Gene Therapy Partnering Terms and Agreements -





Published: May 2014 | Pages: 495

The Gene Therapy Partnering Agreements report provides an understanding and access to the gene therapy partnering deals and agreements entered into by the worlds leading healthcare companies.

 

  • Trends in gene therapypartnering deals
  • Disclosed headlines, upfronts, milestones and royalties by stage of development
  • Gene therapypartnering contract documents
  • Top gene therapy deals by value

 

The Gene Therapy Partnering Terms and Agreements report provides an understanding and access to the gene therapy 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 gene therapypartnering deals. The majority of deals are early development stage whereby the licensee obtains a right or an option right to license the licensors gene therapytechnology or product candidates. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes. 

 

This report provides details of the latest gene therapy, oligonucletides including aptamers agreements announced in the healthcare sectors.  


 

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 a comprehensive listing of all gene therapy partnering deals announced since 2007 including financial terms where available including over 300 links to online deal records of actual gene therapy partnering deals as disclosed by the deal parties. In addition, where available, records include 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.

 

For example, analyzing actual company deals and agreements allows assessment of the following:

 

  • What is actually granted by the agreement to the partner company?

                

  • What exclusivity is granted?

 

  • What are the precise rights granted or optioned?

 

  • What is the payment structure for the deal?

 

  • How aresalesand payments audited?

 

  • What is the deal term?

 

  • How are the key terms of the agreement defined?

 

  • How are IPRs handled and owned?

 

  • Who is responsible for commercialization?

 

  • Who is responsible for development, supply, and manufacture?

 

  • How is confidentiality and publication managed?

 

  • How are disputes to be resolved?

 

  • Under what conditions can the deal be terminated?

 

  • What happens when there is a change of ownership?

 

  • What sublicensing and subcontracting provisions have been agreed?

 

  • Which boilerplate clauses does the company insist upon?

 

  • Which boilerplate clauses appear to differ from partner to partner or deal type to deal type?

 

  • Which jurisdiction does the company insist upon for agreement law?

 

The initial chapters of this report provide an orientation of gene therapy and oligonucleotide dealmaking and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of the trends in gene therapy dealmaking since 2009, including details of average headline, upfront, milestone and royalty terms.

                    

Chapter 3 provides a review of the leading gene therapy deals since 2009. Deals are listed by headline value and by big pharma companies. Where the deal has an agreement contract published at the SEC a link provides online access to the contract.

 

Chapter 4 provides a comprehensive listing of the top 50 big pharma companies with a brief summary followed by a comprehensive listing of gene therapy 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.

 

Chapter 5 provides a comprehensive and detailed review of gene therapy 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 providing easy access to each contract document. The report also includes oligonucleotide and aptamers deals and alliances.

 

Chapter 6 provides a comprehensive and detailed review of technology specific (gene therapy and oligonucleotide) partnering deals signed and announced since 2009. 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

 

The report also includes numerous tables and figures that illustrate the trends and activities in gene therapy partnering and dealmaking since 2009.

 

In conclusion, this report provides everything a prospective dealmaker needs to know about partnering in the research, development and commercialization of gene therapy technologies and products.

 

The report also includes a comprehensive appendix listing gene therapy deals by Company A-Z, deal type, stage of development and therapy focus.

 

Report scope

                            

Gene Therapy Partnering Terms and Agreements is intended to provide the reader with an in-depth understanding and access to gene therapy trends and structure of deals entered into by leading companies worldwide.

 

                                             

Gene Therapy Partnering Terms and Agreements includes:

                                                        

  • Trends in gene therapy dealmaking in the biopharma industry since 2009
  • Analysis of gene therapy deal structure
  • Access to headline, upfront, milestone and royalty data
  • Case studies of real-life gene therapy deals
  • Access to over 200 gene therapy contract documents
  • The leading antibody deals by value since 2009
  • Most active gene therapy dealmakers since 2009
  • The leading gene therapy partnering resources

 

 

In Gene Therapy Partnering Terms and Agreements, the available contracts are listed by:

 

  • Company A-Z
  • Headline value
  • Stage of development at signing
  • Deal component type
  • Specific therapy and technology target

 

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. 

Chapter 1 – Introduction 

Chapter 2 – Trends in gene therapy dealmaking 

2.1. Introduction

2.2. Gene therapy partnering over the years

2.3. Big pharma gene therapy dealmaking activity

2.4. Most active in gene therapy partnering

2.5. Gene therapy partnering by deal type

2.6. Gene therapy partnering by disease type

2.7. Partnering by industry sector

2.8. Average deal terms for gene therapy partnering

2.8.1 Gene therapy headline values

2.8.2 Gene therapy upfront payments

2.8.3 Gene therapy milestone payments

2.8.4 Gene therapy royalty rates

2.9. The anatomy of gene therapy partnering

2.9. The anatomy of a gene therapy deal

2.9.a. Case study 1: Novartis, Quark Pharmaceuticals - 2010

2.9.b. Case study 2: OncoGenex Pharmaceuticals, Teva Pharmaceuticals: Dec 2009

 

Chapter 3 – Leading gene therapy deals 

3.1. Introduction

3.2. Top gene therapy deals by value

3.3. Top big pharma gene therapy deals by value

 

Chapter 4 – Big pharma gene therapy deals 

 

4.1. Introduction

4.2. How to use big pharma gene therapy partnering deals

4.3. Big pharma gene therapy partnering company profiles

Abbott

Amgen

AstraZeneca

Baxter International

Bristol-Myers Squibb

Celgene

Daiichi Sankyo

Dainippon Sumitomo

GlaxoSmithKline

Johnson & Johnson

Merck & Co

Merck KGaA

Mitsubishi Tanabe

Novartis

Pfizer

Roche

Sanofi

Sanofi-Aventis

Shionogi

Shire

Servier

Teva

 

Chapter 5– Gene therapy partnering contracts directory 

5.1. Introduction

5.2. Company A-Z

Alnylam Pharmaceuticals

Amgen

Amsterdam Molecular Therapeutics

Applied Genetic Technologies

Asklepios Biopharmaceutical

AstraZeneca

Atlantic Healthcare

AVI Pharma

Bristol-Myers Squibb

Celladon

Charleys Fund

Chiesi Farmaceutici

Cornell University

DeCODE Genetics

Defense Threat Reduction Agency

Digna Biotech

Dynavax Technologies

Embryome Sciences

Enzon Pharmaceuticals

GenVec

Genzyme

Georgetown University

GlaxoSmithKline

Icagen

Idera Pharmaceuticals

Institut Pasteur

Isis Pharmaceuticals

Lonza

Marina Biotech

MDRNA

Merck KGaA

MorphoSys

NanoViricides

National Institutes of Health

Neurologix

Novartis

OncoGenex Pharmaceuticals

OncoGenex Technologies

Quark Pharmaceuticals

Regulus Therapeutics

Reproductive Genetics Institute

Response Genetics

RiboTask

Saga Investments

Santaris

Stanford University

Targeted Genetics

Teva Pharmaceutical Industries

TheraCour Pharma

UniQure

University of California San Francisco

Xencor

5.3. By deal type

Asset purchase

Assignment

Co-development

Collaborative R&D

Contract service

Co-promotion

Development

Equity purchase

Grant

Licensing

Loan

Manufacturing

Marketing

Option

Research

Sub-license

Supply

Technology transfer

5.4. By stage of development

Discovery

Marketed

Phase I

Phase II

Phase III

Preclinical

Regulatory

5.5. By therapy area

Cardiovascular

Central Nervous System

Gastrointestinal

Genetic disorders

Genitourinary

Infectives

Metabolic

Musculoskeletal

Oncology

Ophthalmics

Orphan disease

Psychiatry

Respiratory

Sensory organs

 

Chapter 6 – Gene therapy dealmaking by technology type 

  

6.1. Introduction

6.2. Deals by gene therapy technology type

Gene therapy

Oligonucleotide

 

Appendices 

Appendix 1- Gene therapy dealmaking by Company A-Z

Appendix 2 - Gene therapy dealmaking by deal type

Appendix 3 - Gene therapy dealmaking by stage of development

Appendix 4 - Gene therapy dealmaking by therapy area

Appendix 5 – Gene therapy partnering resource center

 

Online gene therapy partnering

Gene therapy partnering events

Further reading on gene therapy dealmaking

About Wildwood Ventures

Current Partnering

Current Agreements

Recent titles from CurrentPartnering

Order Form – Technology Reports

 

Table of figures 

 

Figure 1: Gene therapy partnering since 2009

Figure 2: Bigpharma – top 50 – gene therapy deals 2009 to 2014

Figure 3: Big pharma gene therapy deal frequency – 2009 to 2014

Figure 4: Active gene therapy dealmaking activity– 2009 to 2014

Figure 5: Gene therapy partnering by deal type since 2009

Figure 6: Gene therapy partnering by disease type since 2009

Figure 7: Gene therapy partnering by technology type since 2009

Figure 8: Gene therapy deals with a headline value

Figure 9: Gene therapy deal headline value distribution, US$million – discovery stage

Figure 10: Gene therapy deal headline value distribution, US$million – preclinical stage

Figure 11: Gene therapy deal headline value distribution, US$million – phase I stage

Figure 12: Gene therapy deal headline value distribution, US$million – phase II stage

Figure 13: Gene therapy deal headline value distribution, US$million – phase III stage

Figure 14: Gene therapy deal headline value distribution, US$million – regulatory stage

Figure 15: Gene therapy deal headline value distribution, US$million – marketed stage

Figure 16: Summary median headline value by stage of development, 2009-2014

Figure 17: Gene therapy deals with upfront payment values

Figure 18: Gene therapy deal upfront payment distribution, US$million – discovery stage

Figure 19: Gene therapy deal upfront payment distribution, US$million – preclinical stage

Figure 20: Gene therapy deal upfront payment distribution, US$million – phase I stage

Figure 21: Gene therapy deal upfront payment distribution, US$million – phase II stage

Figure 22: Gene therapy deal upfront payment distribution, US$million – phase III stage

Figure 23: Gene therapy deal upfront payment distribution, US$million – regulatory stage

Figure 24: Gene therapy deal upfront payment distribution, US$million – marketed stage

Figure 25: Summary median upfront payments by stage of development, 2009-2014

Figure 26: Gene therapy deals with milestone payments

Figure 27: Gene therapy deal milestone distribution, US$million – discovery stage

Figure 28: Gene therapy deal milestone distribution, US$million – preclinical stage

Figure 29: Gene therapy deal milestone distribution, US$million – phase I stage

Figure 30: Gene therapy deal milestone distribution, US$million – phase II stage

Figure 31: Gene therapy deal milestone distribution, US$million – phase III stage

Figure 32: Gene therapy deal milestone distribution, US$million – regulatory stage

Figure 33: Gene therapy deal milestone distribution, US$million – marketed stage

Figure 34: Gene therapy deals with royalty rates, %

Figure 35: Gene therapy deal royalty rate distribution, US$million – discovery stage

Figure 36: Gene therapy deal royalty rate distribution, US$million – preclinical stage

Figure 37: Gene therapy deal royalty rate distribution, US$million – phase I stage

Figure 38: Gene therapy deal royalty rate distribution, US$million – phase II stage

Figure 39: Gene therapy deal royalty rate distribution, US$million – phase III stage

Figure 40: Gene therapy deal royalty rate distribution, US$million – regulatory stage

Figure 41: Gene therapy deal royalty rate distribution, US$million – marketed stage

Figure 42: Summary median royalty rate by stage of development, 2009-2014

Figure 43: Components of the typical gene therapy deal structure

Figure 44: Top gene therapy deals by value since 2009

Figure 45: Top gene therapy deals by value since 2009

Figure 46: Online partnering resources

Figure 47: Forthcoming partnering events