市場調査レポート

医薬品のリポジショニング:事前の研究開発投資からの付加価値の抽出

Drug Repositioning: Extracting Added Value from Prior R&D Investments

発行 Insight Pharma Reports 商品コード 125506
出版日 ページ情報 英文 114 Pages
納期: 即日から翌営業日
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医薬品のリポジショニング:事前の研究開発投資からの付加価値の抽出 Drug Repositioning: Extracting Added Value from Prior R&D Investments
出版日: 2010年07月23日 ページ情報: 英文 114 Pages

当商品の販売は、2016年07月01日を持ちまして終了しました。

概要

当レポートでは、医薬品リポジショニングの機会とビジネス戦略、法規制の枠組み、化合物リポジショニングのケーススタディ、主要企業の活動、将来的見通しなどについてまとめ、概略下記の構成でお届けいたします。

エグゼクティブサマリー

第1章 イントロダクション:医薬品および医薬品候補のセカンドライフ

  • 標的と医薬品:限界に挑戦
  • 相互依存性ネットワークとしてのヒトの心理学
  • パイプライン侵略の形勢を変える医薬品リパーパシングの活用
  • 治療すべき疾患

第2章 医薬品リポジショニングと知的財産権

  • 特許基準に関する考察
  • リパーパシングの機会を評価するための調査
  • 知的財産のギャップ調査
  • データサポート
  • ケーススタディ

第3章 戦略的コンセプト、科学、治療移行ツール

  • 化合物をリポジショニング候補にするための戦略的考察
  • リパーパシングの機会特定
  • ハイスループットスクリーニングと逆ハイコンテントスクリーニング
  • インフォマティクスの採用
  • 医薬品再調製によるリパーパシングと新たなデリバリー法
  • バイオディフェンスのためのリパーパシング:主流外の戦略

第4章 リポジショニングされた医薬品と法規制当局

  • FDAの505(b)(2)新薬応用
  • EMEAのハイブリッド応用

第5章 医薬品リパーパシング事例

第6章 医薬品リパーパシングビジネスに関与する企業

  • 医薬品リパーパシングに注力したビジネスモデル
  • 小規模専門会社
  • 大手製薬会社
  • 医薬品リパーパシングを促進する民間の尽力

第7章 医薬品リパーパシングの経済的潜在性

  • 創薬、新薬開発におけるコスト削減
  • 医薬品開発の加速
  • リスク解除のメリット
  • プロバイダー見通し
  • サマリーと今後の見通し

参考情報

企業インデックス(ウェブアクセス付き)

目次

Drug repositioning has become a matter of intense interest during the past few years. It is an approach to drug development that calls for reinvestigation of candidates that did not succeed in advanced clinical trials (for reasons other than safety) for potential use in other therapeutic indications.

Discussed in this Report:

  • Intellectual property coverage for new uses of known drugs
  • Tool sets for identifying repositioning opportunities and business strategies
  • Applicable legal frameworks and regulatory timelines for repositioned drugs
  • Case studies of compound repositioning and approaches taken
  • Activities of selected key companies in the drug repositioning business
  • Financial aspects and economic potential of drug repositioning

Drug repositioning is also known as drug repurposing, reprofiling, or retasking. In “on-target repurposing,” a drug' s known phar-macological mechanism is applied to a different therapeutic indication than that for which it was initially developed. Even more innovative is “off-target repurposing,” which looks for pharmacological mechanisms that have not yet been described for a known molecule. In either case, having previously failed during clinical development is not a criterion for repositioning; the avenue is equally open to drugs that are or have been marketed.

Drug repurposing can have very different commercial implications. These will depend on where the drug comes from, how much accessible data exist, and how well the repurposer can exploit the new value chain created by a successfully repurposed drug. This will to a large extent depend on what sort of intellectual property can be secured for the drug' s new use, as examined in Chapter 2 of Drug Repositioning: Extracting Value from Prior R&D Investments. The repurposer fights an uphill battle against examiners who will scrutinize the prior art for“obviousness,” i.e., any public facts that can be construed to have anticipated the new medical use of a known drug.

Together with expert knowledge in pharmacology, state-of-the-art genomic, proteomic, animal model, and bioinformatics tech-nologies are employed to identify repurposing opportunities and business strategies. These more technology-oriented aspects are discussed in Chapter 3, followed by an outline of the regulatory environment for repurposing in Chapter 4. Here, we discuss the applicable legal framework and show that while repurposing can remove the initial 1 - 1.5 years of preclinical and Phase I de-velopment time (the latter only if no new formulation has to be developed and tested), the later stages of the regulatory review process for repurposed drugs are the same as with new chemical entities. Chapter 5 discusses exemplary cases of drug reposi-tioning and the approaches taken, depending on the intended goal.

Drug repurposing has become a new business segment for the life science services industry. Chapter 6 profiles selected key companies that offer platform-based services to identify repurposing opportunities. For the decade ahead to 2020, we predict that cutting-edge repurposing technology will see increasing integration as a standard process of resource utilization, de-risking and acceleration of drug development. In this chapter we also discuss the internal repurposing efforts of Pfizer, Novartis, and Eli Lilly and how these programs tie into their overall development strategies. Drug Repositioning: Extracting Added Value from Prior R&D Investments concludes with a discussion of the financial aspects, considering the benefits of repurposing for larger, smaller, and startup companies.

About the Author

Hermann A.M. Mucke, Ph.D., spent 17 years in academia and industry before he founded H.M. Pharma Consultancy in 2000 to become an independent pharmaceutical consultant, analyst, and science author. His last industry position was Vice President R&D in a European pharmaceutical company, which he helped to take public on the Frankfurt Stock Exchange in 1999. Since then, Dr. Mucke, who holds a Ph.D. in biochemistry from the University of Vienna (Austria), has become a consultant and advisory board member for several European and American pharmaceutical companies and a regular reviewer of drugs and patents for Thomson Current Drugs and Ashley Publications. Dr. Mucke is based in Vienna.

Table of Contents

Executive Summary

Chapter - 1

INTRODUCTION: A SECOND LIFE FOR DRUGS AND DRUG CANDIDATES

  • 1.1. Targets and Agents: Approaching the Limits
  • 1.2. Human Physiology as a Network of Interdependencies
  • 1.3. Leveraging Drug Repurposing To Turn the Tables on Pipeline Erosion
  • 1.4. Finding Another Disease To Treat: On-Target and Off-Target

Chapter - 2

DRUG REPOSITIONING AND INTELLECTUAL PROPERTY

  • 2.1. Considerations Regarding the Patentability Criteria
  • 2.2. Searching Prior Art to Assess Repurposing Opportunities
  • 2.3. Searching For Intellectual Property Gaps
  • 2.4. Data Support: An Indispensable Requirement for Second Use Patenting
  • 2.5. Case Study: Developer Actelion Claims Bosentan for Ovarian Cancer

Chapter - 3

THE STRATEGIC CONCEPT, THE SCIENCE, AND THE TOOLS OF THE THERAPEUTIC SWITCH

  • 3.1. What Strategic Considerations Make a Compound a Repositioning Candidate?
  • 3.2. Identification of Repurposing Opportunities
  • Know the Science
  • Know the Resources
  • Hypothesis-Driven Approaches
  • 3.3. Targeted High-Throughput Screening and Inverse High-Content Screening
  • Phenotypic Screening: Parameter-Free High-Content Screening
  • Multiplexing Animal Tests
  • 3.4. Putting Informatics to Work
  • Case Study for Gene Expression: VVP808
  • Case Study for Virtual Screening and In Silico Docking: SOSA and Entacapone
  • Case Study for Systems Biology: Optimata
  • Data Mining and Ligand-Similarity Approaches
  • New Opportunities Through Grid Computing?
  • 3.5. Repurposing Aided By Drug Reformulation and New Forms of Delivery
  • 3.6. Repurposing for Biodefense: A Strategy Outside of the Mainstream

Chapter - 4

REPOSITIONED DRUGS AND REGULATORY AUTHORITIES

  • 4.1. The FDA' s 505(b)(2) New Drug Application
  • 4.2. The EMEA “Hybrid Application”

Chapter - 5

EXAMPLES OF DRUG REPURPOSING

  • 5.1. Successfully Repositioned Compounds That Were Never Marketed For Their Original Development Targets or Were Withdrawn From the Market
  • Pfizer' s Sildenafil: From Failed Antihypertensive, to Lifestyle Drug, to Orphan Disease
  • Thalidomide: A Colossal Tragedy and a New Beginning
  • Azidothymidine: A Cancer Drug Candidate Repurposed as an HIV Therapeutic and Vice Versa
  • 5.2. Drugs That Were Moderately Successful and Were (Or Are Being) Repurposed
  • Galantamine: Transformed Into an Alzheimer' s Drug, With More Perspectives
  • Cicletanine: An Antihypertensive for Pulmonary Hypertension...And Diabetes?
  • Ropinirole and Pramipexole: Parkinson' s Drugs for Restless Leg Syndrome
  • Benzbromarone: A Potentially Problematic Gout Drug Applied To MRSA Infections
  • Clioquinol: An Old Antiprotozoal As a Lead Compound for Neuroprotection
  • Astemizole: A Problematic Antihistamine with Significant Alternative Perspectives
  • 5.3. Successful Primary-Use Drugs in Repurposing Scenarios
  • Milnacipran and Duloxetine: Two Antidepressants Now Approved for Fibromyalgia
  • Finasteride: From Prostate to Hair Loss
  • Imatinib for Diabetes and Rheumatoid Arthritis
  • 5.4. Failed, and Failed Again...Perhaps For the Wrong Reasons
  • MCI-225: From Psychiatry Drug Candidate, to Gastrointestinal and Urinary Tract Agent

Chapter - 6

COMPANIES IN THE DRUG REPURPOSING BUSINESS

  • 6.1. Business Models Centered On Drug Repurposing: Different From Those for Discovery?
  • 6.2. The Small, Drug-Repurposing Specialists
  • Sosei Group Corp.
  • CombinatoRx, Inc.
  • Ore Pharmaceutical Holdings, Inc.
  • Biovista, Inc.
  • Melior Discovery, Inc.
  • Numedicus Ltd.
  • Vifor Pharma/Galenica Group
  • Aureus Pharma
  • Horizon Discovery Ltd.
  • Tangent Reprofiling Ltd.
  • Anaxomics Biotech SL
  • SOM Biotech SL
  • SWITCHBIOTECH LLC
  • Celentyx Ltd.
  • Almac Group Ltd.
  • 6.3. “Big Pharma” And Drug Repositioning
  • Pfizer
  • Novartis
  • Eli Lilly
  • 6.4. Public Efforts to Facilitate Drug Repurposing

Chapter - 7

THE ECONOMIC POTENTIAL OF DRUG REPURPOSING

  • 7.1. Cost Savings of Repurposing In Discovery and Development
  • 7.2. Acceleration of Drug Development: Time Equals Sales
  • 7.3. The Benefits of De-Risking
  • 7.4. The Repurposing Service Provider' s Perspective
  • 7.5. Summary and Outlook

References

Company Index with Web Addresses

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