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SUMMARY
Overview
Introduction
The targeted therapies market is relatively new in comparison to the cytotoxic
and anti-hormonal therapies markets, and will therefore continue to show
double-figure growth across the seven major pharmaceutical markets to 2014.
Despite products which have already established gold-standard status within
specific tumor types, ample lucrative opportunities exist for pipeline
candidates in the market.
Scope
- Overview of the current targeted therapies market, including profiles of
key products and events impacting each during 2004-14
- Examination of the targeted therapies pipeline with in-depth clinical and
commercial profiles of Phase III candidates, plus expert opinion
- Seven-market sales forecasts from 2004 to 2014 for branded targeted
therapies and key pipeline candidates
- Detailed discussion of key strategic issues in the targeted therapies
market, plus three commercial impact and lifecycle management case studies
Report Highlights
The targeted therapies market was worth $5.1 billion in 2004, and is set to
grow at a CAGR of 13.7% to reach $13.7 billion by 2014. This is due to the
novelty of this market, allowing for further increasing sales of current
marketed products, with no immediate threat from patent expiries and generic
competition.
This sustained growth will allow established products such as
Genentech/Roche's Rituxan and Novartis's Glivec to maintain their blockbuster
status, while allowing newer products such as Genentech/Roche's Herceptin,
Avastin and Tarceva to break the $1 billion sales barrier within the forecast
period.
The introduction of high-potential pipeline products will increase the total
market value of targeted therapies to $19.2 billion by 2014. Those products
developed to inhibit multiple pathways show the most promise, particularly
Onyx Pharmaceuticals/Bayer's sorafenib and Bristol-Myers Squibb's dasatinib,
with forecast sales of over $800m by 2014.
Reasons to Purchase
- Understand market specific drivers and predict the future potential of key
marketed and pipeline targeted therapies
- Assess the impact of product launches and identify the opportunities and
risks for key products within the targeted therapies market
- Adopt knowledge to drive strategic planning for marketed products and
optimize the market penetration of new entrants
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 Genta's 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-Hodgkin's lymphoma dominates the pipeline within thehematological
malignancies
- Based on incidence rates, non-Hodgkin's 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/Bayer's 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 sorafenib's 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
- Pfizer's 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 Sutent's 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
- Pfizer's presence will be advantageous once Sutent gainsmarketing
approval
- Abbott Laboratories' Xinlay (atrasentan)
- Drug profile
- Xinlay's 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
- Abbott's favorable position in the prostate cancer marketwill be
invaluable in Xinlay's market potential
- Abgenix/Amgen's 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
- Amgen's presence will ensure success, althoughprofitability may
increase by targeting earlier lines of therapy
- GlaxoSmithKline's 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
lapatinib's 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 lapatinib's potential
- Schering-Plough's 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 judgeSarasar's 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 FDA's recent rejection of Johnson & Johnson'sZarnestra may
reduce the time between launches of the two farnesyltransferase
inhibitors
- Presence in oncology market will aid commercialization ofSarasar
- Wyeth's 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
- AstraZeneca's Zactima (ZD-6474)
- Drug profile
- Zactima's 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
- Zactima's survival benefit in NSCLC needs to be convincingin order
to compete with Tarceva
- AstraZeneca's strength in the oncology market will be keyin
Zactima's success
- Janssen/Johnson & Johnson's 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 sinceZarnestra's 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 & Johnson's experience will be invaluable toZarnestra
- Zarnestra's niche indication may dilute effects of itsprobable
first-to-market status loss
- Bristol-Myers Squibb's 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 Novartis's AMN-107
- Bristol-Myers Squibb's extensive oncology experience willaid
commercializatioan of dasatinib
- Novartis's 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 Squibb's 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-AAG's 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 Institute's 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
- Æterna Zentaris's 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
- Æterna Zentaris should secure a US marketing partner inorder to
increase commercial potential of Neovastat
- Novartis/Schering AG's 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-787's distinct advantages could recoup any negativerepurcussions
from the CONFIRM-1 interim results
- Schering AG and particularly Novartis's prior oncologyexperience
will be invaluable to PTK-787
- Pfizer's 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
Avastin's leading position
- Pfizer's experience will be advantageous in thedevelopment of
AG-13736
- Forecasts
- Datamonitor drug assessment summary
- CHAPTER 8 PIPELINE APOPTOSIS STIMULATORS ANALYSIS &FORECASTS
- Pipeline overview
- Genta's Genasense (oblimersen)
- Drug profile
- Despite termination of Genta's 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
judgeGenasense's 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
- Telik's 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
- Xenova's TransMID (XR-311)
- Drug profile
- TransMID's 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
TransMID's 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-228's 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 Biologics's 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?
- Iressa's Phase II survival benefit was sufficient togarner FDA
approval
- Concerns over Iressa's 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 Iressa's failed Phase IIItrial
- Tarceva's 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
Gleevec's 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: Genentech's marketed oncology portfolio, 2005
- Table 11: Genentech's pipeline oncology portfolio, 2005
- Table 12: AstraZeneca's marketed oncology portfolio,2005
- Table 13: AstraZeneca's pipeline oncology portfolio,2005
- Table 14: Pfizer's marketed oncology portfolio, 2005
- Table 15: Pfizer's 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-228's sales are currently limited by itstarget indication
- Figure 36: A lack of clinical data and commercialexperience currently
limit FK-228's attractiveness
- Figure 37: MLN-2704's 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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