ID Biomedical Corporation announced today that it has received clearance from the U.S. Food and Drug Administration (FDA) to begin immediate clinical testing of its influenza vaccine, Fluviral, in the United States under an Investigational New Drug application (IND).
The Company intends to ship 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. ID Biomedical also announced that it has completed enrollment of a similar clinical trial of Fluviral in Canada.
The U.S. clinical 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. 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.
"We are very excited to initiate clinical testing of Fluviral in the U.S. We believe this trial data, along with that being obtained from our ongoing Canadian study, will be necessary to support licensure of Fluviral for the U.S. market. We are currently in active discussions with the FDA regarding our clinical and regulatory strategy for Fluviral's entry into the U.S. Once we have a full picture, we can determine whether accelerated approval is feasible for this year," commented Louis F. Fries, M.D., Vice President, Clinical Affairs.
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. The production capacity of ID Biomedical in 2005 is expected to be approximately 22 million doses. 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.