ID Biomedical Corporation announced today it has been advised by the United States Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) that the Company's Influenza Virus Vaccine (Fluviral) has been granted a Fast Track designation.
Under the Food and Drug Administration Modernization Act of 1997, the Fast Track program was implemented to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening disease, and that demonstrate the potential to address unmet medical needs. The Fast Track designation allows for frequent communications with the FDA and the possibility of submitting portions of marketing application (BLA) before the complete BLA is submitted.
Earlier this year, ID Biomedical announced that its flu vaccine was eligible for accelerated approval and priority review. With this newly obtained Fast Track designation, ID Biomedical has access to the major regulatory mechanisms put in place by the FDA to facilitate rapid licensure. These programs are applicable due to the ongoing shortages of influenza vaccine in the United States.
"We are very pleased to receive Fast Track designation for our injectable flu vaccine," said Jane Halpern, ID Biomedical's Vice President of Regulatory Affairs. "This designation along with our access to accelerated approval and priority review mechanisms clearly signal the importance of expanding flu vaccine availability in the United States."
The Company also announced today that the ongoing expansion and upgrading of its Quebec-based flu vaccine manufacturing facilities is on schedule. The construction work to expand the primary influenza vaccine manufacturing site in Quebec City is completed and the validation process has been initiated. The upgrade of the Laval facility has begun to allow additional upstream capabilities. The expansion at the Quebec City facility, the upgrade at the Laval facility and the harmonization of the two facilities will allow ID Biomedical to further increase its production capacity from the 50 million doses production capacity originally announced (utilizing only the Quebec City plant), to approximately 75 million doses per year in 2007, after all expansion and upgrade work is completed at both sites.