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Cancer Drug Discoveries: What the Future Holds: Breast Cancer Chapter
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Description: |
Breast cancer (BC) is the second most common malignancy in women after skin cancer and accounts for one in every three cancers diagnosed. Whilst the incidence of BC continues to rise in many countries there has been a fall in mortality rates from BC over the last decade. This reflects both more effective screening and treatment and an increase in public awareness.
Despite these improvements BC is still particularly prevalent, with an estimated 2.7 million people affected in 2005 in the top seven countries (US, Japan, France, Germany, Italy, Spain and the UK). Survival statistics have improved predominantly due to early detection of the disease which responds well to treatment.
The most interesting drugs in development for BC include the new SORMS (Evista, arzoxifene and Oporia) and the aromatase inhibitor combination atamestane (Intarcia Therapeutics), the epothilone analogues (ixabepilone, patupilone and ZK-EPO) which could compete with taxanes providing a balance can be established between efficacy and toxicity. New targeted therapies encompassing small-molecule drugs such as Tykerb (GlaxoSmithKline) and Iressa (AstraZeneca) and the monoclonal antibodies from Genentech/Roche, Avastin and Omnitarg, indicate the way this sector is going.
Key questions answered include:
- What are the competitive pressures on Novartis’ Femara and how might they affect revenues?
- How will epothilone antagonists change the face of the BC treatment market and what effect will they have on Taxotere and Taxol?
- What are the forecast sales of ixabepilone (BMS), Omnitarg (Genentech/Roche) and arzoxifene (Eli Lilly)?
- What are the challenges facing Intarcia’s atamestane?
- What advantages and disadvantages can be seen in the many combination therapies being developed?
A number of leading BC agents face generic competition over the next five years.
CURRENT PRODUCTS EVALUATED AND FORECAST
ANTI-OESTROGEN
- Nolvadex (AstraZeneca)
- Faslodex (AstraZeneca)
- Arimidex (AstraZeneca)
- Femara (Novartis)
- Aromasin (Pfizer)
- Zoladex (AstraZeneca)
CHEMOTHERAPY
- Taxotere (sanofi-aventis)
- Taxol (BMS)
- Abraxane (AstraZeneca/ Abraxis BioScience)
- Ellence (Pfizer)
- Xeloda (Roche)
- Gemzar (Eli Lilly)
TARGETED THERAPIES
- Avastin (Roche/Genentech/Chugai)
- Herceptin (Roche/Genentech)
- Tykerb (GSK)
UP AND COMING PRODUCTS EVALUATED
PHASE III
- Arzoxifene (Eli Lilly)
- Atamestane (Intarcia Therapeutics)
- Evista (Eli Lilly/Chugai/ Daichii Sankyo)
- Ixabepilone (BMS)
- Oporia (Pfizer)
- Patupilone (Novartis)
- Tesmilifene (YM BioSciences)
PHASE II
- Iressa (AstraZeneca)
- Omnitarg (Genentech/Roche)
- ZK-EPO (Bayer Schering Pharma). |
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Contents: |
BREAST CANCER
EXECUTIVE SUMMARY
THE FACTS
What is BC and How Does it Affect Patients?
Figure 21: Schematic of the Breast2
Risk Factors
Diagnosis
Stages of the Disease
Table 21: TMN Classification in BC
PATIENT STATISTICS
Incidence, diagnosis rates & treatment; now and in the future
Table 22: US prevalence of BC
Figure 22: Cancer Incidence Rates and Cancer Death Rates for Women in the US
Table 23: European prevalence of BC
Table 24: Japanese prevalence of BC
PATIENT MODEL
The prevalence of people living with BC will increase by 20% by 2012
Figure 23: BC Market Opportunities
Table 25: Summary of Patient Population Forecasts in the Top 7 Countries (2005-2012E)
DRUG GROWTH DRIVERS
Figure 24: Impact of biomarker identification on BC patients
Figure 25: Impact of biomarker identification on dose selection studies in BC patients
DRUG GROWTH RISKS/DAMPENERS
THE MARKET
GLOBAL CANCER MARKET
Figure 26: Global Cancer Drug Sales (including Supportive Care) in 2006 (US$472 billion)
Figure 27: Global Cancer Sales Forecasts 2004-2012
THE BREAST CANCER MARKET
GLOBAL BC SALES SPLIT
Figure 28: Global Sales Split (2006)
Figure 29: Global BC Market by Therapy Class (2006)
Figure 210: Global BC Market by Region (2012E)
Figure 211: Global BC Market by Therapy Class (2012E)
US market
Figure 212: BC US Drugs Sales Split (2006)
European market
Figure 213: BC European Drugs Sales Split (2006)
Japanese market
Figure 214: BC Japanese Drugs Sales Split (2006)19
THE PLAYERS
Figure 215: Market Share of BC Players by Sales (2006)20
Players and Products in 2006
Figure 216: Global Market Share of BC Players by Sales (Dec 2012E)22
Players and products in 2012
CURRENT TREATMENTS
Figure 217: Schematic of Treatment Options in BC
SURGERY
RADIATION
HORMONAL THERAPY
Figure 218: Hormones Affecting BC
Table 26: Current Hormonal Therapies
Table 27: Comparison of Leading Hormonal Therapies
Current Products’ Patent Exposure
Table 28: Patent Exposure of Leading Brands
ANALYSIS OF LEADING BRANDS
Hormonal Therapies
Based on the analysis, we have forecast 2005 and 2012E global sales
Anti-Oestrogen Drugs
Figure 219: Mode of Action of Anti-Oestrogens
Nolvadex (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
Faslodex (AstraZeneca)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Figure 220: EFECT Trial Design – Fasoldex vs Aromasin
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
Aromatase inhibitors
Figure 221: Mode of Action of Aromatase Inhibitors
Arimidex (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
Femara (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
Aromasin (Pfizer)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Figure 222: Pfizer’s pipeline addresses over 70% of tumour types
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
LHRH Agonists
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
CHEMOTHERAPY
Table 29: Chemotherapy Combinations Currently Prescribed in Stage I-III BC
Leading Brands
Current Products Patent Exposure
Table 210: Patent Exposure of Leading Brands
ANALYSIS OF LEADING BRANDS
Chemotherapies
Taxanes
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
Taxol (Bristol-Myers Squibb)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Management/clinical expertise
Figure 223: BMS’ oncology pipeline
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
Abraxane (AstraZeneca/Abraxis BioScience)
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
Cytotoxic Agents
Ellence (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
Antimetabolites
Xeloda (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
Competition within the marketplace/gaining share of voice
Sales forecasts and assumptions
Competitor Ratio Analysis
Gemzar (Eli Lilly)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Figure 224: a) Time-to-disease progression and b) overall response rate of metastatic BC to Gemzar treatment
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 THERAPY
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
Table 211: Proposed Filing of New Indication for Avastin
Sales forecasts and assumptions
Competitor Ratio Analysis
Herceptin (Roche/Genentech)
Novelty/rationale for mechanism of action
Figure 225: Mechanism of Action of Herceptin
Proof of concept/clinical data
Table 212: Pivotal Clinical Trials With Herceptin
Management/clinical expertise
Figure 226: A) Herceptin Positive and Negative BC Patient Split and B) Marketing Opportunities for Herceptin in Chemotherapy Patients
Competition within the marketplace/gaining share of voice
Risks associated with developing a drug within a therapeutic class
Filings and approval
Figure 227: Herceptin Has a Comprehensive Clinical Trial Programme to Drive Future Sales Growth
Table 213: Registration Programme for Herceptin
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
Figure 228: GSK to Target a Broad BC Population With Tykerb
Risks associated with developing a drug within a therapeutic class
Filings and approval
Sales forecasts and assumptions
Competitor Ratio Analysis
Sales Forecast of Current BC Drugs
Table 214: Global Sales of Leading BC Drugs 2005-2012E (US$ millions)
RESEARCH & DEVELOPMENT OF BC DRUGS
Figure 229: 2006 Survey: Medicines in Development for Cancer
Table 215: Products in Clinical Development for the Treatment of BC
ANALYSIS OF PHASE III DRUGS
Table 216: New Drugs in Phase III Development to Treat BC
Arzoxifene (Eli Lilly)
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
Atamestane (Intarcia Therapeutics)
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
Evista (Eli Lilly/Chugai Pharmaceutical/Daichii Sankyo)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Figure 230: Evista – Invasive BC Incidence – STAR Trial
Figure 231: Evista – Invasive BC Placebo Trials
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
Ixabepilone (Bristol-Myers Squibb)
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
Oporia (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
Patupilone (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
Tesmilifene (YM BioSciences)
Novelty/rationale for mechanism of action
Proof of concept/clinical data
Figure 232: Pivotal Phase III DEC Study Status
Table 218: YM BioSciences Product Pipeline
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 BC DRUGS 2006E – 2012E
Table 219: Sales Forecasts of Phase III Developmental BC Drugs (US$ million)
Model assumptions
ANALYSIS OF PHASE II DRUGS
Table 220: New Drugs in Phase II Development to Treat BC
Iressa (AstraZeneca)
Novelty/rationale for mechanism of action
Figure 234: Mechanism of Iressa’s 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
Omnitarg (Roche/Genentech)
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
ZK-EPO (Bayer Schering 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
Other Drugs of Interest
AE37 (Generex)
Axitinib (Pfizer)
HER2/neu vaccine (GlaxoSmithKline)
IMC-11F8 (ImClone Systems)
INGN 241 (Introgen Therapeutics)
Recombinant human insulin-like growth factor binding protein-3 (Insmed)
Sprycel (Bristol-Myers Squibb)
XRP6258 (sanofi-aventis)
GLOBAL SALES FORECASTS OF PHASE II BC DRUGS 2006E – 2012E
Table 221: Sales Forecasts of Phase II Developmental BC Drugs (US$ million)
Model assumptions
Sales Forecast of New BC Drugs
Table 222: Sales Forecasts of New Developmental BC Drugs US$ millions (2005-2012E)
COMPETITOR RATIO ANALYSIS - PRODUCTS
Table 223: Rating Score for Clinical Rating
Figure 237: CR Analysis of BC Agents Approved by 2012 – Based on Drug Class
COMPETITOR RATIO ANALYSIS - COMPANIES
Figure 238: CR Analysis of BC Agents Approved by 2012 – Based on Company
WINNERS & LOSERS
Table 224: Summary of Key Companies and Drugs in the BC Market by 2012
Winners (alphabetical)
Losers
DISCONTINUATION OF DRUGS
Table 225: BC Drugs Discontinued During Development
Diagnostic Assays
HER2 diagnostics
HER2/neu diagnostic testing
Fluorescence in situ hybridisation (FISH)
Chromogenic in situ hybridisation (CISH)
InSite HER2/neu kit
“Virtual Cancer Patient” technology - Optimata
New diagnostic tests
Future advances in diagnostics
APPENDIX 2
Patient Model
Table 226: Summary of US BC Patient Population Forecasts
APPENDIX 3
Patient Model
Table 227: Summary of Europe (Top 5) BC Patient Population Forecasts
APPENDIX 4
Patient Model
Table 228: Summary of Japan BC Patient Population Forecasts
APPENDIX 5
Table 229: Global BC Drugs Sales 2005-2012E
APPENDIX 6
Phase transition probability
Table 230: Probability of Launch
APPENDIX 7
Competitor Ratio Analysis Criteria
Table 231: Key BC Drugs on the Market by 2012
GLOSSARY
BIBLIOGRAPHY
WEBSITE REFERENCES
acronyms |
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Companies Mentioned |
- AstraZeneca
- Sanofi-Aventis
- Pfizer
- Roche
- Eli Lilly
- Abraxis BioScience
- Genentech
- Chugai
- GlaxoSmithKline
- Daichii Sankyo
- YM BioSciences
- Bayer Schering Pharma
- Intarcia Therapeutics |
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