Berlin, Sept 21, 2006 - Jerini AG (FSE:JI4) announced today the results of its two pivotal Phase III trials (FAST-1 and FAST-2) for the subcutaneous treatment of hereditary angioedema (HAE). In the FAST-2 study, the primary endpoint was reached, showing a significant reduction in the time to onset of symptom relief. While FAST-1 results were clinically relevant, the primary endpoint was not reached. A supportive analysis combining both studies showed a significant reduction in the time to onset of symptom relief. Secondary endpoints, such as patient and physician reported time to first improvement of symptoms, and the time to almost complete relief of symptoms showed highly significant results in favor of Icatibant. Based on the clinically relevant and consistent results of the two trials, the company intends to apply as planned for expedited reviews by the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA) starting submission at year end 2006, with potential launch in 2007. In one study comparing Icatibant against tranexamic acid, 74 patients were randomized in Europe and Israel (FAST-2). The primary endpoint was met with a median time to onset of symptom relief of 2.0 hours for Icatibant versus 12.0 hours for tranexamic acid. Secondary endpoints entered in the analysis also showed statistically significant differences in favor of Icatibant. Icatibant showed an excellent safety profile in this study.
In the second study comparing Icatibant against placebo, 56 patients were randomized in the United States, Canada, Australia, and Argentina (FAST-1). The primary endpoint of median time to onset of symptom relief was 2.5 hours for Icatibant versus 4.6 hours for placebo. Although clinically relevant, this difference did not reach statistical significance due to an unexpectedly high response to placebo in patients with abdominal pain. In two subgroup analyses, the primary endpoint was met and further analyses are ongoing. The efficacy of Icatibant is highlighted further by the time point at which patients first reported improvement of symptoms. Median times were 0.8 hours for Icatibant versus 16.9 hours for placebo. Icatibant showed an excellent safety profile in this study. The median time at which patients receiving Icatibant in both studies first reported improvement of symptoms was consistent with Jerini's Phase II study results. Further evidence of Icatibant's efficacy is shown in the combined analysis of FAST-1 and FAST-2. In this analysis, a significant reduction in the time to onset of symptom relief was reached, as were all secondary endpoints entered into the combined analysis. The data from both studies are highly consistent, further supporting Icatibant's excellent efficacy in the treatment of HAE. In the treatment of life threatening laryngeal attacks, Icatibant has shown a clinically relevant reduction in the time to symptom relief.
For questions, please contact: Stacy Wiedenmann Director Investor Relations & Corporate Communications Jerini AG Invalidenstr. 130 10115 Berlin T + 49 - 30 - 97893 - 285 X + 49 - 30 - 97893 - 105 firstname.lastname@example.org
Additional Information: Jerini AG is listed on the Prime Standard of the Frankfurt Stock Exchange under the symbol JI4, ISIN: DE0006787476. For more information, please visit the Jerini website at www.jerini.de.
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