In a meeting, the FDA asked ID Biomedical to provide a significant amount of additional information and follow-up from the recently completed adult study prior to further considering initiation of studies in children.
ID Biomedical stated that it was not able to precisely predict how long it may take to generate this data and to what extent additional testing and follow up in adults may be required before obtaining approval to conduct studies in children.
Based on a preliminary assessment of the nature and the amount of information requested by the FDA, the company says that it does not currently expect to begin testing the vaccine in children in the US prior to 2007.
ID Biomedical expects additional dialogue with the FDA regarding the requirements for continuing development of the vaccine candidate.
In a more positive development for the company, it has obtained clearance from Health Canada to begin the first pediatric study of Fluinsure the company’s flu vaccine.
This phase II study will be conducted at three centers in Canada in 160 healthy children, aged 3 to 12 years old, and will evaluate safety and immunogenicity of one-dose and two dose regimens of the vaccine.
ID Biomedical is currently the subject of a takeover bid by pharmaceutical giants GlaxoSmithKline. The deal, approved by both company’s boards of directors, is expected to close late in 2005 or early 2006.