Commercial Insight: Top 20 Oncology Therapy Brands in Australia Revenues of Targeted Therapies Soar While Sales of Cytotoxics an

Sydney, Australia's business district.

NEW YORK, Nov. 4, 2010 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue.

Introduction

The Top 20 cancer therapy brands in Australia reached sales of about $545m in 2008, growing at a CAGR of 30% since 2005. Datamonitor forecasts this growth to slow down considerably to a CAGR of 5.6% between 2008 and 2018 mainly due to maturing markets and the entry of generics for several key products. Sales of the Top 20 brands are expected to reach a total of $940m in 2018.

Scope

*This report focuses on the Top 20 cancer therapy brands in Australia sales and volume forecasts to 2018

*Assessment of Australia-specific drivers and resistors likely to impact the market

*Future market outlook for individual products taking into account key market events, in particular indication expansion and patent expiry

*Case study examining the approval and reimbursement process in Australia

Highlights

Datamonitor forecasts that the molecular targeted therapies will continue to drive growth in the Australian Top 20 cancer therapies market over the forecast period 20082018, with sales increasing from $320m in 2008 to $750m 2018.

The highest-selling brand in Australia in 2008 was Herceptin (trastuzumab; Roche) with sales of just under $120m and a CAGR between 2005 and 2008 of 61%. This drug is well positioned in the HER-2-positive breast cancer market where it received an exceptional reimbursement status.

In 2018, the Australian Top 20 will be led by Rituxan/MabThera (rituximab; Roche) with sales of $225m, followed by Avastin (bevacizumab; Roche) and Herceptin with revenues of $190m and $160m, respectively. Avastin will be the fastest growing brand with a 20082018 CAGR of 38% due to aggressive indication expansion in the coming years.

Reasons to Purchase

*Identify key opportunities and threats that will impact the Australian oncology market as a whole and the Top 20 in particular

*Quantify the future size and scope of the Top 20 Australian cancer therapies market and predict the performance of its key compounds

*Understand critical success factors in growing and defending cancer brand franchises from new entrants and generics

ABOUT DATAMONITOR HEALTHCARE 2

About the Oncology pharmaceutical analysis team 2

CHAPTER 1 EXECUTIVE SUMMARY 3

Strategic scoping and focus 3

Datamonitor insight into the oncology market 3

Related reports 5

Upcoming related reports 6

CHAPTER 2 MARKET DEFINITION 8

Market definition for this report 8

Key data assumptions 9

Accounting for missing Pharmatel Fresenius Kabi sales 9

Split of rituximab sales 13

CHAPTER 3 MARKET OVERVIEW 14

Current and future market overview 14

The molecular targeted therapies class will continue to dominate 17

Herceptin will surrender its leading position to Rituxan/MabThera by 2018 18

Opportunities 20

The number of Australian cancer patients is on the rise, with prostate and breast cancer being most common 20

End-of-life debate highlights need for more funding of high-cost oncology drugs 22

National screening programs aim to detect cancer in early stages 23

Government grants support local cancer research 23

Expensive oncology products are financed by government- and company-backed programs 24

Threats 24

Health reforms aim to lower cancer expenditure 24

The Intravenous Chemotherapy Supply Program is feared to affect pharmacists' reimbursement 25

The impending impact of biosimilars 26

Novel drugs may struggle to get on the Pharmaceutical Benefits Scheme, as Erbitux's case shows 28

CHAPTER 4 BRAND DYNAMICS OVERVIEW 30

Overview of competitive landscape 30

Reimbursement is a key driver of brand choice 30

Special programs fund the use of certain oncology drugs 33

The Chemotherapy Pharmaceuticals Access Program 34

The Herceptin Program 35

Herceptin via the Special Authority Program 37

Risk-sharing agreements 38

CHAPTER 5 BRAND DYNAMICS - MOLECULAR TARGETED THERAPIES 39

Herceptin (trastuzumab; Roche) 39

Drug profile 39

Product positioning 42

HER-2-positive breast cancer 42

SWOT analysis 43

Brand forecast to 2018 43

Launch of subcutaneous formulation may have small impact on sales 44

New clinical trial data may drive use in adjuvant breast cancer setting 45

Approval for neoadjuvant treatment of breast cancer 46

Herceptin's approval in gastric cancer would be first indication outside breast cancer 46

Further uptake of Tykerb/Tyverb in HER-2-positive breast cancer will impact Herceptin's revenues 47

Uptake of biosimilar trastuzumab products 51

Glivec/Gleevec (imatinib; Novartis) 52

Drug profile 53

Product positioning 56

Chronic myeloid leukemia (CML) 56

Gastrointestinal stromal tumors (GIST) 59

Acute lymphoblastic leukemia (ALL) 60

Myelodysplastic syndromes/myeloproliferative diseases (MDS/MPD) 61

Other indications 61

SWOT analysis 61

Brand forecast to 2018 63

Tasigna's and Sprycel's use in first-line CML could significantly impact imatinib sales 64

Recent PBS listing of Sutent in second-line GIST treatment unlikely to take sales away from imatinib 66

Glivec/Gleevec's ability to gain reimbursement for its use in adjuvant GIST treatment is doubtful 67

Slight uptake of Glivec/Gleevec use upon PBS listing for MDS/MPD, ASM, HES, CEL and DFSP 68

PBS listing of Vidaza should not impact Glivec/Gleevec's MDS sales significantly 68

Uptake of generic imatinib products 69

Avastin (bevacizumab; Roche) 69

Drug profile 70

Product positioning 71

Colorectal cancer 72

Breast cancer 77

Non-small cell lung cancer (NSCLC) 79

Renal cell carcinoma (RCC) 81

SWOT analysis 81

Brand forecast to 2018 83

PBS listing of Vectibix in colorectal cancer should not impact Avastin's sales 83

Lack of PBS listing for renal cell carcinoma drugs also hits Avastin 84

Development of Avastin in other indications may add clout to future sales 85

Other Top 20 molecular targeted therapies 86

Rituxan/MabThera (rituximab; Roche) 86

Brand forecast to 2018 87

Thalidomide Pharmion (thalidomide; Celgene) 90

Brand forecast to 2018 91

Velcade (bortezomib; Janssen-Cilag) 94

Brand forecast to 2018 95

Sprycel (dasatinib; Bristol-Myers Squibb) 97

Brand forecast to 2018 98

Tarceva (erlotinib; Roche) 100

Brand forecast to 2018 101

Erbitux (cetuximab; Merck Serono) 104

Brand forecast to 2018 105

CHAPTER 6 BRAND DYNAMICS - CYTOTOXIC THERAPIES 111

Taxotere (docetaxel; Sanofi-Aventis) 111

Drug profile 111

Product positioning 114

Breast cancer 114

Non-small cell lung cancer (NSCLC) 114

Prostate cancer 115

Ovarian cancer 116

Squamous cell carcinoma of the head and neck (SCCHN) 117

SWOT analysis 118

Brand forecast to 2018 119

A possible approval in gastric cancer 119

Launch of 'super generic' Abraxane not likely to impact Taxotere's sales dramatically 120

Uptake of generic docetaxel products 120

Gemzar (gemcitabine; Eli Lilly) 121

Drug profile 121

Product positioning 122

Pancreatic cancer 122

Ovarian cancer 123

Non-small cell lung cancer (NSCLC) 124

Bladder cancer 124

Breast cancer 124

SWOT analysis 125

Brand forecast to 2018 125

Uptake of generic gemcitabine products 126

Other Top 20 cytotoxic therapies 127

Temodal/Temodar (temozolomide; Merck/Schering-Plough) 127

Brand forecast to 2018 127

Xeloda (capecitabine; Roche) 129

Brand forecast to 2018 130

Alimta (pemetrexed; Eli Lilly) 134

Brand forecast to 2018 135

CHAPTER 7 BRAND DYNAMICS - ANTIHORMONAL THERAPIES 139

Zoladex (goserelin; AstraZeneca) 139

Drug profile 139

Product positioning 140

Prostate cancer 141

Breast cancer 141

SWOT analysis 141

Brand forecast to 2018 142

Arimidex (anastrozole; AstraZeneca) 143

Drug profile 144

Product positioning 145

Breast cancer 145

SWOT analysis 147

Brand forecast to 2018 148

Uptake of generic anastrozole products 149

Other Top 20 antihormonal therapies 149

Lupron (leuprorelin; Abbott) 149

Brand forecast to 2018 150

Femara (letrozole; Novartis) 152

Brand forecast to 2018 153

Androcur (cyproterone; Bayer Schering) 156

Brand forecast to 2018 156

Casodex (bicalutamide; AstraZeneca) 157

Brand forecast to 2018 158

CHAPTER 8 CASE STUDY - THE PROCESS FROM TGA APPROVAL TO PBS LISTING 160

Role of the Therapeutic Goods Administration (TGA) 162

Reforms aim to make Therapeutic Goods Administration's approval process faster and more transparent 162

Role of the Pharmaceutical Benefits Advisory Committee 163

High level of evidence needed to show clinical and cost-effectiveness points to a barrier of market entry 163

Role of the Pharmaceutical Benefits Pricing Authority 165

Reforms split the Pharmaceutical Benefits Scheme into two formularies 166

Pricing methods used by the Pharmaceutical Benefits Pricing Authority 169

Reference pricing method is mainly used for products in Formulary 1 169

Cost Plus method is mainly used for products in Formulary 2 170

Need for cost-effectiveness analysis slows down Pharmaceutical Benefits Scheme listing considerably 170

BIBLIOGRAPHY 172

Papers and articles 172

Press releases 187

Websites 189

Datamonitor reports 190

APPENDIX A - THERAPEUTIC RELATIVITY SHEETS RELEVANT TO ONCOLOGY 191

Section 100 items (effective date: May 2009) 191

ATC L01 - Antineoplastic agents (effective date: May 2009) 191

ATC L02 - Endocrine therapy (effective date: May 2009) 194

APPENDIX B - MARKET ASSUMPTIONS 197

Data definitions, limitations and assumptions 197

Standard units 197

Derivation of sales forecasts and pricing trends 197

Exchange rates used in this report 197

Forecast methodology 198

APPENDIX C 199

Contributing experts 199

Report methodology 199

About Datamonitor 200

About Datamonitor Healthcare 200

About the Oncology analysis team 201

Disclaimer 203

LIST OF TABLES

Table 1: Definition of the cancer therapies market in Australia, 2010 8

Table 2: Top 20 cancer therapy brands in Australia, 2008-2018 9

Table 3: Overview of Top 20 cancer therapy molecules with additional sales calculations, 2008 12

Table 4: Sales forecasts of the Top 20 cancer therapy brands in Australia ($m), 2008-2018 15

Table 5: Summary of opportunities and threats in the Australian oncology market, 2010 29

Table 6: The Top 20 cancer therapy brands in Australia, 2008-2018 30

Table 7: Eligibility for Herceptin via the Herceptin Program in Australia, 2009 36

Table 8: Herceptin (trastuzumab) - drug profile, 2010 40

Table 9: Herceptin (trastuzumab) - TGA approval and PBS listing, 2010 41

Table 10: Clinical trial summary for Tykerb/Tyverb for the neoadjuvant and maintenance treatment of HER-2-positive breast cancer 51

Table 11: Glivec/Gleevec (imatinib) - drug profile, 2010 53

Table 12: Glivec/Gleevec (imatinib) - TGA approval and PBS listing, 2010 54

Table 13: Avastin (bevacizumab) - drug profile, 2010 70

Table 14: Avastin (bevacizumab) - TGA approval and PBS listing, 2010 71

Table 15: Rituxan/MabThera (rituximab) - TGA approval and PBS listing, 2010 87

Table 16: Thalidomide Pharmion (thalidomide) - TGA approval and PBS listing, 2010 91

Table 17: Velcade (bortezomib) - TGA approval and PBS listing, 2010 94

Table 18: Sprycel (dasatinib) - TGA approval and PBS listing, 2010 98

Table 19: Tarceva (erlotinib) - TGA approval and PBS listing, 2010 100

Table 20: Erbitux (cetuximab) - TGA approval and PBS listing, 2010 105

Table 21: Taxotere (docetaxel) - drug profile, 2010 111

Table 22: Taxotere (docetaxel) - TGA approval and PBS listing, 2010 112

Table 23: Gemzar (gemcitabine) - drug profile, 2010 121

Table 24: Gemzar (gemcitabine) - TGA approval and PBS listing, 2010 122

Table 25: Temodal/Temodar (temozolomide) - TGA approval and PBS listing, 2010 127

Table 26: Xeloda (capecitabine) - TGA approval and PBS listing, 2010 130

Table 27: Clinical trial summary for Xeloda in combination with Avastin for the treatment of metastatic colorectal cancer 133

Table 28: Alimta (pemetrexed) - TGA approval and PBS listing, 2010 135

Table 29: Zoladex (goserelin) - drug profile, 2010 139

Table 30: Zoladex (goserelin) - TGA approval and PBS listing, 2010 140

Table 31: Arimidex (anastrozole) - drug profile, 2010 144

Table 32: Arimidex (anastrozole) - TGA approval and PBS listing, 2010 145

Table 33: Lupron (leuprorelin) - TGA approval and PBS listing, 2010 150

Table 34: Femara (letrozole) - TGA approval and PBS listing, 2010 153

Table 35: Clinical trial summary for Femara for the (neo)adjuvant treatment of breast cancer 155

Table 36: Androcur (cyproterone) - TGA approval and PBS listing, 2010 156

Table 37: Casodex (bicalutamide) - TGA approval and PBS listing, 2010 158

Table 38: Exchange rates from US dollars, 2008 198

List of Figures

Figure 1: Assumptions to account for missing Pharmatel Fresenius Kabi data 11

Figure 2: Performance of the Top 20 cancer therapy brands in Australia by class, 2008 vs. 2018 17

Figure 3: Performance of the Top 10 cancer therapy brands in Australia, 2008 vs. 2018 19

Figure 4: Average 2001-05 incidence per 100,000 persons of all cancers combined in Australia, by state and territory 21

Figure 5: Projected health and residential aged care expenditure for cancer in Australia, 2002/03-2032/33 25

Figure 6: Overview of different funding programs for oncology products in Australia, 2010 34

Figure 7: Herceptin (trastuzumab) SWOT analysis, 2010 43

Figure 8: Herceptin sales ($m) in Australia, 2008-2018 44

Figure 9: Position of imatinib, dasatinib and nilotinib in the treatment of chronic phase chronic myeloid leukemia (CML) 58

Figure 10: Glivec/Gleevec (imatinib) SWOT analysis, 2010 62

Figure 11: Glivec/Gleevec sales ($m) in Australia, 2008-2018 64

Figure 12: Indexed Avastin sales in the US, five major European markets and Australia, 2004-08 72

Figure 13: Avastin (bevacizumab) SWOT analysis, 2010 82

Figure 14: Avastin sales ($m) in Australia, 2008-2018 83

Figure 15: Rituxan/MabThera sales ($m) in Australia, 2008-2018 88

Figure 16: Thalidomide Pharmion sales ($m) in Australia, 2008-2018 92

Figure 17: Velcade sales ($m) in Australia, 2008-2018 95

Figure 18: Sprycel sales ($m) in Australia, 2008-2018 99

Figure 19: Tarceva sales ($m) in Australia, 2008-2018 101

Figure 20: Erbitux sales ($m) in Australia, 2008-2018 106

Figure 21: Taxotere (docetaxel) SWOT analysis, 2010 118

Figure 22: Taxotere sales ($m) in Australia, 2008-2018 119

Figure 23: Gemzar (gemcitabine) SWOT analysis, 2010 125

Figure 24: Gemzar sales ($m) in Australia, 2008-2018 126

Figure 25: Temodal/Temodar sales ($m) in Australia, 2008-2018 128

Figure 26: Xeloda sales ($m) in Australia, 2008-2018 131

Figure 27: Alimta sales ($m) in Australia, 2008-2018 136

Figure 28: Zoladex (goserelin) SWOT analysis, 2010 142

Figure 29: Zoladex sales ($m) in Australia, 2008-2018 143

Figure 30: Arimidex (anastrozole) SWOT analysis, 2010 148

Figure 31: Arimidex sales ($m) in Australia, 2008-2018 149

Figure 32: Lupron sales ($m) in Australia, 2008-2018 151

Figure 33: Indexed Lupron and Eligard sales in Australia, 2004-08 152

Figure 34: Femara sales ($m) in Australia, 2008-2018 154

Figure 35: Androcur sales ($m) in Australia, 2008-2018 157

Figure 36: Casodex sales ($m) in Australia, 2008-2018 159

Figure 37: Path of approval on the Australian Pharmaceutical Benefits Scheme 161

Figure 38: Factors that the Australian Pharmaceutical Benefits Advisory Committee has identified as informing its decision-making 165

Figure 39: Factors that the Australian Pharmaceutical Benefits Pricing Authority has identified as informing its decision-making 166

Figure 40: The split between the Australian Formulary 1 (F1) and Formulary 2 (F2) 168

Figure 41: Average time from ADEC recommendation to Australian PBS listing for major submissions using a cost-effectiveness analysis approach 171

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Therapy Industry: Commercial Insight: Top 20 Oncology Therapy Brands in Australia Revenues of targeted therapies soar while sales of cytotoxics and antihormonals decline

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