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July 2006 

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Antiviral Therapeutics: Pipelines and Competitive Dynamics

By Peter Norman, M.B.A., Ph.D. 

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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, 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

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. He can be contacted at peter.norman2@btinternet.com.

 


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