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Cancer Drug Discoveries: Prostate Cancer

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More than one million men in the US suffer with prostate cancer (PC) and according to the American Cancer Society 233,000 new cases will be diagnosed in the US in 2005 with an estimated 30,350 deaths.

Improvements in screening and diagnosis have led to significant reductions in mortality since the introduction of the prostate-specific antigen (PSA) test in the 1994. Treatment options vary according to age and the stage of cancer including watchful waiting, surgery, site-directed radiation and hormonal therapies. However, there is a high unmet clinical need for advanced PC patients, particularly those resistant to hormonal treatment.

Research is extremely active in this area and new agents with novel modes of action are being evaluated in clinical trials, including vaccines such as Provenge (Dendreon) and GVAX for hormone refractory PC.

Key points

  • PC is the second leading cause of cancer in men in the US and the third most common cancer worldwide.
  • Sales of PC drugs generated US$2.7 billion sales in 2004.
  • In 2003, PhRMA estimated there were 44 compounds in clinical development for the treatment of PC accounting for 11% of oncology research projects in the US.

Questions answered by this chapter include:

  • What is the principal cause of the market expanding by 55% by 2012?
  • What impact will the patent expiry of Casodex (AstraZeneca) have?
  • Why is much interest being expressed in monoclonal antibody therapies MLN2704 (Millennium Pharmaceuticals) and MDX-010 (Medarex)?
  • The leading PC treatment in 2012 is estimated to be worth nearly US$1 billion a year. What is it and whos developing it?
  • Vantas (Valera Pharmaceuticals) is expected to be one of the fastest growing LHRH agonists - why?

CONTENTS

PROSTATE CANCER (PC)

  • Key bullet points

BACKGROUND TO PC

  • What is PC and how does it affect patients?
  • Patient statistics
    • Incidence, diagnosis rates & treatment; now and in the future
  • Patient growth drivers
    • US
    • Europe
    • Japan

CURRENT TREATMENTS

  • SWOT analysis of radiotherapy treatments
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats

HORMONAL TREATMENT

  • SWOT analysis of hormonal treatments
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
  • SWOT analysis of individual hormonal treatments
  • LHRH agonists
  • LHRH antagonists
  • Anti-androgens
    • Zoladex (AstraZeneca)
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Sales forecasts
  • Lupron (TAP Pharmaceuticals/generics)
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Sales forecasts
  • Eligard (sanofi-aventis/Astellas Pharma)
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Sales forecasts
  • Viadur (Bayer)
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Sales forecasts
  • Vantas (Valera Pharmaceuticals)
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Sales forecasts
  • Plenaxis (Praecis Pharmaceuticals)
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Sales forecasts
  • Casodex (AstraZeneca)
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Sales forecasts

CHEMOTHERAPY

  • SWOT analysis of chemotherapy
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
  • SWOT analysis of individual chemotherapy treatments
  • Taxotere (sanofi-aventis)
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Sales forecast
  • Sales forecast of current PC drugs

RESEARCH & DEVELOPMENT OF PC DRUGS

  • 5-alpha reductase inhibitors
    • Proscar (Merck & Co) and Avodart (GlaxoSmithKline)
  • Non-steroidal SORM (selective oestrogen receptor modulator)
    • Acapodene (GTx Inc)
  • Phase II / III drugs of interest
  • Immunotherapy
  • Vaccines
    • Scientific rationale
  • Provenge (Dendreon) - Phase III
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Probability of success and sales forecast
  • GVAX (Cell Genesys) - Phase III
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Probability of success and sales forecast
  • Monoclonal antibodies
    • Scientific rationale
  • MLN 2704 (Millennium Pharmaceuticals) - Phase II / III
    • Probability of success and sales forecast
  • MDX-010 (Medarex) - Phase II
    • Probability of success and sales forecast
  • Anti-angiogenesis agents
    • Scientific rationale
  • Thalidomid (Celgene) - Phase III
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Probability of success and sales forecast
  • Actimid (CC4047; Celgene Corporation) - Phase II
    • Probability of success and sales forecast
  • ZD4054/ZD6474 (AstraZeneca) - Phase II
  • Gleevec/Glivec (Novartis) - Phase II
  • Gene therapy
    • Scientific rationale
  • Genasense (Genta) - Phase II
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Probability of success and sales forecast
  • Endothelin receptor antagonists
    • Scientific rationale
  • Xinlay (Abbott Laboratories) - Phase III
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Probability of success and sales forecast
  • YM598 (Astellas Pharma) - Phase II
  • Hormonal therapies
    • Degarelix (Ferring) - Phase II
  • Cytotoxics
  • Satraplatin (GPC Biotech/Spectrum Pharmaceuticals) - Phase III
    • Scientific rationale
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Probability of success and sales forecast
  • Vitamin D analogues
    • Scientific rationale
  • DN-101 (Novacea) - Phase II
    • Probability of success and sales forecast
  • Hectorol (Bone Care International) - Phase II
  • Epothilone analogues
  • Ixabepilone (BMS-247550; Bristol-Myers Squibb) - Phase III
    • Strengths
    • Weaknesses
    • Opportunities
    • Threats
    • Probability of success and sales forecast
  • KOS-862 (Kosan/Roche)
  • Selective apoptotic anti-neoplastic drugs (SAAND)
  • OP-461 (OSI Pharmaceuticals) - Phase I/II
  • Sales forecast of new PC drugs

DISCONTINUATION OF DRUGS

THE MARKET - CURRENT AND FUTURE

GLOBAL CANCER MARKET

GLOBAL PC MARKET

  • Key companies in the PC market
    • AstraZeneca
    • Abbott Laboratories
    • sanofi-aventis
  • Leading PC companies in 2012E

BIBLIOGRAPHY

GLOSSARY

APPENDIX 1 - US PC DEMOGRAPHICS 2003-2012

APPENDIX 2 - EUROPEAN PC DEMOGRAPHICS 2003-2012

APPENDIX 3 - JAPANESE PC DEMOGRAPHICS 2003-2012

  • Disclaimer

INDEX OF TABLES

  • Table 1: TNM classification in prostate cancer
  • Table 2: Prostate cancer management
  • Table 3: Current hormonal treatments
  • Table 4: Average wholesale price of LHRH agonists/antagonists
  • Table 5: Global PC sales of new products 2004A-2012E (US$ millions)
  • Table 6: Current PC drugs in clinical development
  • Table 7: Sales forecasts of new developmental drugs (2004A-2012E)
  • Table 8: Potential candidates for prostate cancer discontinued from development

INDEX OF CHARTS

  • Figure 1: Increase in elderly as a % of populations
  • Figure 2: Cancer incidence rates for men - US 1975-2001
  • Figure 3: Prostate cancer treatment algorithm
  • Figure 4: Docetaxel combinations currently in research for HRPC
  • Figure 5: Docetaxel combinations in androgen-dependent prostate cancer
  • Figure 6: Expected US launch timescales for prostate cancer therapeutics
  • Figure 7: Provenge mode of action
  • Figure 8: MDX-010 mechanism of action
  • Figure 9: Global oncology market 2004 - US$24 billion
  • Figure 10: Global PC market by region 2004A - US$2.7 billion
  • Figure 11: Global PC market by region 2012E - US$8.6 billion
  • Figure 12: Global PC market by therapy class 2004 - US$2.7 billion
  • Figure 13: Global PC market by therapy class 2012 - US$8.6 billion
  • Figure 14: Market share of top five PC players by sales (2004A)
  • Figure 15: Market share of top 6 PC players by sales (2012E)
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