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Lev Pharmaceuticals Reports Positive Results in Pivotal Phase III,Trial for Hereditary Angioedema

Company anticipates second quarter BLA filing for C1-inhibitor replacement therapy

NEW YORK, March 14, 2007 /PRNewswire-FirstCall/ -- Lev Pharmaceuticals, Inc. (Lev) today announced positive results from its pivotal U.S. Phase III trial of 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 (C1-inhibitor in Hereditary Angioedema Nanofiltration Generation evaluating Efficacy), 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 Food and Drug Administration 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-licensed acute therapy in the United States.

In the double-blind study, which was conducted at 20 medical centers in the United States, a total of 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 2.0 hours for patients receiving C1-INH compared to greater than four hours, the maximum evaluation period, for patients receiving placebo (p=0.026). Sustained symptom relief was defined as subject-reported symptom relief at three consecutive 15 minute intervals following treatment.

"I'm very pleased with the successful outcome of the CHANGE study for the acute treatment of HAE, and I'm hopeful that this will lead to the much-needed availability of C1-inhibitor therapy for this underserved patient population," said Bruce Zuraw, M.D., Professor of Medicine at the University of California San Diego and Principal Investigator of the Ph
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