Drug Discovery and Preclinical Molecules by Therapy Area - Innovation Focuses on Stem Cell Therapies and Gene Therapies

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Drug Discovery and Preclinical Molecules by Therapy Area - Innovation Focuses on Stem Cell Therapies and Gene Therapies

Summary

GBI Research's new report, "Drug Discovery and Preclinical Molecules by Therapy Area - Innovation Focuses on Stem Cell Therapies and Gene Therapies", provides an in-depth analysis of the unmet needs, drivers and barriers that affect the global Central Nervous System Disorders (CNS), Metabolic Disorders, Immunologic Disorders, Infection, Cardiovascular Disease and Oncology therapeutic markets. The report analyzes the early stage drug development that includes drugs under development in the discovery and preclinical stages of development for the above mentioned indications in the US, the top five countries in Europe (the UK, Germany, France, Italy and Spain) and Japan. Treatment usage patterns, sales value and the annual cost of therapy are forecast until 2017 for the key geographies in the leading therapeutic segments. Further, the report provides competitive benchmarking for the leading companies and analyzes the Mergers and Acquisitions (M&A) and licensing agreements that shape the global market.

The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

GBI Research finds that early stage drug development includes drugs under development in the discovery and preclinical stages of development. These studies are conducted in order to assess the safety and efficacy of the drug. This stage of development plays a key role in drug development as it determines potential molecules to be further processed for development by different companies. Increased strategies like RAS (Risk Assessment Strategies) issued by the US FDA (Food and Drug Administration) are persuading companies to implement safety scrutiny measures at early stages of development.

The majority of the molecules in the early stages of development are being developed for cancer indications. Molecules under development for breast cancer account for 23% of the total early stage development molecules under development for cancer. This is followed by prostate cancer, accounting for 20%, followed by colon cancer (15%).

Other than Oncology, other therapeutic areas with high activity in Research and Development (R&D) in early development phases include Central Nervous System (CNS) disorders, immunological disorders, and metabolic disorders. CNS disorders accounted for 14% of early stage drugs under development, followed by immunological disorders (13%) and metabolic disorders (10%). Compared to other therapeutic areas, there is less R&D activity in the metabolic disorders (9%) and infectious disease (9%) segments.

Scope

- Coverage of pipeline molecules in various discovery and pre-clinical phases of drug development along with pipeline analysis of the leading therapeutic segments, including Oncology, CNS disorders, immunological disorders, infection, metabolic disorders and cardiovascular disorders

- Analysis of the above mentioned disorders market in the leading geographies of the world, which are the US, the UK, Germany, France, Italy, Spain and Japan

- Key drivers and barriers that have a significant impact on the market

- Competitive benchmarking of leading companies. The key companies studied in this report are Hanall Pharmaceutical Co. Ltd, Patrys Limited, F. Hoffmann-La Roche Ltd, Mirna Therapeutics, Inc. and Aphios Corporation

- Key M&A activities and licensing agreements that have taken place between 2005 and 2010 in the global Oncology, CNS disorders, immunological disorders, infection, metabolic disorders and cardiovascular disorders markets

Reasons to buy

- Align your product portfolio to the markets with high growth potential

- Develop market-entry and market expansion strategies by identifying the leading therapeutic segments and geographic markets poised for strong growth

- Reinforce R&D pipelines by identifying new target mechanisms which can produce first-in-class molecules with more efficiency and better safety

- Develop key strategic initiatives by understanding the key focus areas of leading companies

- Exploit in-licensing and out-licensing opportunities by identifying products that could fill portfolio gaps

Table of Contents

1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 6

1.2 List of Figures 8

2 Drug Discovery and Preclinical Molecules by Therapy Area – Introduction 10

2.1 GBI Research Report Guidance 11

3 Drug Discovery and Preclinical Molecules by Therapy Area - Overview 12

3.1 Drug Discovery and Development 12

3.1.1 Drug Development-Stages 13

3.2 Early Stage Drug Discovery Studies- An overview 15

3.3 Early Stage Drug Discovery Design and Planning 16

3.3.1 Early Stage Drug Discovery – Strategic Planning 16

3.3.2 Key Considerations During Early Stage Drug Discovery 16

4 Drug Discovery and Preclinical Molecules by Therapy Area - Technology Landscape 18

4.1 Current System 18

4.1.1 Overview 18

4.1.2 Key Technologies 18

4.1.3 In-vitro ADMET Screening Models 19

4.1.4 In vivo ADMET Screening Models 20

4.1.5 In silico ADMET Screening models 21

4.2 Trends in Technology Models 22

4.2.1 Recent Technology Developments 22

5 Drug Discovery and Preclinical Molecules by Therapy Area - Drug Discovery and Development – A Challenge to Pharmaceutical Companies 27

5.1 Drug Discovery & Development Process 27

5.1.1 Drug Discovery Process 27

6 Drug Discovery and Preclinical Molecules in Therapeutic Segments 28

6.1 Central Nervous System Disorders 31

6.1.1 Alzheimer's disease 31

6.1.2 Parkinson's disease 37

6.1.3 Multiple Sclerosis 42

6.1.4 Schizophrenia 47

6.2 Metabolic Disorders 52

6.2.1 Diabetes 52

6.2.2 Obesity 59

6.3 Immunological Disorders 65

6.3.1 Rheumatoid Arthritis 65

6.3.2 Crohn's Disease 72

6.3.3 Systemic Lupus Erythematosus (SLE) 77

6.3.4 Allergy 82

6.4 Infections 87

6.4.1 HIV/AIDS 87

6.4.2 Hepatitis A, B, C 96

6.5 Cardiovascular Diseases 104

6.5.1 Hypertension 104

6.5.2 Dyslipidemia 109

6.5.3 Pulmonary Arterial Hypertension (PAH) 114

6.5.4 Myocardial Infarction 119

6.6 Oncology 124

6.6.1 Bladder Cancer 124

6.6.2 Lung Cancer 129

6.6.3 Non-Small Cell Lung Cancer (NSLC) 137

6.6.4 Breast Cancer 143

6.6.5 Colon Cancer 154

6.6.6 Melanoma 163

6.6.7 Ovarian Cancer 170

6.6.8 Prostate Cancer 177

7 Drug Discovery and Preclinical Molecules by Therapy Area – Top Five Pharmaceutical Players in Early Stage Drug Discovery 186

7.1 Introduction 186

7.2 Hanall Pharmaceutical 187

7.2.1 Company Overview 187

7.2.2 Pipeline 187

7.3 Patrys Limited 188

7.3.1 Company Overview 188

7.3.2 Pipeline 189

7.4 F. Hoffmann-La Roche Ltd. 189

7.4.1 Company Overview 189

7.4.2 Pipeline 190

7.5 Mirna Therapeutics 190

7.5.1 Company Overview 190

7.5.2 Pipeline 191

7.6 Aphios Corporation 191

7.6.1 Company Overview 191

7.6.2 Pipeline 192

8 Drug Discovery and Preclinical Molecules by Therapy Area – Strategic Consolidations 193

8.1 R&D Licensing Agreements 193

8.1.1 Deals by Indication 193

8.1.2 Deals by Geography 194

8.1.3 Deal Summaries by Therapeutic Class 195

9 Drug Discovery and Preclinical Molecules by Therapy Area – Appendix 202

9.1 Market Definitions 202

9.2 Abbreviations 202

9.3 Research Methodology 207

9.3.1 Coverage 207

9.3.2 Secondary Research 207

9.3.3 Primary Research 208

9.3.4 Expert Panel Validation 208

9.4 Contact Us 208

9.5 Disclaimer 208

9.6 Sources 209

List of Tables

1.1 List of Tables

Table 1: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Alzheimer's Disease, December 2010 32

Table 2: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Parkinson's Disease, December 2010 38

Table 3: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Multiple Sclerosis, December 2010 44

Table 4: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Schizophrenia, December 2010 49

Table 5: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Diabetes, December 2010 54

Table 6: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Obesity, December 2010 61

Table 7: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Rheumatoid Arthritis Therapeutics, December 2010 67

Table 8: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Crohn's Disease, December 2010 74

Table 9: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in SLE, December 2010 79

Table 10: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Allergy, December 2010 84

Table 11: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Patent Expiries of Major Marketed Drugs in HIV/AIDS, December 2010 91

Table 12: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in HIV/AIDS, December 2010 92

Table 13: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Hepatitis Therapeutics, December 2010 99

Table 14: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Hypertension Therapeutics, December 2010 106

Table 15: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Dyslipidemia Therapeutics, December 2010 111

Table 16: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in PAH Therapeutics, December 2010 117

Table 17: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in PAH Therapeutics (%), December 2010 117

Table 18: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Myocardial Infarction Therapeutics, December 2010 121

Table 19: Drug Discovery and Preclinical Molecules by Therapy Area, Bladder Cancer Therapeutics, Prevalence by Country, 2009 124

Table 20: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Bladder Cancer Therapeutics, December 2010 126

Table 21: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in Bladder Cancer Therapeutics (%), December 2010 127

Table 22: Drug Discovery and Preclinical Molecules by Therapy Area, Lung Cancer Categorized by Disease Stage, December 2010 129

Table 23: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Lung Cancer Therapeutics, December 2010 133

Table 24: Drug Discovery and Preclinical Molecules by Therapy Area, Global, NSCLC Treatment by Stage of the Disease, December 2010 138

Table 25: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in NSLC Therapeutics, December 2010 140

Table 26: Drug Discovery and Preclinical Molecules by Therapy Area, Breast Cancer Stage Classification, December 2010 143

Table 27: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Breast Cancer, December 2010 148

Table 28: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Global, Staging of Colon Cancer, December 2010 155

Table 29: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Colon Cancer Therapeutics, December 2010 158

Table 30: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Staging of Melanoma, December 2010 164

Table 31: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Melanoma, December 2010 166

Table 32: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Staging of Ovarian Cancer, December 2010 171

Table 33: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Ovarian Cancer Therapeutics, December 2010 172

Table 34: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Staging of Prostate Cancer, December 2010 177

Table 35: Drug Discovery and Preclinical Molecules by Therapy Area, Global, Early Stage R&D Pipeline by Phase in Prostate Cancer Therapeutics, December 2010 179

Table 36: Drug Discovery and Preclinical Molecules by Therapy Area, Hanall Pharmaceutical – Pipeline Products, December 2010 187

Table 37: Drug Discovery and Preclinical Molecules by Therapy Area, Patrys Limited – Pipeline Products, December 2010 189

Table 38: Drug Discovery and Preclinical Molecules by Therapy Area, F. Hoffmann-La Roche Ltd. – Pipeline Products, December 2010 190

Table 39: Drug Discovery and Preclinical Molecules by Therapy Area, Mirna Therapeutics, Inc. – Pipeline Products, December 2010 191

Table 40: Drug Discovery and Preclinical Molecules by Therapy Area, Aphios Corporation, Inc. – Pipeline Products, December 2010 192

Table 41: Drug Discovery and Preclinical Molecules by Therapy Area, Major Licensing Agreements by Therapeutic Class, Metabolic Disorders (%), 2005–2010 195

Table 42: Drug Discovery and Preclinical Molecules by Therapy Area, Major Licensing Agreements by Therapeutic Class, Immunological Disorders (%), 2005–2010 196

Table 43: Drug Discovery and Preclinical Molecules by Therapy Area, Major Licensing Agreements by Therapeutic Class, Cardiovascular Disorders (%), 2005–2010 198

Table 44: Drug Discovery and Preclinical Molecules by Therapy Area, Major Licensing Agreements by Therapeutic Class, Infections, 2005–2010 199

Table 45: Drug Discovery and Preclinical Molecules by Therapy Area, Major Licensing Agreements by Therapeutic Class, Oncology, 2005–2010 200

Table 46: Drug Discovery and Preclinical Molecules by Therapy Area, Major Licensing Agreements by Therapeutic Class, Central Nervous System Disorders, 2005–2010 201

List of Figures

1.2 List of Figures

Figure 1: Drug Discovery and Preclinical Molecules by Therapy Area, Series of Research Activities Leading to Drug Discovery, December 2010 12

Figure 2: Drug Discovery and Preclinical Molecules by Therapy Area, Stages of Drug Development, December 2010 15

Figure 3: Drug Discovery and Preclinical Molecules by Therapy Area, Preclinical ADMET Studies, December 2010 22

Figure 4: Drug Discovery and Preclinical Molecules by Therapy Area, Recent Technological Developments in Early Stage Development, December 2010 26

Figure 5: Drug Discovery and Preclinical Molecules by Therapy Area by Therapy, December 2010 28

Figure 6: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline in Different Therapeutic Segments December 2010 30

Figure 7: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D pipeline in Alzheimer's Disease (%), December 2010 35

Figure 8: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Alzheimer's Disease (%), December 2010 36

Figure 9: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline in Parkinson's Disease (%), December 2010 40

Figure 10: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Parkinson's Disease (%), December 2010 41

Figure 11: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline in Multiple Sclerosis (%), December 2010 45

Figure 12: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Multiple Sclerosis (%), December 2010 46

Figure 13: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline in Schizophrenia (%), December 2010 50

Figure 14: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Schizophrenia (%), December 2010 51

Figure 15: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D pipeline in Diabetes (%), December 2010 57

Figure 16: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Diabetes (%), December 2010 58

Figure 17: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline in Obesity (%), December 2010 63

Figure 18: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Obesity (%), December 2010 64

Figure 19: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline in Rheumatoid Arthritis Therapeutics (%), December 2010 70

Figure 20: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Rheumatoid Arthritis (%), December 2010 71

Figure 21: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline in Crohn's Disease (%), December 2010 75

Figure 22: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Crohn's Disease (%), December 2010 76

Figure 23: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in SLE (%), December 2010 80

Figure 24: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in SLE (%), December 2010 81

Figure 25: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in Allergy(%), December 2010 85

Figure 26: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Allergy (%), December 2010 86

Figure 27: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline in HIV/AIDS Therapeutics (%), December 2010 94

Figure 28: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in HIV/AIDS (%), December 2010 95

Figure 29: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in Hepatitis Therapeutics (%), December 2010 102

Figure 30: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Hepatitis Therapeutics (%), December 2010 103

Figure 31: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D pipeline by Phase in Hypertension Therapeutics (%), December 2010 107

Figure 32: Drug Discovery and Preclinical Molecules by Therapy Area , Early Stage R&D Pipeline by Mechanism of Action in Hypertension Therapeutics (%), December 2010 108

Figure 33: Drug Discovery and Preclinical Molecules by Therapy Area , Early Stage R&D Pipeline by Phase in Dyslipidemia Therapeutics (%), December 2010 112

Figure 34: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Dyslipidemia Therapeutics (%), December 2010 113

Figure 35: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in PAH (%), December 2010 118

Figure 36: Drug Discovery and Preclinical Molecules by Therapy Area , Early Stage R&D Pipeline by Phase in Myocardial Infarction (%), December 2010 122

Figure 37: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Myocardial Infarction (%), December 2010 123

Figure 38: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Bladder Cancer Therapeutics (%), December 2010 127

Figure 39: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in Lung Cancer Therapeutics (%), December 2010 135

Figure 40: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Lung Cancer Therapeutics (%), December 2010 136

Figure 41: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in NSLC Therapeutics (%), December 2010 141

Figure 42: Drug Discovery and Preclinical Molecules by Therapy Area , Early Stage R&D Pipeline by Mechanism of Action in NSLC Therapeutics (%), December 2010 142

Figure 43: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in Breast Cancer Therapeutics (%), December 2010 152

Figure 44: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Breast Cancer Thereapeutics (%), December 2010 153

Figure 45: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in Colon Cancer Therapeutics (%), December 2010 161

Figure 46: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Colon Cancer Therapeutics (%), December 2010 162

Figure 47: Drug Discovery and Preclinical Molecules by Therapy Area , Early Stage R&D Pipeline by Phase in Melanoma Therapeutics (%), December 2010 168

Figure 48: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Melanoma Therapeutics (%), December 2010 169

Figure 49:Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in Ovarian Cancer Therapeutics (%), December 2010 174

Figure 50: Drug Discovery and Preclinical Molecules by Therapy Area , Early Stage R&D Pipeline by Mechanism of Action in Ovarian Cancer Therapeutics(%), December 2010 175

Figure 51: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Phase in Prostate Cancer Therapeutics (%), December 2010 183

Figure 52: Drug Discovery and Preclinical Molecules by Therapy Area, Early Stage R&D Pipeline by Mechanism of Action in Ovarian Cancer Therapeutics (%), December 2010 184

Figure 53: Drug Discovery and Preclinical Molecules by Therapy Area, Top Five Pharmaceutical Players in Early Stage Drug Develpment, December 2010 186

Figure 54: Drug Discovery and Preclinical Molecules by Therapy Area, Major Licensing Agreements by Indication (%), 2005–2010 193

Figure 55: Drug Discovery and Preclinical Molecules by Therapy Area, Major Licensing Agreements by Geography (%), 2005–2010 194

Companies Mentioned

Hanall Pharmaceutical

Patrys Limited

F. Hoffmann-La Roche Ltd.

Mirna Therapeutics

Aphios Corporation

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