Gastrointestinal Drugs Advisory Committee

Food and Drug Administration

Center for Drug Evaluation and Research

Marriott Washingtonian Center, 9751 Washington Boulevard, Gaithersburg, MD

New drug application (NDA) 21-525, Photofrinâ (porfirmer sodium), Axcan Scandipharm Inc.

“Photodynamic therapy with Photofrinâ is indicated for the ablation of high-grade dysplasia in Barrett’s esophagus among patients who refuse esophagectomy and who are in overall good health.”

Agenda for June 26, 2003

8:30 Call to Order, Introductions: M. Michael Wolfe, M.D., Acting Chair

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

8:45 Opening Comments: Robert Justice, M.D., Director,

Division of Gastrointestinal and Coagulation Drug Products

8:50 Axcan Scandipharm Inc., Presentation

Introduction

François Martin, M.D., Senior Vice President, Scientific Affairs, Axcan Scandipharm, Inc.

Management of High-Grade Dysplasia in Barrett’s Esophagus

Kenneth K. Wang, M.D., Associate Professor of Medicine, Mayo Clinic

Efficacy & Safety of Photofrin Photodynamic Therapy

in the ablation of High-Grade Dysplasia in Barrett’s Esophagus

Bergein F. Overholt, M.D., Medical Director, Thompson Cancer Survival Laser Center Center, Knoxville, TN

Histopathology of High-Grade Dysplasia in Barrett’s Esophagus

Mary P. Bronner, M.D., Director, GI and Hepatic Pathology Program, The Cleveland Clinic Foundation

Conclusion

François Martin, M.D., Senior Vice President, Scientific Affairs

10:35 Break

10:50 Questions on Presentations

11:20 FDA Presentation

Medical Officer’s Presentation

Edvardas Kaminskas, M.D., Division of Gastrointestinal and Coagulation Drug Products

11:50 Questions on Presentation

12:20 Lunch

1:20 Open Public Hearing

2:20 Charge to the Committee

Robert Justice, M.D., Director, Division of Gastrointestinal and Coagulation Drug Products

2:25 Committee Discussion

3:30 Break

3:45 Committee Discussion – continued

5:00 Adjourn