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

nd we look forward to working with the FDA on an expedited review of our license application," commented Judson Cooper, Chairman of Lev.

"The successful outcome of this trial is a credit to our clinical investigators, our clinical and regulatory team, and, most importantly, the HAE patient community and its leaders who have been so supportive of our efforts," said Joshua D. Schein, Ph.D., the company's Chief Executive Officer.

About Hereditary Angioedema

HAE, or hereditary C1-inhibitor deficiency, is a genetic disorder characterized by recurrent attacks of inflammation affecting the extremities (the hands and feet), the face, the urogenital tract, 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 acute attacks in the U.S., the Company believes that replacement therapy with C1-INH is the treatment of choice for HAE in Europe, where it has been used to treat acute HAE attacks for more than 30 years. There are estimated to be 10,000 people with HAE in the United States.

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 currently conducting a registrational Phase III clinical trial of its lead product candidate, C1-INH for the acute and prophylactic treatment of HAE. Lev is also evaluating the development of C1-INH for the treatment of cardiovascular disease and 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 of HAE by the FDA, potentially securing, upon approval, market exclusivity for seven years.

Patients and physicians interested in obtaining more information about Lev's studies for heredit
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