Conference Call Between FDA and Intercell - Ixiaro

Conference Call Between FDA and Intercell
Wednesday, August 13, 2008, 10:30 AM EDT

Agenda:

Pediatric Development Plan for IC51 (JE-PIV):
•Discussion of Agency’s PeRC issues which were emailed by Richard Daemer on July 25, 2008.
•Appropriateness of the clinical studies suggested to support the pediatric licensure apart from the issues mentioned in the 7/25/08 email.
•Appropriateness of age group stratification proposed by Intercell in a fax to FDA dated July 25, 2008. Regarding the lower age group, a discussion as to whether another, lower age cutoff (6 months? 9 months?) would be appropriate in order to not interfere with EPI and routine childhood vaccinations.

Post-Marketing Safety Evaluation:
•Comments on the post-marketing safety evaluation for IC51 that Intercell has submitted.

Pharmacovigilance and Risk Management Plan:
•Appropriateness of the Pharmacovigilance and Risk Management Plan for IC51 that Intercell has submitted.

Meeting attendees:

FDA
Daryll Miller
Richard Daemer
Lew Markoff
Rose Tiernan
Jeff Roberts
Manette Niu

Intercell
From Intercell AG ( Vienna, Austria)
Katrin DUBISCHAR-KASTNER , MD
Medical Affairs Manager
Clinical Development
Elisabeth SCHULLER, MD Head of Pharmacovigilance and Medical Information
    Clinical Development
Shailesh Dewasthaly
Global Head, Regulatory Affairs

From Intercell USA, Inc.
Paul Wilson, President & CEO}

Follow-up information requested in an e-mail on August 14, 2008 from Paul Wilson by Richard Daemer:

To follow up in the next few days, please provide us with a brief written summary of the information you have gathered to date regarding the feasibility of these studies in particular pediatric subpopulations. Please include the name of the organization and individual contacted and a brief summary of the advice/guidance given. We prefer that you wait until you have had a chance to make these inquiries at the U.S. State Department, the Centers for Disease Control, and perhaps at the corresponding organizations in some European countries.

This information will be helpful in formulating a reasonable and effective pediatric plan that meets the requirements of the Pediatric Research Equity Act (PREA). Please let us know if you have any further comments or information leading up to the Pediatric Review Committee meeting on August 27, 2008.

Also regarding the PVP please provide the justification for the sample size of 10,000 subjects. In general we would like to see at least a 20,000 subject post-marketing general safety study. If the vaccine is to be used in elderly individuals please provide safety data for this age group. The post marketing study may need to be tiered to include a certain number of individuals who are 70-79 and 80 or older.
