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Antiviral Therapeutics: Pipelines and Competitive Dynamics

Published by: CHI Insight Pharma Reports

Published: Jul. 1, 2006 - 125 Pages


Table of Contents


Chapter 1. Viral Disorder and Therapeutic Approaches

1.1. Common Viral Infections

1.2. Vaccines or Antiviral Drugs

1.3. Inhibition of Viral Infection of Cells

1.4. Inhibition of Viral Processing




Chapter 2. Review of Major Viral Disorders

2.1. Human Immunodeficiency Virus

2.2. Hepatitis Viruses


Hepatitis A

Hepatitis B

Hepatitis C


2.3. Herpes Viruses


Herpes Simplex Virus

Varicella-Zoster Virus

Cytomegalovirus

Epstein-Barr Virus


2.4. Human Papilloma Virus

2.5. Respiratory Viruses


Influenza

Respiratory Syncytial Virus

Coronaviruses




Chapter 3. Current Treatment

3.1. Human Immunodeficiency Virus


HIV Reverse Transcriptase Inhibitors

HIV Protease Inhibitors

HIV Fusion Inhibitors


3.2. Hepatitis Viruses


Vaccine Treatments

Cytokines

Antiviral Agents


3.3. Herpes Viruses


Viral Replication Inhibitors


3.4. Human Papilloma Viruses

3.5. Respiratory Viruses


Vaccines

Neuraminidase Inhibitors

Antibodies

Inosine Monophosphate Dehydrogenase Inhibitors




Chapter 4. Compounds in Development: New Antiviral Agents

4.1. Human Immunodeficiency Virus


HIV Protease Inhibitors

Reverse Transcriptase Inhibitors

Cell Entry Blockers

HIV Replication Inhibitors

HIV Integrase Inhibitors

HIV Maturation Inhibitors

Combination Therapies


4.2. Hepatitis C


HCV Protease Inhibitors

NS3 Protease Inhibitors

Polymerase Inhibitors

Immunostimulants: Interferons

Toll-like Receptor Agonists

Other Immunoregulators

Viral Replication Inhibitors


4.3. Hepatitis B


DNA Polymerase Inhibitors

Other Agents


4.4. Herpes Viruses


Vaccines

Viral Replication Inhibitors

Viral Uptake Inhibitors

DNA Synthesis Inhibitors

Other Agents


4.5. Human Papilloma Viruses


Vaccines

Interferons

Immunomodulators


4.6. Influenza


New Drugs

New Vaccines

H5N1 Influenza Vaccines




Chapter 5. Company R&D Profiles

5.1. Abbott

5.2. Achillion

5.3. Boehringer Ingelheim

5.4. Biota Holdings

5.5. Bristol-Myers Squibb

5.6. Chiron

5.7. Coley

5.8. Enzo Biochem

5.9. Gilead Sciences

5.10. GlaxoSmithKline

5.11. Hoffmann-La Roche

5.12. Idenix Pharmaceuticals

5.13. Japan Tobacco

5.14. Johnson & Johnson

5.15. Medivir

5.16. Merck & Co.

5.17. Novartis AG

5.18. Panacos Pharmaceuticals

5.19. Pfizer

5.20. sanofi pasteur

5.21. Schering-Plough

5.22. Trimeris

5.23. Valeant

5.24. Vertex

5.25. ViroPharma Incorporated




Chapter 6. EXPERT INTERVIEWS: Dr. Michael G. Cordingley, Boehringer Ingelheim (Canada) Ltd.; Dr. Stef Heylen, Tibotec; Professor Bertil Samuelsson, Medivir AB

6.1. HIV

6.2. Hepatitis

6.3. Other Viral Infections

6.4. Other Issues




References




Glossary




Company Index with Web Sites




FIGURES

Figure 4.1. Schematic of the Domain Structure of the Hepatitis C Virus




TABLES

Table 2.1. Global Distribution of HIV Infection in 2005

Table 2.2. Incidence of Hepatitis A Infection in the United States

Table 2.3. Incidence of Hepatitis B Infection in the United States

Table 2.4. Incidence of Hepatitis C Infection in the United States

Table 3.1. Marketed HIV Reverse Transcriptase Inhibitors

Table 3.2. Marketed HIV Protease Inhibitors

Table 3.3. Leading Vaccine Products for the Treatment of Hepatitis Infections

Table 3.4. Therapeutic Agents for the Treatment of Hepatitis Infections

Table 3.5. Viral Replication Inhibitors for the Treatment of Herpes Simplex Infections

Table 3.6. Viral Replication Inhibitors for the Treatment of CMV Retinitis

Table 4.1. Agents in Clinical Development for the Treatment of HIV Infection

Table 4.2. HIV Vaccines That Are Currently in Clinical Development

Table 4.3. Novel Agents in Development for the Treatment of Hepatitis C Infection

Table 4.4. Novel Agents in Development for the Treatment of Hepatitis B Infection

Table 4.5. Novel Agents in Clinical Development for the Treatment of Herpes Infections

Table 4.6. Novel Agents in Development for the Treatment of Papilloma Infection

Table 4.7. Potential Market for HPV Vaccines

Table 4.8. Novel Influenza Vaccines in Development

Table 5.1. Antiviral Products Marketed by Abbott Laboratories

Table 5.2. Antiviral Agents in Clinical Development by Achillion

Table 5.3. Antiviral Products Marketed by Boehringer Ingelheim

Table 5.4. Boehringer Ingelheim’s Pipeline of Antiviral Agents

Table 5.5. Biota’s Antiviral Development Pipeline

Table 5.6. Bristol-Myers Squibb’s Antiviral Products

Table 5.7. Bristol-Myers Squibb’s Antiviral Pipeline

Table 5.8. Chiron’s Leading Antiviral Vaccines

Table 5.9. Chiron’s Pipeline of Antiviral Vaccines

Table 5.10. Enzo’s Antiviral Pipeline

Table 5.11. Gilead’s Portfolio of Antiviral Drugs

Table 5.12. Gilead’s Antiviral Pipeline

Table 5.13. GlaxoSmithKline’s Portfolio of Antiviral Products

Table 5.14. GlaxoSmithKline’s Antiviral Pipeline

Table 5.15. Roche’s Portfolio of Antiviral Drugs

Table 5.16. Roche’s Antiviral Pipeline

Table 5.17. Idenix’ Antiviral Pipeline

Table 5.18. Japan Tobacco’s Antiviral Pipeline

Table 5.19. Johnson & Johnson’s Antiviral Pipeline

Table 5.20. Medivir’s Antiviral Pipeline

Table 5.21. Merck’s Portfolio of Antiviral Products

Table 5.22. Merck’s Antiviral Pipeline

Table 5.23. Novartis’ Antiviral Pipeline

Table 5.24. Pfizer’s Portfolio of Antiviral Drugs

Table 5.25. Pfizer’s Antiviral Pipeline

Table 5.26. sanofi pasteur’s Portfolio of Viral Vaccines

Table 5.27. sanofi pasteur’s Antiviral Pipeline

Table 5.28. Schering-Plough’s Portfolio of Antiviral Drugs

Table 5.29. Schering-Plough’s Antiviral Pipeline

Table 5.30. Valeant’s Portfolio of Antiviral Drugs

Table 5.31. Valeant’s Antiviral PipelineTable 5.32. Vertex’ Antiviral Pipeline

Table 5.33. ViroPharma’s Antiviral Pipeline

Abstract

Antiviral Therapeutics: Pipelines and Competitive Dynamics assesses the compounds, the clinical data, the companies, and the market-shifting developments in the antiviral therapeutic category. Sales of antiviral agents currently constitute 25% of the anti-infective drug market. The ability of viruses to develop resistance against drugs, coupled with sub-optimal treatment outcomes as a result of failure of patients to comply with the full course of therapy, will continue to provide the commercial and medical incentive for intense R&D activity.

Until recently, much of the effort to develop new antiviral agents was directed toward improved agents for the treatment of HIV and Hepatitis C (HCV). While these indications continue to attract research dollars and to make measurable progress with respect to dosing, deliverability, and efficacy, several new developments have reignited interest in antiviral disease R&D. These include concern about the evolution of avian influenza into a lethal pandemic and recent approvals for vaccines against certain strains of Human Papilloma Virus (HPV) that are associated with high rates of cervical cancer.

Antiviral Therapeutics: Pipelines and Competitive Dynamics surveys the 5 major viral disease categories and their sub-indications- HIV, Hepatitis, Herpes Viruses, Human Papilloma Viruses, and Respiratory Viruses.

For each indication, the report provides:
  • Pathophysiology, incidence and prevalence, symptoms and sequelae.
  • Assessment of current treatment options.
  • Assessment of unmet medical need.
  • Assessment of compounds in development (by agent and by mechanism of action).
  • Profiles of companies active in antiviral R&D
Indication-specific highlights from the study include:
  • HIV. 28 NCEs are in various stages of clinical development for HIV, and 5 will apply for regulatory approval through 2008. Agents in development include reverse transcriptase inhibitors and protease inhibitors, including fixed dose combinations, as well as new mechanistic approaches such as integrase inhibitors, fusion inhibitors, attachment inhibitors, maturation inhibitors, and replication and entry blockers.
  • HCV. Current HCV treatment, a combination of interferon and an antiviral agent, is lengthy, expensive, and effective in only 50% of patients because of poor compliance. Treatments in development are mostly oral agents, with 27 such drugs in various stages of early and mid stage human trials.
  • HPV. With the exception of a Phase II gel formulation analog of imiquimod, there is limited interest in HPV as a therapeutic target for the development of novel antivirals. However, the development of prophylactic vaccines is of considerable interest because of the high association of infection by certain HPV serotypes with the development of cervical cancer. The recent US approval of Merck's Gardasil, and the possible EU approval of GSK's Cervarix in late 2006, are the first entries.
Individuals in R&D, business development, marketing, and strategy who need to stay on top of competitive developments in this fast-moving field will benefit from Antiviral Therapeutics: Pipelines and Competitive Dynamics.

About the Author TBD

Peter Norman, M.B.A., Ph.D., spent 20 years in the pharmaceutical industry in research and development and competitive intelligence before becoming an independent pharmaceutical consultant, analyst, and author. Dr. Norman has authored a number of original scientific papers in major journals and is an inventor with 11 patent applications. He provides consultancy services to several European, American, and Japanese companies and regularly reviews drugs and patents for Thomson Current Drugs and Ashley Publications. Dr. Norman has written reports analyzing most therapeutic areas.

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