全球医药产业研究与发展的最新趋势

1、)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美中药协 (SAPA)北京, 2004)2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) ?)3223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p 2003pGlobal pharmaceutical

2、 sales (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 1992-2003p)40608010012014016018020019921993199419951996199719981999200020012002pYearIndexed 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

3、和新药上市全球销售，研发费用及研发时间和新药上市1992-2002p)5Research 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 compoun

4、d launched)911新药新药 R&D 的过程的过程Target discoveryAssay developmentLead discoveryLead optimisation)611%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)78%13%40%77%

5、34%46%76%88%0%10%20%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 type)8Termination reasons were provided for 498 of the 538 NASs for which development

6、was terminated between 1999 and 2001.新药开发失败的原因新药开发失败的原因 1999-2001)9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)10面对上述的挑战，国际制药界采取了些什么对策？)11New Trends in Drug Develop

7、ment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 Outsourcing)12Many 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 19912,05

8、5PravacholBMSSankyo19902,266FosamaxMerckGentili19932,250LipitorPfizerWarner Lamb19977,972CelexaForest LabsLundbeck19981,451)13Revenues 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 revenue

9、sSource: Analyst reports; annual reports; Pharmaprojects database; literature search; McKinsey analysis)14Why License in/ PartneringTo complement in-house R+D efforts对公司本身对公司本身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

10、的产品失败或者不佳的商业业绩Increasing value of development and marketed products through arrangements with third parties联和开发和销售联和开发和销售)15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-prom

11、otion联合销售 Manufacturing relationships)16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

12、to Millenium + profit shareBayer435Investment and milestones for MilleniumLilly250Cash/equity/loan/milestones/royalties to ISIS forISIS 3521 and antisense discovery collaborationPharmacia230Milestones to Celltech for CDP-870Schering-Plough189Vascular protection agents from AtheroGenicsGenentech185Ca

13、sh/equity/milestones to OSIPfizer155Cash/milestones to OnyxLilly179Investment/milestones for ICOS CialisPharmacia62Milestones to Cambridge Antibody Technology)17Competitors for a given licensing dealPercent of respondentsCompetition for Deals Is Also Increasing5 years agoFewer than 33 to 55 to 8Toda

14、ySource: McKinsey survey)18Cross Functional Deal TeamStandard Processes and Team WorkResearch and DevelopmentMarketingLegalFinancePatentPreselectionInitialEvaluationFull EvaluationNegotiation)19Due DiligenceObtain and review source documentation to provide a reliable evaluation of the:Scientific rat

15、ionalePreclinical SafetyDrug metabolism and pharmacokineticsChemical and pharmaceutical developmentClinical efficacy and safetyRegulatory filabilityPatent status)20Large Number of Opportunities Evaluated for Every Deal Closed 110 Contacts 65 Early Assessments 17 Initial Evaluations 9 Due Diligences

16、3 Neogtiations 1 Deal Closed)21New Trends in Drug Development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 Outsourcing)22AugmentinClaritinZestrilNeurontinNeurontinFloventFloventCipro-Cipro-floxacinfloxac

17、inProcritProcritLovenoxLovenoxDuragesicDuragesicDiflucanDiflucanZocorZocorPravacholPravacholZithromaxZithromaxZoloftZoloftActosActosAmbienAmbienPaxilPaxilNeupogenNeupogenNorvascNorvascFosamaxFosamaxEffexorEffexorRisperdalRisperdalSereventSereventLevaquinLevaquinAciphexAciphexPrevacklPrevacklCelicept

18、CeliceptTopamaxTopamaxGemzarGemzarAriceptAriceptSingulaiSingulair rAdvair/Advair/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)23Life Cycle Management include Prolonged/Modified release dosage forms Fixed combina

19、tion with other drugs Enhanced bioavailability New drug delivery principles Targeted or site-specific drug delivery)24Global Drug Delivery Market, 2001Total Drug Delivery Systems Market = $42.9 billionsOralInhalationTransdermalParenteralOtherTotal Pharmaceutical Market = $350 billions)2530%11%32%19%

20、40%26%0%10%20%30%40%50%60%70%80%90%100%Major companiesOther companiesAverage 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)26Success Story of LCMThe Cardizem Story)27Wellbutrin: Growth of a Blockbuster $millionnNCE exclusivity expires: 2004nPK

21、half-life: 21 hoursn8 days to reach steady-state plasma levelWellbutrin (buproprion HCl) Story (GSK)Wellbtrin SRintroducedWellbtrin XLapproved)28Why Develop Fixed Combination Products? New patent protection Synergistic effects Better therapy Patient compliance Patient convenience Attractive market)2

22、9New Trends in Drug Development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 Outsourcing)30Outsourcing为什么要为什么要 Outsourcing?Outsourcing?Capacity Management 人力资源的调控人力资源的调控 Technology/Specific expertise 新技术

23、新技术Strategic 战略上的考虑Cost control 控制成本Deadline 时间)31新药研发的费用分布新药研发的费用分布 2001)32010203040506019971998199920002001USANon-core marketsGermanyUKFranceJapanSource of patients for clinical trials 1997-2001Year enrolment completedPercentage of total patients recruited)335.47.47.99.313.30.02.04.06.08.010.012.014.0 Respiratory (151) Anti-infectives (222) Cardiovascular system(174) Nervous system (383) Anti-cancer (342)Median duration of enrolment period (months)Impact of therapeutic area on e