Ongoing Pivotal Phase III Trial Examining Both Acute and Prophylactic Treatment
NEW YORK, Dec. 19 /PRNewswire-FirstCall/ -- Lev Pharmaceuticals, Inc. (BULLETIN BOARD: LEVP.OB) announced today that its lead investigational product, C1-esterase inhibitor ("C1-INH"), has been granted "fast track" status by the U.S. Food and Drug Administration (FDA) for the treatment of hereditary angioedema ("HAE").
"In granting fast track status, the FDA has acknowledged that C1-INH has the potential to be an important therapy for the serious disease of HAE," said Joshua Schein, Ph.D., Chief Executive Officer of Lev Pharmaceuticals. "This is the only clinical trial underway, to our knowledge, for the development of a prophylactic treatment for this debilitating and life-threatening condition."
The fast track programs of the FDA are designed to facilitate development and expedited review of investigational drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Compounds designated with fast track status are eligible for accelerated FDA review and/or early submission of portions of the associated Biologics License Application (BLA) for marketing approval.
Lev Pharmaceuticals initiated its Phase III trial of C1-INH in the first quarter of this year. The first part of the study, which is ongoing, is designed to examine the efficacy and safety of C1-INH in the treatment of acute attacks in HAE. The second part of the Phase III study is specifically examining the ability of C1-INH to prevent such inflammatory attacks.
In Europe, C1-INH therapeutics are currently used as replacement therapy for the treatment of HAE and are the treatment of choice for HAE attacks. It is the objective of Lev Pharmaceuticals to bring C1-esterase inhibitor to the U.S. as both an acute and prophylactic treatment for HAE. In 2004, the Company received orphan drug designation from the United States Food and Drug Administration for C1-INH (human) in treating hereditary angioedema. Upon product licensure, orphan drug designation could provide the Company with seven years of marketing exclusivity for its C1-INH product as a treatment for HAE in the United States.
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 6,000 people with HAE in the U.S.
About Lev Pharmaceuticals, Inc.
Lev Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. The Company's product candidates are based on C1-INH, a human plasma protein that mediates inflammation and is potentially applicable as a treatment for a range of medical indications. In addition to hereditary angioedema, Lev Pharmaceuticals is also developing C1-INH for the treatment of acute myocardial infarction, or heart attack, and selective other diseases and disorders in which inflammation plays an underlying role.
Patients and physicians interested in obtaining more information about the Company's Phase III clinical trial should call Lev Pharmaceuticals at 212-682-3096, or visit the Company's website at http://www.levpharma.com/.
Legal notice to investors: Certain matters discussed in this news release are "forward-looking statements." These forward-looking statements, which apply only on the date of this release, generally can be identified by the use of forward-looking terminology such as "may," "will," "expects," "intends," "estimates," "anticipates," "believes," "continues" or words of similar import. Similarly, statements that describe Lev Pharmaceutical's future plans, objectives or goals are also forward-looking statements, which generally involve known and unknown risks, uncertainties and other facts that may cause the actual results, performance or achievements of Lev Pharmaceuticals to be materially different from those expressed or implied by such forward-looking statements. Such factors may include the following: uncertainties associated with product development, the risk that Lev Pharmaceuticals will not obtain approval to market its products, the risk that Lev Pharmaceuticals' products will not gain market acceptance, the risks associated with dependence upon key personnel and the need for additional financing.
CONTACT: Joshua D. Schein, Ph.D., Chief Executive Officer, of Lev Pharmaceuticals, Inc., +1-212-682-3096, jschein@levpharma.com; or Sharon Weinstein, Director of Investor Relations, of Noonan Russo, +1-212-845-4271, sharon.weinstein@eurorscg.com
Web site: http://www.levpharma.com/
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