LEV PHARMA REPORTS POSITIVE RESULTS FROM HAE STUDY

Lev Pharmaceuticals announced positive results from the pivotal U.S. Phase III trial of its C1-esterase inhibitor (C1-INH) for the acute treatment of hereditary angioedema (HAE). In the acute study, which is part of the company's CHANGE trials, the protocol-defined primary endpoint was reached, showing a clinically and statistically significant reduction in the time to sustained relief of acute HAE symptoms.

Based on the positive results of this study, the company intends to submit a biologics license application to the FDA in the second quarter of 2007. HAE, or hereditary C1-inhibitor deficiency, is a rare and life-threatening inflammatory condition for which there is currently no FDA-approved therapy, according to Lev.

In the double-blind study, which was conducted at 20 centers, 71 patients were randomized to either C1-INH or placebo. The primary endpoint was met using the protocol-defined intent-to-treat analysis, with a median time to sustained symptom relief of two hours for patients receiving C1-INH compared with more than four hours, the maximum evaluation period, for patients receiving placebo. Sustained symptom relief was defined as subject-reported symptom relief at three consecutive 15-minute intervals following treatment.

The trial was the world's largest double-blind, placebo-controlled study of a C1-INH completed to date, according to the company. In addition to the acute study, a second trial is examining the prophylactic use of C1-INH in preventing HAE attacks in more severely affected patients. This prophylactic study is ongoing and is expected to conclude in the second half of 2007. Lev has also initiated two open-label studies to provide HAE patients with continued access to C1-INH.