新药早期研发阶段及新药开发阶段的企业联盟

新药早期研发阶段及新药开发阶段的企业联盟 是由出版商Pharmalicensing Ltd.在2006年12月所出版的。 这份英文市场调查报告书包含144 pages 价格从美金2695起跳。

简介

目录

Abstract

Today 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. To become a successful player within the life science industry it is crucial to understand the changing dynamics of the industry' s early stage deal-making trends.

Pharmalicensing' s revised second edition of "Early Stage and Discovery Deals: Strategy, Structure and Payment Terms" analyzes the early stage dealmaking trends and discusses the basics of dealmaking structures, covering payments terms and deal valuations.

Updated with new data including case studies from 2006 and contracts this report aims to assist and guide leading professionals involved in business development through the complex process of early stage dealmaking.

Order this report to

• Discover the benefits of early stage partnering
• Examine the current partnering model
• Uncover ways to find the right partner
• Accumulate tips for structuring and maintaining the right deal
• Understand the cost differences between in-licensed projects and in-house pre-clinical projects

Report sections include

• Extensive selections of case studies from 2006, featuring companies such as Amgen AstraZeneca, GlaxoSmithKline
• A Comprehensive presentation of headline deal values at different phases of early stage development
• Detailed company contracts, highlighting real values and information

Table of Contents

Table of Contents

Executive summary

Executive summary

1. Introduction

2. What are the benefits of early-stage partnering?

• 2.1. The role of partnering in corporate strategy
  • 2.1.1. What are the benefits of out-licensing?
  • 2.1.2. In-licensing: A way of giving an off-patent drug a new life
• 2.2. The revenue from in-licensed products is predicted to have an annual growth rate of 10%
• 2.3. Partnering for pipeline development
  • 2.3.1 One company' s tactics: GlaxoSmithKline' s approach to in-licensing

• 3.1. Licensing to partnering
• 3.2. The traditional licensing model
• 3.3. The transition from straight-forward transactional exchanges to complex partnering agreements
• 3.4. Who benefits from the risk and reward sharing?
• 3.5. Sharing knowledge is a big part of the deal structure
• 3.6. What does the partnering model teach us?
• 3.7. Complex partnering models
  • 3.7.1. Process
  • 3.7.2. How to structure a successful deal
  • 3.7.3. Financing - What aspects should be considered?
• 3.8. A shift in early stage dealmaking
  • 3.8.1. Biotechs competing with pharma for deals

4. Early-stage deal strategies and structures

• 4.1 Successful out-licensing
• 4.2. When do companies partner?
  • 4.2.1. Who benefits from early stage licensing?
  • 4.2.2. License late: A safer but more costly avenue for the licensee
• 4.3. Early and late-stage deals - a cost comparison
  • 4.3.1. What do companies spend on partnering and how successful are the in-licensed projects?
  • 4.4.1. Alliances between biotechnology companies are taking over
    • Case study 4.1 - MedImmune / Infinity Pharmaceuticals
    • Case study 4.2 - PTC Therapeutics / CV Therapeutics
    • Case study 4.3 - Predix Pharmaceuticals / Amgen Inc
    • Case study 4.4 - Medtronic / RVX Therapeutics
    • Case study 4.5 - Enzon Pharmaceuticals / Santaris Pharma
  • 4.4.2. Upfront payment: An important part of the deal structure
    • See case study 4.1 - MedImmune / Infinity Pharmaceuticals
    • Case study 4.6 - GlaxoSmithKline / ChemoCentryx
    • Case study 4.7 - Infinity Pharmaceuticals / Novartis
  • 4.4.3. Why is University out-licensing associated with very early-stage projects?
    • Case study 4.8 - National Institutes of Health (NIH) / Regeneron
    • Case study 4.9 - GlaxoSmithKline / Alimentary Pharmabiotic Centre
    • Case study 4.10 - Biota / NIAID
    • Case study 4.11 - Cystic Fibrosis Foundation / Vertex Pharmaceuticals
• 4.5. Licensing strategy case studies
  • Case study 4.12 - Crucell / Immunobiological Laboratories Co Ltd
  • Case study 4.13 - Galapagos / Cellzome
  • Case study 4.14 - Memory Pharmaceuticals
  • Case study 4.15 - Caprion Pharmaceuticals / Boehringer Ingelheim
  • Case study 4.16 - Cambridge Antibody Technology / AstraZeneca
  • Case study 4.17 - Biorigen / New Life Scientific
  • Case study 4.18 - GTC Biotherapeutics / LFB Biotechnologies
• 4.6. Deal types

5. Payment strategies

• 5.1. Deciding a strategy
• 5.2. Payment options
  • 5.2.1. Upfront payments
    • 5.2.1.1. Conditionality of upfront payments
  • 5.3.2. Loans
  • 5.3.3. Convertible loans
  • 5.3.4. Equity
  • 5.3.5. R&D funding
  • 5.3.6. Annual fixed payments
  • 5.3.7. Milestone payments
  • 5.3.8. Innovative forms of payment - ' quids'
    • 5.3.8.1. Products
    • 5.3.8.2. Extended rights to pipeline/technology
    • 5.3.8.3. Benefit from skills transfer
    • 5.3.8.4. Public relations - An important factor for the early-stage company
    • 5.3.8.5. Other quids
  • 5.3.9. Royalties
    • 5.3.9.1. Issues affecting royalty rates
    • 5.3.9.2 Royalties on combination products
      • Case study 5.1 - Elan Corporation plc / Abbott Pharmaceutical PR Ltd
    • 5.3.9.3. Guaranteed minimum/maximum annual payments
    • 5.3.9.4. Royalty stacking
    • 5.3.9.5. Royalties and supply/purchase contracts
  • 5.3.10. Option payments

6. How to make the right deal

• 6.1. Constructing the deal
• 6.2. Finding the right partner
  • 6.2.1. What attracts a partner?
  • 6.2.2. Where to look for a partner
  • 6.2.3. Sources of information
  • 6.2.4. Building a network
    • 6.2.4.1. Early-stage networking events
    • 6.2.4.2. Networking for early biopharmaceutical executives
  • 6.2.5. Becoming partner of choice
• 6.3. Deal timeframes
• 6.4. Deal valuation
  • 6.4.1. Factors contributing to the deal valuation
    • 6.4.1.1. Intellectual property
    • 6.4.1.2. Development phase
    • 6.4.1.3. Cost of clinical trials
    • 6.4.1.4. Risks associated with commercializing too late
    • 6.4.1.5. Benchmark values
    • 6.4.1.6. Preclinical/clinical data
    • 6.4.1.7. Risk of failure
    • 6.4.1.8. Size and value of therapeutic market
    • 6.4.1.9. Competition for licensing rights
    • 6.4.1.10. Partner' s expertise/reputation in given field
    • 6.4.1.11. Impact on internal R&D programs
  • 6.4.2. Due diligence as a valuation tool
• 6.5. Keeping a deal successful
  • 6.5.1. Commitment to the deal
  • 6.5.2. Know your partner
  • 6.5.3. Thorough due diligence
  • 6.5.4. Patent and IP management
  • 6.5.5. Comprehensive deal agreement
  • 6.5.6. Feasible and achievable milestones
  • 6.5.7. Proactive management of issues
  • 6.5.8. Regular communication
  • 6.5.9. Tracking of payments and royalties
• 6.6. When to negotiate termination
• 6.7. What makes a deal ' newsworthy' ?

7. Deal terms and trends - An analysis of early stage deals

• 7.1. Why are deal-terms put in the public domain?
• 7.2. Does survey data reflect the real deal?
• 7.3. Headline valuations
• 7.5. Components of the deal

Appendix 1 - Glossary of terms

Appendix 2 - Resources

Appendix 3 - Complex deal terms: an outline

Appendix 4 - Press releases

• Case Study 4.1
• Case study 4.2
• Case study 4.3
• Case study 4.4
• Case study 4.5
• Case study 4.6
• Case study 4.7
• Case study 4.8
• Case study 4.9
• Case study 4.10
• Case study 4.11
• Case study 4.12
• Case study 4.13
• Case study 4.15
• Case study 4.16
• Case study 4.17
• Case study 4.18
• Case study 5.1

Appendix 5 - References

Appendix 6 - Biographies

• Acknowledgements
• Pharmalicensing
• Pharmalicensing Order Form

List of Tables

• Table 1. GSK' s - Centers of Excellence for Drug Discovery consists of 7 individual centres. 13Table 2. R&D project mathematical valuation models need to be more complex in order to reflect reality.
• Table 3. Big pharmas dealmaking trends show that they prefer to invest in similar development stages.
• Table 5. The top 5 deal values in Jan 2006 - Oct 2006 combined reached a total of more than $US 1.6 billion.
• Table 6. Top 5 upfront payments between Jan-2006 and Oct-2006.
• Table 7. The top 5 valued University deals, Jan-2006 to Oct-2006.
• Table 8. A summary of different deal types.
• Table 8. Payment strategies - components of the deal
• Table 9. Variants affecting royalty payments
• Table 11. Attributes that attract partners
• Table 11. Major early-stage partnering events
• Table 12. A selection of networking clubs worldwide
• Table 14. Early stage deals deal frames - from contact to signature
• Table 15. Factors contributing to deal valuation
• Table 16. Ongoing due diligence to keep a deal successful
• Table 17. A preclinical project is worth significantly less than a phase I or phase II project.

List of Figures

• Figure 1. Amount raised from partnering 1980-2005. 7
• Figure 2. Between Jan 2006 - Oct 2006, 6 early stage deals were valued at over $US 100 million.
• Figure 3. Deals disclosing upfront payments between Jan 2006-Oct 2006.
• Figure 4. The values of University deals are significantly lower than biotech deals between Jan 2006 and Oct 2006.
• Figure 6. Key information sources for partnering executives
• Figure 7. Lead Molecule R&D projects have increased most in value Jan. 2003 to Oct. 2006.
• Figure 8. Breakdown of discovery deals from 2003 to October 2006*
• Figure 9. Breakdown of lead discovery deals from 2003 to October 2006*
• Figure 10. Preclinical deals from 2003 to October 2006*
• Figure 11. Average total upfront payments by stage of development at deal closing ($ million)
• Figure 13. Average royalty rates by stage of development at deal closing (%)

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