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


Description: The prostate cancer market is on the verge of considerable change with the imminent arrival of new targeted therapies that will prolong patient survival.

Prostate cancer (PCA) is the second leading cause of new cancer cases in men worldwide and the sixth leading cause of cancer death in men. In the US, over two million men currently suffer with PCA and it is estimated that there were 192,311 new cases and 29,698 deaths due to the disease in 2008. There have been dramatic improvements in PCA survival over the last 25 years, mainly due to a combination of earlier diagnosis and improvements in treatments, although rates vary between countries.

The PCA market was estimated to be worth US$5.2 billion in 2008; it is one of the larger segments of the oncology market, alongside breast, non-small cell lung and colorectal cancers. The market is currently driven by the use of hormonal therapies, which are prescribed mainly for advanced hormone-dependent PCA, and include AstraZeneca’s Zoladex (goserelin) and Casodex (bicalutamide), Abbott/Takeda’s Lupron/Lupron Depot (leuprolide subcutaneous injection or intramuscular depot) and sanofi-aventis/Astellas Pharma’s Eligard (leuprolide subcutaneous depot). In addition, sanofi-aventis’ Taxotere (docetaxel) has become the standard treatment for hormone-refractory prostate cancer (HRPCA).

However, the market dynamics will change considerably over the next six years as patents expire and generic competition intensifies. Research into new therapies is extremely active and new agents with novel modes of action are being evaluated in clinical trials, including Dendreon’s Provenge, which is likely to be the first therapeutic cancer vaccine to market, and Bristol-Myers Squibb’s fully-human monoclonal antibody, ipilimumab. Other companies are extending existing products’ indications into PCA, with Roche’s angiogenesis inhibitor, Avastin (bevacizumab), and GlaxoSmithKline’s preventative treatment, Avodart (dutasteride), as the most notable examples.

The analyst estimates that sales of prostate cancer treatments will increase to over US$7.7 billion by 2015, with a compound annual growth rate of 5.9%

There is currently a huge interest in developing new treatments for PCA, with 96 drugs estimated to be in clinical development. The majority of these are the new targeted therapies, including small-molecule tyrosine kinase inhibitors, monoclonal antibodies and therapeutic vaccine candidates. In addition to the development of novel products, some companies are seeking to optimise the life-cycle of drugs already approved in other indications such as Roche’s Avastin (bevacizumab), Pfizer’s Sutent (sunitinib) and Novartis’ Glivec/Gleevec (imatinib).

Hormone-refractory prostate cancer (HRPCA) – a focus of attention
Market opportunities are largest for novel treatment strategies that prolong survival. Many of the new targeted approaches are focused on the treatment of hormone-refractory PCA (HRPCA), an area where, up until the recent approval of Taxotere, there were very few options for patients. Whereas previous research has focused mainly on the hormone-dependency of PCA, the rationale for new drugs coming through research is based on the increasing knowledge of the molecular abnormalities underlying PCA.

The arrival of innovative targeted therapies will not make traditional hormonal or chemotherapies redundant. Rather, targeted therapies will be used in combination with traditional therapies and each other. The limits to combinations will likely be cost, as the novel therapies can be expected to be comparable to recently-launched novel therapies in other cancers, for example Avastin at over US$50,000 per annum.

Shape of the industry in 2008...
The PCA market is currently dominated by a handful of pharmaceutical companies, the most significant of which is AstraZeneca. In 2008, AstraZeneca had a 41% share of the PCA market through the marketing of the LHRH analogue, Zoladex, and the anti-androgen, Casodex. AstraZeneca’s leadership position has been untouchable for many years and is primarily due to the combined androgen blockade therapeutic approach in PCA and expanded licenses for both advanced and locally-advanced PCA in some markets.

...and in 2015
With the advent of the new targeted therapies, the PCA market will change considerably by 2015. In 2008, most drug treatment occurred in the advanced hormone-responsive PCA market segment. By 2015, we expect the balance to shift to the HRPCA segment of the PCA market as more effective products are introduced and combined to address the unmet clinical need for patients in this sector. In addition, there will be significant opportunities to expand within the early PCA market. In addition to HRCPA treatments, Dendreon’s novel therapeutic cancer vaccine, Provenge, should achieve blockbuster sales and ensure a substantial market share for the company.


Contents: EXECUTIVE SUMMARY

WHAT IS PROSTATE CANCER AND HOW DOES IT AFFECT PATIENTS?
Screening
Risk Factors
Stages of the Disease

PATIENT STATISTICS
Incidence, Mortality and Survival

PATIENT MODEL
DRUG GROWTH DRIVERS
DRUG GROWTH RISKS/DAMPENERS

CURRENT TREATMENTS
Watchful Waiting/Active Monitoring
Surgery
Radiotherapy
Hormone Therapy
Chemotherapy

THE CURRENT PROSTATE CANCER MARKET
PLAYERS AND PRODUCTS IN 2008
Geographic Areas

RESEARCH & DEVELOPMENT OF PROSTATE CANCER DRUGS

WHAT THE FUTURE HOLDS
GLOBAL SALES FORECASTS TO 2015
Model Assumptions
PLAYERS AND PRODUCTS IN 2015

COMPETITOR RATIO ANALYSIS
Competitor Ratio Analysis Criteria
COMPETITOR RATIO ANALYSIS - PRODUCTS
COMPETITOR RATIO ANALYSIS - COMPANIES
Winners and Losers
Winners
Losers
Winners/Losers

ANALYSIS OF LEADING BRANDS
Current Products’ Patent Exposure
LHRH Analogues
Eligard
Lupron/Lupron Depot
Zoladex
LHRH Antagonist
Firmagon
Anti-Androgens
Casodex
Chemotherapy
Taxotere

ANALYSIS OF PHASE III DRUGS
Chemotherapy
Cabazitaxel
Orplatna

Angiogenesis Inhibitors
Aflibercept
Avastin
Sprycel
Sutent

Hormone Therapy
Abiraterone
Acapodene
Avodart
MDV3100

Immunotherapy
Ipilimumab
Provenge

Selective Endothelial Receptor Antagonists
Xinlay
ZD4054

ANALYSIS OF PHASE II DRUGS
ASA404
AT-101
OGX-011
Onyvax-P
PROSTVAC
TASQ
Panobinostat

DISCONTINUATION OF DRUGS

APPENDIX 1

APPENDIX 2
PCA Tumour Grading System - Gleason Score

APPENDIX 3
Phase Transition Probability

GLOSSARY
REFERENCES
ACRONYMS

Index of Charts:

Number of New UK Prostate Cancer Cases and Age-Specific Incidence Rates, 2006
International Variation in Prostate Cancer Incidence Rates
US Male Age-Adjusted Prostate Cancer Incidence Rates by Race/Ethnicity (1992-2006)
Projected % Change in Age-Standardised Prostate Cancer Mortality in the US, Europe and Japan, 2002-2015
Incidence and Mortality Rates of Prostate Cancer in Selected Countries
Estimated US Cancer Cases, 2009
Estimated US Cancer Deaths, 2009
Prostate Cancer Incidence, Top Seven Countries (2008-2015)
Prostate Cancer Mortality, Top Seven Countries (2008-2015)
Therapy Sales Split for Major Prostate Cancer Products, 2008
Market Share for Major Branded Prostate Cancer Drugs, 2008
Market Share of Major Prostate Cancer Players by Sales, 2008
US Prostate Cancer Branded Drugs Sales Split, 2008
Sales Forecasts of Current Leading PCA Drugs (US$ millions)
Sales Forecasts of Future Leading PCA Drugs (US$ millions)
Therapy Sales Split for Major Prostate Cancer Products, 2015
Global Market Share of Prostate Cancer Players by Sales (Dec 2015E)
Competitor Ratio Analysis Scores by Product
Current Major Prostate Cancer Products
Major Prostate Cancer Products, 2015
Combined Company Competitor Ratio Analysis Scores
Eligard Prostate Cancer Sales (2008A-2015E)
Lupron Prostate Cancer Sales (2008E-2015E)
Zoladex Prostate Cancer Sales (2008E-2015E)
Firmagon Prostate Cancer Sales (2009E-2015E)
Casodex Prostate Cancer Sales (2008A-2015E)
Taxotere Prostate Cancer Sales (2008A-20015E)
Cabazitaxel Prostate Cancer Sales (2011E-2015E)
Angiogenesis is the Formation of New Blood Vessels
Agents Targeting the VEGF Pathway
Aflibercept Prostate Cancer Sales (2013E-2015E)
Avastin Prostate Cancer Sales (2012E-2015E)
Sprycel Prostate Cancer Sales (2014E-2015E)
Sutent Prostate Cancer Sales (2012E-2015E)
Mode of Action of Abiraterone
Abiraterone Prostate Cancer Sales (2013E-2015E)
Acapodene Prostate Cancer Sales (2011E-1015E)
Avodart Prostate Cancer Sales (2010E-2015E)
Schematic of MDX-010’s Mechanism of Action
Ipilimumab Prostate Cancer Sales (2014E-2015E)
Schematic of Provenge’s Mechanism of Action
Provenge Prostate Cancer Sales (2010E-2015E)
Phase II EPOC Study Results
ZD4054 Prostate Cancer Sales (2012E-2015E)
ASA404 Mechanism of Action
ASA404 Phase II Results
Ascenta AT-101 Pipeline
OGX-011 Phase II Measurable Disease Response
OGX-011 Phase II Conclusions
TASQ Phase Ib Efficacy in HRPCA
Panobinostat Mechanism of Action
TNM Staging System for Prostate Cancer
Gleason Grading System

Index of Tables:

Worldwide Prostate Cancer Population Model (2008-2015)
Prostate Cancer Population Models, Top Seven Countries (2008-2015)
Drugs in Development to Treat Prostate Cancer
Timeline of Selected PCA Development Projects
Sales Forecasts of Current and Future Leading PCA Drugs (US$ millions)
Key Prostate Cancer Drugs Analysed
Summary of Key Companies and Drugs in the PCA Market by 2015
Comparison of Leading PCA Agents
Patent Exposure of Leading Brands
Major Phase III Development Candidates for PCA
Proposed Filings of New Indications for Avastin
Selected Phase II PCA Development Candidates
Drugs Discontinued from Clinical Development in PCA
Probability of Launch


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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