Picovir ? (Pleconaril)

3/27/02


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Table of Contents

Picovir ? (Pleconaril)

Agenda

Clinical Development Program

Application Issues

Overall Study Results

Patient Subgroups

Possible Analysis Populations

Identification of Infected Patients

TaqMan RT-PCR Assay

Fluorescence versus Cycle

ELOSA RT-PCR Assay

TaqMan and ELOSA Gel Analysis

Viral Culture

Resistance in Pivotal Studies

Time to Primary Endpoint Treatment Emergent Resistance

Time to Primary Endpoint Baseline Lack of Susceptibility

Food Effect

Safety

Pleconaril Adult Phase 2 7-day Treatment Studies

Phase 2 Limitations

Studies 843-043 and 843-044 Design

Studies 843-043 and 843-044 Design

Studies 843-043 and 843-044 Design

Studies 843-043 and 843-044 Demographics (ITT)

Pleconaril Efficacy Results

Phase 2 and 3 Clinical Trials

PCR and Culture Status (Trial 43)

PCR and Culture Status (Trial 44)

Quartiles of Time to Healing PCR+ Patients (ITT-I)

Quartiles of Time to Healing All Randomized Patients (ITT)

Quartiles of Time to Healing PCR+ Patients

Quartiles of Time to Healing All Randomized

Loss to Follow-Up PCR + Patients

Impact of Pre-Treatment Cold Medication Use (PCR+ Non-Users)

Impact of Pre-Treatment Cold Medication Use (PCR+ Users)

Impact of Smoking (PCR+ Non-Smokers)

Impact of Smoking (PCR+ Smokers)

Gender Analysis-PCR+ Trials 43 and 44

Smokers by Gender-PCR+ Trials 43 and 044

Time to Resolution of Individual Symptoms-Trial 43 (PCR+)

Time to Resolution of Individual Symptoms-Trial 43 (PCR+)

Time to Resolution of Individual Symptoms-Trial 44 (PCR+)

Time to Resolution of Individual Symptoms-Trial 44 (PCR+)

Secondary Endpoints PCR+ Patients

Efficacy Conclusions-1

Efficacy Conclusions-2

Efficacy Conclusions-3

Safety Review

General Adverse Events ɮ% in Pivotal Studies

Menstrual Disorders

Menstrual Disorders

CYP3A4 Induction

Potential Risk of Unintended Pregnancies

Potential Risk of Unintended Pregnancy

Tachycardia/Palpitations

Tachycardia/Palpitations

Summary of Application Issues

Summary of Application Issues

Summary of Application Issues

Summary of Application Issues

Pleconaril Review Team

Author: CDER User