Table of Contents
ABOUT DATAMONITOR HEALTHCARE
- About the Oncology pharmaceutical analysis team
- Richard Faint - Director of Oncology
CHAPTER 1 EXECUTIVE SUMMARY
- Scope of analysis
- Datamonitor insight into the targeted therapies market
CHAPTER 2 PIPELINE OVERVIEW
- Pipeline overview
- Pipeline by developmental phase & class of drug
- Signal transduction inhibitors and angiogenesis inhibitorsconstitute over half the current targeted therapies pipeline
- Signal transduction inhibitors & angiogenesisinhibitors dominate due to their wide applicability for use and provensuccess in the market to date
- Setbacks suffered by Gentas Genasense may have deterredother developers of apoptosis stimulators
- The specificity of monoclonal antibody target meanspatient potential is restricted, however, success of Rituxan may spurdevelopers on
- The HDAC inhibitors & cell cycle regulators arerestricted in terms of potential molecular target, hence their minimalpresence in the pipeline
- The current late-phase pipeline is relatively sparse dueto the novelty of this market
- As time progresses, the late-phase pipeline will flourishas early-phase candidates move forward in development
- Pipeline by molecular target
- Signal transduction inhibitors
- The EGFR and multiple tyrosine kinases remain the focus ofdevelopment as targets for signal transduction inhibitors
- Angiogenesis inhibitors
- The VEGFR and multiple tyrosine kinases remain the focusof development as targets for angiogenesis inhibitors
- Apoptosis stimulators
- Due to a lack of information from developers, a populartarget for apoptosis is difficult to identify
- HDAC inhibitors
- Cell cycle regulators
- Utility of CDK as a target comes from known mutation/overexpressionin some malignancies
- Other monoclonal antibodies
- The CD family of proteins allows for a highly specifictarget, with proven success via Rituxan
- Pipeline by indication
- The big four tumor types, plus melanoma and RCC are themost popular indications for development
- Constituting over half of all newly diagnosed cancercases, the big four tumor types offer significant commercial potential
- Melanoma and RCC are well characterized in terms of tumorgrowth drivers, thus making them ideal indications for the development oftargeted therapies
- Non-Hodgkins lymphoma dominates the pipeline within thehematological malignancies
- Based on incidence rates, non-Hodgkins lymphoma is themost commercially attractive hematological indication for development
- Pipeline compounds for leukemia are similar across thedifferent types, due to potential for horizontal expansion
- Pipeline by company
- At least 138 companies are involved in the currenttargeted therapies pipeline
- The majority of pipeline compounds are in early-phasetrials, hence two-thirds of companies involved are small biotechnologyfirms
- Top three companies in terms of marketed and pipelineproducts are Genentech, AstraZeneca and Pfizer
- Genentech
- AstraZeneca
- Pfizer
- Key metrics
- Datamonitor pipeline assessment summary
CHAPTER 3 PIPELINE DYNAMICS
- A diverse range of disease subtypes
- Genetic basis of cancer evolution
- Tumorigenesis is the result of cooperative accumulatedmutations
- Existing pharmacotherapy approaches provide limitedtreatment benefit
- Cytotoxic drugs lack specificity
- Hormonal or endocrine therapy provides incremental benefitin selected tumors
- Optimizing current treatment strategies is paramount
- The emergence of targeted treatment heralds a revolutionin cancer pharmacotherapy
- Dynamic cancer market offers significant commercialopportunity
- Ongoing sales growth drives the market
- Intensive R&D produces a rich developmental pipeline
- Growing patient population and significant unmet needspropel innovation in the cancer market
- Cancer epidemiology - an expanding patient base
- Significant areas of unmet need persist
- Clinical and strategic threats to the commercialization ofcancer drugs
- Progressively rising R&D costs threaten industryproductivity
- High attrition rates can be mitigated by improvedstrategic decision-making
- Lengthening drug approval process a consequence ofincreased regulatory demands
- Pharmacoeconomic pressures drive payers to implementrestrictive pricing and reimbursement policies
- Increased therapeutic and generic competition results inreduced periods of market exclusivity
- Segmentation of market will require changes in clinicaltrial methodology
CHAPTER 4 MARKET DEFINITION & PIPELINE CLASSIFICATION
- Targeted therapies overview
- The development of innovative targeted therapies
- Current therapies adversely affect non-malignant cells
- Innovative targeted therapies can address novel propertiesof tumor cells to selectively target them over normal cells
- Key issue is the identification of targets unique tocancer cells
- Market definition
- L1X3 - Antineoplastic monoclonal antibodies
- L1X9 - All other antineoplastics
- Classification of pipeline products
- Signal transduction inhibitors
- A plethora of potential targets along the signalingcascade exist
- Several signal transduction inhibitors have reached themarket, bringing with them their own sets of issues for consideration
- Angiogenesis inhibitors
- Angiogenesis as a normal biological process
- Angiogenesis is known to be abberant in tumor cellproliferation
- Angiogenesis inhibitors as viable antitumor agents cantarget a number of pathways
- At present, only one angiogenesis inhibitor exists in themarket
- Apoptosis stimulators
- Cell death can be induced via a number of differentpathways
- To date, only one apoptosis stimulator has reached themarket
- Histone deacetylase inhibitors
- Despite relative immaturity of development in this classof drugs, the potential to enhance current therapies exists
- Cell cycle inhibitors
- Despite ongoing R&D efforts, all current candidatesremain in the Phase II stage of development
- Pipeline comparator
- Current market situation
CHAPTER 5 MARKETED PRODUCTS FORECAST ANALYSIS
- Country-specific assumptions and effects
- Effect of Medicare Modernization Act in the US
- Biennial price cuts in Japan
- National Institute of Clinical Excellence in the UK
- Product assumptions and effects
- Signal transduction inhibitors
- Erbitux (cetuximab)
- Gleevec (imatinib)
- Herceptin (trastuzumab)
- Iressa (gefitinib)
- Tarceva (erlotinib)
- Targretin (bexarotene)
- Angiogenesis inhibitors
- Apoptosis stimulators
- Other monoclonal antibodies
- Bexxar (tositumomab)
- Campath (alemtuzumab)
- Mylotarg (gemtuzumab)
- MabThera/Rituxan (rituximab)
- Zevalin (ibritumomab)
- Others
- Forecasts
CHAPTER 6 PIPELINE SIGNAL TRANSDUCTION INHIBITORS ANALYSIS& FORECASTS
- Pipeline overview
- Onyx Pharmaceuticals/Bayers sorafenib (BAY 43-9006)
- Drug profile
- Multi-targeted approach allows for clinical development ina wide range of tumors
- Clinical trial data
- Sorafenib in RCC moves into preregistration
- Potential for monotherapy and combination therapy in HCC
- Combination therapy provides opportunity in malignantmelanoma
- Phase II clinical trials
- Acceptable toxicity profile
- Datamonitor comments
- Despite sorafenibs convincing single-agent activity, fullpotential will lie in combination regimens
- Potential first-to-market status and collaboration willensure sorafenib is the leading multi-kinase inhibitor
- Pfizers Sutent (sunitinib malate)
- Drug profile
- Development is ongoing in a variety of tumors due to wideapplicability of use of Sutent
- Clinical trial data
- Sutent shows significant activity among refractory GISTpatients with no alternative treatment options
- Significant activity shown in second-line treatment ofRCC, though ongoing Phase III study is exploring first-line Sutentmonotherapy
- Ongoing Phase II trial in breast cancer followingencouraging preliminary results
- Activity shown in difficult to treat population withneuroendocrine tumors, although large-scale trials are yet to be initiated
- Phase II clinical trials
- Majority of Sutents toxicities are mild in nature
- Datamonitor comments
- Initial regulatory approval will come via GIST patients,although product expansion will need to occur to increase commercialpotential
- Pfizers presence will be advantageous once Sutent gainsmarketing approval
- Abbott Laboratories Xinlay (atrasentan)
- Drug profile
- Xinlays target receptor plays a key role in cancer cellproliferation
- Clinical trial data
- ODAC decision indicates low probability of Xinlay beinggranted FDA approval for prostate cancer
- Activity of Xinlay in NSCLC similar to standardchemotherapy
- Other trials
- Datamonitor comments
- Clinical benefit among a patient population with fewtreatment options means Xinlay could fulfill a significant unmet need
- Abbotts favorable position in the prostate cancer marketwill be invaluable in Xinlays market potential
- Abgenix/Amgens ABX-EGF (panitumumab)
- Drug profile
- Overexpression of EGFR makes an ideal target for ABX-EGFdevelopment
- Clinical trial data
- ABX-EGF shows promise as monotherapy or combinationtherapy across a range of treatment settings for colorectal cancer
- Addition of ABX-EGF appears to enhance standardchemotherapy in NSCLC
- Poor results as a single agent in RCC
- Termination of development in prostate cancer
- Main side effect is a potential indicator of ABX-EGFactivity
- Datamonitor comments
- Humanized nature of ABX-EGF holds some advantages overcompetitor EGFR inhibitors
- Way forward for Amgen lies in ABX-EGF combination regimensand potential development of biomarker
- Amgens presence will ensure success, althoughprofitability may increase by targeting earlier lines of therapy
- GlaxoSmithKlines lapatinib (GW-572016)
- Drug profile
- Lapatinib is unique among the EGFR inhibitors by targetingtwo receptor tyrosine kinases
- Clinical trial data
- HER-2 overexpression in breast cancer justifies validityof lapatinibs target
- Limited single-agent activity indicates combinationregimens including lapatinib are the way forward in NSCLC
- Limited activity has terminated development of lapatinibin colorectal cancer
- Modest activity in urothelial tumors, although unclearwhether GlaxoSmithKline intends to pursue this indication
- Infrequent incidence of Grade 3 or higher toxicity
- Datamonitor comments
- Initial approval in niche breast cancer indication willexpedite subsequent approvals, with potential blockbuster status forlapatinib
- GlaxoSmithKline needs to account for deficiency inoncology market experience to take full advantage of lapatinibs potential
- Schering-Ploughs Sarasar (lonafarnib)
- Drug profile
- Previously wide range of developmental indications forSarasar has been reduced to just two
- Clinical trial data
- Main focus of Sarasar development in MDS, where greatestantitumor activity is shown
- Lack of efficacy has led to termination of pivotal PhaseIII trial in NSCLC
- Lack of clinical data makes it difficult to judgeSarasars potential in breast cancer
- Benefit shown in advanced head and neck cancer, althoughno further trials have been announced
- Limited activity as a single agent, although Sarasar mayshow potential in combination therapy in pancreatic cancer
- Despite encouraging Phase II results in urothelial tractcarcinoma, no further clinical trials are planned
- Lack of single-agent activity in colorectal cancer hashalted development in this indication
- Mild toxicity in the majority of patients, although Grade3 events do occur
- Datamonitor comments
- The FDAs recent rejection of Johnson & JohnsonsZarnestra may reduce the time between launches of the two farnesyltransferase inhibitors
- Presence in oncology market will aid commercialization ofSarasar
- Wyeths temsirolimus (CCI-779)
- Drug profile
- Temsirolimus inhibits a key pathway in tumor cellproliferation
- Clinical trial data
- Encouraging response rates seen for temsirolimus incombination with standard interferon-alfa for RCC in Phase I trials arebeing further investigated
- Substantial antitumor activity in Phase II trials inmantle cell lymphoma led to initiation of a Phase III trial in January2005
- Temsirolimus shows activity as a single agent and incombination with hormonal therapy in breast cancer
- Temsirolimus shows some activity in SCLC, although Wyethhas not stated its intention to pursue this indication
- Temsirolimus does not show activity as a single agent inmelanoma
- Despite encouraging results, Wyeth is not pursuingglioblastome multiforme as a potential indication for temsirolimus
- Mild toxicity means temsirolimus is well tolerated
- Datamonitor comments
- Lucrative opportunites exist for temsirolimus, althoughbroad commercialization would be expedited via an approval in a nicheindication
- Prior commercialization of Mylotarg has given Wyeth theexperience to launch temsirolimus successfully
- AstraZenecas Zactima (ZD-6474)
- Drug profile
- Zactimas ability to inhibit both angiogenesis and signaltransduction should in theory result in greater efficacy in certainpatient subsets
- Clinical trial data
- Phase III trials investigating Zactima in NSCLC areplanned for second half of 2005
- Phase II trial in multiple myeloma failed to meet primaryendpoint
- Other trials
- Datamonitor comments
- Zactimas survival benefit in NSCLC needs to be convincingin order to compete with Tarceva
- AstraZenecas strength in the oncology market will be keyin Zactimas success
- Janssen/Johnson & Johnsons Zarnestra (tipifarnib)
- Drug profile
- Previously wide range of developmental indications forZarnestra have been reduced to just one
- Clinical trial data
- Following rejection of an NDA, the FDA requires Phase IIIdata for Zarnestra in AML before regulatory approval can be considered
- Zarnestra shows activity in MDS, although further study isnot planned in short-term future
- Negative Phase III trial results caused termination ofdevelopment in pancreatic cancer
- Negative Phase III trial results caused termination ofdevelopment in colorectal cancer
- Zarnestra development in breast cancer remains in Phase IItrials
- Minimal activity in prostate cancer has terminateddevelopment in this indication
- Lack of activity in SCLC caused termination of Phase IItrial
- Phase I trial is ongoing for Zarnestra in combination withchemotherapy in advanced NSCLC
- Despite modest activity in brain cancer, follow-up trialshave not been initiated
- Mild toxicity is particularly significant sinceZarnestras main indication is for elderly AML patients where quality oflife is a major issue
- Datamonitor comments
- FDA rejection has caused Zarnestra to lose its lead
- Focus on gene expression profiling may lead tofragmentation of the market
- Johnson & Johnsons experience will be invaluable toZarnestra
- Zarnestras niche indication may dilute effects of itsprobable first-to-market status loss
- Bristol-Myers Squibbs dasatinib (BMS-354825)
- Drug profile
- Dasatinib shows potential to overcome Gleevec resistance
- Clinical trial data
- Dasatinib overcomes Gleevec resistance in CML patients
- Phase I study of dasatinib in solid tumors is ongoing
- Datamonitor comments
- Despite convincing clinical benefit, dasatinib alreadyfaces potential competition from Novartiss AMN-107
- Bristol-Myers Squibbs extensive oncology experience willaid commercializatioan of dasatinib
- Novartiss AMN-107
- Drug profile
- AMN-107 shows potential for greater efficacy than Gleevec
- Clinical trial data
- AMN-107 confers significant activity in Gleevec-resistantCML
- Datamonitor comments
- AMN-107 in a race with Bristol-Myers Squibbs dasatinib toreach the market first
- An opportunity for Novartis to consolidate and expand itsleading role in the CML therapy market
- Kosan Biosciences 17-AAG
- Drug profile
- Potential to disrupt a host of relevant oncology targetsmeans 17-AAG shows a wide range of applicability
- Clinical trial data
- 17-AAG as a single agent induced disease stabilization inmelanoma patients
- 17-AAG with docetaxel resulted in minor tumor responses
- 17-AAG with gemcitabine and cisplatin resulted in twopartial responses
- Some evidence of 17-AAG activity in multiple myeloma
- Phase II trials
- Datamonitor comments
- Although 17-AAGs formulation may provide setbacks,commercial potential can be increased by developing biomarkers to judgeresponse
- Kosan Biosciences should recruit the experience andresources of a key oncology player
- Forecasts
- Datamonitor drug assessment summary
CHAPTER 7 PIPELINE ANGIOGENESIS INHIBITORS ANALYSIS &FORECASTS
- Pipeline overview
- National Cancer Institutes CAI (L-651582,carboxyamidotriazole)
- Drug profile
- Clinical trials completed in a range of tumor types,although further development is unclear
- Clinical trial data
- Phase III trial failed to demonstrate any benefit of CAIover placebo in NSCLC
- Limited evidence for future development of CAI in RCC
- Some activity in ovarian cancer, although furtherdevelopment is unclear
- Datamonitor comments
- CAI left virtually redundant by Avastin and otherlate-stage pipeline angiogenesis inhibitors with superior clinicalprofiles
- Success of CAI depends solely on involvement of apharmaceutical company, which is unlikely to occur
- Aterna Zentariss Neovastat (AE-941)
- Drug profile
- Development of Neovastat scaled down to focus solely onNSCLC
- Clinical trial data
- Final results from Phase III trial in NSCLC expected in2006
- Termination of Neovastat development in RCC followingfailure of Phase III to meet its primary endpoints
- Other indications
- Datamonitor comments
- If ongoing Phase III trial does not meet its primaryendpoints, it could be the end for development of Neovastat
- Aterna Zentaris should secure a US marketing partner inorder to increase commercial potential of Neovastat
- Novartis/Schering AGs PTK-787 (vatalinib)
- Drug profile
- By targeting all known VEGFR tyrosine kinases, PTK-787should show activity across a range of tumor types
- Clinical trial data
- Anticipated regulatory filing for PTK-787 in colorectalcancer delayed to 2007 following disappointing CONFIRM-1 interim results
- Recent initiation of the Phase II GOAL Study in NSCLC
- Phase II trial is ongoing for PTK-787 in glioblastomamultiforme
- Development in other tumors remains in early phases
- Majority of reported toxicities among 1,000 patients havebeen mild to moderate in nature
- Datamonitor comments
- PTK-787s distinct advantages could recoup any negativerepurcussions from the CONFIRM-1 interim results
- Schering AG and particularly Novartiss prior oncologyexperience will be invaluable to PTK-787
- Pfizers AG-13736
- Drug profile
- Clinical trial data
- AG-13736 shows substantial antitumor activity incytokine-refractory metastatic RCC
- AG-13736 does not confer significant activity as a singleagent in AML and MDS
- Demonstration of AG-13736 activity in Phase I study insolid tumors forms the basis of ongoing Phase II trials
- Datamonitor comments
- With a strategic development plan, Pfizer may be able toovercome Avastins leading position
- Pfizers experience will be advantageous in thedevelopment of AG-13736
- Forecasts
- Datamonitor drug assessment summary
CHAPTER 8 PIPELINE APOPTOSIS STIMULATORS ANALYSIS &FORECASTS
- Pipeline overview
- Gentas Genasense (oblimersen)
- Drug profile
- Despite termination of Gentas agreement withSanofi-Aventis, Genasense remains in development for a multitude ofindications
- Clinical trial data
- Benefits of Genasense in CLL may not be enough to offsetthe addition of significant toxicity
- Long-term survival results of Genasense in malignantmelanoma are of significance
- Disappointing Phase III trial results in multiple myelomameans status of further development is unclear
- Early-phase benefits of Genasense in AML requireconfirmation in Phase III clinical trial
- Lack of clinical data in NSCLC makes it difficult to judgeGenasenses potential
- Encouraging Phase II results in prostate cancer, thoughPhase III trials have yet to be initiated
- Ongoing Phase II trial in SCLC will determine if patientbenefit counters additional toxicity
- Promise shown in combination with rituximab in NHL, butrandomized trials have yet to be initiated
- Genasense did not enhance activity of standardinterferon-alfa in RCC
- Other trials
- Datamonitor comments
- Wide range of developmental indications for Genasenseprovides Genta with a significant commercial opportunity
- Termination of agreement with Sanofi-Aventis is a majorsetback for Genta
- Teliks Telcyta (TLK286)
- Drug profile
- Synergy of Telcyta with standard cytotoxics may indicate awide ranging applicability for use
- Clinical trial data
- Convincing Phase II results have initiated two large-scalePhase III trials in ovarian cancer
- Benefit of Telcyta in combination with standardchemotherapy shown in NSCLC
- Telcyta shows some activity as a single agent in breastcancer, although final Phase II results have yet to be published
- Uncertain status of Telcyta in colorectal cancer
- Datamonitor comments
- Telik should seek initial approval of Telcyta in ovariancancer, which should expedite subsequent submissions
- In light of the competition Tarceva will provide forTelcyta, Telik would be prudent in seeking a commercialization partner
- Xenovas TransMID (XR-311)
- Drug profile
- TransMIDs target is highly relevant in brain cancer
- Clinical trial data
- Encouraging Phase II results, active clinical trialprogram and fast-track designation will drive development of TransMID
- Datamonitor comments
- Cumbersome infusion schedule and administration maydetract from TransMIDs broad clinical benefit
- Although Xenova has secured several marketingpartnerships, a glaring omission is one in the lucrative US market
- Forecasts
- Datamonitor drug assessment summary
CHAPTER 9 PIPELINE HISTONE DEACETYLASE INHIBITORS ANALYSIS& FORECASTS
- Pipeline overview
- Gloucester Pharmaceuticals FK-228 (depsipeptide)
- Drug profile
- Broad range of HDAC inhibition should theoreticallyprovide increased efficacy
- Clinical trial data
- Encouraging results in cutaneous T-cell lymphoma requirereplication in ongoing Phase III clinical trial
- A lack of clinical data exists, despite FK-228s Phase IIstatus in prostate cancer and RCC
- Datamonitor comments
- FK-228 likely to become the first HDAC inhibitor to reachthe market
- Commercial success of FK-228 will rely on GloucesterPharmaceuticals collaborating with large pharma
- Forecasts
- Datamonitor drug assessment summary
CHAPTER 10 OTHER PIPELINE MONOCLONAL ANTIBODIES ANALYSIS& FORECASTS
- Pipeline overview
- Millennium Pharmaceuticals/BZL Biologicss MLN-2704
- Drug profile
- MLN-2704 has been developed specifically for prostatecancer
- Clinical trial data
- High doses of MLN-2704 resulted in tumor response andreduction in PSA levels in progressive, metastatic HRPC patients
- Datamonitor comments
- Significant opportunity lies in the prostate cancermarket, although future expansion could occur within other tumor types
- Experience gained in commercialization of Velcade will beinvaluable in the development of MLN-2704
- Forecasts
- Datamonitor drug assessment summary
CHAPTER 11 COMMERCIAL IMPACT & LIFECYCLE MANAGEMENT:CASE STUDIES
- Introduction
- Case study 1
- Iressa and Tarceva: why the difference?
- How have two nearly identical drugs realized such varyinglevels of success in the NSCLC market?
- Iressas Phase II survival benefit was sufficient togarner FDA approval
- Concerns over Iressas potential toxicity restricted itsuse in Japan
- FDA approval of Tarceva was based on a Phase III trialthat demonstrated a two-month survival benefit in the third-line NSCLCsetting
- Phase III ISEL trial comparing Iressa with placebo inadvanced NSCLC failed to show survival benefit
- Negative repercussions of the Iressas failed Phase IIItrial
- Tarcevas potential is currently limited by Alimta in thesecond-line setting, although line extensions will increase uptake andsales
- What if Iressa had not failed?
- Could Iressa pose a threat to Tarceva?
- Future opportunities are plentiful for Tarceva and Iressa
- Case study 2
- Strategies for success: Genentech
- A leading oncology player with winning strategies
- Strengths and weaknesses of a collaborative partnership
- The prime example
- Strategies for success: Novartis
- An entirely new strategy for the pharmaceutical industry
- Early-phase development was slow...
- ...although subsequent approval and launch was remarkablyquick
- Approval for a second indication granted only nine monthsafter Gleevecs initial approval
- Opportunities for continued growth exist...
- ...although some drawbacks and threats have arisen
- The rewards of this strategy are very attractive todevelopers
- Case study 3
- The pharmacoeconomic challenges associated with targetedtherapies
- Unique pharmacoeconomic challenges will arise as targetedtherapies are included in standard chemotherapy regimens
- The cost of standard chemotherapy for cancer
- The inclusion of targeted therapies into standardtreatment regimens
- The impact of monoclonal antibody targeted therapies
- The impact of small molecule targeted therapies
- The problem of adding targeted therapies to standardchemotherapy regimens
- Further effects of pharmacoeconomic issues
- Communicating the value of targeted therapies
APPENDIX A - MARKET DATA & MAJOR BRAND KEY FACTS
- L1X3 (antineoplastic monoclonal antibodies) class marketdata
- L1X9 (all other neoplastics) class market data
- Sales data and forecasts
- PowerPoint Executive Presentation
- APPENDIX B - SALES FORECASTS
- US forecasts
- Japan forecasts
- France forecasts
- Germany forecasts
- Italy forecasts
- Spain forecasts
- UK forecasts
- EU5 forecasts
- Global forecasts
- APPENDIX C
- List of tables
- List of figures
- Methodology
- Datamonitor forecast methodology
- Forecasts for marketed drugs
- Forecasts for pipeline drugs
- Datamonitor drug assessment methodology
- List of abbreviations
- Contributing experts
- US opinion leader 1
- US opinion leader 2
- Bibliography
- About Datamonitor
- About Datamonitor Healthcare
- About the Oncology analysis team
- Disclaimer
List of Tables
- Table 1: Targeted therapies in preregistration, 2005
- Table 2: Targeted therapies in Phase III development,2005
- Table 3: Pipeline targeted therapies by developmentphase & class of drug, 2005
- Table 4: Pipeline signal transduction inhibitors bytarget, 2005
- Table 5: Pipeline angiogenesis inhibitors in developmentby target, 2005
- Table 6: Pipeline apoptosis stimulators in developmentby target, 2005
- Table 7: Pipeline cell cycle regulators in developmentby target, 2005
- Table 8: Pipeline monoclonal antibodies in developmentby target, 2005
- Table 9: Pipeline targeted therapies by indication, 2005
- Table 10: Genentechs marketed oncology portfolio, 2005
- Table 11: Genentechs pipeline oncology portfolio, 2005
- Table 12: AstraZenecas marketed oncology portfolio,2005
- Table 13: AstraZenecas pipeline oncology portfolio,2005
- Table 14: Pfizers marketed oncology portfolio, 2005
- Table 15: Pfizers pipeline oncology portfolio, 2005
- Table 16: Late-phase pipeline targeted therapies salesforecasts ($m), 2005-14
- Table 17: Datamonitor drug assessment summary
- Table 18: Common mutations involved in tumor development
- Table 19: Forecast incidence of cancer across the sevenmajor markets, 2005-13
- Table 20: Examples of naturally occurring angiogenesisstimulators
- Table 21: Current marketed products in the targetedtherapies market, (1 of 2)
- Table 22: Current marketed products in the targetedtherapies market, (2 of 2)
- Table 23: Targeted therapies sales in the seven majormarkets, 2003-04
- Table 24: Late-phase pipeline signal transductioninhibitors in development, 2005 (1 of 2)
- Table 25: Late-phase pipeline signal transductioninhibitors in development, 2005 (2 of 2)
- Table 26: Phase II pipeline signal transductioninhibitors in development, 2005 (1 of 2)
- Table 27: Phase II pipeline signal transductioninhibitors in development, 2005 (2 of 2)
- Table 28: Phase I pipeline signal transductioninhibitors in development, 2005
- Table 29: Ongoing clinical trials involving sorafenib
- Table 30: Ongoing clinical trials involving Sutent
- Table 31: Ongoing clinical trials involving Xinlay
- Table 32: Ongoing clinical trials involving ABX-EGF
- Table 33: Ongoing clinical trials involving lapatinib
- Table 34: Ongoing clinical trials involving Sarasar
- Table 35: Ongoing clinical trials involving temsirolimus
- Table 36: Ongoing clinical trials involving Zactima
- Table 37: Ongoing clinical trials involving Zarnestra
- Table 38: Ongoing clinical trials involving dasatinib
- Table 39: Ongoing clinical trials involving AMN-107
- Table 40: Ongoing clinical trials involving 17-AAG
- Table 41: Xinlay & Sutent forecasting assumptions
- Table 42: Sorafenib & ABX-EGF forecastingassumptions
- Table 43: Lapatinib & Sarasar forecastingassumptions
- Table 44: Temsirolimus & Zactima forecastingassumptions
- Table 45: Zarnestra, dasatinib & AMN-107 forecastingassumptions
- Table 46: Signal transduction inhibitors sales forecasts($m), 2005-14
- Table 47: Research/clinical and commercialattractiveness of pipeline signal transduction inhibitors (1 of 3)
- Table 48: Research/clinical and commercialattractiveness of pipeline signal transduction inhibitors (2 of 3)
- Table 49: Research/clinical and commercialattractiveness of pipeline signal transduction inhibitors (3 of 3)
- Table 50: Late-phase pipeline angiogenesis inhibitors indevelopment, 2005
- Table 51: Phase II pipeline angiogenesis inhibitors indevelopment, 2005
- Table 52: Phase I pipeline angiogenesis inhibitors indevelopment, 2005
- Table 53: Ongoing clinical trials involving Neovastat
- Table 54: Ongoing clinical trials involving PTK-787
- Table 55: Ongoing clinical trials involving AG-13736
- Table 56: PTK-787, Neovastat & AG-13736 forecastingassumptions
- Table 57: Angiogenesis inhibitors sales forecasts ($m),2005-14
- Table 58: Research/clinical and commercialattractiveness of pipeline angiogenesis inhibitors
- Table 59: Late-phase pipeline apoptosis stimulators indevelopment, 2005
- Table 60: Phase II pipeline apoptosis stimulators indevelopment, 2005 (1 of 2)
- Table 61: Phase II pipeline apoptosis stimulators indevelopment, 2005 (2 of 2)
- Table 62: Phase I pipeline apoptosis stimulators indevelopment, 2005
- Table 63: Ongoing clinical trials involving Genasense
- Table 64: Ongoing clinical trials involving Telcyta
- Table 65: Ongoing clinical trials involving TransMID
- Table 66: Genasense forecasting assumptions
- Table 67: Telcyta & TransMID forecasting assumptions
- Table 68: Apoptosis stimulators sales forecasts ($m),2005-14
- Table 69: Research/clinical and commercialattractiveness of pipeline apoptosis stimulators
- Table 70: Pipeline histone deacetylase inhibitors indevelopment, 2005
- Table 71: Ongoing clinical trials involving FK-228
- Table 72: FK-228 forecasting assumptions
- Table 73: FK-228 sales forecasts ($m), 2005-14
- Table 74: Research/clinical and commercialattractiveness of FK-228
- Table 75: Phase II/III pipeline monoclonal antibodies indevelopment, 2005 (1 of 2)
- Table 76: Phase II/III pipeline monoclonal antibodies indevelopment, 2005 (2 of 2)
- Table 77: Phase I pipeline monoclonal antibodies indevelopment, 2005
- Table 78: Ongoing clinical trials involving MLN-2704
- Table 79: MLN-2704 forecasting assumptions
- Table 80: MLN-2704 sales forecasts ($m), 2005-14
- Table 81: Research/clinical and commercialattractiveness of MLN-2704
- Table 82: Key Iressa & Tarceva events in the NSCLCmarket
- Table 83: Rituxan: key facts
- Table 84: Herceptin: key facts
- Table 85: Campath: key facts
- Table 86: Mylotarg: key facts
- Table 87: Bexxar: key facts
- Table 88: Avastin: key facts
- Table 89: Erbitux: key facts
- Table 90: Zevalin: key facts
- Table 91: Gleevec: key facts
- Table 92: Targretin: key facts
- Table 93: Iressa: key facts
- Table 94: Velcade: key facts
- Table 95: Tarceva: key facts
- Table 96: Ontak: key facts
- Table 97: Forecasts for antineoplastic monoclonalantibodies in the US, 2004-14
- Table 98: Forecasts for all other antineoplastics in theUS, 2004-14
- Table 99: Forecasts for marketed targeted therapies inJapan, 2004-14
- Table 100: Forecasts for marketed targeted therapies inFrance, 2004-14
- Table 101: Forecasts for marketed targeted therapies inGermany, 2004-14
- Table 102: Forecasts for marketed targeted therapies inItaly, 2004-14
- Table 103: Forecasts for marketed targeted therapies inSpain, 2004-14
- Table 104: Forecasts for marketed targeted therapies inthe UK, 2004-14
- Table 105: Forecasts for marketed targeted therapies inthe EU5, 2004-14
- Table 106: Global forecasts for antineoplasticmonoclonal antibodies, 2004-14
- Table 107: Global forecasts for all otherantineoplastics, 2004-14
- Table 108: Datamonitor drug assessment parameters
- Table 109: Abbreviations used in Pipeline/CommercialInsight: Innovative Targeted Therapies (1 of 2)
- Table 110: Abbreviations used in Pipeline/CommercialInsight: Innovative Targeted Therapies (2 of 2)
List of Figures
- Figure 1: Signal transduction inhibitors andangiogenesis inhibitors form the bulk of the 2005 targeted therapiespipeline
- Figure 2: A plethora of current early-phase agents willcome to light in the short-term future
- Figure 3: Targeting multiple tyrosine kinases appears tobe the current trend in R&D
- Figure 4: Targeting the primary VEGF receptor appearsthe most popular development strategy
- Figure 5: The majority of developmental agents affectunspecified apoptosis targets
- Figure 6: CDK appears to be the primary developmentaltarget for the cell cycle regulators
- Figure 7: The CD family of proteins appears mostfavorable for development
- Figure 8: Big four tumor types, plus melanoma and RCC,remain popular indications
- Figure 9: Hematological indications with the highestincidence dominate the developmental pipeline
- Figure 10: The majority of pipeline compounds are inearly-phase trials, therefore a high level of fragmentation exists
- Figure 11: Pipeline signal transduction inhibitors salesforecasts, 2005-14
- Figure 12: Pipeline angiogenesis inhibitors salesforecasts, 2005-14
- Figure 13: Pipeline apoptosis stimulators salesforecasts, 2005-14
- Figure 14: Pipeline HDAC inhibitors sales forecasts,2005-14
- Figure 15: Pipeline monoclonal antibodies salesforecasts, 2005-14
- Figure 16: Datamonitor drug assessment summary forpipeline signal transduction inhibitors
- Figure 17: Datamonitor drug assessment summary forpipeline angiogenesis inhibitors
- Figure 18: Datamonitor drug assessment summary forpipeline apoptosis stimulators
- Figure 19: Datamonitor drug assessment summary forpipeline HDAC inhibitors
- Figure 20: Datamonitor drug assessment summary forpipeline monoclonal antibodies
- Figure 21: Global oncology sales, 2002-09
- Figure 22: Oncology pipeline, 2003
- Figure 23: Forecast incidence of cancer across the sevenmajor markets, 2005-13
- Figure 24: Increasing combined incidence for breast,lung, prostate and colorectal cancer with increasing age, 2003
- Figure 25: Incidence increases, while the rate of cureand death reduces disease prevalence
- Figure 26: Point prevalence for colorectal and lungcancer differs markedly despite similar rates of incidence
- Figure 27: Unmet needs in cancer
- Figure 28: The process of tumor angiogenesis
- Figure 29: The multiple tyrosine kinase inhibitors willachieve the greatest commercial success
- Figure 30: The multiple tyrosine kinase inhibitorsappear most attractive in terms of research/clinical and commercialaspects
- Figure 31: PTK-787 is currently the front runner of theangiogenesis inhibitors due to the high patient potential of itsindication
- Figure 32: Candidates with the backing of key oncologyplayers appear most attractive among the pipeline angiogenesis inhibitors
- Figure 33: Genasense is the clear leader due to its widerange of developmental indications
- Figure 34: Route of administration may work against thepipeline apoptosis stimulators
- Figure 35: FK-228s sales are currently limited by itstarget indication
- Figure 36: A lack of clinical data and commercialexperience currently limit FK-228s attractiveness
- Figure 37: MLN-2704s commercial potential will increaseonce indications outside of prostate cancer are explored
- Figure 38: Attractiveness of MLN-2704 will increase oncedevelopment outside of prostate cancer is initiated
- Figure 39: Example of Datamonitor drug assessmentscorecard
- Figure 40: Example of Datamonitor drug assessment graph
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