ID Biomedical pursues accelerated approval of influenza vaccine

Mar 15 2005

ID Biomedical Corporation announced today that it has been advised by the United States Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) that the Company's injectable influenza vaccine is eligible for accelerated approval and priority review mechanisms, allowing possible licensure of the vaccine in time to manufacture product for the 2006/07 season.

Accelerated approval and priority review are specific regulatory programs developed by FDA to expedite the availability of products addressing important needs. ID Biomedical and CBER have outlined a clinical trial program that will allow the Company to submit a Biologics License Application (BLA) later this year.

"We are extremely pleased with the collaborative relationship we have established with CBER, and their clear recognition of the importance of expanding U.S. influenza vaccine availability," said Anthony Holler, M.D., ID Biomedical's Chief Executive Officer. "Obviously nothing is guaranteed and we have a lot of work to do, but we are optimistic we can be in the U.S. market by next year, or a year ahead of expectations."

Approval to market the ID Biomedical flu vaccine in the U.S. will be based on achieving agreed-upon safety and immunogenicity endpoints from clinical trials that are already ongoing in Canada and the United States. Based on discussions with CBER, the trial in the United States, originally announced on January 7, 2005, will be expanded to include up to approximately 1,000 subjects. ID Biomedical believes it will be able to gather this data and, if positive, file a Biologics License Application (BLA) by the end of 2005. If the data and inspection of ID Biomedical's manufacturing facilities are acceptable, the Company will be in the position to manufacture and ship influenza vaccine to the United States market in 2006.

Additional post-approval confirmatory studies will be required. The Company has agreed with CBER to conduct a confirmatory efficacy study in adults and also an additional study of the immunogenicity of Fluviral in the elderly.

The Company also announced that the ongoing expansion and upgrading of its Quebec-based flu vaccine manufacturing facilities is on schedule. ID Biomedical expects that with U.S. regulatory approval of Fluviral and a successful pre-approval inspection of its facilities, the company will be able to produce approximately 20 million doses of influenza vaccine for the U.S. market in 2006, and approximately 40 million doses in 2007. ID Biomedical is also committed to develop a preservative-free formulation of its product for the pediatric population.

ID Biomedical produces Fluviral from its two flu vaccine production facilities located in Laval and Quebec City, Quebec. The Company's Quebec City facility is being expanded to increase total manufacturing capacity to approximately 50 million doses by 2007, and will house what is believed to be the newest egg-based vaccine production facility in the world. Upon FDA approval, Fluviral will be distributed in the U.S. by ID Biomedical's distribution partners: Henry Schein, Inc., AmerisourceBergen Corporation's Specialty Group and McKesson Corporation. These distribution partners have agreed to purchase and distribute 38 million doses of the Company's flu vaccine annually beginning in 2007. If ID Biomedical obtains FDA approval by April 1, 2006 under the accelerated approval mechanism, then the agreement will be applicable to the 2006 season as well.