Lev Announces FDA's Blood Products Advisory Committee to Review Cinryze (TM) (C1 inhibitor)
- Thursday March 13, 6:59 am ET

NEW YORK--(BUSINESS WIRE)--Lev Pharmaceuticals, Inc. (OTCBB: LEVP.OB - News) today announced that it has been advised that the Blood Products Advisory Committee (BPAC) for U.S. Food and Drug Administration (FDA) intends to review the Biologics License Application (BLA) for Cinryze (C1 inhibitor) on May 2, 2008, for the prophylactic treatment of hereditary angioedema (HAE), or C1 inhibitor deficiency.

Advisory committees provide FDA with independent advice from outside experts. The BPAC meeting represents the next stage in the regulatory process for Lev as the Company continues to work with FDA toward obtaining market approval for Cinryze.

“We are pleased to have the opportunity to present our data to the panelists as a part of the regulatory review process for Cinryze,” said Joshua Schein, chief executive officer of Lev. “In addition, we are making important progress in preparing our responses to FDA’s questions from the complete response letter.”

Lev received a complete response letter from FDA on January 30, 2008, which requested information with respect to chemistry, manufacturing, and controls (CMC), as well as additional analyses of existing efficacy data from the Cinryze trials. No additional safety information and no additional clinical trials have been requested to date.

As part of Lev's CHANGE trial (C1 inhibitor in Hereditary Angioedema Nanofiltration Generation evaluating Efficacy), the Company is conducting two open label studies for the treatment and prevention of HAE attacks. More than 100 qualified HAE patients are enrolled in our open label trials and continue to receive Cinryze on a compassionate use basis. To date, over 6,000 doses of Cinryze have been administered in all parts of the CHANGE trials with more than a dozen patients having individually received well over 100 doses.

Additionally, Cinryze has been well tolerated with an adverse event profile no different from placebo. The most common adverse reactions observed have been injection site rash and lightheadedness. No drug-related serious adverse events (SAEs), no immunogenicity and no decrease in efficacy have been observed.

C1 inhibitor has been used for more than 35 years in Europe to treat patients with C1 inhibitor deficiency.

About Hereditary Angioedema

HAE is a rare, severely debilitating, life-threatening genetic disorder caused by a deficiency of C1 inhibitor, a human plasma protein. This condition is the result of a defect in the gene controlling the synthesis of C1 inhibitor. C1 inhibitor maintains the natural regulation of the contact, complement, and fibrinolytic systems, that when left unrestricted, can initiate or perpetuate an attack by consuming the already low levels of endogenous C1 inhibitor in HAE patients. Patients with C1 inhibitor deficiency experience recurrent, unpredictable, debilitating, and potentially life threatening attacks of inflammation affecting the larynx, abdomen, face, extremities and urogenital tract. While there is no approved therapy for acute HAE attacks in the U.S., C1 inhibitor has been used in Europe to treat HAE for more than 35 years. There are estimated to be 10,000 people with HAE in the United States.

For more information on HAE, visit the U.S. HAE Association’s website at: www.haea.org.

About Lev Pharmaceuticals, Inc.

Lev is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. Lev’s lead product candidate, Cinryze (C1 inhibitor), is being developed as a replacement therapy for both the acute and prophylactic treatment of hereditary angioedema (HAE), also known as C1 inhibitor deficiency. Cinryze has been granted orphan drug status for the acute and prophylactic treatment of HAE, potentially securing, upon approval, market exclusivity for seven years. Additionally, Lev is in the process of prioritizing its C1 inhibitor development platform for the treatment of selective other diseases and disorders in which inflammation is known or believed to play an underlying role.

For more information about Lev, C1 inhibitor, or HAE, please contact Lev directly at 212-682-3096, or visit Lev’s website at www.levpharma.com.

F. Ryan Smith
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