Collaborations and Licensing in Global Pharmaceuticals and Biotech

Table of Contents

Chapter 1.Collaborations and licensing in pharma and biotech

• 1.1 Introduction
• 1.2 What is a collaboration?
• 1.3 The industry and reasons for collaborating
  • 1.3.1 The mutual dependency between pharma and biotech
  • 1.3.2 The increasing importance of alliances
• 1.4 What is a licensing deal?
• Chart 1 Pharma revenues from licensed products 2001-2009
  • 1.4.1 Sales from licensing deals
  • 1.4.2 The most competitive areas for deals
• Table 1 Death rates (per 100,000) in U.S 1980-2000.
• Chart 2Percentage U.S population affected by conditions in 2003
• Table 2. % U.S population suffering in 2003

Chapter 2. The Drug Discovery Process

• 2.1Background on the different stages in drug discovery
• 2.2 Approaches used for drug discovery
  • 2.2.1Screening
  • 2.2.2Biotechnology
• 2.3The pre-clinical testing stage
• Chart 3 Number of drugs in pre-clinical development 2004 by company
  • 2.3.1Testing of an investigational new drug
• 2.4 Background information on Clinical Trials
  • 2.4.1 The purpose and results of Phase I Clinical Studies
  • 2.4.2 The purpose of Phase II Clinical Studies.
  • 2.4.3The purpose of Phase III Clinical Studies.
• 2.5 Types of applications for a new drug
  • 2.5.1 Additional data provided by Phase IIIb/IV Studies
  • 2.5.2 The focus of Post-Marketing Studies.
• 2.6 The process of FDA approval
• Chart 4 Number of drugs approved by FDA 1996 - 2003
  • 2.6.1FDA review and decision over a new drug
• Table 3FDA drugs approved 1996-2003

Chapter 3. The Pharmaceutical Industry

• 3.1An overview of the industry
• Table 4 Top performing companies 2002
  • 3.1.1The leading position of the big pharmaceutical companies
• 3.2Worldwide sales and markets
• Chart 5.Global % Pharmaceutical Sales
• Table 5. World leading pharmaceutical companies 2003
• Chart 6. Top pharma companies and market share 2003
• Table 6. Top Ten drug mergers in the USA
• Table 7. Pharmaceutical company market capitalisation
• Chart 7. Pharmaceutical company leaders in market capitalisation 2003
• 3.3Challenges facing the pharmaceutical industry
• Chart 8.Long term growth rate leaders - 5 years to 2003
• 3.4Pharmaceutical Industry R & D background
  • 3.4.1Price control in Europe and Japan affecting the industry
  • 3.4.2Risks involved in developing a new drug
• Table 8.Cost of bringing new drug to market 1976-2003.
• 3.5The cost of bringing a new drug to market
• Chart 9Number of drugs in clinical trials 2004
  • 3.5.1The cost of gaining FDA Approval
  • 3.5.2The costs of manufacturing
  • 3.5.3Advertising and marketing costs
• 3.6Factors affecting the pharmaceutical industry.
  • 3.6.1Factors affecting the development of new products
  • 3.6.2Strategic options available to companies
  • 3.6.3Social factors affecting the industry
  • 3.6.4Economic factors affecting the industry

Chapter 4. The Biotechnology Industry

• 4.1An overview of the industry.
• 4.2Global sales from biotech drugs
• Chart 10.Biotech industry sales
• 4.3Biotech industry market capitalisation
• Chart 11.Change in biotech industry market capitalisation.
• Chart 12.Global sales from genetically engineered drugs
• Chart 13Change in biotech industry revenue
• 4.4FDA approval rate of biotech drugs
• Chart 14. Number of biotech drugs approved by the FDA
  • 4.4.1. Biotech drugs currently in clinical trials
• 4.5. What is biotechnology?
  • 4.5.1. The benefits of biotechnology based products
  • 4.5.2The future of biotech R&D
• Table 9. Biotech leaders in market capitalisation 2003
• Chart 15. Leading biotech companies by market capitalisation 2003
• Table 10.Biotech companies and total revenue 2003
• 4.6. Current situation for biotech companies
• Chart 16. Biotechnology leaders in long term growth rate 2003

Chapter 5.Applications of biotechnology with potential benefits in collaborations

• 5.1The application of Genomic technology in R&D
  • 5.1.1Leading genomics companies
  • 5.1.2Case study of collaboration involving genomics - Genedata and Schering
  • 5.1.3Case Study - RecomGenex and AstraZeneca
  • 5.1.4Case study - Amgen and Infinity Pharmaceuticals
• 5.2The application of proteomics in drug discovery
  • 5.2.1Case Study - Symyx Technologies and Merck
• 5.3The application of Pharmacogenomics in drug discovery
  • 5.3.1Potential benefits of pharmacogenomic
  • 5.3.2Pharmacogenomics alliances Case study -Abbott Laboratories
  • 5.3.3Abbott Laboratories and Iconix Pharmaceuticals
• Table 11.Costs of different types of collaboration
• Chart 18.Number of major deals by companies 1999-2003

Chapter 6. Collaboration types

• 6.1.Costs involved in collaborations
• Table 12.Pharma-biotech alliances and their value
• Chart 17. .Amount spent by Pfizer on biotech alliances
  • 6.1.1Successful collaborations between big pharma and biotech in the past.
  • 6.1.2Eli Lilly and Genentech
  • 6.1.3Johnson and Johnson and Amgen
  • 6.1.4Roche and Genentech
• 6.2Collaboration Strategy
  • 6.2.1Developing the skills needed to attract partners
• 6.3The benefits of collaborating with pharmaceutical companies
  • 6.3.1Collaborations for Co-commercialisation
• 6.4Capitalising on the human genome
  • 6.4.1Genetically engineered drugs on the market
• 6.5The process of collaboration
  • 6.5.1Strategic goals to consider
  • 6.5.2The complexity of deals
  • 6.5.3Gaining competitive advantage
  • 6.5.4A successful collaboration: Bayer/Millenium Collaboration
• 6.6Collaboration Management: Developing and maintain a deal.
  • 6.6.1Collaboration Strategies in different companies
  • 6.6.2Collaboration with biotech as a method to boost pharma pipeline.

Chapter 7. Becoming the partner of choice

• 7.1Objectives that support strategic goals
  • 7.1.2Understanding the value brought to an alliance
  • 7.1.3Identifying and understanding potential partners
• 7.2Due Diligence
• 7.3Promoting capabilities to potential partners
  • 7.3.1Maintaining a relationship through structured interactions
  • 7.3.2Profile of a company which has achieved success in collaborations: Pfizer Inc
    • 7.3.2.1Pfizer and Xenoport
    • 7.3.2.2Pfizer and Perlegen Sciences
    • 7.3.2.3Pfizer and Metabolex
• 7.4 Collaborations by therapeutic area
• Chart 19GSK collaborations in different therapeutic areas 2003
  • 7.4.1Cancer - Roche and Genentech
  • 7.4.2Metabolism Drug - Lipomics Technologies and Bayer
  • 7.4.3Blood - Chiron and Zymequest
  • 7.4.4HIV - Roche and Trimeris
• 7.5Keys to Success in alliances
  • 7.5.1Current trends in deal making
• 7.6 Reasons for deals failing
  • 7.6.1Unsuccessful alliances

Chapter 8. Licensing

• 8.1The dependency of big pharma companies on licensing
• Chart 20Top 20 Pharma Cos sales from licensed products.
• 8.2The importance of Intellectual Property.
  • 8.2.1The value of patents
  • 8.2.2Patentable inventions in biotechnology
  • 8.2.3The value of copyright
• 8.3 Licensing deals
  • 8.3.1 Licensing as an option for small biotechs
• Table 13Leading licensing agreements
  • 8.3.2Pharmaceutical companies and licensing
  • 8.3.3Cost and terms of a licensing deal - case study of Advancis and GlaxoSmithkline
• 8.4Importance of Research Phase at time of licensing deal
  • 8.4.1Timing of licensing deal and risk management
  • 8.4.2Early v Late Stage licensing
• 8.5Current Licensing deal strategies
  • 8.5.1Changes that would benefit current licensing strategies
  • 8.5.2Achieving flexibility in deal making
• 8.6Licensing deals by therapeutic area
  • 8.6.1Blood - Sanofi and NV Organon
  • 8.6.2Cancer - Array Biopharma and Genentech
  • 8.6.3Respiratory - SkyePharma and GlaxoSmithKline
  • 8.6.4Inflammatory diseases - Merck and Biogen

Chapter 9. Different types of licensing deal

• 9.1Out-Licensing deals
  • 9.1.1Out-licensing deal profile - Genentech and Ceregene
  • 9.1.2Reasons for out-licensing
  • 9.1.3Out-licensing trends
• 9.2In-Licensing deals
  • 9.2.1Reasons for in-licensing
  • 9.2.2In-licensing trends
  • 9.2.3 Case Study - Lexicon Genetics and AstraZeneca
• 9.3Achieving success in a licensing deal
  • 9.3.1Factors involved in a successful deal
• 9.4Reasons for deals failing
  • 9.4.1Problems with licensing deals
  • 9.4.2Case study of an unsuccessful licensing deal
• 9.5The future of licensing deals

Chapter 10. Pharmaceutical Company Profiles

• 10.1Pfizer
• Chart 21Pfizer income and expenditure 2003
• 10.2GlaxoSmithKline
• 10.3Merck
• Chart 22. Merck sales and income 2003
• 10.4AstraZeneca
• Chart 23. AstraZeneca revenue and expenditure 2003
• 10.5Johnson & Johnson
• 10.6Aventis
• 10.7Bristol Myers-Squibb
• Chart 24BMS sales and income 2003
  • 10.8Novartis
• 10.9Wyeth
• Chart 25Wyeth Sales and income 2003
• 10.10Eli Lilly & Co
• Chart 26Eli Lilly sales and income 2003

Chapter 11. Biotechnology company profiles

• 11.1Amgen
• Chart 27Amgen income and loss 2003
• 11.2Genentech
• 11.3Serono
• 11.4Biogen
• Chart 28Biogen investment and income 2003
• 11.5Genzyme
• Chart 29Genzyme income and loss 2003
• 11.6MedImmune
• Chart 30MedImmune revenue and income 2003
• 11.7Chiron
• 11.8Gilead
• Chart 31Gilead revenues and loss 2003
• 11.9Millenium
• Chart 32Millenium revenues and losses 2003
• 11.10Intermune
• Chart 33Intermune revenues and loss 2003
• 11.11Celltech

Chapter 12. Conclusion

• 12.1What lies ahead for pharma/biotech?
• 12.2Alliance management
• 12.3The current partner of choice
• 12.4Matching supply and demand
• 12.5Market forces to be aware of
• 12.6Challenges and issues for the future

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