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

NEW YORK, Aug. 9, 2012 /PRNewswire/ -- announces that a new market research report is available in its catalogue:

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

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


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.


- 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

Table of Contents1 Table of Contents1 Table of Contents 61.1 List of Tables 91.2 List of Figures 92 Introduction 103 Epigenetics R&D Pipeline – Overview of Epigenetics 114 Epigenetics R&D Pipeline – Applications of Epigenetics 134.1 Epigenetics in Cancer 144.2 Epigenetics in Other Disease Conditions 144.2.1 Central Nervous System Disorders 144.2.2 Epigenetics in Aging 154.2.3 Diabetes and Obesity 155 Epigenetics R&D Pipeline – Mechanisms and Targets 165.1 DNA Methyltransferase 165.1.1 Histone Modifications 175.2 New Targets 185.2.1 Lysine-specific Demethylase 1 185.2.2 Enhancer of Zeste Homolog 2 185.2.3 Bromodomain and Extra-terminal Proteins 185.2.4 Ribonucleic Acid 196 Epigenetics R&D Pipeline – Marketed Products 206.1 Vidaza (azacitidine) – Celgene Corporation 216.1.1 Product Description 216.1.2 Mechanism of Action 226.1.3 R&D 226.1.4 Adverse Effects 226.2 Zolinza (vorinostat) – Merck & Co.Inc. 236.2.1 Product Description 236.2.2 Mechanism of Action 246.2.3 R&D 246.2.4 Adverse Effects 246.3 Istodax (romidepsin) – Celgene Corporation 256.3.1 Product Description 256.3.2 Mechanism of Action 266.3.3 R&D 266.3.4 Adverse Effects 266.4 Dacogen (decitabine) – Eisai Co., Ltd. 266.4.1 Product Description 266.4.2 Mechanism of Action 286.4.3 R&D 286.4.4 Adverse Effects 287 Epigenetic R&D Pipeline – Analysis 297.1 Epigenetics R&D Pipeline – Pipeline by Stage of Development 307.1.1 Epigenetics R&D Pipeline – Discovery 317.1.2 Epigenetics R&D Pipeline – Phase I 327.1.3 Epigenetics R&D Pipeline – Phase I/II 377.1.4 Epigenetics R&D Pipeline – Phase II 387.1.5 Epigenetics R&D Pipeline – Phase III 417.2 Epigenetics R&D Pipeline – Pipeline Analysis by Indication 427.3 Epigenetics R&D Pipeline – Pipeline Analysis by Mechanism of Action 437.4 Epigenetics R&D Pipeline – Late-stage Pipeline Molecules 447.4.1 LBH589 (panobinostat) 447.4.2 Belinostat 447.4.3 Entinostat 447.4.4 Vorinostat 458 Epigenetics R&D Pipeline – Challenges, Opportunities and Trends 468.1 Challenges in Dealing with Epigenetics 468.1.1 Physician Response to Epigenetic-based Therapies 478.1.2 Lack of Specificity of Epigenetic-based Therapies 488.1.3 Toxicity 488.1.4 Unknown Mechanism of Action 498.1.5 Better Combination or Better Specificity? 498.1.6 Technological Challenges 508.2 Opportunities in Epigenetics 508.2.1 Cancer Market Potential 508.2.2 New Indications 518.2.3 Resolving Toxicity and Specificity Issue will Increase Uptake of Epigenetic-based Drugs 518.2.4 Exploring New Target and Undefined Epigenetic Enzymes 518.3 Trends in Epigenetics Research 518.3.1 Shift to the New Potential Targets 518.3.2 Combination Therapies with Two or More Epigenetics Drugs with Different Mechanisms of Action 519 Epigenetics R&D Pipeline – Leading Players 539.1 Merck & Co., Inc. 549.1.1 Business Overview 549.1.2 Epigenetic Portfolio 549.2 Novartis AG 559.2.1 Business Overview 559.2.2 Epigenetic Portfolio 559.3 Syndax Pharmaceuticals, Inc. 559.3.1 Business Overview 559.3.2 Epigenetic Portfolio 569.4 4SC AG 569.4.1 Business Overview 569.4.2 Epigenetic Portfolio 569.5 GlaxoSmithKline Plc 579.5.1 Business Overview 579.5.2 Deals 579.6 Celgene Corporation 579.6.1 Business Overview 579.6.2 Epigenetic Portfolio 579.7 MethylGene Inc. 589.7.1 Business Overview 589.7.2 Epigenetic Portfolio 589.8 Pharmacyclics, Inc. 589.8.1 Business Overview 589.8.2 Epigenetic Portfolio 589.9 TopoTarget A/S 599.9.1 Business Overview 599.9.2 Epigenetic Portfolio 599.10 S*BIO Pte Ltd 599.10.1 Business Overview 599.10.2 Epigenetic Portfolio 599.11 Curis, Inc. 609.11.1 Business Overview 609.11.2 Epigenetic Portfolio 6010 Epigenetics R&D Pipeline – Strategic Consolidation 6110.1 M&A Deals 6210.1.1 Celgene Corporation Completes Acquisition of Gloucester Pharmaceuticals 6210.1.2 Celgene Corporation Acquires the Rights to Vidaza through the Acquisition of Pharmion Corporation 6210.1.3 Eisai Co., Ltd Completes Acquisition of MGI Pharma Inc. 6210.1.4 4SC AG Successfully Completes Transaction of Nycomed Oncology Projects 6210.1.5 Astex Pharmaceuticals Enters into an Asset Transfer Agreement with GlaxoSmithKline 6210.2 Licensing Deals 6310.2.1 Celleron Therapeutics Enters into Licensing Agreement with AstraZeneca Plc 6310.2.2 Spectrum Pharmaceuticals Enters into Licensing Agreement with TopoTarget A/S 6310.2.3 CellCentric Enters into Licensing Agreement with Takeda Pharma 6310.2.4 Cellzome Announces Second Major Strategic Drug Discovery Alliance with GlaxoSmithKline in Inflammatory Diseases 6410.2.5 4SC Enters into Licensing Agreement with Yakult Honsha for Japan for Resminostat 6410.3 Co-development Deals 6410.3.1 Pharmacyclics Enters into Collaboration with Les Laboratoires Servier 6410.3.2 Curis Enters into Co-development Agreement with the Leukemia & Lymphoma Society 6510.3.3 Constellation Pharma Enters into Epigenetics Drug Discovery Collaboration Agreement 6510.3.4 Leukemia & Lymphoma Society Enters into an Agreement with EpiZyme Inc. 6510.3.5 Aphios Enters into Research and Co-development Agreement with VivaCell Biotech 6610.3.6 EpiZyme Enters into an Agreement with Eisai 6610.3.7 EpiZyme Enters into Co-development Agreement with GlaxoSmithKline 6610.3.8 EpiTherapeutics Enters into Co-development Agreement with Abbott Laboratories, Inc 6610.4 Expectations of Epigenetics Research in the Future 6711 Epigenetics R&D Pipeline – Appendix 6811.1 Market Definitions 6811.2 Abbreviations 6811.3 Sources 7011.4 Research Methodology 7111.4.1 Coverage 7111.4.2 Secondary Research 7111.4.3 Primary Research 7111.4.4 Therapeutic Landscape 7211.4.5 Geographical Landscape 7511.4.6 Pipeline Analysis 7511.4.7 Competitive Landscape 7511.5 Expert Panel Validation 7511.6 Contact Us 7511.7 Disclaimer 75

List of Tables

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

List of Figures

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

Companies Mentioned

Merck & Co., Inc.Novartis AGSyndax Pharmaceuticals, Inc.4SC AGGlaxoSmithKline PlcCelgene CorporationMethylGene Inc.Pharmacyclics, Inc.TopoTarget A/SS*BIO Pte LtdCuris, Inc.

To order this report: Research and Development Industry: Epigenetics R&D Pipeline - Histone Deacetylases (HDACs) Offer the Most Promising Targets and Outnumber Other Classes of Epigenetic Targets

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