecords.
UnderTakeda’soffer,onlyActospatientswhohavealreadysuedorwhohavealreadyhiredalawyertofilealawsuitwouldbeeligibletoparticipateinthesettlement,thepeoplesaid.Thatlimitationisdesignedtohelpthecompanyavoidpayingtoresolveanewwaveofsuits,thepeopleadded.
“Thereisnodealanditishighlyquestionablewhethertherewillbeonewithoutfurtherscorched-earthlitigation,”PaulPennock,oneoftwolawyersoverseeingthefederal-courtlitigationforplaintiffs,saidinane-mail“ButatleastTakedarecognizesthatattemptingtocompensatethesecancervictimsandtheirfamiliesistherightthingtodo.”
Takeda’sLawyer
TakedahiredDouglasMarvin,alawyerwithWilliams&ConnollyLLPinWashington,tohelpnegotiatethepotentialdealwithlawyersforformerActospatients,thepeoplesaid.Marvinhelpednegotiatea$4.85billionsettlementwithMercktoresolveabout30,000lawsuitsoveritswithdrawnpainkillerVioxxin2007.
Marvindidn’treturnacallseekingcommentafterregularbusinesshoursTuesday.
Takedahasfacedatleastninetrialssince2013overclaimsithidActos’scancerrisks,includingtheLouisianatrial.Thecompanyhaswonthreedefenseverdictsandotherdamageawardsagainstthedrugmakerhavebeenthrownoutorareonappeal.
Still,fivejuriesthathavereviewedtheevidenceofTakeda’shandingofActoshaveheldthecompanyliableforconsumers’injuries.
PotentialJudgments
“IfTakedacansettlethemultidistrictcasesfor$2.2billion,theyshouldsignthepapersandleavetown,”ErikGordonaprofessorattheUniversityofMichigan’sbusinessandlawschoolswhoteachesaboutclass-actionsettlements.
“Giventheresultsofthetrialssofarandthenumberofpotentialjudgmentsagainstthecompany,$2.2.billionisabargain,”Gordonadded.
FormerActosusersarguedTakedaexecutivesignoredordownplayedconcernsaboutthedrug’scancer-causingpotentialbeforeitwentonsaleintheU.S.in1999andmisledU.S.regulatorsaboutthemedicine’srisks.
LillywasTakeda’sU.S.partnerinsellingandmarketingthedrugoversevenyearsstartingin1999.Thatpartnershipendedin2006,withLillyretainingrightstosellActosinpartsofAsiaandEurope,aswellasinCanadaandMexico.
LillyofficialscontendTakedaagreedtocoveralllegalcostsstemmingfromitsU.S.salesofActosandforalltheLouisianaverdict.
Takeda’ssettlementofferismorethandoublewhatStrykerCorp.agreedtopaylastyeartoresolveclaimsoveritsrecalledartificialhipsandmorethantriplethe$650millionGermandrugmakerBoehringerIngelheimGmbHpaidtosettlelawsuitsoveritsPradaxablood-thinningdrug.
TheconsolidatedActoscasesinLouisianaareInReActos(Pioglitazone)ProductsLiabilityLitigation,11-md-02299,U.S.DistrictCourt,WesternDistrictofLouisiana(Lafayette).
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