ID BIOMEDICAL RECEIVES CLEARANCE FOR FLUVIRAL CLINICAL TESTING IN THE U.S.

ID Biomedical has received clearance from the FDA to begin immediate clinical testing of its influenza vaccine, Fluviral, in the U.S. under an investigational new drug (IND) application.

The company intends to ship the product to the U.S. and initiate enrollment of subjects before the end of January 2005. The Fluviral vaccine to be tested was produced using a terminal sterile filtration step. This minor modification to the production process is an FDA requirement for flu vaccines entering the U.S. market.

The trial will involve approximately 300 healthy adults from age 18 to 64. This randomized, double-blind, comparator-controlled study is designed to evaluate the safety and immunogenicity of Fluviral in healthy adults.

ID Biomedical also has completed enrollment of a similar clinical trial of Fluviral in Canada. The Canadian clinical trial enrolled 658 people and is also designed to compare the safety and immunogenicity of Fluviral utilizing the new production process versus a comparator flu vaccine. The Canadian trial is being conducted in adults in two age groups, 50 to 64 years old and over 64 years of age, thereby addressing a key vaccine target population in both the U.S. and Canada.

Between the Canadian and U.S. studies, ID Biomedical will test Fluviral in 958 people, with 528 subjects receiving Fluviral and 430 receiving a comparator influenza vaccine. Over the last several years, over 40 million doses of Fluviral have been distributed throughout Canada. ID Biomedical is the market leader for influenza vaccines in Canada, and is one of only two flu vaccine manufacturers located in North America.