Abstract
The Clinical Stage Partnering Agreements in Biopharma report provides
comprehensive understanding and unprecedented access to the clinical stage
agreements entered into by the worlds leading biopharma companies.
The report provides a detailed understand and analysis of how and why
companies enter clinical stage partnering deals.
Understanding the flexibility of a prospective partner' s negotiated deals
terms provides critical insight into the negotiation process in terms of what
you can expect to achieve during the negotiation of terms. Whilst many smaller
companies will be seeking details of the payments clauses, the devil is in the
detail in terms of how payments are triggered - contract documents provide
this insight where press releases and databases do not.
This report contains over 1000 links to online copies of actual clinical stage
contract documents as submitted to the Securities Exchange Commission by
biopharma companies and their partners. Contract documents provide the answers
to numerous questions about a prospective partner' s flexibility on a wide
range of important issues, many of which will have a significant impact on
each party' s ability to derive value from the deal.
The initial chapters of this report provide an orientation of clinical stage
dealmaking and business activities. Chapter 1 provides an introduction to the
report, whilst chapter 2 provides an analysis of the trends in clinical stage
partnering as well as a discussion on the merits and attributes of dealmaking
at each stage of clinical development.
Chapter 3 provides an overview of the structure of clinical stage partnering
deal contracts. The chapter includes numerous case studies to enable
understanding of both pure deals and multicomponent clinical stage partnering
deals.
Chapters 4, 5 and 6 provide a review of the leading phase I, II and III
clinical stage partnering deals since 2000, respectively. Deals are listed by
headline value, signed by bigpharma, most active bigpharma, and most active of
all biopharma companies. Where the deal has an agreement contract published at
the SEC a link provides online access to the contract.
Chapter 7 provides a comprehensive listing of the top 50 bigpharma companies
with a brief summary followed by a comprehensive listing of clinical stage
contract documents available in the public domain. Each deal title links via
Weblink to an online version of the actual contract document, providing easy
access to each contract document on demand.
Chapters 8, 9 and 10 provide a comprehensive listing of all phase I, II and
III clinical stage agreement contracts since 2003 available in the public
domain, respectively. Each chapter is organized by A-Z, therapeutic area, and
deal type. Each deal title links via Weblink to an online version of the
actual contract document, providing easy access to each contract document on
demand. The report also includes numerous tables and figures that illustrate
the trends and activities in clinical stage dealmaking since 2000.
In conclusion, this report provides everything a prospective dealmaker needs
to know about clinical stage partnering, enabling thorough learning, education
and due diligence prior and during the clinical stage dealmaking process.
Table of Contents
Executive Summary
Chapter 1 - Introduction
Chapter 2 - Trends in clinical stage dealmaking
- 2.1. Introduction
- 2.2. Difference between phase I, II and III stage deals
- 2.2.1. Trends in clinical stage deals
- 2.3. Trends in phase I deals since 2000
- 2.3.1. Attributes of phase I deals
- 2.4. Trends in phase II deals since 2000
- 2.4.1. Attributes of phase II deals
- 2.5. Trends in phase III deals since 2000
- 2.5.1. Attributes of phase III deals
- 2.6. Reasons for entering into clinical stage partnering deals
- 2.6.1. Licensors reasons for entering clinical stage deals
- 2.6.2. Licensees reasons for entering clinical stage deals
- 2.7. The future of clinical stage partnering deals
Chapter 3 - Overview of clinical stage deal structure
- 3.1. Introduction
- 3.2. Pure versus multi-component partnering deals
- 3.3. Pure licensing agreement structure
- 3.3.1. Example pure licensing agreements
- 3.3.1.a. Case study 1: Coley Pharmaceutical - Dynavax Technologies -
June 2007
- 3.3.1.b. Case study 2: Bristol-Myers Squibb - Pharmacopeia - October 2007
- 3.4. Multicomponent clinical stage partnering agreements
- 3.4.1. Example multicomponent clinical stage clauses
- 3.4.1.a. Case study 3: Idera - Merck KGaA - December 2007
Chapter 4 - Leading phase I clinical stage deals
- 4.1. Introduction
- 4.2. Top phase I clinical stage deals by value
- 4.3. Top phase I clinical stage deals signed by bigpharma
- 4.4. Most active phase I clinical stage dealmakers
- 4.5. Bigpharma phase I clinical stage deal activity
Chapter 5 - Leading phase II clinical stage deals
- 5.1. Introduction
- 5.2. Top phase II clinical stage deals by value 70
- 5.3. Top phase II clinical stage deals signed by bigpharma
- 5.4. Most active phase II clinical stage dealmakers
- 5.5. Bigpharma phase II clinical stage deal activity
Chapter 6 - Leading phase III clinical stage deals
- 6.1. Introduction
- 6.2. Top phase III clinical stage deals by value
- 6.3. Top phase III clinical stage deals signed by bigpharma
- 6.4. Most active phase III clinical stage dealmakers
- 6.5. Bigpharma phase III clinical stage deal activity
Chapter 7 - Bigpharma clinical stage partnering agreements
- 7.1. Introduction
- 7.2. How to use clinical stage partnering agreements
- 7.3. Company clinical stage partnering 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
- 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
- Takeda
- Tanabe Seiyaku
- TAP Pharmaceuticals
- Teva
- UCB
- Watson
- Wyeth
Chapter 8 - Phase I partnering agreement directory 2003-early 2008
- 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
- Genetic
- Genitourinary
- Autoimmune/Inflammatory
- Infection
- Metabolism
- Musculoskeletal
- Oncology
- Respiratory
- Sensory Organ / Oral Health
- Delivery
- 8.4. By deal type
- Collaborative R&D
- Co-development
- Co-marketing
- Co-promotion
- Development
- Distribution
- Joint venture
- Licensing
- M&A
- Manufacturing
- Marketing
- Promotion
- Research
- Supply
Chapter 9 - Phase II partnering agreement directory 2003-early 2008
- 9.1. Introduction
- 9.2. Company A-Z
- 9.3. By therapy area
- Accident/Hospital/Trauma
- Blood/Lymphatic System
- Cardiovascular
- Central nervous System
- Dermatology
- Gastrointestinal
- Genetic
- Genitourinary
- Autoimmune/Inflammatory
- Infection
- Metabolism
- Musculoskeletal
- Oncology
- Respiratory
- Sensory Organ / Oral Health
- Delivery
- 9.4. By deal type
- Collaborative R&D
- Co-development
- Co-marketing
- Co-promotion
- Development
- Distribution
- Joint venture
- Licensing
- M&A
- Manufacturing
- Marketing
- Promotion
- Research
- Supply
Chapter 10 - Phase III agreement directory 2003-early 2008
- 10.1. Introduction
- 10.2. Company A-Z
- 10.3. By therapy area
- Accident/Hospital/Trauma
- Blood/Lymphatic System
- Cardiovascular
- Central nervous System
- Dermatology
- Gastrointestinal
- Genetic
- Genitourinary
- Autoimmune/Inflammatory
- Infection
- Metabolism
- Musculoskeletal
- Oncology
- Respiratory
- Sensory Organ / Oral Health
- Delivery
- 10.4. By deal type
- Collaborative R&D
- Co-development
- Co-marketing
- Co-promotion
- Development
- Distribution
- Joint venture
- Licensing
- M&A
- Manufacturing
- Marketing
- Promotion
- Research
- Supply
Appendices
- Appendix 1 - Clinical stage partnering references
- Appendix 2 - Resources
- Appendix 3 - Deal type definitions
- Appendix 3 - Deal type definitions
- Appendix 4 - Example clinical stage partnering contract
- About CurrentPartnering
- Recent report titles from CurrentPartnering
- Order Form - Reports
- Order form - Company Dealmaking Profiles
Table of figures
- Figure 1: Definition of clinical phases in dealmaking
- Figure 2: Trends in clinical stage deal announcements, 2000-2007
- Figure 3: Trends in phase I deal announcements, 2000-2007
- Figure 4: Trends in phase II deal announcements, 2000-2007
- Figure 5: Trends in phase III deal announcements, 2000-2007
- Figure 6: Components of the pure licensing deal structure
- Figure 7: Top phase I clinical stage deals by value since 2003
- Figure 8: Bigpharma - top 50 - phase I clinical stage deals since 2003
- Figure 9: Most active phase I clinical stage dealmakers 2003-early 2008
- Figure 10: Bigpharma - top 50 - phase I clinical stage deals since 2003
- Figure 11: Top phase II clinical stage deals by value since 2003
- Figure 12: Bigpharma - top 50 - phase II clinical stage deals since 2003
- Figure 13: Most active phase II clinical stage dealmakers 2003-early 2008
- Figure 14: Bigpharma - top 50 - phase II clinical stage deals since 2003
- Figure 15: Top phase III clinical stage deals by value since 2003
- Figure 16: Bigpharma - top 50 - phase III clinical stage deals since 2003
- Figure 17: Most active phase III clinical stage dealmakers 2003-early 2008
- Figure 18: Bigpharma - top 50 - phase III deals since 2003
- Figure 19: Online partnering resources
- Figure 20: Deal type definitions
- Figure 21: Partnering agreement between Alfacell and Par - Jan 2008
