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Stakeholder Opinions: Small Cell Lung Cancer and Malignant
Mesothelioma - Limited R&D Activity Provides Opportunity for Early-
Phase Pipeline Drugs

Description:    SCLC accounts for one-fifth of all lung tumor types. More than 80,000 new cases are expected to
                be diagnosed in 2007 in the seven major markets, although it is set to decrease due to changing
                smoking habits. Mesothelioma is rarer, although incidence is expected to increase in the coming
                years in Europe and Japan given the heavy use of asbestos in the 1970s and long latency period of
                the disease.

                Scope of this title:
                Overview of small cell lung cancer (SCLC) and mesothelioma, including epidemiology, staging,
                prognosis and unmet needs Review of current treatment modalities and physician opinion of
                existing and future treatment strategies Evaluation of key drugs currently used in the treatment of
                SCLC and mesothelioma Assessment of late-phase drugs in development for SCLC and
                mesothelioma including key opinion leaders view on their potential

                Highlights of this title:
                Despite decreasing incidence, unmet needs in SCLC remain high due to poor prognosis and lack of
                effective treatment. R&D interest in the disease is low; however, this represents an opportunity for
                developing companies in the SCLC market. Alimta is approved for other lung cancer indications
                including NSCLC and mesothelioma. It is in a Phase III trial in SCLC and we believe that, although
                unlikely to show significant efficacy advantage over current standard, Alimta may potentially
                demonstrate toxicity advantages, in which case, it may usurp etoposide as standard therapy.
                Incidence of malignant mesothelioma may have peaked in the US but is set to increase over the
                next two decades in Europe and Japan due to the later uptake of asbestos in these markets.
                Nevertheless, overall incidence of mesothelioma remains low; as is the R&D interest in the disease.

                Reasons to order your copy:
                Evaluate opportunities and risks in the SCLC and mesothelioma markets by analyzing the clinical
                and commercial attractiveness of key drugs Assess key success factors that drive the SCLC and
                mesothelioma markets to estimate the potential of existing and pipeline drugs for the diseases
                Understand current and future competitive dynamics of SCLC and mesothelioma to determine the
                future size and scope of the markets



Contents:       ABOUT OUR HEALTHCARE 2
                 About the Oncology pharmaceutical analysis team 2
                 Nish Saini - Lead Analyst, Oncology 2

                Chapter 1.

                 Executive summary 3
                 Scope of analysis 3
                 Our insight into the small cell lung cancer market 3

                Chapter 2.

                 Sclc overview 10
                 Introduction 10
                 Subtypes 11
                 SCLC strongly associated with smoking 12
                 Diagnosis 13
                 Staging - VALG or IASLC system? 13
                 Nearly two-thirds are diagnosed in extensive stage 14
                 Prognosis 15
Poor prognosis in extensive stage 15
Slow improvement in prognosis 16
Epidemiology 17
One-fifth of lung cancer cases are SCLC 17
Decreasing incidence of SCLC 18
Incidence calculation 20
Incidence forecast calculation 21

Chapter 3.

Current sclc treatment options 24
Introduction 24
Treatment modalities 24
Limited stage 24
Surgical care remains confined to few patients 24
Quality of surgery depends on surgeon specialty 25
Surgery plus chemotherapy 25
Chemoradiotherapy improves survival in limited stage SCLC 31
Prophylactic cranial irradiation (PCI) for distant recurrence 32
Extensive stage 33
Chemotherapy alone is the primary treatment modality 33
Chemotherapy regimens 33
CAV superseded by PE regimen 33
Addition of a third agent to PE brings mixed results 34
Ifosfamide improves survival at the expense of increased toxicity 34
Paclitaxel not recommended for SCLC 34
Taxotere confers modest efficacy 35
Alternating regimens? 35
Carboplatin as alternative to cisplatin 36
Carboplatin plus etoposide more popular than cisplatin plus etoposide in the EU 37
Irinotecan in Japan 38
Success not replicated in the West 39
Amrubicin in Japan 41
High-dose and dose-intense chemotherapy in SCLC 41
Second-line therapy 41
Hycamtin remains the only approved drug for relapsed SCLC 42
No standard therapy for refractory SCLC 43
Amrubicin is used commonly in Japan 43
Summary of Phase II trial results for second-line SCLC 46

Chapter 4.

Unmet needs in sclc 47
Introduction 47
Unmet needs 47
Improving prognosis of SCLC 47
Need for earlier diagnosis 47
Strong association with smoking 48
Low curative surgery rate 48
Lack of efficacious drugs 49
Less toxic drug regimens required 49
Low R&D interest 50

Chapter 5.

Sclc pipeline analysis 52
Pipeline drugs for SCLC 52
Pipeline drugs by phase 54
Low number of Phase III drugs 54
Pipeline drugs by drug class 55
Two-thirds are molecular-targeted therapy 55
Pipeline drugs by phase and drug class 56
Late-phase pipeline drug profile 57
Alimta (pemetrexed) - Eli Lillly 57
Profile 57
Trial results 59
Toxicity may be the key for Alimta in SCLC 61
Potential US patent extension for Alimta 62
Thalomid (thalidomide) - Celgene/Pharmion 62
Trial results 63
Limited potential in SCLC 64
Other key pipeline drugs in Phase II development 64
Picoplatin - Poniard Pharmaceuticals 65
Avastin (bevacizumab) - Genentech/Roche 66
Nexavar (sorafenib) - Bayer Schering/Onyx 67
Iressa (gefitinib) - AstraZeneca 68
Recentin (AZD2171) - AstraZeneca 69

Chapter 6.

Malignant mesothelioma 70
Disease overview 70
Types of mesothelioma 70
Causes 70
Staging 72
Stage distribution 73
Prognosis 74
Epidemiology 75
Current treatment options 77
Surgery 77
Radiotherapy 77
Chemotherapy 77
Alimta 78
Gemzar 79
Unmet needs in malignant mesothelioma 80
Pipeline analysis 81
Pipeline drug by phase 82
Pipeline drug by drug class 83
Late-phase pipeline drug profile 84
Zolinza (vorinostat) - Merck & Co 84
Onconase (ranpirnase) - Alfacell 85
APPENDIX 87
Contributing experts 87
UN Population Data 87
Bibliography

List of Tables

List of Figures
105
About Us 107
About Our Healthcare 107
About the Oncology analysis team 108
Disclaimer

 List of Tables
 Table 1: Incidence of SCLC in the seven major markets, 2002 20
 Table 2: Estimated incidence rates for SCLC, 2002-2016 22
 Table 3: Forecast SCLC incidence, 2007-2016 22
 Table 4: Five-year survival rates following resection by stage 25
 Table 5: Results of major 1980s and 1990s trials of neoadjuvant chemotherapy in SCLC, 1984-
1994 27
 Table 6: Results of Phase II trial by Tsuchiya et al. (2005) 29
 Table 7: Results of major trials of adjuvant chemotherapy in SCLC, 1978-2000 30
 Table 8: Indirect comparison of amrubicin versus topotecan in second-line SCLC, 1997-2006 44
 Table 9: Summary of recent Phase II trial results for second-line treatment of SCLC, 2003-06 46
            Table   10:   Pipeline drugs for SCLC, 2007 52
            Table   11:   Ongoing late-phase clinical trials for SCLC, 2007 57
            Table   12:   Summary results of Phase II trial by Socinski et al. (2006) 59
            Table   13:   Summary results of Phase III trial by Breton et al. (2006) 63
            Table   14:   Summary results of Phase II trial by Cooney et al. (2005) 63
            Table   15:   Ongoing Phase II trials of Avastin in SCLC, 2007 67
            Table   16:   Various staging systems used for mesothelioma 72
            Table   17:   Epidemiologic features of malignant mesothelioma, 2005 75
            Table   18:   Summary results of Phase III trial by Vogelzang et al. (2003) 78
            Table   19:   Pipeline drugs for malignant mesothelioma, 2007 81
            Table   20:   Ongoing late-phase clinical trials for mesothelioma, 2007 84
            Table   21:   Summary results of Phase II trial by Mikulski et al. (2002) 85
            Table   22:   Interim analysis of Phase IIIb trial for Onconase in mesothelioma, 2006 86
            Table   23:   UN Population Data, 2002-2016

            List of Figures
            Figure 1: Anatomy of the respiratory system 11
            Figure 2: Stage distribution at diagnosis 14
            Figure 3: Two-year survival rate and median survival by stage 15
            Figure 4: Five-year survival rates of NSCLC and SCLC in the US, 1975-2002 16
            Figure 5: Two- and five-year survival rates for SCLC in the US, 1973-2002 17
            Figure 6: Proportion of SCLC versus NSCLC in the US and EU, 2006 18
            Figure 7: Incidence rate of SCLC in the US,1975-2003 19
            Figure 8: Incidence of SCLC in the seven major markets, 2002 21
            Figure 9: Forecast SCLC incidence, 2007, 2010, 2013, 2016 23
            Figure 10: Use of various chemotherapy regimens in the EU for SCLC in first line, 2006 37
            Figure 11: Use of various chemotherapy regimens in Japan for SCLC in first line, 2005 39
            Figure 12: Sales volume of cigarettes in China, 1981-1995 48
            Figure 13: Pipeline drugs for SCLC by phase, 2007 54
            Figure 14: Pipeline drugs for SCLC by drug class, 2007 55
            Figure 15: Pipeline drugs by phase and drug class, 2007 56
            Figure 16: Percentage use of Alimta by indication in the five major EU markets, 2006 58
            Figure 17: Summary results of Phase II trial by Socinski et al. (2006) 60
            Figure 18: Correlation between mesothelioma incidence and asbestos use, 1995-2000 71
            Figure 19: Stage distribution at diagnosis in the US, 1996-2002 73
            Figure 20: Five-year survival rates for mesothelioma in the US, 1975-1998 74
            Figure 21: Incidence rate of malignant mesothelioma in the US, Europe and Japan, 2005 76
            Figure 22: Unmet needs in malignant mesothelioma, 2007 80
            Figure 23: Pipeline drugs for mesothelioma by phase, 2006 82
            Figure 24: Pipeline drugs for mesothelioma by drug class, 2006 83




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