Jerini reports one phase 3 trial of Icatibant meets goal, one does not

New York, Sept. 21 - Jerini AG said that one phase 3 trial of Icatibant for the subcutaneous treatment of hereditary angioedema reached its primary endpoint while another failed to do so.

The "FAST-2" study showed a significant reduction in the time to onset of symptom relief while the "FAST-1" did not do so, although the Berlin-based pharmaceutical company described the results as "clinically relevant."

A supportive analysis combining both studies showed a significant reduction in the time to onset of symptom relief, Jerini added, noting that 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 results, Jerini said it will go ahead with plans for expedited reviews by the Food and Drug Administration and the European Medicines Agency. Submissions will start at the end of 2006 and a launch could follow in 2007.

Kos Pharmaceuticals, Inc. has the rights to Icatibant in North America.

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