Slide # 1

VALGANCICLOVIR FOR THE

TREATMENT OF CMV RETINITIS

Slide # 2

GOAL

Roche seeks approval recommendation:

Valganciclovir (Val-GCV) is indicated for the treatment of CMV retinitis in patients with AIDS

Slide # 3

AGENDA AND PRESENTERS

DEVELOPMENT PROGRAM & STUDY RESULTS- Mary Jean Stempien, MD, MS

INTRODUCTION- Mary Jean Stempien, MD, MS Director, Medical Research, Roche

CLINICAL BACKGROUND- Daniel F. Martin, MD Associate Professor of Ophthalmology Emory University School of Medicine

Slide # 4

EXPERTS

Gary Koch, Ph.D.

Professor of BiostatisticsUniversity of North Carolina, Chapel Hill

Nancy C. Sambol, Pharm.D.

Associate Clinical Professor Department of Biopharmaceutical SciencesUniversity of California, San Francisco

Slide # 5

CLINICAL BACKGROUND

Slide # 6

CLINICAL BACKGROUND

Daniel F. Martin, M.D.Associate Professor of OphthalmologyEmory University School of Medicine

Clinical Features of CMV Retinitis

Impact of HAART

Treatment Options

Slide # 7

Slide # 8

Slide # 9

Slide # 10