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Clinical Stage Partnering Terms and Agreements in Pharma and Biotech Product Image

Clinical Stage Partnering Terms and Agreements in Pharma and Biotech

  • ID: 2520312
  • September 2014
  • Region: Global
  • 2608 Pages +
  • CurrentPartnering

FEATURED COMPANIES

  • 3SBio
  • Baxter International
  • Daiichi Sankyo
  • Hospira
  • Novartis
  • Servier
  • MORE

The Clinical Stage Partnering Terms and Agreements in Pharma and Biotech report provides comprehensive understanding and unprecedented access to the 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 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 2,000 links to online copies of actual clinical stage deals and contract documents as submitted to the READ MORE >

FEATURED COMPANIES

  • 3SBio
  • Baxter International
  • Daiichi Sankyo
  • Hospira
  • Novartis
  • Servier
  • MORE

Executive Summary

Chapter 1 – Introduction

Chapter 2 – Why do companies partner clinical stage compounds?

2.1. Introduction
2.2. The role of clinical stage partnering
2.2.1. In-licensing at clinical stage
2.2.2. Out-licensing at clinical stage
2.3. Difference between phase I, II and III stage deals
2.4. Reasons for entering into clinical stage partnering deals
2.4.1. Licensors reasons for entering clinical stage deals
2.4.2. Licensees reasons for entering clinical stage deals
2.5. The future of clinical stage partnering deals

Chapter 3 – 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 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 : Argos Therapeutics – Medinet
3.6.1.b. Case study : Pfizer - GlycoMimetics
3.7. Multicomponent clinical stage partnering agreements
3.7.1. Example multicomponent clinical stage clauses
3.7.1.a. Case study: Gilead Sciences – GlobeImmune

Chapter 4 – Clinical stage partnering payment strategies

4.1. Introduction
4.2. 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 clinical stage deal making

5.1. Introduction
5.2. Clinical stage partnering over the years
5.2.1. Trends in phase I deals since 2009
5.2.1.1. Attributes of phase I deals
5.2.2. Trends in phase II deals since 2009
5.2.2.2. Attributes of phase II deals
5.2.3. Trends in phase III deals since 2009
5.2.3.1. Attributes of phase III deals
5.3. Big pharma clinical stage dealmaking activity
5.4. Big biotech clinical stage dealmaking activity
5.5. Clinical stage partnering by deal type
5.6. Clinical stage partnering by disease type
5.7. Partnering by clinical stage technology type

Chapter 6 – Average payment terms for clinical stage partnering

6.1. Introduction
6.2. Guidelines for clinical stage payment terms
6.2.1. Upfront payments
6.2.2. Milestone payments
6.2.3. Royalty payments
6.3. Clinical stage payment terms – deal data analysis
6.3.1. Public data
6.3.2. Survey data
6.4. Payment terms analysis
6.4.1. Clinical stage headline values
Phase I
Phase II
Phase III
6.4.2. Clinical stage upfront payments
Phase I
Phase II
Phase III
6.4.3. Clinical stage milestone payments
Phase I
Phase II
Phase III
6.4.4. Clinical stage royalty rates
Phase I
Phase II
Phase III

Chapter 7 – Leading clinical stage deals

7.1. Introduction
7.2. Top clinical stage deals by value

Chapter 8 – Big pharma and big biotech clinical stage partnering deals

8.1. Introduction
8.2. How to use big pharma/big biotech clinical stage partnering deals
8.3. Big pharma clinical stage partnering company profiles
Abbott
Abbott Japan
Abbott Laboratories
Abbvie
Actavis
Actavis
Actavis (acquired by Watson)
Watson Pharmaceuticals
Allergan
Amgen
Astellas
Astellas Pharma US
AstraZeneca
Baxter International
Bayer
Bayer Healthcare
Bayer Innovation
Bayer Schering Pharma
Bayer Vital
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
Chugai Pharmaceutical
Chugai Pharma Marketing
CSL
Daiichi Sankyo
Dainippon Sumitomo
Eisai
Eisai Inc
Eli Lilly
Endo Pharmaceuticals
Forest Laboratories
Forest Laboratories Ireland
Gilead Sciences
GlaxoSmithKline
Grifols
Hospira
Johnson & Johnson
Janssen Biotech
Janssen Research & Development
Kyowa Hakko Kirin
Lundbeck
Merck & Co
Merck Sharpe & Dohme
Merck KGaA
Merck Serono
Mitsubishi Tanabe
Mylan
Novartis
Novo Nordisk
Otsuka
Pfizer
Pfizer Japan
Wyeth
Purdue
Roche
Genentech
Sanofi
Sanofi-Aventis
Sanofi-Pasteur
Servier
Shionogi
Shionogi-ViiV Healthcare
Shionogi
Shionogi Pharma
Shire
Takeda
Teva
Teva Pharmaceutical Industries
UCB
Valeant
8.4. Big biotech clinical stage partnering company profiles
3SBio
Acorda Therapeutics
Actelion
Alkermes
Array Biopharma
Bavarian Nordic
Biocon
BioMarin Pharmaceuticals
Cangene
Cubist
Dendreon
Elan
Emergent BioSolutions
Galapagos
Genmab
Grifols
Ipsen
Isis Pharmaceuticals
LFB Group
Medivation
Morphosys
Nektar Therapeutics
NPS Pharmaceuticals
Onyx Pharmaceuticals
Optimer
PDL BioPharma
Regeneron Pharmaceuticals
SciClone Pharmaceuticals
Seattle Genetics
Spectrum Pharmaceuticals
Swedish Orphan Biovitrum
The Medicines Company
Vertex Pharmaceuticals
ViroPharma

Chapter 9 – Clinical stage partnering contracts directory

9.1. Introduction
9.2. Company A-Z
9.3. By deal type
Asset purchase
Assignment
Bigpharma outlicensing
Co-development
Collaborative R&D
Co-market
Contract service
Co-promotion
CRADA
Cross-licensing
Development
Distribution
Equity purchase
Evaluation
Grant
Interests
Joint venture
Licensing
Litigation
Loan
Manufacturing
Marketing
Material transfer
Option
Promotion
Research
Settlement
Sub-license
Supply
Technology transfer
Termination
Warranty
9.4. By stage of development
Discovery
Formulation
Marketed
Phase I
Phase II
Phase III
Preclinical
Regulatory
9.5. By therapy area

Chapter 10 – Clinical stage dealmaking by development stage

10.1. Introduction
10.2. Deals by clinical stage
10.2.1. Phase I deals
10.2.2. Phase II deals
10.2.3. Phase III deals

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Appendices

Introduction
Appendix 1 – Directory of clinical stage deals by company A-Z 2009-2014
Appendix 2 – Directory of clinical stage deals by deal type 2009-2014
Appendix 3 – Directory of clinical stage deals by therapy area 2009-2014
Appendix 4 – Partnering resource center
Online partnering
Partnering events
Further reading on dealmaking

Table of figures

Figure 1: Definition of clinical phases in dealmaking
Figure 2: Agreements signed by phase of development (2009-2014), % of all deals
Figure 3: Components of the pure licensing deal structure
Figure 4: Payment options for clinical stage partnering deals
Figure 5: Issues affecting royalty rates
Figure 6: Clinical stage partnering frequency 2009-2014
Figure 7: Phase I clinical stage partnering since 2009
Figure 8: Phase II clinical stage partnering since 2009
Figure 9: Phase III clinical stage partnering since 2009
Figure 10: Big pharma – top 50 – clinical stage deals 2009 to 2014
Figure 11: Big pharma clinical stage deal frequency – 2009 to 2014
Figure 12: Big biotech – top 50 – clinical stage deals 2009 to 2014
Figure 13: Big biotech clinical stage deal frequency – 2009 to 2014
Figure 14: Clinical stage partnering by deal type since 2009
Figure 15: Clinical stage partnering by disease type since 2009
Figure 16: Clinical stage partnering by technology type since 2009
Figure 17: Review of upfront payments for clinical stage deals 2009-2014, US$m
Figure 18: Review of milestone payments for clinical stage deals, median US$m
Figure 19: Review of royalty payments for clinical stage deals, median%
Figure 20: Clinical stage deals with a headline value
Figure 21: Clinical stage deal headline value distribution, US$million – phase I stage
Figure 22: Clinical stage deal headline value distribution, US$million – phase II stage
Figure 23: Clinical stage deal headline value distribution, US$million – phase III stage
Figure 24: Summary median headline value by clinical stage of development, 2009-2014
Figure 25: Clinical stage deals with upfront payment values
Figure 26: Clinical stage deal upfront payment distribution, US$million – phase I stage
Figure 27: Clinical stage deal upfront payment distribution, US$million – phase II stage
Figure 28: Clinical stage deal upfront payment distribution, US$million – phase III stage
Figure 29: Summary median upfront payments by clinical stage of development, 2009-2014
Figure 30: Clinical stage deals with milestone payments
Figure 31: Clinical stage deal milestone distribution, US$million – phase I stage
Figure 32: Clinical stage deal milestone distribution, US$million – phase II stage
Figure 33: Clinical stage deal milestone distribution, US$million – phase III stage
Figure 34: Summary median milestone payments by stage of development, 2009-2014
Figure 35: Clinical stage deals with royalty rates, %
Figure 36: Clinical stage deal royalty rate distribution, US$million – phase I stage
Figure 37: Clinical stage deal royalty rate distribution, US$million – phase II stage
Figure 38: Clinical stage deal royalty rate distribution, US$million – phase III stage
Figure 39: Summary median royalty rate by stage of development, 2009-2014
Figure 40: Top clinical stage deals by value since 2009

Abbott
Abbott Japan
Abbott Laboratories
Abbvie
Actavis
Actavis
Actavis (acquired by Watson)
Watson Pharmaceuticals
Allergan
Amgen
Astellas
Astellas Pharma US
AstraZeneca
Baxter International
Bayer
Bayer Healthcare
Bayer Innovation
Bayer Schering Pharma
Bayer Vital
Biogen Idec
Boehringer Ingelheim
Bristol-Myers Squibb
Celgene
Chugai Pharmaceutical
Chugai Pharma Marketing
CSL
Daiichi Sankyo
Dainippon Sumitomo
Eisai
Eisai Inc
Eli Lilly
Endo Pharmaceuticals
Forest Laboratories
Forest Laboratories Ireland
Gilead Sciences
GlaxoSmithKline
Grifols
Hospira
Johnson & Johnson
Janssen Biotech
Janssen Research & Development
Kyowa Hakko Kirin
Lundbeck
Merck & Co
Merck Sharpe & Dohme
Merck KGaA
Merck Serono
Mitsubishi Tanabe
Mylan
Novartis
Novo Nordisk
Otsuka
Pfizer
Pfizer Japan
Wyeth
Purdue
Roche
Genentech
Sanofi
Sanofi-Aventis
Sanofi-Pasteur
Servier
Shionogi
Shionogi-ViiV Healthcare
Shionogi
Shionogi Pharma
Shire
Takeda
Teva
Teva Pharmaceutical Industries
UCB
Valeant
3SBio
Acorda Therapeutics
Actelion
Alkermes
Array Biopharma
Bavarian Nordic
Biocon
BioMarin Pharmaceuticals
Cangene
Cubist
Dendreon
Elan
Emergent BioSolutions
Galapagos
Genmab
Grifols
Ipsen
Isis Pharmaceuticals
LFB Group
Medivation
Morphosys
Nektar Therapeutics
NPS Pharmaceuticals
Onyx Pharmaceuticals
Optimer
PDL BioPharma
Regeneron Pharmaceuticals
SciClone Pharmaceuticals
Seattle Genetics
Spectrum Pharmaceuticals
Swedish Orphan Biovitrum
The Medicines Company
Vertex Pharmaceuticals
ViroPharma

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