Anti-Infective Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Holiday Inn, The Ballrooms

8120 Wisconsin Ave., Bethesda, MD. 20879

New Drug Applications (NDA) 21-144

for Ketek™ (telithromycin), Adventis Pharmaceuticals Inc.

Agenda - April 26, 2001

8:00 Call to Order, Introductions Lyman Barth Reller, M.D., Chair

8:05 Meeting Statement Thomas H. Perez, M.P.H., Executive Secretary

8:10 Opening Remarks Dianne Murphy, M.D., Director, ODE IV

Janice Soreth, M.D., Acting Director, Division of Anti-Infective Drug Products

8:15 Cardiology Presentation Jeremy Ruskin, M.D.

9:00 FDA Post-Marketing Review of Torsades de Pointe Douglas Shaffer, M.D.

9:20 Break

9:35 Adventis Presentation:

Introduction - - - - - Mindell Seidlin, M.D.,Vice President, Clinical Development, AntiInfectives

Microbiology - - - - Andre Bryskier, M.D., Senior Director, Clinical Microbiology

Human Pharmacology - - - Vijay Bhargava, Ph.D., Senior Director, Drug Metabolism and Pharmacokinetics

Clinical Efficacy & Safety - - Bruno Leroy, M.D., Senior Director, Clinical Development, AntiInfectives

ECG Analysis - - - Claude Benedict, M.D., Senior Vice President, Preclinical and Early Clinical Development

Conclutions - - - - - Mindell Seidlin, M.D., Vice President, Clinical Development, AntiInfectives

11:15 Question and Answer Session

11:45 Lunch

12:45 FDA Presentation:

Clinical Efficacy - - - - - - - - - George Rochester, Ph.D., Senior Statistician, Division of Biometrics III

Resistant S. pneumoniae - - Alma Davidson, M.D., Medical Officer, Division of AntiInfective Drug Products

General Safety Profile - - - - David Ross, M.D., Ph.D., Team Leader, Division of AntiInfective Drug Products

Hepatic Effects - Edward Cox, M.D., Medical Officer, Div. of Special Pathogens & Immunologic Drug Products

1:55 Drug- Induced Liver Disease - - - Zachary D. Goodman, M.D., Armed Forces Institute of Pathology

2:15 FDA Presentation Summary - - - - David Ross, M.D.

2:25 Question and Answer Session

2:40 Break

2:55 Open Public Hearing

3:55 Discussion of Questions and Vote

6:00 Adjourn