BioWorld International Correspondent

Although its pivotal trial program that assessed the potential of Icatibant in hereditary angioedema (HAE) delivered mix results last fall, Jerini AG is pressing ahead with a new drug application filing planned for the third quarter.

A pre-NDA meeting and dialogue with the FDA has provided Jerini with the "clarity" needed to proceed, the company said last week.

Icatibant, a synthetic peptide antagonist of the bradykinin B2 receptor, missed the primary endpoint of the FAST-1 Phase III clinical trial in September, which compared its efficacy with that of placebo.

It hit the endpoint in a second trial known as FAST-2, a head-to-head comparison with tranexamic acid. It previously communicated that it needed data from two clinical trials in its FDA submission, whereas data from just one would suffice for a European filing. (See BioWorld International, Sept. 27, 2006.)

The Berlin-based company will include data from the two trials in its submission package, Stacy Wiedemann, director of investor relations and corporate communications, told BioWorld International.

"Discussions with the FDA included the efficacy and safety of Icatibant as shown in the FAST-1 and FAST-2 trials. We pointed out to the FDA that our analysis of the data did not show any significant differences between the two trials with respect to the efficacy of Icatibant, and also to placebo and comparator. The FDA's answer was that they will review the data," she said.

The company is due to have a pre-submission meeting with the London-based European Medicines Agency this month, after which it will divulge the specific timeline associated with its European Union marketing authorization application. Leiden, the Netherlands-based Pharming Group NV filed an MAA with the EMEA for its rival product Rhucin (recombinant C1 inhibitor) in the third quarter of last year.

Jerini also is planning to move Icatibant into a Phase II trial in drug-induced angioedema this year and is in discussions with the FDA and the EMEA on trial design. The occurrence rate of the complication is between 0.3 percent and 0.7 percent in the 50 million people receiving ACE inhibitors, Wiedemann said.

The company's share price dropped €0.20 to €3.90 (US$5.11) on the release of the news last week, but gradually climbed upward to reach €4.24 by Monday's close.