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Lev Pharmaceuticals Completes Phase III Prophylaxis Trial of,C1-Esterase Inhibitor for Hereditary Angioedema

vailable in the second half of 2007 after the data have been collected, verified and analyzed. In addition to the pivotal CHANGE trial, Lev has initiated two open-label studies to provide HAE patients with continued access to C1-INH.

Lev intends to submit a Biologics License Application, or BLA, to the U.S. Food and Drug Administration, or FDA, during the second quarter of 2007 for marketing approval of C1-INH for the acute treatment of HAE attacks based on the results of the first portion of the CHANGE study. The results from the prophylactic portion of the study, when available and if supportive, are expected to be used to expand the label indication.

About Hereditary Angioedema

HAE is a genetic disorder characterized by recurrent attacks of inflammation affecting the extremities (the hands and feet), the face, the abdomen, and the larynx. The inflammation can be disfiguring, debilitating, or, in the case of laryngeal attacks, life-threatening. HAE is caused by a deficiency of the plasma protein C1-INH. While there is no approved therapy for the condition in the U.S., replacement therapy with C1-INH is the treatment of choice for HAE in Europe, where it has been used safely and effectively for over 30 years. There are estimated to be approximately 10,000 people with HAE in the U.S.

About Lev Pharmaceuticals, Inc.

Lev is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. The Company is also evaluating the development of C1-INH for the treatment of acute myocardial infarction, or heart attack, and selective other diseases and disorders in which inflammation is known or believed to play an underlying role. Lev's C1-INH has been granted orphan drug status for the treatment and prevention of HAE, potentially securing, upon approval, market exclusivity for seven years. The Company has also received fast track designation status from the FDA, which facil
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