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Cancer Drug Discoveries: What the Future Holds: Renal Cancer Chapter


Description: The renal cell carcinoma (RCC) market was estimated to be worth around US$1 billion in 2006, with a growth rate of 36% YoY. It has constituted a relatively small segment of the oncology market but has more recently attracted considerable research and development investment from big pharmaceutical, biotechnology and specialty pharma companies.

The market is currently driven by the use of the following immunomodulating agents: Schering-Plough’s Intron A (interferon [IFN] alpha-2b), Roche’s Roferon-A (IFN alpha-2a) and Novartis’ Proleukin (aldesleukin); with new market entrants Bayer/Onyx Pharmaceuticals’ Nexavar (sorafenib) and Pfizer’s Sutent (sunitinib) making significant inroads into the market in 2006, their first year of sales.

The launch of more effective targeted agents and greater use of combination therapies instead of monotherapies, with the establishment of existing and new agents as adjuvant therapy in early-stage disease will contribute to the RCC market’s most eventful decade.

There are significant opportunities for effective new products to expand rapidly, as a large percentage of patients are currently not treated with drug therapies and are not cured by surgery alone. These patients are candidates for adjuvant therapy.

We forecast that sales of RCC treatments will increase to US$3 billion by 2009 and over US$6 billion by 2012 due to the launch of up to nine new therapies. The RCC market is in its most exciting phase of evolution!

Key questions answered include:
What are the reasons behind the expected increase in the patient population with RCC?
What impact will the new oral agents have on a market currently dominated by injectables?
Why is only 25% of the global RCC market in Europe?
What are the prospects for GSK’s pazopanib and what revenue contribution might it make in 2012?
What challenges must Novartis overcome with Proleukin and its new product everolimus if it is to maintain market presence?
What factors are limiting Wilex’ Rencarex commercialisation?
CURRENT PRODUCTS EVALUATED AND FORECAST
Intron-A/PEG-Intron (Schering-Plough)
Roferon-A/Pegasys (Roche)
Proleukin (Novartis/Chiron)
Nexavar (Bayer/Onyx Pharmaceuticals)
Sutent (Pfizer)
UP AND COMING PRODUCTS EVALUATED
PHASE III
Avastin (Roche/Genentech/Chugai)
Everolimus (Novartis)
Pazopanib (GSK)
Rencarex (Wilex)
Torisel (Wyeth)
TroVax (Oxford BioMedica/ sanofi-aventis)
Tykerb (GSK)

PHASE II
rIL-21 (Zymogenetics/Novo Nordisk)
Revlimid (Celgene)
Talactoferrin (Agennix)
ABT-510 (Abbott)
AS1411 (Antisoma)


Around 50% of early-stage patients are not cured by surgery and around 80% of patients with advanced disease fail to respond to approved therapies.

The development of novel, targeted therapies as front-line and/or second-line therapies for metastatic disease, may address this issue


Contents: RENAL CELL CARCINOMA

EXECUTIVE SUMMARY

THE FACTS
What is RCC and why are we interested in it?
Figure 61: Structure of the Kidney

PATIENT STATISTICS
Incidence, diagnosis rates and treatment; now and in the future
Figure 62: World age-standardised incidence rates for kidney cancer, selected countries, 2002 estimates

PATIENT MODEL
The number of patients with RCC will have a CAGR 2005A-2012E of 267%
Table 61: Summary of Patient Population Forecasts

DRUG GROWTH DRIVERS

DRUG GROWTH RISKS/DAMPENERS

THE MARKET

GLOBAL CANCER MARKET
Figure 63: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$47 billion)
Figure 64: Global Cancer Sales 2004A-2012E

THE RCC MARKET

GLOBAL SALES SPLIT
Figure 65: Global sales split (2006)
US market
Figure 66: RCC US Drugs Sales Split (2006A)
European market
Figure 67: RCC European Drugs Sales Split (2006A)
Japanese market
The major players14
Players and Products in 2006
Players and products in 2012
Figure 69: Global Market share of RCC players by sales (Dec 2012E)

CURRENT TREATMENTS
Leading Brands
Table 62: Comparison of Leading RCC Agents
Current Products’ Patent Exposure
Table 63: Patent Exposure of Leading Brands

ANALYSIS OF LEADING BRANDS
Immunomodulating agents
Immunomodulating agents
Interferon (IFN) alpha
Intron A/PEG-Intron (Schering-Plough)
Roferon-A/Pegasys (Roche)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Table 64: Sales forecasts for interferon products
Competitor Ratio Analysis
Proleukin (Novartis/Chiron)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Nexavar (Bayer/Onyx Pharmaceuticals)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Sutent (Pfizer)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis

GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2005A–2012E
Table 65: Sales Forecasts of Current Leading RCC Drugs (US$ millions)
Model assumptions

NEW DRUGS IN R&D
Table 66: Drugs in Development to Treat RCC

ANALYSIS OF PHASE III DRUGS
Table 67: New Drugs in Phase III Development to Treat RCC
Avastin (Roche/Genentech/Chugai)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Everolimus (Novartis)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Pazopanib (GlaxoSmithKline)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Rencarex (Wilex)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Torisel (Wyeth)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
TroVax (Oxford BioMedica/sanofi-aventis)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Tykerb (GlaxoSmithKline)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis

GLOBAL SALES FORECASTS OF PHASE III RCC DRUGS 2006E–2012E
Table 68: Sales Forecasts of Phase III Developmental RCC Drugs (US$ million)
Model assumptions

ANALYSIS OF PHASE II DRUGS
Table 69: New Drugs in Early Clinical Development to Treat RCC
Immunomodulators
Angiogenic inhibitors
Novel agents
Immunomodulators
rIL-21 (ZymoGenetics/Novo Nordisk)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Revlimid (Celgene)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Talactoferrin (Agennix)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise74
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Angiogenesis inhibitors
ABT-510 (Abbott)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Novel agents
AS1411 (Antisoma)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Other Interesting Phase II Drugs
ABT-751 (Abbott)
Recentin (AstraZeneca)
GTI-2040 (Lorus Therapeutics)
Ipilimumab (Medarex/Bristol-Myers Squibb)
Ixabepilone (Bristol-Myers Squibb)
Vatalinib (Novartis/Bayer Schering Pharma)
Volociximab (PDL BioPharma/Biogen Idec)
XL880 (Exelixis)

GLOBAL SALES FORECASTS OF PHASE II RCC DRUGS 2006A – 2012E
Table 610: Sales Forecasts of Phase II Developmental RCC Drugs (US$ million)
Model assumptions

COMPETITOR RATIO ANALYSIS - PRODUCTS
Table 611: Rating Score for Clinical Rating
Figure 611: CR Analysis of RCC Agents Approved by 2012 – Based on Drug Class
COMPETITOR RATIO ANALYSIS - COMPANIES
Figure 612: CR Analysis of RCC Agents Approved by 2012 – Based on Company
WINNERS & LOSERS
Table 612: Summary of Key Companies and Drugs in the RCC Market by 2012
Winners (alphabetical)
Losers

DISCONTINUATION OF DRUGS
Table 613: Drugs Discontinued (or ‘on hold’) from Clinical Development in RCC

APPENDIX 1
Figure 613: RCC Tumour Staging Systems
Tumor, Node, Metastasis (TNM) Staging of Renal Cell Carcinoma92

APPENDIX 2
Phase Transition Probability
Table 614: Probability of Launch

Appendix 3
Patient Model
Table 615: Summary of US RCC Patient Population Forecasts
Table 616: Summary of Europe (Top 5) RCC Patient Population Forecasts
Table 617: Summary of Japan RCC Patient Population Forecasts

Appendix 4
Table 18: Global RCC Drugs Sales 2005A-2012E

APPENDIX 5
Competitor Ratio Analysis Criteria
Table 619: Key RCC Drugs on the Market by 2012

GLOSSARY

REFERENCES

ACRONYMS


Summary: The renal cell carcinoma market was estimated to be worth around US$1 billion in 2006, with a growth rate of 36% YoY. Find out more about market developments in this chapter of Cancer Drug Discoveries.




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