Manufacturing and Supply Agreements in Biopharma

Table of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Trends in manufacturing and supply dealmaking

• 2.1. Introduction
• 2.2. Difference between manufacturing and supply deals
• 2.3. Trends in manufacturing deals since 2000
• 2.4. Trends in supply deals since 2000
  • 2.4.1. When supply can be useful
• 2.5. Pure deals and multi-component deals
  • 2.5.1. Attributes of pure manufacturing and supply deals
  • 2.5.2. Attributes of manufacturing and supply in multi-component deals
• 2.6. Reasons for including manufacturing and supply options in a multicomponent deal
• 2.7. The future of manufacture and supply as part of multicomponent deals

Chapter 3 - Overview of manufacturing deal structure

• 3.1. Introduction
• 3.2. Pure versus multi-component manufacturing deals
• 3.3. Pure manufacturing agreement structure
  • 3.3.1. Example manufacturing agreements
    • 3.3.1.a. Case study 1: Lonza - Tercica - May 2007
    • 3.3.1.b. Case study 2: Cardinal Health - Targanta - March 2007
• 3.4. Manufacturing rights as part of a wider alliance agreement
  • 3.4.1. Example multicomponent manufacturing clauses
    • 3.4.1.a. Case study 3: Janssen - Vertex - June 2006
    • 3.4.1.b. Case study 4: Ipsen - Medicis - March 2006

Chapter 4 - Overview of supply deal structure

• 4.1. Introduction
• 4.2. Supply agreement structure
  • 4.2.1. Example supply agreements
    • 4.2.1.a. Case study 5: Novartis - Unigene - January 2007
    • 4.2.1.b. Case study 6: Watson - Savient - June 2006
• 4.3. Supply rights as part of a wider alliance agreement
  • 4.3.1. Example co-marketing right clauses
    • 4.3.1.a. Case study 7: Shionogi - BioCryst - February 2007
    • 4.3.1.b. Case study 8: Schering Plough - Xoma - May 2006

Chapter 5 - Leading manufacturing deals

• 5.1. Introduction
• 5.2. Top manufacturing deals by value
• 5.3. Top pure manufacturing deals
• 5.4. Top manufacturing deals signed by bigpharma
• 5.5. Most active manufacturing dealmakers
• 5.6. Bigpharma manufacturing deal activity

Chapter 6 - Leading supply deals

• 6.1. Introduction 93
• 6.2. Top supply deals by value
• 6.3. Top pure supply deals
• 6.4. Top supply deals signed by bigpharma
• 6.5. Most active supply dealmakers
• 6.6. Bigpharma supply deal activity

Chapter 7 - Bigpharma manufacturing and supply agreements

• 7.1. Introduction
• 7.2. How to use manufacturing and supply agreements
• 7.3. Company manufacturing and supply agreement listings
  • Abbott
  • Actavis
  • Akzo Nobel
  • Alcon Labs
  • Allergan
  • Altana
  • Amgen
  • Astellas
  • AstraZeneca
  • Baxter International
  • Bayer
  • Bayer Schering Pharma AG
  • Biogen Idec
  • Boehringer Ingelheim
  • Bristol-Myers Squibb
  • Cephalon
  • Chugai
  • CSL
  • Dainippon Sumitomo
  • Eisai
  • Eli Lilly
  • Forest Laboratories
  • Genentech
  • Genzyme
  • Gilead Sciences
  • GlaxoSmithKline
  • Johnson & Johnson
  • King
  • Lundbeck
  • Menarini
  • Merck & Co
  • Merck - Serono KGaA
  • Mitsubishi
  • Novartis AG
  • Novo Nordisk
  • Nycomed Pharma
  • Otsuka
  • Pfizer
  • Procter & Gamble
  • Roche
  • Sanofi-Aventis
  • Schering Plough
  • Serono
  • Shionogi Seiyaku
  • Shire
  • Solvay
  • Takeda
  • Tanabe Seiyaku
  • TAP Pharmaceuticals
  • Teva
  • UCB
  • Watson
  • Wyeth

Chapter 8 - Manufacturing agreement directory 2003-7

• 8.1. Introduction
• 8.2. Company A-Z
• 8.3. By therapy area
  • Accident/Hospital/Trauma
  • Blood/Lymphatic System
  • Cardiovascular
  • Central nervous System
  • Dermatology
  • Gastrointestinal
  • Genitourinary
  • Autoimmune/Inflammatory
  • Infection
  • Metabolism
  • Musculoskeletal
  • Oncology
  • Respiratory
  • Sensory Organ / Oral Health
  • Drug Delivery
  • OTC
• 8.4. By stage of development at signing
  • Discovery
  • Preclinical
  • Phase I
  • Phase II
  • Phase III
  • Registration
  • Formulation
  • Market

Chapter 9 - Supply agreement directory 2003-7

• 9.1. Introduction
• 9.2. Company A-Z
• 9.3. By therapy area
  • Accident/Hospital/Trauma
  • Agriculture
  • Blood/Lymphatic System
  • Cardiovascular
  • Central nervous System
  • Dermatology
  • Gastrointestinal
  • Genetic
  • Genitourinary
  • Autoimmune/Inflammatory
  • Infection
  • Metabolism
  • Musculoskeletal
  • Oncology
  • Respiratory
  • Sensory Organ / Oral Health
  • Over the Counter
• 9.4. By stage of development at signing
  • Discovery
  • Preclinical
  • Phase I
  • Phase II
  • Phase III
  • Registration
  • Formulation
  • Market

Appendices

• Appendix 1 - Manufacturing and supply references
• Appendix 2 - Resources
• Appendix 3 - Deal type definitions
• Appendix 3 - Deal type definitions
• Appendix 4 - Example manufacturing document
• Appendix 5 - Example supply document
• About CurrentPartnering
• Recent report titles from CurrentPartnering
• Order Form - Reports
• Order form - Company Dealmaking Profiles

TABLE OF FIGURES

• Figure 1: Definition of manufacturing and supply
• Figure 2: Types of manufacturing agreement
• Figure 3: Trends in manufacturing deal announcements, 2000-2007
• Figure 4: Manufacturing deals signed at what phase of development, 2000-2007
• Figure 5: Trends in supply deal announcements, 2000-2007
• Figure 6: Supply deals signed at what phase of development, 2000-2007
• Figure 7: Situations where supply deals can prove useful
• Figure 8: Pure versus multi-component manufacturing deal announcements, 2000-2007
• Figure 9: Stage of development at which pure and multi-component manufacturing deals are announced 2000-2007
• Figure 10: Pure versus multi-component supply deal announcements, 2000-2007
• Figure 11: Stage of development at which pure and multi-component supply deals are announced 2000-2007
• Figure 14: Components of the manufacturing deal structure
• Figure 15: Components of the supply deal structure
• Figure 16: Top manufacturing deals by value since 2003
• Figure 17: Top pure manufacturing deals by value since 2003
• Figure 18: Top manufacturing deals signed by bigpharma value since 2003
• Figure 19: Most active manufacturing dealmakers 2003-7
• Figure 20: Bigpharma - top 50 - manufacturing deals since 2003
• Figure 21: Top supply deals by value since 2003
• Figure 22: Top pure supply deals by value since 2003
• Figure 23: Bigpharma - top 50 - supply deals since 2003
• Figure 24: Most active supply dealmakers 2003-7
• Figure 25: Bigpharma - top 50 - supply deals since 2003
• Figure 26: Online partnering resources
• Figure 27: Deal type definitions
• Figure 28: Manufacturing agreement between Tercica and Lonza, May 2007
• Figure 29: Supply agreement between Novartis and Unigene, January 2007