Table of Contents

Evolving Trends in Biopharmaceutical Licensing Executive Summary 10
Introduction to biopharmaceutical licensing 10
Biopharmaceutical deals and trends 11
Drivers and resistors facing biopharmaceutical licensing 12
Companies involved in biopharmaceutical licensing 13
The evolutionary pattern of biopharmaceutical licensing 14

Chapter 1 Introduction to biopharmaceuticals and licensing 16
Summary 16
Introduction 17
Overview of the biopharmaceutical industry 17
The Biopharma-Pharma relationship 18
The licensing process 21
Meeting the licensing challenge 22
Biopharma continues to shine 24

Chapter 2 Biopharmaceutical deals and trends 26
Summary 26
Introduction 27
Biopharmaceutical licensing trends 27
Number and average value of Biopharma licensing deals 28
Licensing deal partners 30
Biopharma’s standing: out-licensing versus in-licensing deals 31
Licensing deal types 32
Licensing trends in drug development 34
The rising costs of early-stage licensing 35
Mid-stage deal-making: lucrative prospects 40
Therapeutic focus in Biopharma licensing 41

Chapter 3 Drivers and resistors of biopharmaceutical licensing 44
Summary 44
Introduction 45
Overview of drivers and resistors in biopharmaceutical licensing 45
Key drivers 46
Generating cash 46
Pharma turns to Biopharma to maintain revenue growth; Biopharma gaining an upper hand 48
Risk sharing 50
Access to expertise 50
Key resistors 52
Reduced control 52
Increasing complexity of licensing deals: positive for Biopharma but with a higher risk attached 52
Stricter regulatory and political environments 53
Future strategic direction 58

Chapter 4 Leading companies involved in biopharmaceutical licensing 62
Summary 62
Introduction 63
Who is looking to Biopharma and why? 63
Two sides of the Pharma coin: GlaxoSmithKline and Roche 64
GlaxoSmithKline: a Biopharma façade? 64
Roche: building upon an established presence in Biopharma 71
The Biopharma/Pharma dynamic 76
Amgen: the leading Biopharma 76
Gilead: diversification after market domination 80
Cephalon: a Biopharma out-licensor 83
Alnylam: a developer of novel therapeutics based on RNA interference 85

Chapter 5 The evolutionary pattern of biopharmaceutical licensing 90
Summary 90
Introduction 91
The big deals of 2008: a sign of what is to come? 91
Who holds the future to ImClone? 91
The Roche and Genentech saga 92
Biopharma to Biopharma: Genzyme and Isis 93
Takeda looks to Biopharma for entry to the US market 94
Pfizer and Wyeth 95
Are M&As the new licensing? 97
Potential arrival of biosimilars: a catalyst for Biopharma M&A 98
The financial crisis and the future of Biopharma 99
The promise of emerging markets 101
Keys to future success 104
Recommendations and strategies for future Biopharma licensing deals and alliances 105

Chapter 6 Appendix 110
MedTRACK data 110
Index 111

List of Figures
Figure 1.1: Number of NMEs and BLAs approved by the US FDA 19
Figure 1.2: Strengths of Biopharma and Pharma 21
Figure 1.3: Overview of the pharmaceutical licensing process 23
Figure 1.4: Global sales* of Biopharma vs. Pharma 24
Figure 2.5: Number and average value of Biopharma licensing deals, 2001–08 28
Figure 2.6: Number of top 20 Biopharma licensing deals by partner, 2001–08 30
Figure 2.7: Number of Biopharma in- and out-licensing deals by partner, 2004–08 31
Figure 2.8: Biopharma licensing by deal type, 2001–08 32
Figure 2.9: Biopharma out-licensing distribution by clinical stage, 2001–08 34
Figure 2.10: Early-stage deal models with associated pros & cons 36
Figure 2.11: Early-stage alliances—number of deals and deal size, 2001–08 37
Figure 2.12: Trends in technology, Biopharma out-licensing, 2002–07 38
Figure 2.13: Number of Biopharma out-licensing deals ($100m+ nominal deal value) by clinical stage, 2005–08 40
Figure 2.14: Therapeutic focus in Biopharma licensing deals, 2005–08 41
Figure 3.15: Drivers and resistors facing biopharmaceutical licensing 46
Figure 3.16: Biopharma R&D spend 47
Figure 3.17: Biopharma funding 47
Figure 3.18: Progression of Biopharma’s involvement in licensing deals 49
Figure 3.19: Estimated last patent expiry dates of selected proteins 56
Figure 3.20: Future strategic directions for Biopharma in meeting current challenges 58
Figure 4.21: Biopharma’s transition via forward and downward integration 64
Figure 5.22: Announced number of Biopharma mergers & acquisitions, 2001–08 97
Figure 5.23: Drug patent expiries in the US, 2008-2012 100
Figure 5.24: Future licensing and alliance scenarios for Biopharma 104

List of Tables
Table 4.1: GSK’s licensing and alliance activity, 2008 67
Table 4.2: GSK’s licensing and alliance activity, 2007 68
Table 4.3: GSK’s licensing and alliance activity, 2006 69
Table 4.4: GSK’s licensing and alliance activity, 2005 70
Table 4.5: Roche’s licensing and alliance activity, 2008 71
Table 4.6: Roche’s licensing and alliance activity, 2007 72
Table 4.7: Roche’s licensing and alliance activity, 2006 73
Table 4.8: Roche’s licensing and alliance activity, 2005 74
Table 4.9: Amgen’s licensing and alliance activity, 2007-08 77
Table 4.10: Amgen’s licensing and alliance activity, 2005-06 78
Table 4.11: Gilead’s licensing and alliance activity, 2005–07 80
Table 4.12: Cephalon’s licensing and alliance activity, 2005–07 83
Table 4.13: Alnylam’s licensing and alliance activity, 2005–07 85
Table 5.14: Sales in 7MM and pharmerging markets ($m), 2003-07 101