Discovery, Preclinical and Clinical Stage Partnering Terms and Agreements in Pharma and Biotech -





Published: March 2014 | Edition: 4 | Pages: 1,749

The Discovery, Preclinical and Clinical Stage Partnering Terms and Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the discovery, preclinical and clinical stage partnering deals and agreements entered into by the worlds leading healthcare companies.

 

The report provides a detailed understanding and analysis of how and why companies enter discovery, preclinical and clinical stage partnering deals. The majority of deals are where the licensee obtains a right or an option right to license the licensors product or compound. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

 

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 do not.

 

This report contains over 8,000 links to online copies of actual discovery, preclinical and clinical stage deals and contract documents as submitted to the Securities Exchange Commission by 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 discovery, preclinical and clinical stage deal making and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of why companies partner discovery, preclinical and clinical stage compounds/products.

 

Chapter 3 provides an overview of discovery, preclinical and clinical stage deals strategy and deal structure including numerous case studies. Chapter 4 provides an overview of the various payment strategies used in discovery, preclinical and clinical stage deals.

 

Chapters 5 to 7 provide a review of discovery, preclinical and clinical stage deal making since 2009. 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 8 provides a detailed analysis of discovery, preclinical and clinical stage payment terms including average headline, upfront, milestone and royalty rates for discovery deals.

 

Chapter 9 provides a review of the leading discovery, preclinical and clinical stage deal by headline value.

 

Chapter 10 provides a comprehensive listing of the top 50 big pharma and big biotech companies with a brief summary followed by a comprehensive listing of discovery, preclinical and clinical stage deals, as well as contract documents available in the public domain. Where available, 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 11 to 13 provides a comprehensive and detailed review of discovery, preclinical and clinical stage partnering deals signed and announced since 2009, where a contract document is available in the public domain. The chapter is organized by company A-Z, stage of development at signing, deal type (collaborative R&D, co-promotion, licensing etc), and specific therapy focus. Each deal title links via Weblink to an online version of the deal record and where available, the 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 discovery, preclinical and clinical stage partnering and deal making since 2009.

 

In addition, a comprehensive appendix is provided organized by partnering company A-Z, deal type, therapy focus and technology type. Each deal title links via Weblink to an online version of the deal record and where available, the contract document, providing easy access to each contract document on demand.

 

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of discovery, preclinical and clinical stage products and compounds.

TABLE OF CONTENTS 

 

Executive Summary 

                           

Chapter 1 – Introduction 

  

Chapter 2 – Why do company’s partner discovery, preclinical and clinical stage compounds? 

 

2.1. Introduction

2.2. The role of discovery, preclinical and clinical stage partnering

2.2.1. In-licensing at clinical stage

2.2.2. Out-licensing at discovery stage

2.2.3. Out-licensing at clinical stage

2.3. Difference between discovery, preclinical and clinical stage deals

2.4. Reasons for entering into discovery, preclinical and clinical stage partnering deals

2.4.1. Licensors reasons for entering discovery, preclinical and clinical stage deals

2.4.2. Licensees reasons for entering discovery, preclinical and clinical stage deals

2.5. The future of discovery, preclinical and clinical stage partnering deals

 

Chapter 3 – Discovery, preclinical and clinical stage deal strategies and structure 

 

3.1. Introduction

3.2. At what stage do companies partner?

3.2.1. Partnering early in pharmaceutical/biotech

3.2.1.1. Discovery and preclinical stage partnering case studies

3.2.1.1.a. Case study: LEO Pharma - 4SC

3.2.1.1.b. Case study: Heptares Therapeutics - Cubist

3.2.1.1.c. Case study: Pfizer - Repligen

3.2.1.1.d. Case study: Janssen Pharmaceutical - Evotec

3.2.2. Partnering later in pharmaceutical/biotech

3.2.2.1. Clinical stage partnering case studies

3.2.2.1.a. Case study: Roche – Genentech - Chiasma

3.2.2.1.b. Case study: Teva – Xenon Pharmaceuticals

3.2.2.1.c. Case study: AstraZeneca - Ardelyx

3.2.2.1.d. Case study: Baxter – Onconova Therapeutics

3.3. Early and later stage partnering – a risk/cost comparison

3.4. What do companies spend on discovery, preclinical and clinical stage partnering?

3.5. Pure versus multi-component partnering deals

3.6. Pure licensing agreement structure

3.6.1. Example pure licensing agreements

3.6.1.a. Case study : Coley Pharmaceutical – Dynavax Technologies

3.6.1.b. Case study : Bristol-Myers Squibb - Pharmacopeia

3.7. Multicomponent partnering agreements

3.7.1. Example multicomponent deal clauses

3.7.1.a. Case study: Idera – Merck KGaA         

 

Chapter 4 – Discovery, preclinical and clinical stage partnering payment strategies 

 

4.1. Introduction

4.2. Discovery, preclinical and clinical stage payment strategies

4.3. Payment options   

4.3.1. Headline values  

4.3.2. Upfront payments

4.3.2.1. Conditionality of upfront payments

4.3.3. Loans

4.3.4. Convertible loans

4.3.5. Equity

4.3.6. R&D funding

4.3.7. Licensing fees

4.3.8. Milestone payments

4.3.9. Royalty payments

4.3.9.1. Issues affecting royalty rates

4.3.9.2. Royalties on combination products

4.3.9.2.a. Case study: Scripps Research Institute-Cyanotech

4.3.9.3. Guaranteed minimum/maximum annual payments

4.3.9.4. Royalty stacking

4.3.9.5. Royalties and supply/purchase contracts

4.3.10. Quids

4.3.11. Option payments

 

Chapter 5 – Trends in discovery stage deal making 

 

5.1. Introduction

5.2. Discovery stage partnering over the years

5.2.1. Attributes of discovery deals

5.3. Big pharma discovery stage dealmaking activity

5.4. Big biotech discovery stage dealmaking activity

5.5. Discovery stage partnering by deal type

5.6. Discovery stage partnering by disease type

5.7. Partnering by discovery stage technology type

                                           

Chapter 6 – Trends in preclinical stage deal making 

 

6.1. Introduction

6.2. Preclinical stage partnering over the years

6.2.1. Attributes of preclinical deals

6.3. Big pharma preclinical stage dealmaking activity

6.4. Big biotech preclinical stage dealmaking activity

6.5. Preclinical stage partnering by deal type

6.6. Preclinical stage partnering by disease type

6.7. Partnering by preclinical stage technology type

 

Chapter 7 – Trends in clinical stage deal making 

 

7.1. Introduction

7.2. Clinical stage partnering over the years

7.2.1. Trends in phase I deals since 2009

7.2.1.1. Attributes of phase I deals

7.2.2. Trends in phase II deals since 2009

7.2.2.2. Attributes of phase II deals

7.2.3. Trends in phase III deals since 2009

7.2.3.1. Attributes of phase III deals

7.3. Big pharma clinical stage dealmaking activity

7.4. Big biotech clinical stage dealmaking activity

7.5. Clinical stage partnering by deal type

7.6. Clinical stage partnering by disease type

7.7. Partnering by clinical stage technology type

 

Chapter 8 – Average payment terms for discovery, preclinical and clinical stage partnering 

 

8.1. Introduction

8.2. Guidelines for discovery, preclinical and clinical stage payment terms

8.2.1. Upfront payments           

8.2.2. Milestone payments        

8.2.3. Royalty payments

8.3. Discovery, preclinical and clinical stage payment terms – deal data analysis

8.3.1. Public data

8.3.2. Survey data

8.4. Payment terms analysis

8.4.1. Discovery, preclinical and clinical stage headline values

8.4.2. Discovery, preclinical and clinical stage upfront payments

8.4.3. Discovery, preclinical and clinical stage milestone payments

8.4.4. Discovery, preclinical and clinical stage royalty rates

 

Chapter 9 – Leading discovery, preclinical and clinical stage deals 

 

9.1. Introduction

9.2. Top discovery stage deals by value           

9.3. Top preclinical stage deals by value

9.4. Top clinical stage deals by value   

 

Chapter 10 – Big pharma and big biotech discovery, preclinical and clinical stage partnering deals 

                                                                       

10.1. Introduction

10.2. How to use big pharma/big biotech partnering deals

10.3. Big pharma discovery, preclinical and clinical stage partnering company profiles

Abbott

Actavis (merged with Watson Pharmaceuticals Oct 2012)

Actelion

Allergan

Amgen

Aspen Pharmacare

Astellas

AstraZeneca

Baxter International

Bayer

Biogen Idec

Boehringer Ingelheim

Bristol-Myers Squibb

Celgene

CSL

Daiichi Sankyo

Dainippon Sumitomo

Eisai

Eli Lilly

Endo Pharmaceuticals

Forest Laboratories

Galderma        

Gilead Sciences           

GlaxoSmithKline          

Grifols 

Hospira

Johnson & Johnson

Kyowa Hakko Kirin

Lundbeck

Menarini          

Merck & Co     

Merck KGaA

Mitsubishi Tanabe

Mylan  

Novartis          

Novo Nordisk

Otsuka

Pfizer  

Purdue

Roche 

Sanofi  

Servier

Shionogi

Shire   

Takeda

Teva   

UCB    

Valeant

Warner Chilcott

10.4. Big biotech clinical stage partnering company profiles

Acorda Therapeutics

Actelion           

Alexion Pharmaceuticals

Alkermes

Alnylam Pharmaceuticals         

AMAG Pharmaceuticals           

Amgen

Amylin Pharmaceuticals           

Anika Therapeutics      

Bavarian Nordic           

Biocon 

BioCryst Pharmaceuticals

Biogen Idec

BioMarin Pharmaceuticals

Biota Holdings

Cangene          

Celgene           

CSL     

Cubist 

Elan    

Emergent BioSolutions

Enzo Biochem  

Enzon Pharmaceuticals

Exelixis

Genmab          

Gilead Sciences           

Immunomedics

Intermune        

Isis Pharmaceuticals

Morphosys      

Nektar Therapeutics

NPS Pharmaceuticals

Onyx Pharmaceuticals

PDL BioPharma           

Questcor Pharmaceuticals

Regeneron Pharmaceuticals

Roche

SciClone Pharmaceuticals

Seattle Genetics          

Spectrum Pharmaceuticals

Targacept        

The Medicines Company

UCB    

United Therapeutics

Vertex Pharmaceuticals

ViroPharma

 

 

 

 

Chapter 11 – Discovery stage partnering contracts directory 

 

11.1. Introduction

11.2. Company A-Z

11.3. By deal type

11.4. By stage of development

11.5. By therapy area

 

Chapter 12 – Preclinical stage partnering contracts directory 

 

12.1. Introduction         

12.2. Company A-Z

12.3. By deal type

12.4. By stage of development

12.5. By therapy area

 

Chapter 13 – Clinical stage partnering contracts directory 

  

13.1. Introduction         

13.2. Company A-Z      

13.3. By deal type

13.4. By stage of development

13.5. By therapy area

 

About Wildwood Ventures 

 

Current Partnering

Current Agreements

Recent titles from Current Partnering

Order Form – Reports

Order Form – Reports

Order Form – Therapy Reports

 

Appendices 

 

Introduction

 

Appendix 1 – Directory of discovery stage deals by company A-Z 2009-2014

Appendix 2 – Directory of discovery stage deals by deal type 2009-2014

Appendix 3 – Directory of discovery stage deals by therapy area 2009-2014

Appendix 4 – Directory of preclinical stage deals by company A-Z 2009-2014    

Appendix 5 – Directory of preclinical stage deals by deal type 2009-2014           

Appendix 6 – Directory of preclinical stage deals by therapy area 2009-2014

Appendix 7 – Directory of clinical stage deals by company A-Z 2009-2014         

Appendix 8 – Directory of clinical stage deals by deal type 2009-2014   

Appendix 9 – Directory of clinical stage deals by therapy area 2009-2014

Appendix 10 – Partnering resource center

 

Online partnering         

Partnering events        

Further reading on dealmaking

 

Table of figures 

 

Figure 1: Definition of discovery, preclinical and clinical phases in dealmaking

Figure 2: Agreements signed by phase of development (2009-2014), % of all deals where stage disclosed

Figure 3: Components of the pure licensing deal structure

Figure 4: Payment options for discovery, preclinical and clinical stage partnering deals

Figure 5: Issues affecting royalty rates

Figure 6: Discovery stage partnering frequency 2009-2014

Figure 7: Big pharma – top 50 – discovery stage deals 2009 to 2014

Figure 8: Big pharma discovery stage deal frequency – 2009 to 2014

Figure 9: Big biotech – top 50 – discovery stage deals 2009 to 2014

Figure 10: Big biotech discovery stage deal frequency – 2009 to 2014

Figure 11: Discovery stage partnering by deal type since 2009

Figure 12: Discovery stage partnering by disease type since 2009

Figure 13: Discovery stage partnering by technology type since 2009

Figure 14: Preclinical stage partnering frequency 2009-2014

Figure 15: Big pharma – top 50 – preclinical stage deals 2009 to 2014

Figure 16: Big pharma preclinical stage deal frequency – 2009 to 2014

Figure 17: Big biotech – top 50 – preclinical stage deals 2009 to 2014

Figure 18: Big biotech preclinical stage deal frequency – 2009 to 2014

Figure 19: Preclinical stage partnering by deal type since 2009

Figure 20: Preclinical stage partnering by disease type since 2009

Figure 21: Preclinical stage partnering by technology type since 2007

Figure 22: Clinical stage partnering frequency 2009-2014

Figure 23: Phase I clinical stage partnering since 2009

Figure 24: Phase II clinical stage partnering since 2009

Figure 25: Phase III clinical stage partnering since 2009

Figure 26: Big pharma – top 50 – clinical stage deals 2009 to 2014

Figure 27: Big pharma clinical stage deal frequency – 2009 to 2014

Figure 28: Big biotech – top 50 – clinical stage deals 2009 to 2014

Figure 29: Big biotech clinical stage deal frequency – 2009 to 2014

Figure 30: Clinical stage partnering by deal type since 2009

Figure 31: Clinical stage partnering by disease type since 2004

Figure 32: Clinical stage partnering by technology type since 2009

Figure 33: Review of median upfront payments for discovery, preclinical and clinical stage deals 2009-2014, US$m

Figure 34: Review of median milestone payments for discovery, preclinical and clinical stage deals 2009-2014, US$m

Figure 35: Review of median royalty payments for clinical stage deals 2009-2014, %

Figure 36: Discovery, preclinical and clinical stage deals with a headline value

Figure 37: Discovery stage deal headline value distribution, US$million

Figure 38: Preclinical stage deal headline value distribution, US$million

Figure 39: Phase I clinical stage deal headline value distribution, US$million

Figure 40: Phase II clinical stage deal headline value distribution, US$million

Figure 41: Phase III clinical stage deal headline value distribution, US $million

Figure 42: Summary median headline value by stage of development, 2009-2014

Figure 43: Discovery, preclinical and clinical stage deals with upfront payment values

Figure 44: Discovery stage deal upfront payment distribution, US$million

Figure 45: Preclinical stage deal upfront payment distribution, US$million

Figure 46: Clinical stage deal upfront payment distribution, US$million – phase I stage

Figure 47: Clinical stage deal upfront payment distribution, US$million – phase II stage

Figure 48: Clinical stage deal upfront payment distribution, US$million – phase III stage

Figure 49: Summary median upfront payments by stage of development, 2009-2014

Figure 50: Discovery, preclinical and clinical stage deals with milestone payments

Figure 51: Discovery stage deal milestone distribution, US$million

Figure 52: Preclinical stage deal milestone distribution, US$million

Figure 53: Clinical stage deal milestone distribution, US$million – phase I stage

Figure 54: Clinical stage deal milestone distribution, US$million – phase II stage

Figure 55: Clinical stage deal milestone distribution, US$million – phase III stage

Figure 56: Summary median milestone payments by stage of development, 2009-2014

Figure 57: Discovery, preclinical and clinical stage deals with royalty rates, %

Figure 58: Discovery stage deal royalty rate distribution, US$million

Figure 59: Preclinical stage deal royalty rate distribution, US$million

Figure 60: Clinical stage deal royalty rate distribution, US$million – phase I stage

Figure 61: Clinical stage deal royalty rate distribution, US$million – phase II stage

Figure 62: Clinical stage deal royalty rate distribution, US$million – phase III stage

Figure 63: Summary median royalty rate by stage of development, 2009-2014

Figure 64: Top discovery stage deals by value since 2009

Figure 65: Top preclinical stage deals by value since 2009

Figure 66: Top clinical stage deals by value since 2009