Biotech Values

[genisi]

LEVP looks in good spot to be the first one approved and get the Orphan Drug exclusivity for Cinryze.

Lev's Cinryze(TM) BLA Accepted for Filing by FDA

http://biz.yahoo.com/bw/071001/20071001005524.html?.v=1

Monday October 1, 7:15 am ET
Application for Acute Treatment of Hereditary Angioedema Granted Priority Review

NEW YORK--(BUSINESS WIRE)--Lev Pharmaceuticals, Inc. ("Lev" or the "Company") (OTCBB:LEVP.OB - News) today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's filing of its Biologics License Application (BLA) for Cinryze(TM) (C1 inhibitor) for the acute treatment of hereditary angioedema (HAE). In addition, the FDA has designated the submission for priority review, which targets an FDA action by January 30, 2008. Lev submitted the BLA on July 31, 2007. Priority review status is granted by the FDA to products that, if approved, would be a significant improvement over existing therapies.

"We are extremely pleased that the FDA has accepted our Cinryze(TM) BLA for filing and designated it for priority review," said Joshua D. Schein, Ph.D., Chief Executive Officer of Lev. "The priority designation supports our belief in the potential of Cinryze(TM) as a replacement therapy for the treatment of HAE. There currently is no acute therapy specifically approved for the treatment of HAE, and we believe that Cinryze(TM), if approved, would represent an important option in improving the lives of patients with the disease."

The BLA submission is based on data from the Company's pivotal Phase III acute trial which met its protocol-defined, pre-specified primary endpoint with statistical significance as reported on March 14, 2007. Additional details regarding the acute study results will be presented at the 2007 Annual Meeting of the American College of Allergy, Asthma & Immunology in November.

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