HEALTHCARE Building Biotech Technology Transfer Opportunities Sponsor and developer strategies for success By Alison Sahoo
Alison Sahoo Alison Sahoo is a pharmaceutical industry analyst with more than 10 years of experience researching the development of medicines and medical devices. She holds a BS in Physics from McGill University and an MBA in International Business from Rutgers University. She has written on a large number of healthcare topics including allergies, aesthetic products and procedures, biopharmaceuticals, clinical nutrition, contract research and manufacturing, diabetes, diagnostic imaging, gastrointestinal disease, generics, healthcare financing, infection control, long term care, obesity, overthe-counter (OTC) medications, Rx-to-OTC switch, stroke management, vaccines and other subjects. Copyright 2010 Business Insights Ltd This Management Report is published by Business Insights Ltd. All rights reserved. Reproduction or redistribution of this Management Report in any form for any purpose is expressly prohibited without the prior consent of Business Insights Ltd. The views expressed in this Management Report are those of the publisher, not of Business Insights. Business Insights Ltd accepts no liability for the accuracy or completeness of the information, advice or comment contained in this Management Report nor for any actions taken in reliance thereon. While information, advice or comment is believed to be correct at the time of publication, no responsibility can be accepted by Business Insights Ltd for its completeness or accuracy. ii
Table of Contents Building Biotech Technology Transfer Opportunities Executive Summary 8 Overview of biotech tech transfer 8 Why biotech tech transfer deals fail 9 Strategies to ensure successful biotech tech transfer deals 10 The future of biotech tech transfer deals 11 Chapter 1 Overview of biotech tech transfer 14 Summary 14 The biotechnology industry today 15 Biotechnology technologies and techniques 15 Proliferation of investigational products Funding issues 18 18 Need to partner to advance product development The emergence of biotechnology brokers 19 20 Drug development challenges 21 More complicated disease targets 22 Escalating costs 22 Increased regulatory scrutiny 23 Diminished in-house R&D resources 24 Types of biotech tech transfer relationships 26 Academic R&D infusions 28 Biotech biotech deals 29 Pharma biotech alliances 30 Licensing 32 R&D collaborations 33 Sales, distribution and co-marketing agreements 33 Joint ventures 33 Acquisitions 34 Volume of recent deals 35 Relationship trends 51 Volume and value 51 iii
Ownership 52 Conclusion 53 Chapter 2 Why biotech tech transfer deals fail 56 Summary 56 High failure rates 57 Symptoms of deal failure 57 Factors that do not affect deal failure 58 Implications of deal failure 59 Impact on technology developers 60 Impact on technology sponsors 61 Lost value of failed deals 61 Main causes of biotech tech transfer failure 62 Due diligence failures 64 Technology performance 66 Patent issues 67 Developer organization strength Deal structure 67 69 Financial compensation Management changes 70 71 Cultural differences 72 Project organization and expectations 74 Other preventable problems 76 Technology failure 77 Conclusion 77 Chapter 3 Strategies to ensure successful biotech tech transfer deals 80 Summary 80 Measures of success 81 Success for the technology developer 81 Success for the technology sponsor 82 Key biotech tech transfer strategies 82 Strategies for both technology developers and sponsors 82 Meeting technology challenges Strategies for technology developers 82 85 Optimizing resources 85 Thinking like a customer 88 Working with professional tech transfer organizations 89 iv
Prolific publishing Strategies for technology sponsors 91 92 Thorough technology identification and due diligence 93 Structuring innovative deal terms 98 Addressing compensation issues 105 Fostering an entrepreneurial developer environment 105 Ensuring effective alliance management 106 Navigating cultural chasms 108 Addressing international intellectual property challenges 110 Conclusion 113 Chapter 4 The future of biotech tech transfer deals 116 Summary 116 Introduction 117 The future of drug development 117 Impact of the economy 119 US healthcare reform 120 Biosimilars 121 Biotechnology in 2010-2015 123 Where biotech fits into Big Pharma 125 Dedicated biotechnology companies 127 Biotech tech transfer deal trends 2010-2015 129 Volume and value 130 Ownership 132 Intellectual property issues 133 Success rates 134 Conclusion 135 Index 136 v
List of Figures Figure 1.1: Frequency of biotech tech transfer deals by type of institution 27 Figure 1.2: Number and volume of biopartnering deals, 1997-2009 52 Figure 1.3: Acquisitions as a proportion of biotech tech transfer deals, 53 Figure 2.4: Characteristics of biotech tech transfer failure causes 63 Figure 2.5: Relative importance to sponsor of technology developer 66 Figure 3.6: Strategies to optimize biotech tech transfer opportunities 83 Figure 4.7: Biopharmaceutical vs. other pharmaceutical sales, 2009-2015 124 Figure 4.8: Impact of industry and economic trends on conventional and biotech drug developers, Figure 4.9: 2009-2015 125 Relative importance of biotechnology for leading pharmaceutical companies, 2009 vs. 2015 127 Figure 4.10: Number and average size of global biotech companies, 2009-2015 130 Figure 4.11: Number and volume of biopartnering deals, 2009-2015 132 List of Tables Table 1.1: Definition of biotechnology techniques 17 Table 1.2: Biotech tech transfer deals, 2009 36 Table 1.3: Biotech tech transfer deals, 2009 (Contd.) 37 Table 1.4: Biotech tech transfer deals, 2009 (Contd.) 38 Table 1.5: Biotech tech transfer deals, 2009 (Contd.) 39 Table 1.6: Biotech tech transfer deals, 2009 (Contd.) 40 Table 1.7: Biotech tech transfer deals, 2009 (Contd.) 41 Table 1.8: Biotech tech transfer deals, 2009 (Contd.) 42 Table 1.9: Biotech tech transfer deals, 2009 (Contd.) 43 Table 1.10: Biotech tech transfer deals, 2009 (Contd.) 44 Table 1.11: Biotech tech transfer deals, 2009 (Contd.) 45 Table 1.12: Biotech tech transfer deals, 2009 (Contd.) 46 Table 1.13: Biotech tech transfer deals, 2009 (Contd.) 47 Table 1.14: Biotech tech transfer deals, 2009 (Contd.) 48 Table 1.15: Biotech tech transfer deals, 2009 (Contd.) 49 Table 1.16: Biotech tech transfer deals, 2009 (Contd.) 50 Table 3.17: Technology transfer areas of interest for Merck & Co., 2010 95 Table 3.18: Technology transfer areas of interest for Merck & Co., 2010 (Contd.) 96 Table 3.19: Novartis private equity fund holdings, 2010 100 Table 3.20: Novartis private equity fund holdings, 2010 (Contd.) 101 Table 3.21: Novartis private equity fund holdings, 2010 (Contd.) 102 Table 3.22: Novartis private equity fund holdings, 2010 (Contd.) 103 Table 4.23: Millions of older and overweight persons in the US and EU, 2009-2015 119 Table 4.24: Biosimilars approved in the US and EU, 2010 121 vi