ID Biomedical's injectable influenza vaccine Fluviral is eligible for priority review at FDA, the company announced March 15.

Accelerated approval processes could allow for licensure of the vaccine in time for the 2006-2007 flu season, ID Biomedical said.

The firm appears to acknowledge that Fluviral will not be on the market in 2005; ID Biomedical previously said it would be able to produce 10 mil.-15 mil. doses for the U.S. during the upcoming flu season.

The company now plans to submit a BLA later this year following successful completion of ongoing clinical trials.

ID Biomedical is conducting one trial with 658 subjects in Canada, where the product is already approved. It also began enrollment in early 2005 for a U.S. study, which was slated to include 300 healthy adults (¹ Also see "ID Biomedical To Initiate Fluviral Trial For U.S. Approval By End Of January" - Pink Sheet, 7 January, 2005.).

Under a new agreement with FDA, the American study will be expanded to include up to roughly 1,000 subjects, the company said.

ID Biomedical also has agreed to conduct a confirmatory efficacy study in adults and an immunogenicity study in the elderly to satisfy post-approval requirements.

The firm expects to be able to manufacture and ship Fluviral to the U.S. in 2006, assuming clinical data and manufacturing facilities are deemed acceptable by FDA.

Quebec-based manufacturing facilities for the vaccine are currently being upgraded to allow for production of 20 mil. doses for the U.S. market in 2006 and 40 mil. doses in 2007.

ID Biomedical has distribution contracts with Henry Schein, AmerisourceBergen's Specialty Group and McKesson to purchase 38 mil. doses annually beginning in 2007 (² Also see "ID Biomedical To Decide On 2005 U.S. Flu Vaccine Production By Late January" - Pink Sheet, 6 December, 2004.).

The company said those agreements will apply in the 2006 season as well if Fluviral is approved by FDA before April 1, 2006.

- Andrew Dove

FDA Accepts ID Biomedical’s Fluviral For Accelerated Approval Pathway

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