世界の製薬・バイオテクノロジー業界における臨床段階での提携条件と契約 (2016年～2023年)

当レポートでは、世界の製薬・バイオテクノロジー業界における臨床段階での提携条件と契約について調査し、前臨床段階での取引理由と戦略、支払条件、主要25社の動向などをまとめています。

目次

エグゼクティブサマリー

第1章 イントロダクション

第2章 企業は臨床段階での化合物について提携契約をなぜ結ぶのか

• イントロダクション
• 前臨床段階の提携の役割
  • 前臨床段階でのインライセンシング
  • 前臨床段階でのアウトライセンシング
• 創薬、前臨床、臨床段階の取引の違い
• 前臨床段階の提携契約を締結する理由
  • ライセンサーが前臨床段階の契約を締結する理由
  • ライセンシーが前臨床段階の契約を締結する理由
• 前臨床段階の提携取引の未来

第3章 前臨床段階の取引戦略と構造

• イントロダクション
• 企業はどの段階で提携するのか
  • 製薬/バイオテクノロジー業界における早期の提携
  • 製薬/バイオテクノロジー業界における後期の提携
• 初期段階と後期段階の提携- リスクとコストの比較
• 企業による前臨床段階の提携への支出
• 純粋対多要素提携取引
• 純粋ライセンシング契約の構造
• 多要素前臨床段階の提携契約

第4章 前臨床段階の提携における支払戦略

• イントロダクション
• 前臨床段階の支払戦略
• 支払いオプション

第5章 前臨床段階の取引動向

• イントロダクション
• 長年にわたる前臨床段階の提携
• 前臨床段階の提携、取引タイプ別
• 前臨床段階の提携、疾患別
• 前臨床段階の提携、技術タイプ別
• 前臨床段階の提携、2015年以来最も活躍する企業別

第6章 前臨床段階の提携の支払条件

• イントロダクション
• 前臨床段階の支払条件に関するガイドライン
• 前臨床段階の支払条件- 取引データ分析
• 支払条件分析

第7章 主要な前臨床段階の取引

第8章 最も活躍する前臨床段階の取引企業主要25社

第9章 前臨床段階の提携契約一覧

第10章 開発段階別の前臨床段階の取引

• イントロダクション
• 前臨床段階別の取引

付録

Wildwood Venturesについて

The Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 report provides comprehensive understanding and unprecedented access to the preclinical stage partnering deals and agreements entered into by the worlds leading healthca

The Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 report provides a detailed understanding and analysis of how, why and what terms companies enter preclinical stage partnering deals. These deals tend to be multicomponent, starting with collaborative R&D, and commercialization of outcomes.

This report provides details of the latest preclinical agreements announced in the healthcare sector.

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 over 2,400 preclinical stage partnering deals announced since 2016 including financial terms, where available, including links to online deal records of actual preclinical 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.

The initial chapters of this report provide an orientation of preclinical stage deal making and business activities. Chapter 1 provides an introduction to the report, whilst chapter 2 provides an overview of why companies partner preclinical stage compounds/products.

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

Chapter 5 provides a review of preclinical stage deal making since 2016. Deals activity is reviewed by year, stage of development at signing, therapeutic area, technology type, as well as most active dealmakers.

Chapter 6 provides a detailed analysis of preclinical stage payment terms including headline, upfront, milestone and royalty rates.

Chapter 7 provides a review of the leading preclinical stage deal by headline value. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

Chapter 8 provides a comprehensive listing of the top 25 most active preclinical stage dealmaker companies. Each deal title links via Current Agreements deals and alliances database to an online version of the full deal record, and where available, the actual contract document, providing easy access to each deal record on demand.

Chapter 9 provides a comprehensive and detailed review of preclinical stage partnering deals signed and announced since 2016, where a contract document is available in the public domain.

Chapter 10 provides a comprehensive directory of preclinical stage partnering deals since 2016.

The report includes deals announced by hundreds of life science companies including big pharma such as Abbott, Abbvie, Actavis, Amgen, Astellas, AstraZeneca, Baxter, Bayer, Biogen Idec, BMS, Celgene, Eisai, Eli Lilly, Gilead, GSK, J&J, Kyowa Hakko, Merck, Mitsubishi, Mylan, Novartis, Pfizer, Roche, Sanofi, Shire, Takeda, Teva, and Valeant, amongst many others.

The report also includes numerous tables and figures that illustrate the trends and activities in preclinical stage partnering and deal making since 2016.

In addition, a comprehensive appendix of all preclinical deals since 2016 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 preclinical stage products and compounds.

Key benefits

Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 provides the reader with the following key benefits:

• In-depth understanding of preclinical stage deal trends since 2016
• Access to headline, upfront, milestone and royalty data
• Analysis of the structure of preclinical stage agreements with numerous real life case studies
• Insight into the terms included in a preclinical stage agreement, together with real world clause examples
• Understand the key deal terms companies have agreed in previous deals
• Undertake due diligence to assess suitability of your proposed deal terms for partner companies

Report scope

• Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 is intended to provide the reader with an in-depth understanding and access to preclinical stage deal trends and structure of deals entered into by leading companies worldwide.

Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 includes:

• Trends in preclinical stage dealmaking in the biopharma industry since 2016
• Analysis of preclinical stage deal structure
• Access to headline, upfront, milestone and royalty data
• Case studies of real-life preclinical stage deals
• Access to over 2,400 preclinical stage deals
• The leading preclinical stage deals by value since 2016
• Most active preclinical stage dealmakers since 2016
• The leading preclinical stage partnering resources

In Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023, the available contracts are listed by:

• Company A-Z
• Headline value
• Stage of development at signing
• Deal type
• Specific therapy 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.

The Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 report provides comprehensive access to available deals and contract documents for over 2,400 preclinical stage deals. Analyzing actual contract agreements allows assessment of the following:

• What are the precise rights granted or optioned?
• What is actually granted by the agreement to the partner company?
• What exclusivity is granted?
• What is the payment structure for the deal?
• How are sale sand 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?

Benefits

The Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2016-2023 report provides the reader with the following key benefits:

• In-depth understanding of preclinical stage deal trends since 2016
• Access to headline, upfront, milestone and royalty data
• Comprehensive access to over 2,400 preclinical stage deals together with contract documents if available
• Detailed access to actual preclinical stage deals entered into by the leading 25 big pharma and big biotech companies along with other biopharma companies
• Analysis of the structure of preclinical stage agreements with numerous real life case studies
• Identify leading preclinical stage deals by value since 2016
• Identify the most active preclinical stage dealmakers since 2016
• Full listing of preclinical stage deals by company A-Z, phase of development, deal type, therapy and technology focus
• Understand the key deal terms companies have agreed in previous deals
• Undertake due diligence to assess suitability of your proposed deal terms for partner companies

Table of Contents

Executive Summary

Chapter 1 - Introduction

Chapter 2 - Why do companies partner preclinical stage compounds?

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

Chapter 3 - Preclinical 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 1
  • 3.2.1.1.b. Case study 2
  • 3.2.1.1.c. Case study 3
  • 3.2.1.1.d. Case study 4
  • 3.2.2. Partnering later in pharmaceutical/biotech
  • 3.2.2.1. Clinical stage partnering case studies
  • 3.2.2.1.a. Case study 5
  • 3.2.2.1.b. Case study 6
  • 3.2.2.1.c. Case study 7
  • 3.2.2.1.d. Case study: 8
• 3.3. Early and later stage partnering - a risk/cost comparison
• 3.4. What do companies spend on preclinical stage partnering?
• 3.5. Pure versus multi-component partnering deals
• 3.6. Pure licensing agreement structure
  • 3.6.1. Example pure preclinical stage licensing agreements
  • 3.6.1.a. Case study 9
  • 3.6.1.b. Case study 10
• 3.7. Multicomponent preclinical stage partnering agreements
  • 3.7.1. Example multicomponent preclinical stage clauses
  • 3.7.1.a. Case study: 11
  • 3.7.1.b. Case study 12

Chapter 4 - Preclinical stage partnering payment strategies

• 4.1. Introduction
• 4.2. Preclinical 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 13
  • 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 preclinical stage deal making

• 5.1. Introduction
• 5.2. Preclinical stage partnering over the years
  • 5.2.1. Attributes of preclinical deals
• 5.3. Preclinical stage partnering by deal type
• 5.4. Preclinical stage partnering by disease type
• 5.5. Partnering by preclinical stage technology type
• 5.6. Preclinical stage partnering by most active company since 2016

Chapter 6 - Payment terms for preclinical stage partnering

• 6.1. Introduction
• 6.2. Guidelines for preclinical stage payment terms
  • 6.2.1. Upfront payments
  • 6.2.2. Milestone payments
  • 6.2.3. Royalty payments
• 6.3. Preclinical stage payment terms - deal data analysis
  • 6.3.1. Public data
  • 6.3.2. Survey data
• 6.4. Payment terms analysis
  • 6.4.1. Preclinical stage headline values
  • 6.4.2. Preclinical stage deal upfront payments
  • 6.4.3. Preclinical stage deal milestone payments
  • 6.4.4. Preclinical stage royalty rates

Chapter 7 - Leading preclinical stage deals

• 7.1. Introduction
• 7.2. Top preclinical stage deals by value

Chapter 8 - Top 25 most active preclinical stage dealmakers

• 8.1. Introduction
• 8.2. Top 25 most active preclinical stage dealmakers

Chapter 9 - Preclinical stage partnering contracts directory

• 9.1. Introduction
• 9.2. Preclinical stage deals with contracts 2016 to 2023

Chapter 10 - Preclinical stage deal making by development stage

• 10.1. Introduction
• 10.2. Deals by preclinical stage

Appendices

• Appendix 1 - Preclinical stage dealmaking by companies A-Z
• Appendix 2 - Preclinical stage dealmaking by industry sector
• Appendix 3 - Preclinical stage dealmaking by stage of development
• Appendix 4 - Preclinical stage dealmaking by therapy area
• Appendix 5 - Preclinical stage dealmaking by technology type

About Wildwood Ventures

• Current Partnering
• Current Agreements
• Recent titles from Current Partnering

Table of figures

• Figure 1: Definition of discovery, preclinical and clinical phases in dealmaking
• Figure 2: Components of the pure licensing deal structure
• Figure 3: Payment options for preclinical stage partnering deals
• Figure 4: Issues affecting royalty rates
• Figure 5: Preclinical stage partnering frequency 2016 - 2023
• Figure 6: Preclinical stage partnering by deal type since 2016
• Figure 7: Preclinical stage partnering by disease type since 2016
• Figure 8: Preclinical stage partnering by technology type since 2016
• Figure 9: Top 25 most active preclinical stage dealmakers, 2016 to 2023
• Figure 10: Review of upfront payments for preclinical stage deals
• Figure 11: Review of milestone payments for preclinical stage deals
• Figure 12: Review of royalty payments for preclinical stage deals
• Figure 13: Preclinical stage deals with a headline value
• Figure 14: Preclinical stage deals with an upfront value
• Figure 15: Preclinical stage deals with a milestone value
• Figure 16: Preclinical stage deals with a royalty rate value
• Figure 17: Top preclinical stage deals by value since 2016
• Figure 18: Most active preclinical stage dealmakers 2016 to 2023