Shingles (herpes zoster) is a viral infection caused by reactivation of dormant varicella zoster, the virus that causes chicken pox. The current standard of care for herpes zoster is a 7-day course of antiviral medication, of which three are currently approved in the US (acyclovir, valacyclovir and famvir). Inhibitex hopes its drug, FV-100 will be the fourth. This report discusses the rationale for FV-100, the early evidence, the factors that could influence the drug's chance for success in phase II, and market considerations that will weigh on Inhibitex and its potential collaborators alike.

Published: July 22nd, 2010

Number of pages: 16

Authors: Dr. Drew Applefield and Dr. Ilana Fogelman




TABLE OF CONTENTS

INTRODUCTION
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1. Shingles (Herpes Zoster)
− Epidemiology
− Disease mechanisms
− Current treatments

INHIBITEX’S FV-100
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1. Product Characterization
2. Clinical Data
− Description of early studies

CLINICAL AND REGULATORY DISCUSSION
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1. Rationale for FV-100
2. Evidence of Activity
3. Safety Profile
4. Ongoing Phase II Trial

MARKET ISSUES
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1. Market Size
2. FV-100’s Competitive Advantages
3. Generic Competition
4. Impact of Adult Vaccination For VZV
5. Immunocompromised Patients Must Be Addressed In Future Studies

CONCLUSION
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