Food and Drug Administration

Center for Drug Evaluation and Research

Dermatologic and Ophthalmic Drugs Advisory Committee

Holiday Inn, The Ballrooms, Montgomery Village Avenue, Gaithersburg, Maryland

September 10, 2003

DRAFT Agenda

NDA 21-576, Methyl aminolevulinate hydrochloride, (Methyl aminolevulinate cream, 168mg/g) by PhotoCure ASA

8:30 Call to Order and Opening Remarks Robert S. Stern, M.D.

Conflict of Interest Statement Kimberly L. Topper, M.S.

8:45 Introduction Jonathan Wilkin, M.D.

9:00 Industry Presentation

Introduction Kjetil Hestdal, M.D., Ph.D.,
Regulatory Overview William Clementi, Pharm.D., F.C.P.
Photodynamic therapy with methyl aminolevulinate (MAL PDT).

Non-surgical Treatment of BCC Kjetil Hestdal, M.D., Ph.D.
Overview of Clinical Development

Program of MAL PDT in BCC Kjetil Hestdal, M.D., Ph.D.
Efficacy in BCC: Placebo controlled studies David M. Pariser, M.D., FACP
Efficacy in BCC: Active controlled studies,

including long term follow-up David M. Pariser, M.D.
Efficacy in High–Risk BCC,

including long term follow-up Prof Dédée F Murrell MA ,BMBCh , FAAD
Safety, including skin sensitization John Posner, Ph.D., FRCP
MAL PDT in BCC Benefit/risk Kjetil Hestdal, M.D., Ph.D.

10:00 Committee Discussion

10:30 Break

10:45 FDA Presentation - Markham Luke, M.D., Ph.D.

Methyl aminolevulinate Cream (MAL) Brenda Vaughan, M.D.

with Curettage and Photodynamic Therapy (PDT) Mohamed Al Osh, M.D.

for Nodular Basal Cell Carcinoma (BCC)

11:45 Committee Discussion

12:15 Lunch

1:15 Open Public Hearing

2:15 Committee Discussion

3:15 Break

3:30 Questions

5:30 Adjournment