The Fastest Growing Biotechnology Companies: Growth strategies, comparative analyses and company profiles

The Fastest Growing Biotechnology Companies: Growth strategies, comparative analyses and company profiles
Table of Contents

The Fastest Growing Biopharmaceutical Companies

Executive Summary 16

Summary of key findings 16

Comparitive analyses of growth strategies 17

Theravance, Inc - company profile and analysis 18

ISTA Pharmaceuticals - company profile and analysis 19

Palatin Technologies - company profile and analysis 20

Pharmion Corporation – company profile and analysis 21

Amylin Pharmaceuticals - company profile and analysis 22

Trimeris, Inc - company profile and analysis 23

ViroPharma Inc - company profile and analysis 24

NPS Pharmaceuticals - company profile and analysis 25

SIGA Technologies, Inc - company profile and analysis 26

Idenix Pharmaceuticals - company profile and analysis 27

Chapter 1 Key findings and industry

analysis 30

Summary 30

Overview of the biotechnology sector 31

Recent developments 32

Current applications 33

Structure of the biotechnology industry 35

The pharmaceutical-biopharmaceutical relationship 35

Emergence of the biopharmaceutical sector 36

Characteristics of the biopharmaceutical industry 40

Collaborative corporate environment 40

Highly technology and intellectual property 41

High venture capital investment 42

High risk and costs associated with drug development 42

Identifying fast growth companies- Methodology 44

Purpose and value of the analysis 45

Candidates identified as fast growth companies 46

Chapter 2 Comparitive analyses of growth

strategies 48

Summary 48

The Fastest Growing Biopharmaceutical Companies 49

The evolving nature of the biopharmaceutical industry 56

Comparative analysis of R&D strategies 57

Revenue versus R&D expenditure 57

Early Phase R&D Strategies 60

Late Stage Clinical Development 61

Sponsored Research Payment Strategies 62

Analysis by Therapeutic Area 64

Comparative analysis of commercialization strategies 67

Platform positioning 67

The modern extended biopharmaceutical enterprise 71

Comparative analysis of manufacturing strategies 74

Comparion of restructuring and cost containment strategies 75

Case Study: Downsizing R&D at Trimeris, Inc. 76

Chapter 3 Theravance, Inc. 79

Summary 79

Company address and contact details 80

Company overview and history 80

Business profile 81

Discussion and analysis of financial data 81

Source and details of income 81

Review of proprietary technologies 83

Patents and proprietary rights 83

Strategic approach and positioning 83

Strategic approach 83

SWOT Analysis 84

Strengths 84

Weaknesses 85

Opportunities 85

Threats 86

Joint ventures, collaborations and M&A activity 87

Theravance's collaboration with GlaxoSmithKline (GSK) 87

License, development and commercialization agreement with Astellas 88

License agreement with AstraZeneca AB 88

Product development programs 88

Bacterial infections 88

Telavancin 89

TD-1792 89

Respiratory 90

Horizon program (formerly Beyond Advair) 90

Inhaled bifunctional muscarinic anatgonist-beta2 agonist (MABA)

program 91

Inhaled long-acting muscarinic antagonist (LAMA) program 91

Gastrointestinal motility disorders 92

Research programs 92

Chapter 4 ISTA Pharmaceuticals, Inc. 96

Summary 96

Company Address and Contact Details 97

Company overview and history 97

Business profile 99

Discussion and analysis of financial data 99

Source and details of income 100

Review of proprietary technologies 100

Patents and proprietary rights 101

Strategic approach and positioning 104

Strategic approach 104

SWOT analysis 105

Strengths 105

Weaknesses 105

Opportunities 106

Threats 107

Joint ventures, collaborations and M&A activity 108

Xibrom, Istalol, Bepotastine, Ecabet Sodium, Latanoprost and Iganidipine

collaborations with Senju 108

Vitrase commercialization outside the US 108

Collaboration with Otsuka Pharmaceutical 109

Marketed products 109

Xibrom™ (bromfenac) 109

Istalol® 110

Vitrase® 111

Product development programs 111

T-Pred (tobramycin and prednisolone acetate combination product) 112

Bepotastine 112

Ecabet sodium 113

Strong steroid product 113

Chapter 5 Palatin Technologies Inc 118

Summary 118

Company address and contact details 119

Company overview and history 119

Business profile 120

Discussion and analysis of financial data 120

Source and details of income 121

Review of proprietary technologies 121

Patents and proprietary rights 122

Strategic approach and positioning 124

Strengths 124

Strength in MC expertise 124

Weaknesses 124

Termination of collaborative agreement with King Pharmaceuticals 124

Limited product pipeline portfolio 125

Opportunities 125

Threats 125

Joint ventures, collaborations and M&A activity 126

Strategic alliance with AstraZeneca AB 126

Collaborative development and marketing agreement with King

Pharmaceuticals 126

Strategic collaboration agreement with Mallinckrodt 127

Product development programs 128

Bremelanotide (formerly PT-141) 129

Male sexual dysfunction (MED) 129

Female sexual dysfunction (FSD) 129

Development of novel natriuretic receptor compounds 129

Chapter 6 Pharmion Corporation 134

Summary 134

Company address and contact details 135

Company overview and history 135

Business profile 138

Discussion and analysis of financial data 138

Source and details of income 138

Review of proprietary technologies 139

Patents and proprietary rights 140

Strategic approach and positioning 142

Strengths 142

Vidaza: potential future growth and revenue opportunities 142

Formation of strategic alliances 142

Weaknesses 143

Lack of manufacturing capabilities 143

Opportunities 144

Acquisition by Celgene 144

Inorganic growth 144

FDA approval of Vidaza NDA supplement for IV administration 144

Threats 145

Litigations 145

Intense competition 145

Cost containment pressures 146

Joint ventures, collaborations and M&A activity 147

M&A history 147

Acquisition of Cabrellis Pharmaceuticals 147

Joint ventures and collaborations 148

Marketed products 148

Vidaza (azacitidine for injection) 148

Thalidomide Pharmion 149

Innohep 149

Refludan 150

Product development programs 152

Amrubicin 152

Oral azacitidine 152

Satraplatin 152

MGCD0103 153

Chapter 7 Amylin Pharmaceuticals, Inc. 158

Summary 158

Company address and contact details 159

Company overview and history 159

Business profile 160

Discussion and analysis of financial data 160

Source and details of income 162

Review of proprietary technologies 162

Patents and proprietary rights 163

Strategic approach and positioning 164

Strengths 164

Strategic alliances 164

Byetta 164

New management team 165

Weaknesses 165

Reliance on third party manufacturers 165

Narrow customer concentration 166

Opportunities 167

Exenatide (long acting release) LAR 167

INTO obesity program 167

Threats 168

Competition 168

Joint ventures, collaborations and M&A activity 168

Joint ventures and collaborations 168

Marketed products 169

Byetta (exenatide) injection 169

Symlin 170

Product development programs 173

Diabetes product development 173

Exenatide LAR program 173

Obesity product development program 173

Pramlintide 173

Pramlintide and Leptin 174

Pramlintide PYY 3-36 174

Chapter 8 Trimeris, Inc. 178

Summary 178

Company address and contact details 179

Company overview and history 179

Business profile 181

Discussion, analysis of financial data 181

Details of income 181

Review of proprietary technologies 183

Patents and proprietary rights 183

Strategic approach and positioning 183

Strengths 184

Collaboration with Roche 184

Fuzeon 185

Weaknesses 185

T-1249 on hold 185

Opportunities 186

HIV drugs market 186

TRI-1144 186

Strategic shift in the company’s focus 187

Threats 188

Market acceptance of Fuzeon 188

Intense competition 188

Joint ventures, collaborations and M&A activity 189

Joint ventures and collaborations 189

Marketed products 190

Fuzeon 190

Product development programs 191

FUZEON 191

T-1249 191

Next generation fusion inhibitor peptide drug candidates 191

Chapter 9 ViroPharma Inc. 196

Summary 196

Company address and contact details 197

Company overview and history 197

Business profile 198

Discussion and analysis of financial data 198

Source and details of income 201

Review of proprietary technologies 201

Patents and proprietary rights 201

Strategic approach and positioning 202

Strengths 202

Strategic partnerships 202

Fast track status 203

Weaknesses 204

Lack of manufacturing capabilities 204

Customer concentration 204

Opportunities 205

Camvia™ (maribavir) 205

Threats 205

Dependence of continued sales of Vancocin 205

Joint ventures, collaborations and M&A activity 206

Joint ventures and collaborations 206

Cytomegalovirus and GlaxoSmithKline 206

Hepatitis C and Wyeth 207

Vancocin capsules and Eli Lilly 208

Picornaviruses and Schering-Plough Corporation 208

Marketed products 209

Vancocin 209

Product development programs 209

Camvia™ (maribavir) 209

HCV-796 210

NTCD (non-toxigenic C. difficile) 211

Antiviral discovery 211

Chapter 10 NPS Pharmaceuticals Inc. 214

Summary 214

Company Address and Contact Details 215

Company overview and history 215

Business profile 216

Discussion and analysis of financial data 216

Source and details of income 216

Review of proprietary technologies 217

Patents and proprietary rights 220

Strategic approach and positioning 220

Strategic approach 220

Outsource non-core competencies 220

Build a diversified pipeline of products addressing a variety of

medical conditions 221

Collaborate or out-license to reduce risk and accelerate the

commercialization of select product candidates 221

SWOT analysis 221

Strengths 221

Weaknesses 222

Opportunities 222

Threats 224

Joint ventures, collaborations and M&A activity 225

Joint ventures and collaborations 225

Amgen Inc 225

AstraZeneca 225

GlaxoSmithKline 226

Janssen 226

Kirin Brewery of Tokyo (pharmaceutical division) 226

Nycomed 227

Marketed products 228

Sensipar®/Mimpara® (Cinacalcet HCI) 228

Preotact™ (PREOS®) 228

Product development programs 230

Teduglutide (ALX-0600) 230

Calcilytics 230

Glycine reuptake inhibitors (GlyT-1) 230

Metabotropic glutamate receptors (mGluRs) 231

Chapter 11 SIGA Technologies, Inc. 234

Summary 234

Company address and contact details 235

Company overview and history 235

Business profile 237

Discussion and analysis of financial data 237

Source and details of income 240

Review of proprietary technologies 240

Patents and proprietary rights 241

Strategic approach and positioning 244

SWOT analysis 244

Strengths 244

Weaknesses 244

Opportunities 245

Threats 246

Joint ventures, collaborations and M&A activity 246

Collaborative research and licenses 246

Product development programs 248

Anti-infectives 248

Anti-smallpox drug 248

Other antivirals in development 248

Junín 249

Lassa fever 249

Ebola/Marburg 249

HTS discovery campaign 250

Dengue 250

Bunyavirus 250

Sortase 250

Chapter 12 Idenix Pharmaceuticals, Inc. 254

Summary 254

Company address and contact details 255

Company overview and history 255

Business profile 257

Discussion and analysis of financial data 257

Source and Details of Income 257

Review of proprietary technologies 260

Patents and proprietary rights 260

Strategic approach and positioning 261

Strategic approach 261

Focusing on HCV and HIV drug discovery and development

programs only 261

Discontinuation of the HBV franchise 261

Trimmed workforce 261

SWOT Analysis 262

Strengths 262

Weaknesses 263

Opportunities 263

Threats 264

Joint ventures, collaborations and M&A activity 264

Joint ventures and collaborations 264

Marketed products 266

Tyzeka®/Sebivo® (telbivudine) 266

Product development programs 267

IDX-899 267

IDX184 267

Chapter 13 Appendix 270

Methodology statement 270

Primary Data and Information Gathering 270

Secondary data and information gathering 270

Market share analysis and market forecast predictions 271

Definitions of Product-Life Cycle stages 272

Glossary of abbreviations and acronyms 275

Index 280

List of Figures

Figure 1.1: Evolution of the biopharmaceutical corporation 37

Figure 2.2: Analysis of R&D expenditure v revenues, 2006 59

Figure 2.3: Sponsored Research Payment Strategies 63

Figure 2.4: Sponsored research payment strategies 70

Figure 2.5: The principles of the extended enterprise 71

Figure 5.6: Disease area focus, Palatin Technologies 128

Figure 5.7: Annual product history, Palatin Technologies 130

Figure 7.8: Annual product history, Amylin Pharmaceuticals 171

Figure 7.9: Product pipeline, Amylin Pharmaceuticals 175

Figure 8.10: Annual product history, Trimeris 187

Figure 8.11: Product pipeline, Trimeris 192

Figure 9.12: Annual product history, ViroPharma 199

Figure 10.13: Annual product history, NPS Pharmaceuticals 218

Figure 10.14: Product pipeline, NPS 224

Figure 10.15: Disease area focus, NPS Pharmaceuticals 227

Figure 11.16: Annual product history, SIGA Technologies 238

Figure 11.17: Product pipeline, SIGA Technologies 247

Figure 12.18: Annual product history, Idenix Pharmaceuticals 258

Figure 12.19: Product pipeline, Idenix Pharmaceuticals 266

List of Tables

Table 1.1: Top 20 pharmaceutical companies ranked by revenues (2006) 39

Table 2.2: Summary analysis of the fastest growing biopharmaceutical companies, 2006 ($m) 51

Table 2.3: Fastest growing biopharmaceutical companies by net income/loss from operations, 2002-06 ($m) 52

Table 2.4: The top 20 biopharmaceutical companies by revenue in 2006 ($m) 53

Table 2.5: Summary analysis of fastest growing biopharmaceutical companies 2006 ($m) 54

Table 2.6: Fastest growing biopharmaceutical companies by revenues and % growth, 2002-06 ($m) 54

Table 2.7: Fastest growing biopharmaceutical companies by R&D expenditure, 2002-06 ($m) 55

Table 2.8: Company Analysis: Proprietary Technology versus Therapeutic Area 66

Table 2.9: Fastest growing biopharmaceutical companies by revenues and % growth, 2002-06 ($m) 69

Table 2.10: Company analysis by approved marketed product 69

Table 3.11: Company address and contact details 80

Table 3.12: Theravance Income Statement, 2002–2006 ($ millions) 82

Table 3.13: Theravance product development programs 93

Table 4.14: Company address and contact details 97

Table 4.15: ISTA Income Statement ($ millions 2002–2006) 102

Table 4.16: ISTA marketed product sales ($ millions 2005–2006) 103

Table 4.17: ISTA product development and pipeline 115

Table 5.18: Company address and contact details 119

Table 5.19: Palatin Income Statement ($ millions) year ended June 30, 2003–2007 123

Table 5.20: Palatin product development and pipeline 131

Table 6.21: Company address and contact details 135

Table 6.22: Pharmion Income Statement ($ millions 2002–2006) 141

Table 6.23: Pharmion marketed product sales ($ millions, 2002–2006) 151

Table 6.24: Pharmion product development and pipeline 155

Table 7.25: Company address and contact details 159

Table 7.26: Amylin Pharmaceuticals Income Statement, ($ millions, 2002–2006) 161

Table 7.27: Amylin Pharmaceuticals Income Statement ($ millions, 2002–2006) 172

Table 7.28: Amylin Pharmaceuticals product development and pipeline 176

Table 8.29: Company address and contact details 179

Table 8.30: Trimeris Income Statement ($ millions 2002–2006) 182

Table 8.31: Trimeris product development and pipeline 193

Table 9.32: Company address and contact details 197

Table 9.33: ViroPharma Income Statement ($ millions, 2002–2006) 200

Table 9.34: ViroPharma product development and pipeline 212

Table 10.35: Company address and contact details 215

Table 10.36: NPS Pharmaceuticals Income Statement ($ millions 2002–2006) 219

Table 10.37: Marketed products 220

Table 10.38: Marketed products 229

Table 10.39: NPS Pharmaceuticals product development and pipeline 232

Table 11.40: Company address and contact details 235

Table 11.41: SIGA Technologies Income Statement ($ millions, 2002–2006) 239

Table 11.42: SIGA Technologies- issued patents as of December 31, 2006 242

Table 11.43: SIGA Technologies provisional patents and patent applications as of Dec 31, 2006 243

Table 11.44: SIGA Technologies product development and pipeline 252

Table 12.45: Company address and contact details 255

Table 12.46: Idenix Pharmaceuticals Income Statement ($ millions, 2002–2006) 259

Table 12.47: Idenix Pharmaceuticals product development and pipeline 268

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