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Follow on Google News | Early Stage and Discovery Deals : Strategy, Structure and Payment Terms 2nd EditionToday early stage partnering is a core component of both biotech and pharmaceutical business strategy, allowing companies to access promising new and emerging compounds and technologies.
By: Sunil Nair Table of Contents Table of Contents 2 Executive summary 6 1. Introduction 7 2. What are the benefits of early-stage partnering? 9 2.1. The role of partnering in corporate strategy 9 2.1.1. What are the benefits of out-licensing? 2.1.2. In-licensing: 2.2. The revenue from in-licensed products is predicted to have an annual growth rate of 10%. 11 2.3. Partnering for pipeline development... 12 2.3.1 One company’s tactics: GlaxoSmithKline’ 3. The evolving role of partnering in the biotech and pharma industries.. 15 3.1. Licensing to partnering15 3.2. The traditional licensing model..15 3.3. The transition from straight-forward transactional exchanges to complex partnering agreements.... 17 3.4. Who benefits from the risk and reward sharing?.. 19 3.5. Sharing knowledge is a big part of the deal structure.. 22 3.6. What does the partnering model teach us?23 3.7. Complex partnering models...23 3.7.1. Process 24 3.7.2. How to structure a successful deal. 25 3.7.3. Financing – What aspects should be considered?.. 27 3.8. A shift in early stage dealmaking... 28 3.8.1. Biotechs competing with pharma for deals... 29 4. Early-stage deal strategies and structures. 31 4.1 Successful out-licensing... 31 4.2. When do companies partner?....32 4.2.1. Who benefits from early stage licensing? 33 4.2.2. License late: A safer but more costly avenue for the licensee....33 4.3. Early and late-stage deals - a cost comparison... 34 4.3.1. What do companies spend on partnering and how successful are the in-licensed projects?.... 34 4.4.1. Alliances between biotechnology companies are taking over 35 Case study 4.1 – MedImmune / Infinity Pharmaceuticals ..37 Case study 4.2 – PTC Therapeutics / CV Therapeutics ....37 Case study 4.3 – Predix Pharmaceuticals / Amgen Inc. 38 Case study 4.4 – Medtronic / RVX Therapeutics 38 Case study 4.5 – Enzon Pharmaceuticals / Santaris Pharma .... 39 4.4.2. Upfront payment: An important part of the deal structure. 39 See case study 4.1 – MedImmune / Infinity Pharmaceuticals .... 41 Case study 4.6 – GlaxoSmithKline / ChemoCentryx.. 41 Case study 4.7 – Infinity Pharmaceuticals / Novartis 41 4.4.3. Why is University out-licensing associated with very early-stage projects?43 Case study 4.8 – National Institutes of Health (NIH) / Regeneron ..45 Case study 4.9 – GlaxoSmithKline / Alimentary Pharmabiotic Centre 45 Case study 4.10 – Biota / NIAID .. 46 Case study 4.11 – Cystic Fibrosis Foundation / Vertex Pharmaceuticals. 46 4.5. Licensing strategy case studies.47 Case study 4.12 – Crucell / Immunobiological Laboratories Co Ltd.47 Case study 4.13 – Galapagos / Cellzome.48 Case study 4.14 – Memory Pharmaceuticals .... 48 Case study 4.15 – Caprion Pharmaceuticals / Boehringer Ingelheim.. 49 Case study 4.16 – Cambridge Antibody Technology / AstraZeneca49 Case study 4.17 – Biorigen / New Life Scientific 50 Case study 4.18 – GTC Biotherapeutics / LFB Biotechnologies. 51 4.6. Deal types 51 5. Payment strategies 54 5.1. Deciding a strategy. 54 5.2. Payment options.. 54 5.2.1. Upfront payments.55 5.2.1.1. Conditionality of upfront payments... 55 5.3.2. Loans 56 5.3.3. Convertible loans..56 5.3.4. Equity... 56 5.3.5. R&D funding. 56 5.3.6. Annual fixed payments.. 57 5.3.7. Milestone payments.. 57 5.3.8. Innovative forms of payment - ‘quids’..58 5.3.8.1. Products 58 5.3.8.2. Extended rights to pipeline/technology.. 58 5.3.8.3. Benefit from skills transfer.... 59 5.3.8.4. Public relations – An important factor for the early-stage company.59 5.3.8.5. Other quids....60 5.3.9. Royalties.. 60 5.3.9.1. Issues affecting royalty rates 60 5.3.9.2 Royalties on combination products ... 61 Case study 5.1 - Elan Corporation plc / Abbott Pharmaceutical PR Ltd.... 62 5.3.9.3. Guaranteed minimum/maximum annual payments... 62 5.3.9.4. Royalty stacking 62 5.3.9.5. Royalties and supply/purchase contracts. 63 5.3.10. Option payments64 6. How to make the right deal.65 6.1. Constructing the deal...65 6.2. Finding the right partner... 65 6.2.1. What attracts a partner? 66 6.2.2. Where to look for a partner.66 6.2.3. Sources of information... 69 6.2.4. Building a network69 6.2.4.1. Early-stage networking events 69 6.2.4.2. Networking for early biopharmaceutical executives...70 6.2.5. Becoming partner of choice72 6.3. Deal timeframes... 73 6.4. Deal valuation. 74 6.4.1. Factors contributing to the deal valuation 74 6.4.1.1. Intellectual property 75 6.4.1.2. Development phase....76 6.4.1.3. Cost of clinical trials 76 6.4.1.4. Risks associated with commercializing too late ....76 6.4.1.5. Benchmark values.. 76 6.4.1.6. Preclinical/ 6.4.1.7. Risk of failure77 6.4.1.8. Size and value of therapeutic market.... 77 6.4.1.9. Competition for licensing rights....77 6.4.1.10. Partner’s expertise/reputation in given field. 78 6.4.1.11. Impact on internal R&D programs.. 78 6.4.2. Due diligence as a valuation tool. 78 6.5. Keeping a deal successful.... 81 6.5.1. Commitment to the deal 81 6.5.2. Know your partner81 6.5.3. Thorough due diligence. 82 6.5.4. Patent and IP management82 6.5.5. Comprehensive deal agreement.. 82 6.5.6. Feasible and achievable milestones....83 6.5.7. Proactive management of issues. 83 6.5.8. Regular communication. 83 6.5.9. Tracking of payments and royalties 84 6.6. When to negotiate termination...84 6.7. What makes a deal ‘newsworthy’? 7. Deal terms and trends – An analysis of early stage deals... 86 7.1. Why are deal-terms put in the public domain? 86 7.2. Does survey data reflect the real deal?. 87 7.3. Headline valuations 87 7.5. Components of the deal... 91 Appendix 1 - Glossary of terms.... 94 Appendix 2 - Resources 97 Appendix 3 – Complex deal terms: an outline....98 Appendix 4 – Press releases 101 For more information kindly visit: http://www.bharatbook.com/ Website: www.bharatbook.com End
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