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Clinical Stage Partnering Agreements in Biopharma

Published by: CurrentPartnering

Published: Jun. 1, 2008 - 440 Pages


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

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

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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

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.

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