Schering-Plough Corporation: PharmaVitae Profile

This analysis examines the historical and forecast performance for Schering-Plough in the ethical pharma sector. The profile encompasses global company strategy, portfolio and pipeline analysis and assessment of financial performance, with 1-6 year sales forecasts for key drugs. An interactive forecasting and analysis tool provides continually updated quantitative and qualitative information.

Report Highlights

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ABOUT DATAMONITOR HEALTHCARE 2
About the Cardiovascular and Diabetes pharmaceutical analysis team: 2
CHAPTER 1 EXECUTIVE SUMMARY 3
Objective of the analysis 3
Datamonitor Key insights 3
Related reports 5
Acknowledgements 5
CHAPTER 2 BACKGROUND 8
Business Implications 8
Introduction 8
Scope 9
Definition of unmet needs 10
Clinical unmet needs in cardiovascular markets 10
Commercial Unmet Needs in cardiovascular markets 16
Commercial opportunities across cardiovascular indications 19
Response to the unmet need 22
Summary 23
CHAPTER 3 NOVEL DRUG TARGETS IN CV MEDICINE 24
Business Implications 24
Introduction 24
Bridging the ""innovation gap"" 25
Cardiovascular drug targets 25
New technologies allow expansion into novel targets 27
A lack of commercially viable drug targets 28
Biologics drive market growth 29
Monoclonal antibodies (MAbs) 30
Application of MAbs in cardiovascular disease 30
ReoPro (abciximab) profile 30
MAbs in the cardiovascular pipeline 31
BI-204 for atherosclerosis 31
TB-402 for thrombosis 33
Therapeutic vaccines 34
The need for therapeutic vaccines for chronic cardiovascular disease 34
Angiotensin vaccines for hypertension 34
Protherics's Angiotensin Therapeutic Vaccine 36
Cytos Biotechnology's CYT006-AngQ 36
Outlook for angiotensin vaccines 37
CHAPTER 4 STEM CELLS FOR USE IN CV MEDICINE 39
Business Implications 39
Introduction 39
The biology of stem cells 40
Derivation 41
Embryonic stem cells (ESCs) 42
Adult stem cells (ASCs) 42
The use of embryonic versus adult stem cells 43
Proliferation 43
Differentiation and pluripotency 44
Allogeneic versus autologous stem cells 44
The development timeline for stem cell technology 46
The exploitation of stem cells 47
Stem cell therapy 47
Use in regenerative medicine and tissue engineering 47
Stem cell transplantation 47
Stem cells for use in drug discovery 48
Screening arrays of compounds 48
Predictive toxicology 48
Stem cell therapy in cardiovascular medicine 48
Current status 48
The need for cardiovascular regeneration 49
Myocardial infarction and myocardial ischemia 49
Heart failure 50
Stem cell suitability for cardiovascular regeneration 50
Embryonic stem cells (ESCs) 51
Adult stem cells (ASCs) 51
Clinical development of stem cells for cardiovascular disease 54
Current clinical trial focus 54
Clinical trial results 57
Summary and future focus 66
Future clinical trial focus 67
Commercial landscape 69
International markets 70
Key players and products 70
Company Profiles 83
Aastrom Biosciences 83
Advanced Cell Technology 86
Angioblast Systems 88
Athersys 89
BioHeart 91
Cardio3BioSciences 93
Osiris Therapeutics 94
Development hurdles for stem cell therapy 96
Commercial risk associated with small companies 97
Research capacity 97
Regulation 100
Ethics and the perception of stem cells 101
Reimbursement 102
Intellectual property 102
CHAPTER 5 GENE THERAPY FOR USE IN CV MEDICINE 105
Business Implications 105
Introduction 106
Key definitions 106
Genomics 106
Gene therapy 107
The evolution of gene therapy 108
Discovery timeline 108
Approaches to gene therapy 110
In vivo versus ex vivo gene therapy 110
Gene delivery strategies 112
The use of vectors 112
Vector types 112
Delivery modalities 115
Systemic delivery 115
Non-systemic delivery 116
Disease targets for gene therapy 116
Research activity by indication 117
Cancer 117
Inherited diseases 118
Other targets 119
Gene therapy targets in cardiovascular disease 119
Therapeutic angiogenesis 124
Coronary artery disease (CAD) and myocardial ischemia 124
Peripheral arterial disease (PAD) 125
Heart failure 125
The beta-adrenergic (beta-AR) receptor signaling pathway 125
SERCA2a 126
Hypertension 127
ACE gene linked to high blood pressure in men 127
Targets in dyslipidemia 128
LDL-cholesterol and triglycerides 128
HDL-cholesterol 130
Other dyslipidemic targets 131
Gene therapies in the drug development pipeline 132
Current status 132
Current status of clinical trials of gene therapy 133
Gene therapy for coronary artery disease 133
Gene therapy for peripheral arterial disease 137
Gene therapy for heart failure 140
The beta-adrenergic receptor (beta-AR) signaling pathway 140
SERCA2a 140
Gene therapy for dyslipidemia 141
Gene therapy for hypertension 141
Future perspectives in gene therapy 142
Summary of preclinical and clinical research 142
Restenosis 142
Commercial landscape 143
International markets 143
Key players and products 144
Cardium Therapeutics 146
Development hurdles for gene therapy 148
Research and informatics 148
APPENDIX 150
Bibliography 150
About Datamonitor 154
About Datamonitor Healthcare 154
About the Cardiovascular Disease analysis team 155
Report methodology 155
Disclaimer 156
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Table 1: Schering-Plough - PharmaVitae forecasts at a glance 7
Table 2: OBS acquisition builds the base 13
Table 3: Key product developments, Q1 2008 27
Table 4: Schering-Plough product deals and alliances, Q1 2008 28
Table 5: Schering-Plough technology deals and alliances, Q1 2008 28
Table 6: Schering-Plough M&A activity, Q1 2008 29
Table 7: Schering-Plough company announcements, 2008 29
Table 8: Schering-Plough future product milestones 2008-09 30
Table 9: Schering-Plough product portfolio overview, global sales ($m), 2001-07 42
Table 10: Schering-Plough product portfolio overview, global sales ($m), 2007-13 44
Table 11: Schering-Plough therapy portfolio overview, sales ($m), 2001-07 50
Table 12: Schering-Plough therapy portfolio overview, sales ($m), 2007-13 52
Table 13: Schering-Plough portfolio overview by geographic region, sales ($m), 2001-07 60
Table 14: Schering-Plough portfolio overview by geographic region, sales ($m), 2007-13 62
Table 15: Schering-Plough launch portfolio overview ($m), 2007-13 67
Table 16: Schering-Plough core portfolio overview ($m), 2007-13 68
Table 17: Schering-Plough expiry portfolio overview ($m), 2007-13 69
Table 18: Schering-Plough portfolio overview by molecule type ($m), 2001-07 73
Table 19: Schering-Plough product portfolio overview by molecule type ($m), 2007-13 74
Table 20: Schering-Plough product portfolio overview by source ($m), 2001-07 79
Table 21: Schering-Plough product portfolio overview by source ($m), 2007-13 81
Table 22: Total Schering-Plough sales by business unit ($m), 2001-07 86
Table 23: Schering-Plough profit and loss account ($m), 2001-07 88
Table 24: Schering-Plough balance sheet ($m), 2001-07 90
Table 25: Schering-Plough operating revenue/cost analysis ($m), 2001-07 93
Table 26: Schering-Plough operating cost ratio analysis (% of total revenues), 2001-07 95
Table 27: Schering-Plough operating cost ratio analysis (% of total revenues), 2007-13 96
Table 28: Schering-Plough operating revenue/cost analysis ($m), 2007-13 99
Table 29: Schering-Plough capital employed ($m), 2001-07 103
Table 30: Schering-Plough EBIT return on capital employed ($m), 2001-07 106
Table 31: Schering-Plough EBIT pre-tax return/Capital employed driver analysis ($m), 2001-07 107
Table 32: SGP market capitalization vs. S&P 500 ($ billion), 2001-07 109
Table 33: Schering-Plough total shareholder returns (annual %), 2001-07 110
Table 34: Key products overview, sales ($m) 114
Table 35: NuvaRing: overview 115
Table 36: NuvaRing: sales forecast ($m), 2007-13 117
Table 37: Oral contraceptive market, sales ($m), 2001-13 118
Table 38: Nasonex: overview 121
Table 39: Nasonex: sales forecast ($m), 2007-13 122
Table 40: Top four nasal corticosteroids, sales ($m), 2001-07 123
Table 41: Peg-Intron: overview 124
Table 42: Intron A: overview 125
Table 43: Rebetol: overview 126
Table 44: Peg-Intron & Intron A: sales forecast ($m), 2007-13 127
Table 45: Rebetol: sales forecast ($m), 2007-13 127
Table 46: Remicade: overview 130
Table 47: Golimumab: overview 131
Table 48: Remicade: sales forecast ($m), 2007-13 132
Table 49: Golimumab: sales forecast ($m), 2006-12 132
Table 50: Anti-TNF market overview 133
Table 51: Asenapine: overview 135
Table 52: Asenapine: sales forecast ($m), 2007-13 137
Table 53: Bridion: overview 141
Table 54: Bridion: sales forecast ($m), 2007-13 142
Table 55: Phase III efficacy results of Bridion vs Neostigmine 143
Table 56: Zetia/Vytorin: overview 144
Table 57: Zetia/Vytorin: sales forecast ($m), 2007-13 145
Table 58: Major dyslipidemia therapeutics, sales ($m), 2001-07 146
Table 59: Temodar: overview 149
Table 60: Temodar: sales forecast ($m), 2007-13 151
Table 61: Schering-Plough's R&D pipeline (Phase I-registration) 153
Table 62: Schering-Plough's indication broadening pipeline (Phase I-registration) 155
Figure 1: Schering-Plough prescription pharmaceutical performance, sales ($m) and growth rate (%), 2001-13 5
Figure 2: Schering-Plough financial performance ($m), 2001-13 6
Figure 3: Five events dominate SGP's five-phase action agenda timeline 8
Figure 4: Claritin triggered profit decay ($m), 2001-04 9
Figure 5: SGP's portfolio expansion, sales ($m), 2001-07 10
Figure 6: Schering-Plough SWOT analysis 16
Figure 7: Schering-Plough prescription pharmaceutical performance, sales ($m) and growth rate (%), 2001-13 39
Figure 8: Schering-Plough key sales growth driver & resistors ($m), 2001-07 43
Figure 9: Schering-Plough key sales growth drivers & resistors ($m), 2007-13 46
Figure 10: Schering-Plough prescription pharmaceutical sales by therapy area ($m), 2001-13 49
Figure 11: Schering-Plough prescription pharma sales by therapy area, (% of total), 2001-13 57
Figure 12: Schering-Plough prescription pharmaceutical sales by geographic region ($m), 2001-13 59
Figure 13: Schering-Plough drivers and resistors by geographic region, sales ($m), 2001-07 60
Figure 14: Schering-Plough drivers and resistors by geographic region, sales ($m), 2007-13 62
Figure 15: Schering-Plough prescription pharmaceutical sales by geographic region (% of total), 2001-13 64
Figure 16: Schering-Plough launch/core/expiry configuration ($m), 2007-13 71
Figure 17: Schering-Plough prescription pharmaceutical sales by molecule type ($m), 2001-13 72
Figure 18: Schering-Plough growth drivers & resistors by molecule type ($m), 2007-13 76
Figure 19: Schering-Plough prescription pharmaceutical sales by source ($m), 2001-13 78
Figure 20: Schering-Plough growth drivers & resistors by source ($m), 2001-07 79
Figure 21: Schering-Plough growth drivers & resistors by source ($m), 2007-13 83
Figure 22: Schering-Plough operating revenue/cost analysis ($m), 2001-13 92
Figure 23: Schering-Plough operating cost ratio analysis (% of total revenues), 2001-13 98
Figure 24: Schering-Plough return on capital employed, EBIT margin and capital turnover, 2001-07 102
Figure 25: Return on capital employed formula 108
Figure 26: SGP market cap vs. S&P 500 ($ billion), 2001-07 110
Figure 27: SGP total shareholder returns vs. S&P 500, 2001-07 ($m) 111
Figure 28: Schering-Plough's Hep C franchise, sales ($m), 2001-13 129
Figure 29: Dyslipidemia treatment sales ($m), 2001-07 147
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