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

ase III trial. "I'd also like to thank all the HAE patients whose active participation in this study made this advance possible."

The Phase III study examined the efficacy and safety of C1-INH in patients suffering from moderate to severe acute HAE attacks in the face, abdomen or genitals. Laryngeal attacks, which can be life-threatening, were treated in the study with C1-INH on an open label basis. In the double-blind study, C1-INH was effective as analyzed across all attack sites. Additionally, 21 out of 21 laryngeal attacks were successfully treated with open-label C1-INH. To date, more than 400 acute treatments of C1-INH have been administered in all parts of the CHANGE trials with no drug-related serious adverse events (SAEs), no immunogenicity and no reports of injection site reactions.

"The results of this study confirm the extensive clinical experience in Europe where C1-inhibitor has been used to treat acute HAE attacks for more than 30 years. Upon FDA approval, this therapy will be welcomed by all patients with this debilitating disease," said Michael Frank, M.D., Distinguished Professor, Departments of Pediatrics and Medicine, Duke University School of Medicine, and an Investigator in the Phase III trial.

The CHANGE trial, the Company believes, is the world's largest double-blind, placebo-controlled study of C1-INH completed to date and is designed to determine the efficacy and safety of C1-INH in the treatment of HAE. In addition to the acute study, a second phase of the CHANGE 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.

"This study brings us one step closer to making this important therapy available to patients in the U.S. who suffer from this debilitating condition, a
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