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


Description: The prostate cancer (PCA) market was estimated to be worth US$3 billion in 2006, with a growth rate of over 5% YoY. It is one of the larger segments of the oncology market, alongside breast, non-small cell lung and colorectal cancers. PCA is the second leading cause of cancer in men in the US and the third most common cancer worldwide. More than two million men in the US suffer with PCA and, according to the American Cancer Society, 234,460 new cases were diagnosed in the US in 2006, with an estimated 27,350 deaths.

The market is currently driven by the use of hormonal therapies: AstraZeneca’s Zoladex (goserelin) and Casodex (bicalutamide), TAP Pharmaceutical Products’ (Abbott/Takeda) Lupron (leuprolide subcutaneous injection or intramuscular depot), sanofi-aventis/Astellas Pharma’s Eligard (leuprolide subcutaneous depot) and Bayer Schering Pharma’s Viadur (leuprolide subcutaneous implant). In addition, sanofi-aventis’ Taxotere (docetaxel) is now licensed and has become the standard treatment for hormone-refractory prostate cancer.

In 2006, sales of PCA drugs were dominated by hormonal therapies (luteinising hormone-releasing hormone agonists/antagonists and anti-androgens) prescribed mainly for advanced hormone-dependent PCA. The arrival of innovative targeted therapies will not make these traditional therapies redundant. Newer therapies will be launched mainly into the hormone-refractory market, an area of current unmet need, whereas hormonal therapies will maintain sales value by continuing their expansion into the treatment of localised disease, while still dominating advanced hormone-dependent PCA.

Key questions answered include:
The patient population suffering from PCA is increasing at 4.8% per year. What clinical and sociological factors are influencing this?
What are the strengths and weaknesses of Dendreon’s Provenge and Cell Genesys’ GVAX and which is likely to dominate?
What pipeline products will AstraZeneca introduce to maintain its leading position in the PCA market despite generic competition to Casodex (2008) and Zoladex (2011)?

CURRENT PRODUCTS EVALUATED AND FORECAST
LHRH ANALOGUES
Eligard (sanofi-aventis/ Astellas Pharma)
Lupron (TAP Pharmaceutical Products)
Zoladex (AstraZeneca)

ANTI-ANDROGENS
Casodex (AstraZeneca)

CHEMOTHERAPY
Taxotere (sanofi-aventis)


UP AND COMING PRODUCTS EVALUATED
PHASE III
Satraplatin (GPC Biotech/ Pharmion/ Spectrum Pharmaceuticals)
Asentar (Novacea)
Degarelix (Ferring/Astellas)
Avastin (Roche/Genentech/Chugai)
Xinlay (Abbott)
GVAX (Cell Genesys)
Provenge (Dendreon)

PHASE II
AS1404 (Antisoma/Novartis)
CC-4047 (Celgene)
ZD4054 (AstraZeneca)
Genasense (Genta)
Ozarelix (AEterna/Zentaris)
Ipilimumab (BMS/Medarex)

By 2012 more patients will be treated with curative intent rather than being actively monitored.


Contents: EXECUTIVE SUMMARY

THE FACTS
What is PCA and why are we interested in it?
Figure 51: Schematic of prostate gland

PATIENT STATISTICS
Incidence, diagnosis rates and treatment; now and in the future
Figure 52: Incidence and mortality rates of PCA in selected countries (2002E)

PATIENT MODEL
The number of patients with PCA will have a CAGR (2005A-2012E) of 48%
Table 51: Summary of Patient Population Forecasts

DRUG GROWTH DRIVERS

DRUG GROWTH RISKS/DAMPENERS

GLOBAL CANCER MARKET
Figure 53: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$472 billion)
Figure 54: Global Cancer Sales 2004A-2012E

THE PCA MARKET
Figure 55: Global Sales Split (2006)
US market
Figure 56: PCA US Drugs Sales Split (2006)
European market
Figure 57: PCA European Drugs Sales Split (2006)
Japanese market
The major players
Figure 58: Market Share of PCA Players by Sales (Dec 2006)
Players and Products in 2006
Players and products in 2012
Figure 59: Global Market Share of PCA Players by Sales (Dec 2012E)

CURRENT TREATMENTS
Watchful waiting/active monitoring
Surgery
Radiotherapy
Hormonal treatment
Chemotherapy
Leading Brands
Table 52: Comparison of Leading PCA Agents
Current Products’ Patent Exposure
Table 53: Patent Exposure of Leading Brands

ANALYSIS OF LEADING BRANDS
LHRH analogues
Anti-androgens
Chemotherapy
LHRH Analogues
Eligard (sanofi-aventis/Astellas Pharma)
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
Lupron (TAP Pharmaceutical Products)
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
Zoladex (AstraZeneca)
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
Anti-Androgens
Casodex (AstraZeneca)
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
Chemotherapy
Taxotere (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

GLOBAL SALES FORECASTS OF CURRENT TREATMENTS 2005A–2012E
Table 54: Sales Forecasts of Current Leading PCA Drugs (US$ millions)
Model assumptions

NEW DRUGS IN R&D
Table 55: Drugs in Development to Treat PCA
Drugs for PCA prevention
5-Alpha Reductase Inhibitors
Proscar (Merck & Co) and Avodart (GlaxoSmithKline)
Non-Steroidal Selective Oestrogen Receptor Modulator (SORM)
Acapodene (GTx)

ANALYSIS OF PHASE III DRUGS
Table 56: New Drugs in Phase III Development to Treat PCA
Chemotherapy
Hormone/Vitamin D therapies
Targeted therapies
Vaccines
Chemotherapy
Satraplatin (GPC Biotech/Pharmion/Spectrum 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
Hormone/Vitamin D therapies
Asentar (Novacea)
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
Degarelix (Ferring/Astellas Pharma)
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
Targeted Therapies
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
Xinlay (Abbott Laboratories)
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
Vaccines
GVAX (Cell Genesys)
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
Provenge (Dendreon)
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 PCA DRUGS 2006A–2012E
Table 57: Sales Forecasts of Phase III Developmental PCA Drugs (US$ million)
Model assumptions

ANALYSIS OF PHASE II DRUGS
Table 58: New Drugs in Early Clinical Development to Treat PCA
Angiogenesis inhibitors
Gene therapy
Hormonal therapies
Monoclonal antibodies
Angiogenesis inhibitors
AS1404 (Antisoma/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
CC-4047 (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
ZD4054 (AstraZeneca)
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
Gene Therapy
Genasense (Genta)
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
Hormonal Therapies
Ozarelix (AEterna Zentaris/Spectrum 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
Monoclonal Antibodies
Ipilimumab (Bristol-Myers Squibb/Medarex)
Novelty/rationale for mechanism of action
Figure 510: Schematic of MDX-010’s 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
Recentin (AstraZeneca)
Gleevec/Glivec (Novartis)
GTI-2040 (Lorus Therapeutics)
Ixabepilone (Bristol-Myers Squibb)
Zactima (AstraZeneca)

GLOBAL SALES FORECASTS OF PHASE II PCA DRUGS 2006A – 2012E
Table 59: Sales Forecasts of Phase II Developmental PCA Drugs (US$ millions)
Model assumptions

COMPETITOR RATIO ANALYSIS – PRODUCTS
Table 510: Rating Score for Clinical Rating
Figure 511: CR Analysis of PCA Agents Approved by 2012 – Based on Drug Class

COMPETITOR RATIO ANALYSIS – COMPANIES
Figure 512: CR Analysis of PCA Agents Approved by 2012 – Based on Company

WINNERS & LOSERS
Table 511: Summary of Key Companies and Drugs in the PCA Market by 2012
Winners (alphabetical)
Losers

DISCONTINUATION OF DRUGS
Table 512: Drugs Discontinued (or ‘on hold’) from Clinical Development in PCA

APPENDIX 1
Figure 513: TNM Staging System for PCA

APPENDIX 2
PCA Tumour Grading System – Gleason Score

APPENDIX 3
Phase transition probability
Table 513: Probability of Launch

APPENDIX 4
Patient Model
Table 514: Summary of US PCA Patient Population Forecasts
Table 515: Summary of Europe (Top 5) PCA Patient Population Forecasts
Table 16: Summary of Japan PCA Patient Population Forecasts

APPENDIX 5
Table 517: Global PCA Drugs Sales 2005A-20012E (US$ millions)

APPENDIX 6
Competitor Ratio Analysis Criteria
Table 518: Key PCA Drugs on the Market by 2012
Glosary

REFERENCES

ACRONYMS


Summary: Prostate cancer is the second leading cause of cancer in the US and the third most common cancer worldwide. More than two million men in the US suffer with prostate cancer. Find out more about market developments in this chapter of Cancer Drug Discoveries.




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