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医薬品・バイオテクノロジー・診断における治験段階別の提携条件と契約動向

Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016

発行 Current Partnering, a division of Wildwood Ventures Limited 商品コード 117615
出版日 ページ情報 英文 1,000+ pages
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医薬品・バイオテクノロジー・診断における治験段階別の提携条件と契約動向 Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016
出版日: 2016年05月02日 ページ情報: 英文 1,000+ pages
概要

当レポートでは、世界の主要ヘルスケア企業による臨床段階の提携契約や合意内容について分析し、企業が臨床段階で提携する理由、契約戦略と契約構造、契約のレビュー、支払い条件、主な治験契約の金額別レビューなどをまとめています。

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 企業が治験段階の化合物で提携する理由?

  • イントロダクション
  • 治験段階における提携の役割
  • 第1相、2相、3相における取引の違い
  • 治験段階別提携契約を締結する理由
  • 将来の治験契約動向

第3章 治験段階における契約の戦略と構造

  • イントロダクション
  • 企業がどの段階で提携するか?
  • 初期・後期段階の提携−リスク/コストの比較
  • 企業が治験契約に費やす金額は?
  • 単純対多要素構成契約
  • 単純ライセンシング契約構造
  • 多要素提携契約

第4章 治験提携におけるペイメント戦略

  • イントロダクション
  • 治験ペイメント戦略
  • ペイメント手段

第5章 治験契約形成の動向

  • イントロダクション
  • 長年に渡る治験提携
  • 大手製薬企業の治験契約活動
  • 大手バイオテクノロジー企業の治験契約活動
  • 治験提携:契約タイプ別
  • 治験提携:疾病タイプ別
  • 提携:治験技術タイプ別

第6章 治験提携の平均的な支払条件

  • イントロダクション
  • 治験支払条件のガイドライン
  • 治験支払−契約データ分析
  • 支払条件の分析

第7章 主要な治験契約

  • イントロダクション
  • 主要な治験契約:金額別

第8章 大手製薬企業および大手バイオテクノロジー企業の治験契約

  • イントロダクション
  • 大手製薬企業/大手バイオテクノロジー企業の治験契約方法
  • 大手製薬企業の治験提携企業プロファイル
  • 大手バイオテクノロジー企業の治験提携企業プロファイル

第9章 治験提携契約ディレクトリ

  • イントロダクション
  • 企業A-Z
  • 契約タイプ別
  • 開発段階別
  • 治療領域別

第10章 治験契約形成:開発段階別

  • イントロダクション
  • 契約:治験段階別

Wildwood Ventures について

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目次
Product Code: CP2057

The Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016 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 2,000 preclinical stage partnering deals announced since 2010 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 2010. 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 50 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 2010, where a contract document is available in the public domain.

Chapter 10 provides a comprehensive directory of preclinical stage partnering deals since 2010.

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 2010.

In addition, a comprehensive appendix of all preclinical deals since 2010 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 2010-2016 provides the reader with the following key benefits:

  • In-depth understanding of preclinical stage deal trends since 2010
  • 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 2010-2016 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 2010-2016 includes:

  • Trends in preclinical stage dealmaking in the biopharma industry since 2010
  • 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 2,000 preclinical stage deals
  • The leading preclinical stage deals by value since 2010
  • Most active preclinical stage dealmakers since 2010
  • The leading preclinical stage partnering resources

In Global Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016, 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 2010-2016 report provides comprehensive access to available deals and contract documents for over 2,000 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 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?

Benefits

The Preclinical Stage Partnering Terms and Agreements in Pharma and Biotech 2010-2016 report provides the reader with the following key benefits:

  • In-depth understanding of preclinical stage deal trends since 2010
  • Access to headline, upfront, milestone and royalty data
  • Comprehensive access to over 2,000 preclinical stage deals together with contract documents if available
  • Detailed access to actual preclinical stage deals entered into by the leading fifty 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 2010
  • Identify the most active preclinical stage dealmakers since 2010
  • 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: LEO Pharma - 4SC
        • 3.2.1.1.b. Case study: Heptares Therapeutics - Cubist
        • 3.2.1.1.c. Case study: Incyte - Agenus Bio
        • 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: Servier - GeNeuro
        • 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 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 : Merck and Co. - Tesaro
      • 3.6.1.b. Case study : Marina Biotech - Mirna Therapeutics
  • 3.7. Multicomponent preclinical stage partnering agreements
    • 3.7.1. Example multicomponent preclinical stage clauses
      • 3.7.1.a. Case study: Eleven Biotherapeutics - ThromboGenics
      • 3.7.1.b. Case study: Pfizer - InSite Vision

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: 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 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, 2010 to 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 50 most active preclinical stage dealmakers

  • 8.1. Introduction
  • 8.2. Top 50 most active preclinical stage dealmakers

Chapter 9 - Preclinical stage partnering contracts directory

  • 9.1. Introduction
  • 9.2. Preclinical stage deals with contracts 2010 to 2016

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: Agreements signed by phase of development (2010- 2016), % of all deals
  • Figure 3: Components of the pure licensing deal structure
  • Figure 4: Payment options for preclinical stage partnering deals
  • Figure 5: Issues affecting royalty rates
  • Figure 6: Preclinical stage partnering frequency 2010- 2016
  • Figure 7: Preclinical stage partnering by deal type since 2010
  • Figure 8: Preclinical stage partnering by disease type since 2010
  • Figure 9: Preclinical stage partnering by technology type since 2010
  • Figure 10: Top 50 most active preclinical stage dealmakers, 2010 to 2016
  • Figure 11: Review of upfront payments for preclinical stage deals
  • Figure 12: Review of milestone payments for preclinical stage deals
  • Figure 13: Review of royalty payments for preclinical stage deals
  • Figure 14: Preclinical stage deals with a headline value
  • Figure 15: Preclinical stage deals with an upfront value
  • Figure 16: Preclinical stage deals with a milestone value
  • Figure 17: Preclinical stage deals with a royalty rate value
  • Figure 18: Top preclinical stage deals by value since 2010
  • Figure 19: Most active preclinical stage dealmakers 2010 to 2016
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