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SUMMARY
Overview
Introduction
Cancer treatment continues to undergo a paradigm shift with the inclusion of
molecular targeted therapies (MTT) into standard regimens. With this
transition, an entirely new set of clinical and commercial challenges have
emerged. This report analyzes the MTT market by examining the commercialized
and late-phase pipeline products, highlighting issues and strategic
recommendations for developers.
Scope
- Seven major pharmaceutical market sales forecasts from 2005 to 2015 for
approved molecular targeted therapies and key pipeline candidates
- Review of the current targeted therapies market, including profiles,
product-specific assumptions and events over the forecasted period
- Research and analysis of the targeted therapies pipeline with in-depth
clinical and commercial assessment of Phase III candidates, plus expert opinion
- Examination of product pipeline by phase, mode of action, indication, drug
class and developer, plus two commercial impact case studies
Report Highlights
In 2005, the MTT market was worth $7.5 billion and the forecast sales of
already marketed drugs in this class are expected to grow to $25.2 billion by
2015, at a CAGR of 12.9%. This growth will be driven mainly by
Genentech/Roche's Rituxan, Herceptin and Avastin as well as Novartis' Gleevec,
all of which have already reached blockbuster status.
274 different pipeline MTTs have been identified. The introduction of current
late-phase candidates, including the pre-registered agents Tykerb (lapatinib;
GlaxoSmithKline) and Zolinza (vorinostat; Merck), will further increase the
market's total value by $3.8 billion, enabling the targeted therapies market
to reach $29.1 billion in 2015.
The rise in cost of cancer treatment is unsustainable with growing
pharmacoeconomic pressures challenging healthcare payers globally. To counter
these hurdles, developers must become more effective at communicating the
value of their products. To this end, a comprehensive understanding of the
targeted therapies market and pipeline is critical.
Reasons to Purchase
- Acquire a detailed appreciation and impartial perspective of the targeted
cancer therapies market as a whole
- Consider and react to the specific events influencing the future potential
of marketed and pipeline targeted therapies
- Gain an insight into the emerging clinical, developmental and commercial
challenges and opportunities facing key developmental and marketed MTT drugs
TABLE OF CONTENTS
- ABOUT DATAMONITOR HEALTHCARE
- About the Oncology pharmaceutical analysis team
- Nish Saini - 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 and class of drug
- The cell cycle and apoptosis targeted agents make up the largest
number of MTTs in the pipeline
- Segmentation of drugs by developmental phase reflects attrition rate
of drug development in the oncology market
- Targeted therapy remains a promising anticancer drug development
strategy
- Developmental agents by phase for each class
- Pipeline by indication
- MTTs are being investigated in 29 different cancers
- The 'big four' tumor types are the most popular indications for
development
- Pipeline by mode of action
- Pipeline MTTs are being directed against a huge variety and
combination of molecular targets
- The VEGF/VEGFR family remains the focus of development for MTTs
- Pipeline by company
- There are over 150 different companies developing targeted therapies
- Top three companies in terms of number of pipeline MTT products are
Pfizer, Novartis and GlaxoSmithKline
- Pfizer
- Novartis
- GlaxoSmithKline
- 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 co-operative accumulated mutations
- Existing pharmacotherapy approaches provide limited treatment benefit
- Cytotoxic drugs lack specificity
- Hormonal or endocrine therapy provides incremental benefit in selected
tumors
- Optimizing current treatment strategies is paramount
- The emergence of targeted treatment heralds a revolution in cancer
pharmacotherapy
- Dynamic cancer market offers significant commercial opportunity
- Ongoing sales growth drives the market
- Intensive R&D produces a rich developmental pipeline
- Growing patient population and significant unmet needs propel
innovation in the cancer market
- Cancer epidemiology - an expanding patient base
- Significant areas of unmet need persist
- Clinical and strategic threats to the commercialization of cancer drugs
- Progressively rising R&D costs threaten industry productivity
- High attrition rates can be mitigated by improved strategic
decision-making
- Lengthening drug approval process - a consequence of increased
regulatory demands
- Pharmacoeconomic pressures drive payers to implement restrictive
pricing and reimbursement policies
- Therapeutic and generic competition reduces periods of market
exclusivity
- Segmentation of market will require changes in clinical trial
methodology
- CHAPTER 4 MARKET DEFINITION & PIPELINE CLASSIFICATION
- Targeted therapies overview
- The development of molecular targeted therapies
- Current therapies are less cancer cell-specific
- The strategy is to target the specific survival factors of a tumor
- Key issue is the identification of targets unique to cancer cells
- Market definition
- L1X3 - Antineoplastic monoclonal antibodies
- L1X9 - All other antineoplastics
- Classification of pipeline products
- Angiogenesis inhibitors
- Angiogenesis as a normal biological process
- Angiogenesis is known to be abberant in tumor cell proliferation
- Angiogenesis inhibitors as viable antitumor agents can target a
number of pathways
- At present, only one angiogenesis inhibitor exists in the market
- Single-target signal transduction inhibitors
- A plethora of potential targets exist along the signaling cascade
- Several signal transduction inhibitors have reached the market,
bringing with them their own sets of issues for consideration
- Multi-targeted inhibitors
- Multi-targeted inhibitors have certain advantages over single
targeted agents
- Approval of three multi-targeted inhibitors
- Cell cycle and apoptosis targeted inhibitors
- Only one cell cycle inhibitor has entered Phase III
- Cell death can be induced via a number of different pathways
- To date, only one apoptosis stimulator has reached the market
- Epigenetic modulators
- Despite relative immaturity of development in this class of drugs,
the potential to enhance current therapies exists
- Immunomodulatory and immunoconjugated therapeutics
- Antibody-based technologies are an effective anticancer approach
- 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
- Generic erosion assumptions
- Product assumptions and effects
- Angiogenesis inhibitors
- Genentech/Roche's Avastin (bevacizumab)
- Single-target signal transduction inhibitors
- ImClone/Bristol-Myers Squibb/Merck KGaA's Erbitux (cetuximab)
- Novartis's Gleevec/Glivec (imatinib)
- Genentech/Roche's Herceptin (trastuzumab)
- AstraZeneca's Iressa (gefitinib)
- OSI Pharmaceuticals/Genentech/Roche's Tarceva (erlotinib)
- Eisai's Targretin (bexarotene)
- Multi-targeted inhibitors
- Onyx Pharmaceuticals/Bayer AG's Nexavar (sorafenib)
- Bristol-Myers Squibb's Sprycel (dasatinib)
- Pfizer's Sutent (sunitinib)
- Cell cycle and apoptosis targeted agents
- Ortho Biotech/Millennium Pharmaceuticals' Velcade (bortezomib)
- Immunomodulatory and immunoconjugated therapeutics
- GlakoSmithKline's Bexxar (tositumomab)
- Schering AG/Berlex's Campath (MabCampath; alemtuzumab)
- Wyeth's Mylotarg (gemtuzumab)
- Biogen IDEC/Genentech/Roche's Rituxan/MabThera (rituximab)
- Biogen Idec/Schering AG's Zevalin (ibritumomab)
- Eisai's Ontak (Onzar; denileukin)
- Forecasts
- CHAPTER 6 PIPELINE ANGIOGENESIS INHIBITORS ANALYSIS & FORECASTS
- Pipeline overview
- AstraZeneca's AZD2171
- Drug Profile
- Clinical Trial Data
- AZD2171 as a monotherapeutic agent
- AZD2171 in combination with chemotherapy appears to be a promising
approach
- AZD2171 has potential in NSCLC in combination with standard
chemotherapy regimens and with Iressa
- Datamonitor Comments
- As a potentially more potent inhibitor of angiogenesis, and given
its formulation, AZD2171's future may be very promising
- AstraZeneca's strength in the oncology market will be key in
AZD2171's success
- GlaxoSmithKline's Pazopanib (GW 786034)
- Drug Profile
- Clinical Trial Data
- Pazopanib as a possible second-line monotherapy treatment for
metastatic RCC
- Co-administration with Tykerb may alter the pharmacokinetics of
pazopanib
- Other Indications
- Datamonitor Comments
- Initial approval in RCC will force pazopanib to compete against the
already approved Sutent and Nexavar
- Tykerb may well enhance the success of pazopanib but at what price?
- Novartis/Schering AG's Vatalanib (PTK-787)
- Drug Profile
- Clinical Trial Data
- Anticipated regulatory filing for vatalanib in CRC is becoming
increasingly unlikely following disappointing CONFIRM-1 and CONFIRM-2
interim results
- Recent update of vatalanib in Gleevec-resistant GIST patients
- Recent update of the Phase II GOAL Study in NSCLC
- Novartis/Schering AG adopt an aggressive approach, investigating
vatalanib in a number of indications
- Datamonitor Comments
- Vatalanib unlikely to compete with Avastin in the metastatic CRC
market
- Schering AG's and particularly Novartis's prior oncology experience
will be invaluable to vatalanib
- Novartis and Schering AG are determined to exploit any commercial
potential vatalanib may have
- Sanofi Aventis/Regeneron's VEGF-Trap
- Drug Profile
- Clinical Trial Data
- VEGF-Trap enters Phase III for ovarian cancer
- VEGF-Trap in Phase II for NSCLC and RCC
- Selecetd Phase I clinical studies in solid tumors
- VEGF-Trap demonstrates similar side effects to Avastin
- Datamonitor Comments
- Fierce competition with Avastin in the ovarian cancer market
- Presence in oncology field will aid commercialisation of VEGF-Trap
- Forecasts
- Datamonitor drug assessment summary
- CHAPTER 7 PIPELINE SINGLE-TARGET SIGNAL TRANSDUCTION INHIBITORS ANALYSIS
& FORECASTS
- Pipeline overview
- Amgen's Vectibix (panitumumab; ABX-EGF)
- Drug Profile
- Overexpression of EGFR makes an ideal target for Vectibix development
- Clinical Trial Data
- Vectibix is approved for metastatic CRC and showing promise in a
range of other treatment settings
- Addition of Vectibix does not enhance standard chemotherapy in NSCLC
- Vectibix fails as a single agent in RCC
- Main side effect is a potential indicator of Vectibix activity
- Datamonitor Comments
- Humanized nature of Vectibix will challenge its competitor EGFR
inhibitors
- Vectibix versus Erbitux
- Third-line setting for metastatic CRC is a good place to start
- Amgen should focus on combination regimens while considering the
intellectual property issues
- Potential development of a biomarker for Vectibix
- Amgen's presence will ensure success with profitability increasing
by targeting earlier lines of therapy
- Schering-Plough's Sarasar (Lonafarnib)
- Drug Profile
- Clinical Trial Data
- Main focus of Sarasar development in MDS, where greatest antitumor
activity is shown
- Farnesyl transferase inhibitors predominately in hematological
disorders
- Lack of efficacy has led to termination of pivotal Phase III trial
in NSCLC
- Lack of clinical data makes it difficult to judge Sarasar's
potential in breast cancer
- Initiation of a Phase II trial in Ovarian Cancer
- Benefit shown in advanced head and neck cancer, although no further
trials have been announced
- Currently no further trials planned for pancreatic cancer,
urothelial carcinoma and colorectal cancer
- Mild toxicity in the majority of patients, although grade 3 events
do occur
- Datamonitor Comments
- Sarasar's chances for approval will be delayed beyond 2007
- Sarasar racing against Johnson & Johnson's Zarnestra as the
first farnesyl transferase inhibitor to reach the market
- Presence in oncology market will aid commercialization of Sarasar
- Abbott Laboratories' Xinlay (atrasentan)
- Drug Profile
- Xinlay's target receptor plays a key role in cancer cell
proliferation
- Clinical Trial Data
- FDA do not approve Xinlay for prostate cancer
- Other trials
- Datamonitor Comments
- Despite its rejection by the FDA, Xinlay's future may still be
promising
- Abbott's favorable position in the prostate cancer market will be
invaluable
- Wyeth's Temsirolimus (CCI-779)
- Drug Profile
- Temsirolimus inhibits a key pathway in tumor cell proliferation
- Clinical Trial Data
- Promising Phase III results in RCC reported at ASCO 2006
- Temsirolimus showing promise in mantle cell lymphoma
- Temsirolimus trial in breast cancer is discontinued
- Combination studies with temsirolimus initiated in malignant melanoma
- Combination studies with temsirolimus initiated in glioblastome
multiforme
- Temsirolimus as a monotherapy
- Mild toxicity means temsirolimus is well tolerated
- Datamonitor Comments
- Targeting poor prognosis patients may eventually accelerate
temsirolimus'expansion within RCC
- Temsirolimus will have to face Velcade in the MCL market
- Prior commercialization of Mylotarg and Neumega will provide Wyeth
with valuable insight into the oncology market
- Janssen/Johnson & Johnson's Zarnestra (tipifarnib)
- Drug Profile
- Clinical Trial Data
- Following rejection of NDA, the FDA requires Phase III data for
Zarnestra in AML before regulatory approval can be considered
- Zarnestra shows activity in MDS
- Zarnestra development in breast cancer remains in Phase II trials
- Following modest activity in brain cancer, further trials have been
initiated
- Initiation of Phase II trials in large granular lymphocyte leukemia
and malignant melanoma
- Negative Phase III trial results caused termination of development
in solid tumors
- Phase I trial is ongoing for Zarnestra in combination with
chemotherapy in advanced NSCLC
- Mild toxicity is particularly significant since Zarnestra's main
indication is for elderly AML patients where quality of life is a major
issue
- Datamonitor Comments
- Schering-Plough's Sarasar catching up with Zarnestra as the first
farnesyl transferase inhibitor to reach the market
- Johnson & Johnson limiting Zarnestra's target population in the
short term
- Johnson & Johnson's experience will be invaluable to Zarnestra
- YM Bioscience's TheraCIM (Theraloc; Nimotuzumab)
- Drug Profile
- Clinical Trial Data
- Phase III for pediatric pontine (brain stem) glioma
- Phase II pediatric trial demonstrated activity
- Positive efficacy and favorable toxicity data for Phase II trial
results of TheraCIM
- Datamonitor Comments
- Phase III trial results required to verify the efficacy of this agent
- Forecasts
- Datamonitor drug assessment summary
- CHAPTER 8 PIPELINE MULTI-TARGETED INHIBITORS ANALYSIS & FORECASTS
- Pipeline overview
- GlaxoSmithKline's Tykerb/Tycerb (Lapatinib)
- Drug Profile
- Tykerb is unique among the EGFR inhibitors, targeting two receptor
tyrosine kinases
- Clinical Trial Data
- Tykerb set to penetrate the breast cancer market
- Tykerb did not meet the primary endpoint in mRCC Phase III study
- Tykerb monotherapy shows no activity in BTC but shows promise in HCC
- Tykerb appears to have little activity in SCCHN
- Other clinical trials
- Datamonitor Comments
- Tykerb's dual ErbB targeting mechanism will lead to a significant
patient potential
- Tykerb and capecitabine combination looking to become the
gold-standard for second-line metastatic beast cancer
- Tykerb's ability to threaten Herceptin still hangs in the balance
- GSK also looks to secure a future for Tykerb as part of combination
regimens
- GSK's limited oncology portfolio will be bolstered by the arrival of
Tykerb
- ChemGenex Pharmaceuticals' Ceflatonin (CGX-635, Myelostat)
- Drug Profile
- Clinical Trial Data
- Ceflatonin aims to restore Gleevec sensitivity in CML patients
- Datamonitor Comments
- Despite convincing clinical benefit, Ceflatonin will face strong
competition from Bristol-Myers Squibb's Sprycel and Novartis's Tasigna
- Ipsen's Somatuline (Lanreotide)
- Drug Profile
- Clinical Trial Data
- Somatuline enters Phase III for entero-pancreatic endocrine tumors
- Somatuline in neuroendocrine tumors
- Datamonitor Comments
- Somatuline will benefit from its marketed status
- Somatuline may end up competing with Sutent in neuroendocrine tumors
- Novartis's Tasigna (Nilotinib, AMN-107)
- Drug Profile
- Clinical Trial Data
- Tasigna receives fast track and orphan drug status for
Gleevec-resistant CML
- Promising Phase II interim data reported
- Only one BCR-ABL mutation is insensitive to Tasigna
- Tasigna shows promise for Gleevec-resistant metastatic GIST patients
- Datamonitor Comments
- Tasigna ready to challenge Bristol-Myers Squibb's already approved
Sprycel
- Novartis looking to expand its leading role in the CML therapy market
- AstraZeneca's Zactima (Vandetanib; ZD6474)
- Drug Profile
- Clinical Trial Data
- Zactima granted Orphan Drug designation and Fast Track status for
Thyroid cancer
- Following promising Phase II results, a Phase III trial of Zactima
in combination with Taxotere has begun in NSCLC
- Zactima shown to be more effective than Gefitinib in NSCLC
- Initiation of Phase II trial in Glioma
- Datamonitor Comments
- Zactima set to enjoy a monopoly of thyroid cancer niche market
- Only two other agents share the multi-targeted characteristics of
Zactima
- Zactima will need to overcome Tarceva in the NSCLC market
- AstraZeneca's strength in the oncology market will be key in
Zactima's success
- Eli Lilly's Enzastaurin (LY317615)
- Drug Profile
- Clinical Trial Data
- Enzastaurin granted Orphan Drug status by the EMEA and FDA
- Enzastaurin in Phase III for Glioblastoma Multiforme
- Enzastaurin in Phase III for B-Cell Lymphoma
- Other clinical trials
- Datamonitor Comments
- Enzastaurin fulfills significant unmet needs in recurrent GBM setting
- Eli Lilly adopt a risky stragtegy for enzastaurin in BCL
- Eli Lilly
- Cephalon's Lestaurtinib (CEP-701)
- Drug Profile
- Clinical Trial Data
- Datamonitor Comments
- Lestaurtinib may be the first in its class to reach the market
- Cephalon's recent acquisition of Trisenox will provide invaluable
experience of the leukemia market
- Forecasts
- Datamonitor drug assessment summary
- CHAPTER 9 PIPELINE CELL CYCLE AND APOPTOSIS TARGETED AGENTS ANALYSIS &
FORECASTS
- Pipeline overview
- Genta's Genasense (Oblimersen)
- Drug Profile
- Despite termination of Genta's agreement with Sanofi-Aventis,
Genasense remains in development for a multitude of indications
- Clinical Trial Data
- Benefits of Genasense in CLL may not be enough to offset the
addition of significant toxicity
- Long-term survival results of Genasense in malignant melanoma are of
significance
- Disappointing Phase III trial results in multiple myeloma means
status of further development is unclear
- Early-phase benefits of Genasense in AML require confirmation in
Phase III clinical trial
- Promise shown in combination with rituximab in NHL, but randomized
trials have yet to be initiated
- Lack of clinical data in NSCLC makes it difficult to judge
Genasense's potential
- Encouraging Phase II results in prostate cancer, though Phase III
trials have yet to be initiated
- Ongoing Phase II trial in SCLC will determine if patient benefit
counters additional toxicity
- Genasense did not enhance activity of standard interferon-alfa in RCC
- Other trials
- Datamonitor Comments
- Approval of Genasense is looking increasingly unlikely
- Termination of agreement with Sanofi-Aventis is a major setback for
Genta
- Telik's Telcyta (TLK286)
- Drug Profile
- Telcyta: a small molecule prodrug with dual antitumor activity
developed using Telcyta's TRAP technology
- Clinical Trial Data
- Telcyta has Fast Track status for both NSCLC and Ovarian cancer
- Telcyta in NSCLC
- Telcyta in ovarian cancer
- Telcyta shows some activity as a single agent in breast cancer,
although final Phase II results have yet to be published
- Datamonitor Comments
- Telik was unfortunate to use Iressa as a comparator in Telcyta's
ASSIST-2 trial
- Penetrating the second- and third-line ovarian cancer market
- Without a partner, Telik will struggle to commercialize Telcyta
- Celtic Pharma/Xenova's TransMID (XR-311)
- Drug Profile
- TransMID's target is highly relevant in glioma
- Clinical Trial Data
- Encouraging Phase II results, active clinical trial program and Fast
Track designation will drive development of TransMID
- Datamonitor Comments
- Cumbersome infusion schedule and administration may detract from
TransMID's broad clinical benefit
- Although Xenova has secured several marketing partnerships, a
glaring omission is one in the lucrative US market
- Sanofi-Aventis's Alvocidib (Flavopiridol)
- Drug Profile
- Clinical Trial Data
- Continuous infusion dosing schedules fail to demonstrate clinical
activity
- Modified dosing regimen drives further development in CLL
- Alvocidib proves ineffective in hepatocellular carcinoma
- Initiation of a Phase II trial involving alvocidib in pancreatic
cancer
- Datamonitor Comments
- Alvocidib's checkered history leaves KOLs cynical about its future
clinical potential
- Alvocidib may show more promise as part of a combination regimen
- Presence in oncology field will aid commercialization of alvocidib
- Novogen's Phenoxodiol
- Drug Profile
- Clinical Trial Data
- Phenoxodiol's Fast Track status in Ovarian Cancer
- The OVATURE trials
- Initiation of a Phase I/II trial for Phenoxodiol plus Taxotere in
ovarian cancer
- Phenoxodiol in Phase I for a variety of solid tumors
- Datamonitor Comments
- Toxicity will be the key factor for phenoxodiol's success
- Sanofi-Aventis as a marketing partner?
- Forecasts
- Datamonitor drug assessment summary
- CHAPTER 10 PIPELINE EPIGENETIC MODULATORS ANALYSIS & FORECASTS
- Pipeline overview
- Merck's Zolinza (Vorinostat, SAHA)
- Drug Profile
- Clinical Trial Data
- Zolinza granted Priority Review for CTCL following promising Phase
IIb results
- FDA granted Orphan Drug designation for multiple myeloma
- Zolinza in Phase III trial for malignant pleural mesothelioma
- Other clinical trials
- Datamonitor Comments
- Zolinza will serve to increase Merck's oncology portfolio
- Merck conscious to not limit the use of Zolinza to just CTCL and
myeloma
- Zolinza may face competition from Gloucester Pharmaceuticals'
romidepsin
- Gloucester Pharmaceuticals' Romidepsin (FK-228, depsipeptide)
- Drug Profile
- Broad range of HDAC inhibition should theoretically provide
increased efficacy
- Clinical Trial Data
- Romidepsin has fast track status and orphan drug status for CTCL
- Encouraging results in CTCL require replication in a Phase III
clinical trial
- Romidepsin also showing promise in PTCL
- Romidepsin in Phase II for HRPC despite lack of preclinical evidence
for this indication
- Datamonitor Comments
- Romidepsin may have difficulty competing with Merck's Zolinza in the
CTCL market
- Further evaluation is needed to establish the clinical activity of
combination therapy using HDAC inhibitors with cytotoxic drugs
- Commercial success of romidepsin will rely on Gloucester
Pharmaceuticals collaborating with large pharma
- Forecasts
- Datamonitor drug assessment summary
- CHAPTER 11 PIPELINE IMMUNOMODULATORY AND IMMUNOCONJUGATED THERAPEUTICS
ANALYSIS & FORECASTS
- Pipeline overview
- Wilex's Rencarex (WX-G250)
- Drug Profile
- MN/CA IX Antigen - A Highly Specific Tumor Target
- Mode of Action of Rencarex - ADCC
- Clinical Trial Data
- Rencarex in Phase III for non-metastatic RCC (the ARISER trial)
- Completed Phase I & II trials for metastatic RCC
- Datamonitor Comments
- Rencarex may face a number of hurdles
- Genmab's Ofatumumab (HuMax-CD20)
- Drug Profile
- Clinical Trial Data
- Genmab hoping ofatumumab will demonstrate a preferred efficacy
profile over Rituxan in the clinic
- Ofatumumab receives fast track status for CLL and enters a Phase III
trial
- Genmab initiate a pivotal trial in NHL
- Datamonitor Comments
- Genmab should look to compare ofatumumab with Rituxan in a Phase III
trial
- Commercial success of ofatumumab will rely on Genmab collaborating
with large pharma
- Forecasts
- Datamonitor drug assessment summary
- CHAPTER 12 COMMERCIAL IMPACT & LIFECYCLE MANAGEMENT: CASE STUDIES
- Introduction
- Case study one
- Clinical, developmental and commercial challenges to combining
molecular targeted therapies
- How to optimally utilize molecular targeted therapies in the context
of combinatorial regimens
- Intellectual property implications associated with combining
targeted therapies
- Lessons to be learnt from already marketed targeted therapies
- Differences and similarities between monoclonal antibodes and small
molecules
- Effectively demonstrating the clinical and pharamcoeconomic value of
combinatorial MTT strategies is critical
- Case study two
- Comparing marketed and pipeline MTTs: The evolving trends
- Segmentation of MTTs by structural class
- Segmentation of MTTs by indication
- Approval paths experienced by the marketed MTTs
- Developing a targeted therapy for a niche tumor over one of the 'big
four' tumor types - Which strategy should Pharma pursue?
- APPENDIX A - MARKET DATA & MAJOR BRAND KEY FACTS
- L1X3 (antineoplastic monoclonal antibodies) class market data
- 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
- Five Major European Markets (EU5) Forecasts
- Seven Major Markets 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
- Abbreviations
- Contributing experts
- Bibliography
- About Datamonitor
- About Datamonitor Healthcare
- About the Oncology analysis team
- Disclaimer
- List of Tables
- Table 1: Molecular targeted therapies in preregistration, 2006
- Table 2: Molecular targeted therapies in Phase III development, 2006
- Table 3: Pipeline molecular targeted therapies by development phase
and class of drug, 2006
- Table 4: Pipeline molecular targeted therapies by indication, 2006
- Table 5: Specific target/targets with two candidates in the pipeline,
2006
- Table 6: Specific target/targets with three or more candidates in the
pipeline, 2006
- Table 7: Number of products in the pipeline targeting key molecular
drivers of cancer, 2006
- Table 8: Companies with two candidates in the molecular targeted
therapies pipeline, 2006
- Table 9: Companies with three candidates in the molecular targeted
therapies pipeline, 2006
- Table 10: Companies with four or more candidates in the molecular
targeted therapies pipeline, 2006
- Table 11: Pfizer's marketed oncology portfolio, 2006
- Table 12: Pfizer's molecular targeted cancer therapies portfolio, 2006
- Table 13: Novartis' marketed oncology portfolio, 2006
- Table 14: Novartis' molecular targeted cancer therapies portfolio, 2006
- Table 15: GSK's marketed oncology portfolio, 2006
- Table 16: GSK's molecular targeted cancer therapies portfolio, 2006
- Table 17: Late-phase pipeline targeted therapies sales forecasts for
the seven major markets ($m), 2006-2015
- Table 18: Datamonitor drug assessment summary for late-phase pipeline
molecular targeted cancer therapies, 2006
- Table 19: Common mutations involved in tumor development
- Table 20: Forecast incidence of cancer across the seven major markets,
2005-2013
- Table 21: Examples of naturally occurring angiogenesis stimulators
- Table 22: Recently approved multi-targeted inhibitors, 2006
- Table 23: Current targeted therapy marketed products, 2006 (1 of 2)
- Table 24: Current targeted therapy marketed products, 2006 (1 of 2)
- Table 25: Targeted therapies sales in the seven major markets, 2005
- Table 26: Clinical pipeline for Nexavar, 2006
- Table 27: Clinical pipeline for Sprycel, 2006
- Table 28: Summary of Phase II Sprycel clinical trial results
- Table 29: Clinical pipeline for Sutent, 2006
- Table 30: Approved indications for Rituxan in the US and EU, 2006
- Table 31: Late-phase pipeline angiogenesis inhibitors, 2006
- Table 32: Phase II pipeline angiogenesis inhibitors, 2006
- Table 33: Phase I pipeline angiogenesis inhibitors, 2006
- Table 34: Ongoing clinical trials involving AZD2171, 2006
- Table 35: Ongoing clinical trials involving pazopanib, 2006
- Table 36: Ongoing clinical trials involving vatalanib, 2006
- Table 37: Ongoing clinical trials involving VEGF-Trap, 2006
- Table 38: Forecasting assumptions for late-phase angiogenesis
inhibitors, 2006
- Table 39: Angiogenesis inhibitors sales forecasts ($m), 2006-2015
- Table 40: Research/clinical and commercial attractiveness of pipeline
angiogenesis inhibitors, 2006
- Table 41: Late-phase pipeline single-target signal transduction
inhibitors, 2006
- Table 42: Phase II pipeline single-target signal transduction
inhibitors, 2006
- Table 43: Phase I pipeline single-target signal transduction
inhibitors, 2006
- Table 44: Ongoing clinical trials involving Vectibix, 2006
- Table 45: Ongoing clinical trials involving Sarasar, 2006
- Table 46: Ongoing clinical trials involving Xinlay, 2006
- Table 47: Historical development of Xinlay, 1994-2005
- Table 48: Ongoing Phase II/III trials involving temsirolimus, 2006
- Table 49: Ongoing clinical trials involving Zarnestra, 2006
- Table 50: Phase I/II trial involving Nexavar, Tarceva, Temsirolimus
and Zarnestra, 2006
- Table 51: Forecasting assumptions for late-stage pipeline
single-target signal transduction inhibitors (1 of 2)
- Table 52: Forecasting assumptions for late-stage pipeline
single-target signal transduction inhibitors (2 of 2)
- Table 53: Single-target signal transduction inhibitors sales forecasts
($m), 2006-2015
- Table 54: Research/clinical and commercial attractiveness of pipeline
single-target signal transduction inhibitors (1 of 2)
- Table 55: Research/clinical and commercial attractiveness of pipeline
single-target signal transduction inhibitors (2 of 2)
- Table 56: Late-phase pipeline multi-targeted inhibitors, 2006
- Table 57: Phase II pipeline multi-targeted inhibitors, 2006
- Table 58: Phase I pipeline multi-targeted inhibitors, 2006
- Table 59: Ongoing breast cancer clinical trials involving Tykerb, 2006
- Table 60: Ongoing non-breast cancer clinical trials involving Tykerb,
2006
- Table 61: Summary of key Tykerb breast cancer clinical trials, 2006
- Table 62: Ongoing clinical trials involving Ceflatonin, 2006
- Table 63: Ongoing trials involving Somatuline, 2006
- Table 64: Ongoing clinical trials involving Tasigna, 2006
- Table 65: Zactima's multiple anticancer targets
- Table 66: Ongoing clinical trials involving Zactima
- Table 67: Ongoing clinical trials involving enzastaurin, 2006
- Table 68: Ongoing clinical trials involving lestaurtinib
- Table 69: Forecasting assumptions for late-stage pipeline
multi-targeted inhibitors (1 of 2)
- Table 70: Forecasting assumptions for late-stage pipeline
multi-targeted inhibitors (2 of 2)
- Table 71: Multi-targeted inhibitors sales forecasts ($m), 2006-2015
- Table 72: Research/clinical and commercial attractiveness of pipeline
multi-targeted inhibitors (1 of 2)
- Table 73: Research/clinical and commercial attractiveness of pipeline
multi-targeted inhibitors (2 of 2)
- Table 74: Late-phase pipeline cell cycle and apoptosis targeted
agents, 2006
- Table 75: Phase II pipeline cell cycle and apoptosis targeted agents,
2006
- Table 76: Phase I pipeline cell cycle and apoptosis targeted agents,
2006
- Table 77: Ongoing clinical trials involving Genasense, 2006
- Table 78: Ongoing clinical trials involving Telcyta, 2006
- Table 79: NSCLC clinical trial data summary for Telcyta, 2006
- Table 80: Key Phase III trials of Telcyta for ovarian cancer, 2006
- Table 81: Ongoing clinical trials involving TransMID, 2006
- Table 82: Ongoing clinical trials involving alvocidib, 2006
- Table 83: Ongoing clinical trials involving phenoxodiol, 2006
- Table 84: Forecasting assumptions for late-stage pipeline cell cycle
and apoptosis targeted agents (1 of 2)
- Table 85: Forecasting assumptions for late-stage pipeline cell cycle
and apoptosis targeted agents (2 of 2)
- Table 86: Cell cycle and apoptosis targeted agents sales forecasts
($m), 2006-2015
- Table 87: Research/clinical and commercial attractiveness of pipeline
cell cycle and apoptosis targeted agents
- Table 88: Late-phase pipeline epigenetic modulators, 2006
- Table 89: Phase II pipeline epigenetic modulators, 2006
- Table 90: Phase I pipeline epigenetic modulators, 2006
- Table 91: Ongoing clinical trials involving Zolinza, 2006
- Table 92: Ongoing clinical trials involving romidepsin, 2006
- Table 93: Zolinza forecasting assumptions
- Table 94: Zolinza sales forecasts ($m), 2006-2015
- Table 95: Research/clinical and commercial attractiveness of Zolinza
- Table 96: Late-phase pipeline immunomodulatory and immunoconjugated
therapeutics, 2006
- Table 97: Phase II pipeline immunomodulatory and immunoconjugated
therapeutics, 2006
- Table 98: Phase I pipeline immunomodulatory and immunoconjugated
therapeutics, 2006
- Table 99: Ongoing clinical trial involving Rencarex, 2006
- Table 100: Ongoing clinical trial involving ofatumumab, 2006
- Table 101: Forecasting assumptions for late-phase immunomodulatory and
immunoconjugated therapeutics
- Table 102: Late-phase immunomodulatory and immunoconjugated
therapeutics sales forecasts ($m), 2006-2015
- Table 103: Research/clinical and commercial attractiveness of the
late-phase immunomodulatory and immunoconjugated therapeutics
- Table 104: Phase I/II trial involving Nexavar, Tarceva, Temsirolimus
and Zarnestra in GBM or gliosarcoma patients, 2006
- Table 105: Examples of combinatorial approaches of MAbs with
chemotherapy
- Table 106: Comparative characteristics of small molecules and MAbs
- Table 107: Single agents versus multiple agents in combination
- Table 108: Marketed molecular targeted cancer therapies, 2006
- Table 109: Rituxan: key facts
- Table 110: Herceptin: key facts
- Table 111: Campath: key facts
- Table 112: Mylotarg: key facts
- Table 113: Bexxar: key facts
- Table 114: Avastin: key facts
- Table 115: Erbitux: key facts
- Table 116: Zevalin: key facts
- Table 117: Gleevec: key facts
- Table 118: Targretin: key facts
- Table 119: Iressa: key facts
- Table 120: Velcade: key facts
- Table 121: Tarceva: key facts
- Table 122: Sprycel: key facts
- Table 123: Nexavar: key facts
- Table 124: Sutent: key facts
- Table 125: Ontak: key facts
- Table 126: Forecasts for marketed targeted therapies for the US ($m),
2005-2015
- Table 127: Forecasts for marketed targeted therapies for Japan ($m),
2005-2015
- Table 128: Forecasts for marketed targeted therapies for France ($m),
2005-2015
- Table 129: Forecasts for marketed targeted therapies for Germany ($m),
2005-15
- Table 130: Forecasts for marketed targeted therapies for Italy ($m),
2005-15
- Table 131: Forecasts for marketed targeted therapies for Spain ($m),
2005-15
- Table 132: Forecasts for marketed targeted therapies in the UK ($m),
2005-15
- Table 133: Forecasts for marketed targeted therapies for the EU5 ($m),
2005-2015
- Table 134: Forecasts for marketed targeted therapies for the seven
major markets ($m), 2005-2015
- Table 135: Datamonitor drug assessment parameters
- Table 136: Abbreviations used in Pipeline/Commercial Insight:
Molecular Targeted Cancer Therapies (1 of 2)
- Table 137: Abbreviations used in Pipeline/Commercial Insight:
Molecular Targeted Cancer Therapies (2 of 2)
- List of Figures
- Figure 1: Pipeline molecular targeted therapies by development phase
and class of drug, 2006
- Figure 2: Pipeline molecular targeted therapies by class of drug, 2006
- Figure 3: Pipeline molecular targeted therapies by development phase,
2006
- Figure 4: Angiogenesis inhibitors by developmental phase, 2006
- Figure 5: Single-target signal transduction inhibitors by
developmental phase, 2006
- Figure 6: Multi-targeted inhibitors by developmental phase, 2006
- Figure 7: Cell cycle and apoptosis targeted agents by developmental
phase, 2006
- Figure 8: Epigenetic inhibitors by developmental phase, 2006
- Figure 9: Immunomodulatory and immunoconjugated therapeutics by
developmental phase, 2006
- Figure 10: Pipeline molecular targeted therapies by solid tumor
indication, 2006
- Figure 11: Pipeline molecular targeted therapies by hematological
malignancy, 2006
- Figure 12: Number of products in the pipeline targeting key molecular
drivers of cancer, 2006
- Figure 13: Companies with four or more candidates in the molecular
targeted therapies pipeline, 2006
- Figure 14: Pipeline angiogenesis inhibitors sales forecasts for the
seven major markets ($m), 2006-2015
- Figure 15: Pipeline single-target signal transduction inhibitors sales
forecasts for the seven major markets ($m), 2006-2015
- Figure 16: Pipeline multi-targeted inhibitors sales forecasts for the
seven major markets ($m), 2006-2015
- Figure 17: Pipeline cell cycle and apoptosis targeted agents sales
forecasts for the seven major markets ($m), 2006-2015
- Figure 18: Pipeline epigenetic modulators sales forecasts for the
seven major markets ($m), 2006-2015
- Figure 19: Pipeline immunomodulatory and immunoconjugated therapeutics
sales forecasts for the seven major markets ($m), 2006-2015
- Figure 20: Datamonitor drug assessment summary for pipeline
angiogenesis inhibitors, 2006
- Figure 21: Datamonitor drug assessment summary for pipeline
single-target signal transduction inhibitors, 2006
- Figure 22: Datamonitor drug assessment summary for pipeline
multi-targeted inhibitors, 2006
- Figure 23: Datamonitor drug assessment summary for pipeline cell cycle
and apoptosis targeted agents, 2006
- Figure 24: Datamonitor drug assessment summary for epigenetic
modulators, 2006
- Figure 25: Datamonitor drug assessment summary for immunomodulatory
and immunoconjugated therapeutics, 2006
- Figure 26: Global oncology sales ($m), 2002-09
- Figure 27: Oncology pipeline including supportive care, 2006
- Figure 28: Forecast incidence of cancer across the seven major
markets, 2005-2013
- Figure 29: Combined incidence for breast, lung, prostate and
colorectal cancer rises with age in seven major markets, 2003
- Figure 30: Incidence increases, while the rate of cure and death
reduces disease prevalence
- Figure 31: Point prevalence for colorectal and lung cancer differs
markedly despite similar rates of incidence
- Figure 32: Unmet needs in cancer, 2006
- Figure 33: The process of tumor angiogenesis
- Figure 34: Approaches to inhibition of VEGF signaling
- Figure 35: Angiogenesis inhibitors sales forecasts ($m), 2006-2015
- Figure 36: Research/clinical and commercial attractiveness of pipeline
angiogenesis inhibitors, 2006
- Figure 37: Single-target signal transduction inhibitors sales
forecasts ($m), 2006-2015
- Figure 38: Research/clinical and commercial attractiveness of pipeline
single-target signal transduction inhibitors, 2006
- Figure 39: Design of Phase III Tykerb plus capecitabine versus
capecitabine alone trial
- Figure 40: Multi-targeted inhibitors sales forecasts ($m), 2006-2015
- Figure 41: Research/clinical and commercial attractiveness of pipeline
multi-targeted inhibitors
- Figure 42: Telcyta's mechanism of action
- Figure 43: TransMID's mode of action
- Figure 44: Cell cycle and apoptosis targeted agents sales forecasts
($m), 2006-2015
- Figure 45: Research/clinical and commercial attractiveness of pipeline
cell cycle and apoptosis targeted agents
- Figure 46: Zolinza sales forecasts ($m), 2006-2015
- Figure 47: Research/clinical and commercial attractiveness of Zolinza
- Figure 48: Rencarex induced ADCC
- Figure 49: Rencarex Phase II results: median survival
- Figure 50: Late-phase immunomodulatory and immunoconjugated
therapeutics sales forecasts ($m), 2006-2015
- Figure 51: Research/clinical and commercial attractiveness of the
late-phase immunomodulatory and immunoconjugated therapeutics, 2006
- Figure 52: Number of marketed MAbs and small molecules, 2006
- Figure 53: Number of late-phase MAbs and small molecules, 2006
- Figure 54: Number of marketed molecular targeted therapies for solid
tumors and hematological malignancies, 2006
- Figure 55: Number of late-phase molecular targeted therapies for solid
tumors and hematological malignancies, 2006
- Figure 56: Number of molecular targeted therapies approved in the 'big
four' tumor types, 2006
- Figure 57: Number of late-phase molecular targeted therapies in the
'big four' tumor types, 2006
- Figure 58: Marketed molecular targeted therapies by indication, 2006
- Figure 59: Phase I, II and III molecular targeted therapies by
indication, 2006
- Figure 60: Approval paths of the marketed molecular targeted therapies
- Figure 61: Advantages and disadvantages of developing an MTT in one of
the 'Big Four' tumor types
- Figure 62: Advantages and disadvantages of developing an MTT in a
niche tumor type
- Figure 63: Example of Datamonitor drug assessment scorecard
- Figure 64: Example of Datamonitor drug assessment graph
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