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エピジェネティクスR&Dパイプライン:ヒストンデアセチラーゼ(HDAC)が最も有望な標的

Epigenetics R&D Pipeline - Histone Deacetylases (HDACs) Offer the Most Promising Targets and Outnumber Other Classes of Epigenetic Targets

発行 GBI Research 商品コード 248228
出版日 ページ情報 英文 75 Pages
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エピジェネティクスR&Dパイプライン:ヒストンデアセチラーゼ(HDAC)が最も有望な標的 Epigenetics R&D Pipeline - Histone Deacetylases (HDACs) Offer the Most Promising Targets and Outnumber Other Classes of Epigenetic Targets
出版日: 2012年07月31日 ページ情報: 英文 75 Pages
概要

エピジェネティクスは、多くの人間の病気において重要な役割を果たし、細胞分化の決定要素として浮上しています。

当レポートでは、エピジェネティクス標的について調査分析し、課題や問題点、エピジェネティクス研究における動向や機会などを取り上げ、製品パイプラインの概要と後期R&D分子について検証し、主要企業プロファイルも含めて、概略以下の構成でお届けいたします。

第1章 目次

第2章 イントロダクション

第3章 エピジェネティクスの概要

第4章 エピジェネティクスの適用

  • 癌におけるエピジェネティクス
  • その他の疾患の症状におけるエピジェネティクス

第5章 機序と標的

  • DNAメチルトランスフェラーゼ(DNAメチル基転移酵素)
  • 新しい標的

第6章 上市製品

  • Vidaza (azacitidine):Celgene Corporation
  • Zolinza (vorinostat):Merck & Co.Inc.
  • Istodax (romidepsin):Celgene Corporation
  • Dacogen (decitabine):エーザイ

第7章 分析

  • 開発段階別パイプライン
  • 適応別パイプライン分析
  • 作用機序別パイプライン分析
  • 後期パイプライン分子

第8章 課題、機会、動向

  • エピジェネティクス対応の課題
  • エピジェネティクスの機会
  • エピジェネティクス研究の動向

第9章 主要企業

  • Merck & Co., Inc.
  • Novartis AG
  • Syndax Pharmaceuticals, Inc.
  • 4SC AG
  • GlaxoSmithKline Plc
  • Celgene Corporation
  • MethylGene Inc.
  • Pharmacyclics, Inc.
  • TopoTarget A/S
  • S*BIO Pte Ltd
  • Curis, Inc.

第10章 戦略的統合

  • M&A取引
  • ライセンス取引
  • 共同開発取引
  • 将来におけるエピジェネティクス研究の予測

第11章 付録

図表

目次

Summary

GBI Research, a leading business intelligence provider, has released its latest research, entitled "Epigenetics R&D Pipeline - Histone Deacetylases (HDACs) Offer the Most Promising Targets and Outnumber Other Classes of Epigenetic Targets". The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts. The report provides an insight into the epigenetic targets being studied and the challenges, issues, trends and opportunities in epigenetic research. It also outlines the product pipeline and discusses late-stage R&D molecules, as well as profiles of the major companies currently active in epigenetic research and in-depth analysis of strategic consolidations.

Epigenetics refers to a regulatory system that selectively regulates gene expression in different cells without actually affecting the genomic makeup of the Deoxyribonucleic Acid (DNA) sequence. Epigenetics is emerging as a key determinant of cellular differentiation, and epigenetic regulation of gene expression has been seen to play a vital role in a number of diseases.

There are currently only four epigenetic-based drugs in the market, namely Vidaza, Zolinza, Dacogen and Istodax. They act by inhibiting either Histone Deacetylases (HDAC) or DNA Methyltransferase (DNMT). The last few years have seen a surge of research into epigenetic modification and its usefulness in the treatment of a wide range of disease conditions. Analysis of the product pipeline reveals that the majority of research is centered on histone modifications. Clinical trials targeting HDACs clearly outnumber any other class of epigenetic targets. New targets such as RNA, BET, E2HZ are also being explored. Early epigenetics research was largely focused on its application for the treatment of cancer, although researchers and pharmaceutical companies now understand its potential for neurodegenerative diseases, metabolic disorders and aging. The lack of selectivity and the toxicity of first-generation epigenetic-based drugs are the key challenges in epigenetic research that need to address. There is no clear consensus among researchers as to whether research should focus on developing better combinations or better specificity. Some pharmaceutical companies such as Phamacyclics are developing drugs that are target specific while others are involved in investigating epigenetic-based combination therapies and developing novel epigenetic-based drugs.

The massive potential of epigenetics, both from a therapeutic and business point of view, has attracted substantial interest from academia, investors, and pharmaceutical and biotechnology companies. Epigenetics has been one of the most widely studied areas in recent years and has emerged as a promising focus in drug discovery. Expectations are high, and fulfilling them while also addressing key challenges and issues could be possible with collaborative efforts from academia and pharmaceutical companies.

Scope

  • Existing and new targets being explored in R&D
  • Detailed epigenetic pipeline analysis
  • In-depth discussion of the challenges, trends and opportunities in epigenetic research
  • Analysis of epigenetic-based marketed products
  • Profiles of the top companies active in epigenetics
  • Information on strategic consolidation in the epigenetic space

Reasons to buy

  • Identify the advantages of epigenetic therapies and understand market potential
  • Gain an insight into the targets being explored in R&D
  • Understand the key challenges, issues, trends and opportunities in epigenetic research
  • Identify the key players best positioned to take advantage of the epigenetic therapeutics' market potential

Executive Summary

Scientific Study into Epigenetics Could Offer a Medical Breakthrough for Cancer Treatment.

Epigenetics is emerging as a key determinant of cellular differentiation, playing a vital role in a number of human diseases, according to a new report by pharmaceutical experts GBI Research.

The new report* examines epigenetics, which refers to a selective regulation of gene expression within different cells that does not affect the genomic makeup of the Deoxyribonucleic Acid (DNA) sequence.

The last few years have seen a surge in research into epigenetic modification of the chromatin within a cell's genome. Epigenetic changes appear to regulate differentiation of stem cells as well as giving rise to malignant cells, which include cancerous cells. Given the huge market potential and considerable unmet need, it is unsurprising that almost every major pharmaceutical company has an epigenetic program in oncology. The growing number of cancer patients worldwide offers a lucrative market for epigenetic-based molecules, and the successful launch of just one drug could generate huge revenues.

Despite the field's optimism and the boom in epigenetic research over the last decade, however, several critical challenges need to be addressed before epigenetics is seen as a viable treatment option and a potential business investment.

Epigenetic targets are structurally complex, requiring a great deal of work to be characterized, and investigations into innovative drug discovery against new targets involve a high level of risk. The toxicity of epigenetic-derived drugs is an important challenge for researchers and investors, as currently marketed epigenetic-based drugs can cause serious adverse effects, and these risks have led to a low uptake of epigenetic therapies in the market.

It also remains unknown as to why first-generation epigenetic-based therapies have been particularly successful against hematological cancers, and the unknown mechanism of action is daunting for researchers and pharmaceutical industries worldwide. Despite extensive research, very few targets have been identified, and so a great deal of work is still necessary to characterize and understand the consequences of their actions. Little is known about the chromatin modifications in cancer, or the mechanisms by which epigenomes influence the pathogenesis of various disease conditions.

GBI Research believes that these challenges will not be resolved by a single organization, but instead demand coordinated and collaborative efforts from academia and pharmaceutical companies over time, in order to solve this medical mystery.

Epigenetics R&D Pipeline - Histone Deacetylases (HDACs) Offer the Most Promising Targets and Outnumber Other Classes of Epigenetic Targets

The report provides an insight into the epigenetic targets being studied and the challenges, issues, trends and opportunities in epigenetic research. It also outlines the product pipeline and discusses late-stage R&D molecules, as well as profiles of the major companies currently active in epigenetic research and in-depth analysis of strategic consolidations.

The report is built using data and information sourced from proprietary databases, primary and secondary research and in-house analysis by GBI Research's team of industry experts.

Table of Contents

1 Table of Contents 6

  • 1.1 List of Tables 9
  • 1.2 List of Figures 9

2 Introduction 10

3 Epigenetics R&D Pipeline - Overview of Epigenetics 11

4 Epigenetics R&D Pipeline - Applications of Epigenetics 13

  • 4.1 Epigenetics in Cancer 14
  • 4.2 Epigenetics in Other Disease Conditions 14
    • 4.2.1 Central Nervous System Disorders 14
    • 4.2.2 Epigenetics in Aging 15
    • 4.2.3 Diabetes and Obesity 15

5 Epigenetics R&D Pipeline - Mechanisms and Targets 16

  • 5.1 DNA Methyltransferase 16
    • 5.1.1 Histone Modifications 17
  • 5.2 New Targets 18
    • 5.2.1 Lysine-specific Demethylase 1 18
    • 5.2.2 Enhancer of Zeste Homolog 2 18
    • 5.2.3 Bromodomain and Extra-terminal Proteins 18
    • 5.2.4 Ribonucleic Acid 19

6 Epigenetics R&D Pipeline - Marketed Products 20

  • 6.1 Vidaza (azacitidine) - Celgene Corporation 21
    • 6.1.1 Product Description 21
    • 6.1.2 Mechanism of Action 22
    • 6.1.3 R&D 22
    • 6.1.4 Adverse Effects 22
  • 6.2 Zolinza (vorinostat) - Merck & Co.Inc. 23
    • 6.2.1 Product Description 23
    • 6.2.2 Mechanism of Action 24
    • 6.2.3 R&D 24
    • 6.2.4 Adverse Effects 24
  • 6.3 Istodax (romidepsin) - Celgene Corporation 25
    • 6.3.1 Product Description 25
    • 6.3.2 Mechanism of Action 26
    • 6.3.3 R&D 26
    • 6.3.4 Adverse Effects 26
  • 6.4 Dacogen (decitabine) - Eisai Co., Ltd. 26
    • 6.4.1 Product Description 26
    • 6.4.2 Mechanism of Action 28
    • 6.4.3 R&D 28
    • 6.4.4 Adverse Effects 28

7 Epigenetic R&D Pipeline - Analysis 29

  • 7.1 Epigenetics R&D Pipeline - Pipeline by Stage of Development 30
    • 7.1.1 Epigenetics R&D Pipeline - Discovery 31
    • 7.1.2 Epigenetics R&D Pipeline - Phase I 32
    • 7.1.3 Epigenetics R&D Pipeline - Phase I/II 37
    • 7.1.4 Epigenetics R&D Pipeline - Phase II 38
    • 7.1.5 Epigenetics R&D Pipeline - Phase III 41
  • 7.2 Epigenetics R&D Pipeline - Pipeline Analysis by Indication 42
  • 7.3 Epigenetics R&D Pipeline - Pipeline Analysis by Mechanism of Action 43
  • 7.4 Epigenetics R&D Pipeline - Late-stage Pipeline Molecules 44
    • 7.4.1 LBH589 (panobinostat) 44
    • 7.4.2 Belinostat 44
    • 7.4.3 Entinostat 44
    • 7.4.4 Vorinostat 45

8 Epigenetics R&D Pipeline - Challenges, Opportunities and Trends 46

  • 8.1 Challenges in Dealing with Epigenetics 46
    • 8.1.1 Physician Response to Epigenetic-based Therapies 47
    • 8.1.2 Lack of Specificity of Epigenetic-based Therapies 48
    • 8.1.3 Toxicity 48
    • 8.1.4 Unknown Mechanism of Action 49
    • 8.1.5 Better Combination or Better Specificity? 49
    • 8.1.6 Technological Challenges 50
  • 8.2 Opportunities in Epigenetics 50
    • 8.2.1 Cancer Market Potential 50
    • 8.2.2 New Indications 51
    • 8.2.3 Resolving Toxicity and Specificity Issue will Increase Uptake of Epigenetic-based Drugs 51
    • 8.2.4 Exploring New Target and Undefined Epigenetic Enzymes 51
  • 8.3 Trends in Epigenetics Research 51
    • 8.3.1 Shift to the New Potential Targets 51
    • 8.3.2 Combination Therapies with Two or More Epigenetics Drugs with Different Mechanisms of Action 51

9 Epigenetics R&D Pipeline - Leading Players 53

  • 9.1 Merck & Co., Inc. 54
    • 9.1.1 Business Overview 54
    • 9.1.2 Epigenetic Portfolio 54
  • 9.2 Novartis AG 55
    • 9.2.1 Business Overview 55
    • 9.2.2 Epigenetic Portfolio 55
  • 9.3 Syndax Pharmaceuticals, Inc. 55
    • 9.3.1 Business Overview 55
    • 9.3.2 Epigenetic Portfolio 56
  • 9.4 4SC AG 56
    • 9.4.1 Business Overview 56
    • 9.4.2 Epigenetic Portfolio 56
  • 9.5 GlaxoSmithKline Plc 57
    • 9.5.1 Business Overview 57
    • 9.5.2 Deals 57
  • 9.6 Celgene Corporation 57
    • 9.6.1 Business Overview 57
    • 9.6.2 Epigenetic Portfolio 57
  • 9.7 MethylGene Inc. 58
    • 9.7.1 Business Overview 58
    • 9.7.2 Epigenetic Portfolio 58
  • 9.8 Pharmacyclics, Inc. 58
    • 9.8.1 Business Overview 58
    • 9.8.2 Epigenetic Portfolio 58
  • 9.9 TopoTarget A/S 59
    • 9.9.1 Business Overview 59
    • 9.9.2 Epigenetic Portfolio 59
  • 9.10 S*BIO Pte Ltd 59
    • 9.10.1 Business Overview 59
    • 9.10.2 Epigenetic Portfolio 59
  • 9.11 Curis, Inc. 60
    • 9.11.1 Business Overview 60
    • 9.11.2 Epigenetic Portfolio 60

10 Epigenetics R&D Pipeline - Strategic Consolidation 61

  • 10.1 M&A Deals 62
    • 10.1.1 Celgene Corporation Completes Acquisition of Gloucester Pharmaceuticals 62
    • 10.1.2 Celgene Corporation Acquires the Rights to Vidaza through the Acquisition of Pharmion Corporation 62
    • 10.1.3 Eisai Co., Ltd Completes Acquisition of MGI Pharma Inc. 62
    • 10.1.4 4SC AG Successfully Completes Transaction of Nycomed Oncology Projects 62
    • 10.1.5 Astex Pharmaceuticals Enters into an Asset Transfer Agreement with GlaxoSmithKline 62
  • 10.2 Licensing Deals 63
    • 10.2.1 Celleron Therapeutics Enters into Licensing Agreement with AstraZeneca Plc 63
    • 10.2.2 Spectrum Pharmaceuticals Enters into Licensing Agreement with TopoTarget A/S 63
    • 10.2.3 CellCentric Enters into Licensing Agreement with Takeda Pharma 63
    • 10.2.4 Cellzome Announces Second Major Strategic Drug Discovery Alliance with GlaxoSmithKline in Inflammatory Diseases 64
    • 10.2.5 4SC Enters into Licensing Agreement with Yakult Honsha for Japan for Resminostat 64
  • 10.3 Co-development Deals 64
    • 10.3.1 Pharmacyclics Enters into Collaboration with Les Laboratoires Servier 64
    • 10.3.2 Curis Enters into Co-development Agreement with the Leukemia & Lymphoma Society 65
    • 10.3.3 Constellation Pharma Enters into Epigenetics Drug Discovery Collaboration Agreement 65
    • 10.3.4 Leukemia & Lymphoma Society Enters into an Agreement with EpiZyme Inc. 65
    • 10.3.5 Aphios Enters into Research and Co-development Agreement with VivaCell Biotech 66
    • 10.3.6 EpiZyme Enters into an Agreement with Eisai 66
    • 10.3.7 EpiZyme Enters into Co-development Agreement with GlaxoSmithKline 66
    • 10.3.8 EpiTherapeutics Enters into Co-development Agreement with Abbott Laboratories, Inc 66
  • 10.4 Expectations of Epigenetics Research in the Future 67

11 Epigenetics R&D Pipeline - Appendix 68

  • 11.1 Market Definitions 68
  • 11.2 Abbreviations 68
  • 11.3 Sources 70
  • 11.4 Research Methodology 71
    • 11.4.1 Coverage 71
    • 11.4.2 Secondary Research 71
    • 11.4.3 Primary Research 71
    • 11.4.4 Therapeutic Landscape 72
    • 11.4.5 Geographical Landscape 75
    • 11.4.6 Pipeline Analysis 75
    • 11.4.7 Competitive Landscape 75
  • 11.5 Expert Panel Validation 75
  • 11.6 Contact Us 75
  • 11.7 Disclaimer 75

List of Tables

  • Table 1: Epigenetic R&D Pipeline, Marketed Drugs, 2011 20
  • Table 2: Epigenetic Product Pipeline, Discovery, 2012 31
  • Table 3: Epigenetic R&D Pipeline, Phase I, 2012 32
  • Table 4: Epigenetics R&D Pipeline, Phase I/II, 2012 37
  • Table 5: Epigenetic R&D Pipeline, Phase II 38
  • Table 6: Epigenetic R&D Pipeline, Phase III, 2012 41

List of Figures

  • Figure 1: Epigenetic R&D Pipeline, Epigenetic Mechanism 11
  • Figure 2: Epigenetic R&D Pipeline, Approved Drugs that Target Epigenetic Mechanism, 2012 12
  • Figure 3: Epigenetic R&D Pipeline, Pipeline by Therapy Area, (%), 2012 13
  • Figure 4: Epigenetic R&D Pipeline, Vidaza Snapshot, 2012 21
  • Figure 5: Epigenetic R&D Pipeline, Zolinza Snapshot,2012 23
  • Figure 6: Epigenetic R&D Pipeline, Istodax Snapshot, 2012 25
  • Figure 7: Epigenetic R&D Pipeline Dacogen Snapshot,2012 27
  • Figure 8: Epigenetics R&D Pipeline, Pipeline by Stage of Development, 2012 30
  • Figure 9: Epigenetic R&D Pipeline, Pipeline Analysis by Indication, 2012 42
  • Figure 10: Epigenetic R&D Pipeline, Epigenetics by Mechanism of Action, 2012 43
  • Figure 11: Epigenetic R&D Pipeline, Challenges in Dealing with Epigenetics, 2012 47
  • Figure 12: Epigenetic R&D Pipeline, Single Drug vs. Combinations in Development 52
  • Figure 13: Epigenetic R&D Pipeline, Leading Players by R&D Programs, 2012 53
  • Figure 14: GBI Research Market Forecasting Model 74
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