Epigenetic Drug & Diagnostic Pipelines: DNA Methylation, HDAC Inhibitors, and Emerging New Targets Report
CHI Insight Pharma Reports
June 1, 2010 168 Pages - SKU: CHI2713877
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Epigenetics is a rapidly growing field with promising implications for treatment of cancer and potentially other diseases. Research interest in epigenetics has exploded in recent years, and considerable progress has been made in the commercialization of discoveries in this field.
Discussed in this Report:
- Diagnostic applications of epigenetics
- Diseases and conditions targeted by current and emerging epigenetic-based therapies
- Companies marketing and/or developing therapies that target epigenetic changes within the disease process
- Current and projected markets for epigenetic diagnostic and therapeutic products
- Strategic issues and major challenges for developers of epigenetic-based products
- Thought-leader interviews
Many companies have recognized the potential benefits of epigenetic-based diagnostic and therapeutic products. Two epigenetic tests for colorectal cancer screening are CE-marked and available in Europe, and a number of epigenetic tests are available through clinical laboratories in the United States as laboratory developed tests (LDTs). Four epigenetic drugs have now been approved by the US FDA.
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- EXECUTIVE SUMMARY
- CHAPTER 1
- INTRODUCTION
- Scope and Organization of the Report
- CHAPTER 2
- OVERVIEW OF EPIGENETICS
- 2.1. Definition of Epigenetics
- 2.2. Mechanisms of Epigenetics
- DNA Methylation
- Histone Modification
- Other Mechanisms
- 2.3. Methods to Detect Differences in DNA Methylation
- 2.4. Targets for Current and Emerging Epigenetic Drugs
- CHAPTER 3
- DIAGNOSTIC COMPANIES IN EPIGENETICS
- 3.1. Companies Developing Epigenetic-Based Diagnostic Tests
- Epigenomics
- OncoMethylome Sciences
- Orion Genomics
- Other Diagnostic Activities in Epigenetics (DNA Methylation)
- Diagnostic Activities in Epigenetics (Histone Modification)
- 3.2. Clinical Laboratories Offering Tests to Detect DNA Methylation Changes
- 3.3. Epigenetics/DNA Methylation Test Agreements
- CHAPTER 4
- MAJOR DISEASES/CONDITIONS TARGETED BY NEW AND/OR EMERGING EPIGENETIC DRUGS
- 4.1. Hematological Cancers
- 4.2. Solid Tumors
- 4.3. Other Emerging Disease Indications
- CHAPTER 5
- EPIGENETIC DRUGS ON THE MARKET AND IN DEVELOPMENT
- 5.1. Drugs Targeting DNA Methylation (DNA Hypomethylation Drugs)
- Celgene’s Vidaza
- Eisai’s and Johnson & Johnson’s Dacogen
- SuperGen
- 5.2. HDAC Inhibitors
- Merck’s Zolinza (vorinostat)
- Celgene’s Istodax (romidepsin)
- 4SC
- Acetylon Pharmaceuticals
- Celleron Therapeutics
- Chroma Therapeutics
- EnVivo Pharmaceuticals
- Johnson & Johnson Pharmaceutical Research & Development
- Karus Therapeutics
- MethylGene
- Novartis
- Oncolys BioPharma
- Pharmacyclics
- Repligen
- Syndax Pharmaceuticals
- TopoTarget and Spectrum Pharmaceuticals
- 5.3. Emerging Therapies Directed Against Other Epigenetic Targets
- CellCentric
- Constellation Pharmaceuticals
- Epizyme
- SuperGen
- CHAPTER 6
- BUSINESS CONSIDERATIONS IN EPIGENETICS
- 6.1. Epigenetics Markets
- Diagnostic Epigenetic Market
- Therapeutic Epigenetic Market
- 6.2. Major Challenges/Hurdles and Strategic Issues for Diagnostic Companies in Epigenetics
- Need for More Biomarkers, Validation Studies, and Outcome Studies
- Delivery of New Diagnostic Tests: IVD versus CLIA Laboratory
- Penetrating the Market: Diagnostic Platform(s)
- Health Economics and Reimbursement
- Intellectual Property Issues
- Penetrating the Market: Physician Education
- Does the Test Affect Physicians’ Decisions?
- Acceptance by Experts; Incorporation into Guidelines
- Physician Education
- 6.3. Major Challenges/Hurdles and Strategic Issues for Therapeutic Companies in Epigenetics
- Safety Concerns with Epigenetic Drugs
- Certain Market Segments Becoming Highly Competitive (HDAC Inhibitors)
- Development Issues Common to Other Emerging Cancer Therapies
- Development Issues Common to Other Companies Focusing on Novel Targets
- Issues Facing Companies as They Launch Novel Epigenetic Therapies
- 6.4. Evaluating DNA Methylation Markers for Non-Epigenetic Cancer Therapies
- 6.5. Evolution of Companies in Epigenetics
- Diagnostic Epigenetic Companies
- Agreements in the Epigenetic Therapy Market; Companies Entering and Exiting the Market
- CHAPTER 7
- EXPERT INTERVIEWS
- 7.1. Walter C. Ogier, President and Chief Executive Officer, Acetylon Pharmaceuticals
- 7.2. Nessa Carey, PhD, Scientific Director, CellCentric
- 7.3. Alan Drummond, PhD, Chief Scientific Officer, Chroma Therapeutics
- 7.4. Mark A. Goldsmith, MD, PhD, President and Chief Executive Officer, Constellation Pharmaceuticals
- 7.5. Kees Been, President and Chief Executive Officer
- Dana Hilt, MD, Senior Vice President, Clinical Development and Chief Medical Officer, EnVivo Pharmaceuticals
- 7.6. Oliver Schacht, PhD, CFO, Epigenomics AG, CEO, Epigenomics Inc.
- 7.7. Robert Gould, PhD, President and Chief Executive Officer, Epizyme
- 7.8. Jeffrey M. Besterman, PhD, Executive Vice President, Research & Development and Chief Scientific Officer, MethylGene
- 7.9. Harry Schrickx, WW Vice President Business Development, OncoMethylome Sciences SA, President, OncoMethylome Sciences, Inc.
- 7.10. Kamran Tahamtanzadeh, Founder & CEO, PrognosDx Health
- 7.11. James R. Rusche, PhD, Senior Vice President, Research and Development, Repligen
- 7.12. Joanna Horobin, MD, President & Chief Executive Officer, Syndax Pharmaceuticals
- 7.13. Henri Lichenstein, PhD, Chief Development Officer, TopoTarget A/S
- REFERENCES
- COMPANY INDEX WITH WEB ADDRESSES
- FIGURES
- Figure 1.1. Number of Abstracts Per Year from PubMed Search for “epigenetic OR epigenetics OR epigenomic OR epigenomics”
- Figure 2.1. The Epigenetic Pathway
- Figure 2.2. The Increasing Structural Complexity of Genetic Information from the Double-Helical Structure of DNA, through Nucleosome and Chromatin Structures, to the Chromosome
- Figure 2.3. Schematic of the Nucleosome Showing Types of Post-Translational Modifications That Can Occur and the Enzymes Responsible for Them
- Figure 2.4. Proposed Mechanism of Action of DNA Methylation Inhibitors in Cancer Therapy
- TABLES
- Table 2.1. Methods Available to Analyze DNA Methylation
- Table 3.1. Companies Developing and/or Offering Epigenetic-Based Diagnostic Tests
- Table 3.2. Clinical Laboratories Developing and/or Offering Epigenetic-Based Diagnostic Tests for Cancer
- Table 3.3. Epigenetic Agreements
- Table 4.1. Incidence of Hematological Cancers in the United States
- Table 4.2. Incidence of Selected Cancers (Solid Tumors) in the United States (2009)
- Table 5.1. Companies Marketing and Developing DNA Methylation Inhibitors
- Table 5.2. Companies Marketing and Developing HDAC Inhibitors
- Table 5.3. Companies Developing Novel Therapies Targeting Sirtuins
- Table 5.4. Companies Developing Other Emerging Epigenetic Therapies
- Table 6.1. Reported 2009 Sales of Approved Epigenetic Drugs
- Table 6.2. Selected Epigenetic Therapeutic Agreements
- Table 6.3. Selected Companies That Have Out-Licensed Epigenetic Drug Technology/Compounds and No Longer Appear to be Active in the Epigenetics Field
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