Intercell’s encephalitis vaccine ready for filing
Thursday, August 24, 2006, 10:18
Intercell AG said a safety analysis of its Japanese Encephalitis vaccine showed no serious side effects, moving the Austrian biotechnology company closer to introducing the product next year. The shares rose to a record. The company is preparing an application to the US Food and Drug Administration, and will publish full results of the analysis next May, Vienna-based Intercell said today in a statement to the stock exchange. Japanese Encephalitis is a virus spread by mosquitoes that affects the nervous system.
Results for Intercell’s Japanese Encephalitis virus vaccine in the pivotal Phase III safety trial, which included 2,683 randomized subjects, are positive. Intercell’s JE vaccine was well tolerated, no critical adverse events were observed. With these results, the preparations for the filing process with the United States Food and Drug Administration (FDA) are fully on track for an anticipated market launch in the United States in 2007. The pivotal Phase III safety trial was conducted at 39 study sites in Austria, Germany, Romania, Israel, Australia, New Zealand and in the US, and included 2,683 randomized subjects. The study was designed to analyze the safety and tolerability of Intercell’s investigational vaccine in a multicenter, multinational, double-blind, placebo-controlled randomized study.
Major endpoints of this study were the frequency of adverse events in both test groups, as well as local tolerability findings in both groups. First analyses of this trial show that Intercell’s investigational Japanese Encephalitis vaccine was systemically and locally well tolerated. Overall, the local tolerability and general safety profile of the Intercell JE vaccine appeared to be comparable with placebo. The Phase III clinical trial program consists of several additional clinical trials including a pivotal immunogenicity trial, a single shot trial, and a co-vaccination trial for travelers, which are all expected to be completed by early 2007. To date, more than 4,800 of the approximately 5,370 trial participants have been enrolled and vaccinated in these clinical trials. The pivotal Phase III clinical trial program is designed to meet regulatory requirements in the United States, Europe and Australia. Assuming approval by the regulatory authorities, the first market launch is anticipated for 2007. Preparations for the submission of a BLA (Biologics License Application) to the FDA have commenced.
Full clinical results of the pivotal immunogenicity trial are planned to be presented at the Annual Meeting of the American Society of Tropical Medicine and Hygiene (ASTMH), November 12-16, Atlanta, and full clinical results of the pivotal safety trial are planned to be presented at the 10th Conference of the International Society of Travel Medicine, May 20-24, 2007 in Vancouver, Canada. Shares of the company rose 32 cents, or 2.2%, to € 14.90 at 9:53 a.m. in Frankfurt after rising as high as € 14.99, the highest since the company went public in February 2005. (Bloomberg, intercell.com)