全球医药产业研究与发展的趋势课件.ppt

1、)全球医药产业全球医药产业研究研究与发展的与发展的最新趋势最新趋势胡江滨美中药协(SAPA)北京,20041)报告内容 全球制药界新药开发最新概况 新药开发值得注意的走向 Project in-licensing项目引进 Life Cycle Management(LCM)产品周期的管理 OutsourcingWhat Why and(How)?2)223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p 2003pGlobal pharmaceutical sa

2、les(US$billion)4204450100200300400500600Yearp=projectionSource:Sales data for 1992-2001 supplied by IMS Health全球药品销售全球药品销售 1992-2003p3)0608010012014016018020019921993199419951996199719981999200020012002pYearIndexed values(1992=100)全球研发费用全球新药上市研发时间(3 year moving average)全球销售全球销售，研发费用及研发时间和新药上市全球销售，研发

3、费用及研发时间和新药上市1992-2002p4)Research Late DevelopmentEarly DevelopmentRegulatory assessmentCommercial-isationPre-clinical evaluationClinical evaluation2.9yrs1.5yrs5.7yrsUS FDA:1.0 yrsEMEA:1.3 yrs Japanese MHLW:1.4 yrsDuration(median)Attrition(Number of compounds entering stage per compound launched)911新

4、药新药 R&D 的过程的过程Target discoveryAssay developmentLead discoveryLead optimisation5)11%16%44%79%0%10%20%30%40%50%60%70%80%90%100%First human dose toMarket临床一期First patient dose toMarket临床二期First pivotal dose toMarket临床三期Submission to market申报Success rate新药上市的成功机率新药上市的成功机率6)8%13%40%77%34%46%76%88%0%10%20

5、%30%40%50%60%70%80%90%100%First human dose tomarketFirst patient dose tomarketFirst pivotal dose tomarketSubmission to marketSuccess rateChemical entitiesBiotechSuccess rate to market by product type7)Termination reasons were provided for 498 of the 538 NASs for which development was terminated betw

6、een 1999 and 2001.新药开发失败的原因新药开发失败的原因 1999-20018)目前新药开发遇到的困境 R&D成本和风险不断提高 Pipelines becoming thinner新药项目越来越少 Increasing costs for promotion新药上市的费用越来越高 Shorter product life cycles新药产品周期不断缩短 Rising generic exposure非专利药抢占市场越来越早9)面对上述的挑战，国际制药界采取了些什么对策？10)New Trends in Drug Development目前的新走向 Now the class

7、ic drug discovery model is supplemented by传统的新药开发模式由下面两种方式进行补充 Project in-licensing项目引进 Life Cycle Management(LCM)产品周期的管理 Outsourcing11)Many blockbuster drugs are externally sourced许多重磅炸弹都是从其它公司引进的。DrugLicenseeLicensorLaunched 2002 sales(mio USD)PaxilGSKNovo Nordisk 19912,055PravacholBMSSankyo19902,

8、266FosamaxMerckGentili19932,250LipitorPfizerWarner Lamb19977,972CelexaForest LabsLundbeck19981,45112)Revenues from in-licensing are increasing引进项目的产品销售正在不断提高Share of revenues from in-licensingTop 10 pharmacos*Classified products account for over 70%of prescription revenuesSource:Analyst reports;annu

9、al reports;Pharmaprojects database;literature search;McKinsey analysis13)Why License in/PartneringTo complement in-house R+D efforts对公司对公司本身本身R&D 的补充的补充To hedge against unexpected product failure or disappointing commercial performance以防不可预期的产品失败或者不佳的商业业绩以防不可预期的产品失败或者不佳的商业业绩Increasing value of devel

10、opment and marketed products through arrangements with third parties联和开发和销售联和开发和销售14)项目引进包括哪些方面 In-licensing/Partnering for global development 项目引进与联合开发 Discovery/Research Platform collaborations研究平台的合作 New drug delivery technologies新的给药剂型 Co-marketing,co-promotion联合销售 Manufacturing relationships15)

11、项目引进案例 1999-2002 CompanyTotal$MMDealBristol-Myers Squibb2,000Equity stake of$1 bn&$1 bn cash for co-development&co-promotion of IMC-225Novartis1,600Purchase from GSK of Famvir and DenavirRoche1,100Purchase from GSK of KytrilAventis450Milestones to Millenium+profit shareBayer435Investment and milesto

12、nes for MilleniumLilly250Cash/equity/loan/milestones/royalties to ISIS forISIS 3521 and antisense discovery collaborationPharmacia230Milestones to Celltech for CDP-870Schering-Plough189Vascular protection agents from AtheroGenicsGenentech185Cash/equity/milestones to OSIPfizer155Cash/milestones to On

13、yxLilly179Investment/milestones for ICOS CialisPharmacia62Milestones to Cambridge Antibody Technology16)Competitors for a given licensing dealPercent of respondentsCompetition for Deals Is Also Increasing5 years agoFewer than 33 to 55 to 8TodaySource:McKinsey survey17)Cross Functional Deal TeamStand

14、ard Processes and Team WorkResearch and DevelopmentMarketingLegalFinancePatentPreselectionInitialEvaluationFull EvaluationNegotiation18)Due DiligenceObtain and review source documentation to provide a reliable evaluation of the:Scientific rationalePreclinical SafetyDrug metabolism and pharmacokineti

15、csChemical and pharmaceutical developmentClinical efficacy and safetyRegulatory filabilityPatent status19)Large Number of Opportunities Evaluated for Every Deal Closed 110 Contacts 65 Early Assessments 17 Initial Evaluations 9 Due Diligences 3 Neogtiations 1 Deal Closed20)New Trends in Drug Developm

16、ent目前的新走向 Now the classic drug discovery model is supplemented by传统的新药开发模式由下面两种方式进行补充 Project in-licensing项目引进 Life Cycle Management(LCM)产品周期的管理 Outsourcing21)AugmentinClaritinZestrilNeurontinNeurontinFloventFloventCiproCipro-floxacinfloxacinProcritProcritLovenoxLovenoxDuragesicDuragesicDiflucanDifl

17、ucanZocorZocorPravacholPravacholZithromaxZithromaxZoloftZoloftActosActosAmbienAmbienPaxilPaxilNeupogenNeupogenNorvascNorvascFosamaxFosamaxEffexorEffexorRisperdalRisperdalSereventSereventLevaquinLevaquinAciphexAciphexPrevacklPrevacklCeliceptCeliceptTopamaxTopamaxGemzarGemzarAriceptAriceptSingulaiSing

18、ulair rAdvairAdvair/SeretideSeretide*Only drugs with revenues of more than US$100 million per year are included.Why Life Cycle Management?今后十年内专利过期的新药22)Life Cycle Management include Prolonged/Modified release dosage forms Fixed combination with other drugs Enhanced bioavailability New drug delivery

19、 principles Targeted or site-specific drug delivery23)Global Drug Delivery Market,2001Total Drug Delivery Systems Market=$42.9 billionsOralInhalationTransdermalParenteralOtherTotal Pharmaceutical Market=$350 billions24)30%11%32%19%40%26%0%10%20%30%40%50%60%70%80%90%100%Major companiesOther companies

20、Average percentage of R&D expenditure by company allocated to line extensions199719992001各大公司用于LCM方面的研发费用25)Success Story of LCMThe Cardizem Story26)Wellbutrin:Growth of a Blockbuster$millionnNCE exclusivity expires:2004nPK half-life:21 hoursn8 days to reach steady-state plasma levelWellbutrin(bupro

21、prion HCl)Story(GSK)Wellbtrin SRintroducedWellbtrin XLapproved27)Why Develop Fixed Combination Products?New patent protection Synergistic effects Better therapy Patient compliance Patient convenience Attractive market28)New Trends in Drug Development目前的新走向 Now the classic drug discovery model is sup

22、plemented by传统的新药开发模式由下面两种方式进行补充 Project in-licensing项目引进 Life Cycle Management(LCM)产品周期的管理 Outsourcing29)Outsourcing为什么要为什么要 Outsourcing?Outsourcing?1.Capacity Management 人力资源的调控人力资源的调控 2.Technology/Specific expertise 新技术新技术3.Strategic 战略上的考虑4.Cost control 控制成本5.Deadline 时间30)新药研发的费用分布新药研发的费用分布 200

23、131)010203040506019971998199920002001USANon-core marketsGermanyUKFranceJapanSource of patients for clinical trials 1997-2001Year enrolment completedPercentage of total patients recruited32)5.47.47.99.313.30.02.04.06.08.010.012.014.0 Respiratory(151)Anti-infectives(222)Cardiovascular system(174)Nervo

24、us system(383)Anti-cancer(342)Median duration of enrolment period(months)Impact of therapeutic area on enrolment period(n)=number of clinical studies 33)22%0%5%10%15%20%25%30%CMC outsourcing expenditure as apercentage of total CMC expenditure(average)18%0%5%10%15%20%25%30%Average percentage of R&D F

25、TEs working in CMC Outsourcing of CMC12%0%5%10%15%20%25%30%Average percentage of R&D expenditure invested in CMC Proportion of R&D expenditure spent on CMC activities in 2001Proportion of R&D Full Time Equivalents allocated to CMC in 2001CMC outsourcing expenditure as a percentage of total CMC expenditure34)Conclusions 结语 开发具有国内或国外水平的新药不仅要依靠企业本身的实力,还要眼光向外.有效的引进新项目及专利是目前国际上流行做法.对已有的上市产品，要利用新技术进行多次开发和产品周期管理(LCM)，以维持和延续产品的寿命和市场份额。一旦中国的产品质量，技术及GMP得已保证，Outsourcing,Generic chemical drug and biotech strategy 中国的制药企业对上述所提的问题都得到加强时，那么中国制药企业的崛起将为时不远35)Questions?谢谢谢谢!36