全球醫(yī)藥產(chǎn)業(yè)研究與發(fā)展的最新趨勢(shì)ppt課件

1、全球醫(yī)藥產(chǎn)業(yè)研討與開(kāi)展全球醫(yī)藥產(chǎn)業(yè)研討與開(kāi)展的最新趨勢(shì)的最新趨勢(shì)胡江濱胡江濱美中藥協(xié)美中藥協(xié) (SAPA)北京北京, 2004報(bào)告內(nèi)容 全球制藥界新藥開(kāi)發(fā)最新概略 新藥開(kāi)發(fā)值得留意的走向 Project in-licensing工程引進(jìn) Life Cycle Management (LCM)產(chǎn)品周期的管理 OutsourcingWhat Why and (How) ?223236249285296297308337364396010020030040050060019921993199419951996199719981999200020012002p 2003pGlobal pharmace

2、utical sales (US$ billion)4204450100200300400500600Yearp = projectionSource: Sales data for 1992-2001 supplied by IMS Health全球藥品銷(xiāo)售全球藥品銷(xiāo)售 1992-2003p0608010012014016018020019921993199419951996199719981999200020012002pYearIndexed values (1992 = 100)全球研發(fā)費(fèi)用全球新藥上市研發(fā)時(shí)間 (3 year moving average)全球銷(xiāo)售全球銷(xiāo)售，研發(fā)費(fèi)用及

3、研發(fā)時(shí)間和新藥上市全球銷(xiāo)售，研發(fā)費(fèi)用及研發(fā)時(shí)間和新藥上市1992-2002pResearch 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 compo

4、und launched)911新藥新藥 R&D 的過(guò)程的過(guò)程Target discoveryAssay developmentLead discoveryLead optimisation11%16%44%79%0%10%20%30%40%50%60%70%80%90%100%First human dose toMarket臨床一期First patient dose toMarket臨床二期First pivotal dose toMarket臨床三期Submission to market申報(bào)Success rate新藥上市的勝利機(jī)率新藥上市的勝利機(jī)率8%13%40%77%34

5、%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 typeTermination reasons were provided for 498 of the 538 NASs for which development was

6、terminated between 1999 and 2001.新藥開(kāi)發(fā)失敗的緣由新藥開(kāi)發(fā)失敗的緣由 1999-2001目前新藥開(kāi)發(fā)遇到的姿態(tài) R&D本錢(qián)和風(fēng)險(xiǎn)不斷提高 Pipelines becoming thinner新藥工程越來(lái)越少 Increasing costs for promotion 新藥上市的費(fèi)用越來(lái)越高 Shorter product life cycles新藥產(chǎn)品周期不斷縮短 Rising generic exposure非專利藥搶占市場(chǎng)越來(lái)越早面對(duì)上述的挑戰(zhàn)，國(guó)際制藥界采取了些什么對(duì)策？New Trends in Drug Development目前的新走向N

7、ow the classic drug discovery model is supplemented by傳統(tǒng)的新藥開(kāi)發(fā)方式由下面兩種方式進(jìn)展補(bǔ)充Project in-licensing工程引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管理OutsourcingMany blockbuster drugs are externally sourced許多重磅炸彈都是從其它公司引進(jìn)的。Drug LicenseeLicensorLaunched 2002 sales(mio USD)Paxil GSKNovo Nordisk19912,055Pravachol BMSSan

8、kyo19902,266FosamaxMerckGentili19932,250LipitorPfizerWarner Lamb19977,972CelexaForest LabsLundbeck 19981,451Revenues from in-licensing are increasing引進(jìn)工程的產(chǎn)品銷(xiāo)售正在不斷提高Share of revenues from in-licensingTop 10 pharmacos* Classified products account for over 70 % of prescription revenuesSource: Analyst r

9、eports; annual reports; Pharmaprojects database; literature search; McKinsey analysisWhy License in/ PartneringTo complement in-house R+D efforts對(duì)公司本身對(duì)公司本身R& D 的補(bǔ)充的補(bǔ)充To hedge against unexpected product failure or disappointing commercial performance以防不可預(yù)期的產(chǎn)品失敗或者不佳的商業(yè)業(yè)績(jī)以防不可預(yù)期的產(chǎn)品失敗或者不佳的商業(yè)業(yè)績(jī)Increas

10、ing value of development and marketed products through arrangements with third parties聯(lián)和開(kāi)發(fā)和銷(xiāo)售聯(lián)和開(kāi)發(fā)和銷(xiāo)售工程引進(jìn)包括哪些方面In-licensing/Partnering for global development 工程引進(jìn)與結(jié)合開(kāi)發(fā)Discovery/Research Platform collaborations研討平臺(tái)的協(xié)作New drug delivery technologies新的給藥劑型Co-marketing, co-promotion結(jié)合銷(xiāo)售Manufacturing relat

11、ionships工程引進(jìn)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 shareBayer

12、435Investment 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 AtheroGenicsGenentech185Cash/equity/milestones to OSIPfize

13、r155Cash/milestones to OnyxLilly179Investment/milestones for ICOS CialisPharmacia62Milestones to Cambridge Antibody TechnologyCompetitors for a given licensing dealPercent of respondentsCompetition for Deals Is Also Increasing5 years agoFewer than 33 to 55 to 8TodaySource: McKinsey surveyCross Funct

14、ional Deal TeamStandard Processes and Team WorkResearch and DevelopmentMarketingLegalFinancePatentPreselectionInitialEvaluationFull EvaluationNegotiationDue DiligenceObtain and review source documentation to provide a reliable evaluation of the:Scientific rationalePreclinical SafetyDrug metabolism a

15、nd pharmacokineticsChemical and pharmaceutical developmentClinical efficacy and safetyRegulatory filabilityPatent statusLarge Number of Opportunities Evaluated for Every Deal Closed 110 Contacts 65 Early Assessments 17 Initial Evaluations 9 Due Diligences 3 Neogtiations 1 Deal ClosedNew Trends in Dr

16、ug Development目前的新走向Now the classic drug discovery model is supplemented by傳統(tǒng)的新藥開(kāi)發(fā)方式由下面兩種方式進(jìn)展補(bǔ)充Project in-licensing工程引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管理OutsourcingAugmentinClaritinZestrilNeurontinNeurontinFloventFloventCipro-Cipro-floxacinfloxacinProcritProcritLovenoxLovenoxDuragesicDuragesicDifluc

17、anDiflucanZocorZocorPravacholPravacholZithromaxZithromaxZoloftZoloftActosActosAmbienAmbienPaxilPaxilNeupogenNeupogenNorvascNorvascFosamaxFosamaxEffexorEffexorRisperdalRisperdalSereventSereventLevaquinLevaquinAciphexAciphexPrevacklPrevacklCeliceptCeliceptTopamaxTopamaxGemzarGemzarAriceptAriceptSingul

18、aiSingulair rAdvair/Advair/SeretideSeretide*Only drugs with revenues of more than US $100 million per year are included. Why Life Cycle Management ?今后十年內(nèi)專利過(guò)期的新藥Life Cycle Management includeProlonged/Modified release dosage formsFixed combination with other drugsEnhanced bioavailabilityNew drug deliv

19、ery principlesTargeted or site-specific drug deliveryGlobal Drug Delivery Market, 2001Total Drug Delivery Systems Market = $42.9 billionsOralInhalationTransdermalParenteralOtherTotal Pharmaceutical Market = $350 billions30%11%32%19%40%26%0%10%20%30%40%50%60%70%80%90%100%Major companiesOther companie

20、sAverage percentage of R&D expenditure by company allocated to line extensions199719992001各大公司用于LCM方面的研發(fā)費(fèi)用Success Story of LCMThe Cardizem StoryWellbutrin: Growth of a Blockbuster $millionnNCE exclusivity expires: 2004nPK half-life: 21 hoursn8 days to reach steady-state plasma levelWellbutrin (b

21、uproprion HCl) Story (GSK)Wellbtrin SRintroducedWellbtrin XLapprovedWhy Develop Fixed Combination Products?New patent protectionSynergistic effectsBetter therapyPatient compliancePatient convenienceAttractive marketNew Trends in Drug Development目前的新走向Now the classic drug discovery model is supplemen

22、ted by傳統(tǒng)的新藥開(kāi)發(fā)方式由下面兩種方式進(jìn)展補(bǔ)充Project in-licensing工程引進(jìn)Life Cycle Management (LCM)產(chǎn)品周期的管理OutsourcingOutsourcing為什么要 Outsourcing?Capacity Management 人力資源的調(diào)控 Technology/Specific expertise 新技術(shù)Strategic 戰(zhàn)略上的思索Cost control 控制本錢(qián)Deadline 時(shí)間新藥研發(fā)的費(fèi)用分布新藥研發(fā)的費(fèi)用分布 2001010203040506019971998199920002001USANon-core mark

23、etsGermanyUKFranceJapanSource of patients for clinical trials 1997-2001Year enrolment completedPercentage of total patients recruited5.47.47.99.313.30.02.04.06.08.010.012.014.0 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 enrolm