NEW YORK, March 17 /PRNewswire-FirstCall/ -- Lev Pharmaceuticals, Inc. (“LevPharma”) , a developer of therapeutics for inflammatory diseases, announced today that the Company will be presenting information on its ongoing Phase III study for hereditary angioedema (“HAE”) at the 2006 Dallas Regional Meeting of the Hereditary Angioedema Association, March 17-19, at the Harvey Hotel in Irving, Texas. The presentation, to be given by Jason Bablak, the Company’s Vice President, Regulatory Affairs, is scheduled for Saturday, March 18 at 11:15 am (CT).
LevPharma’s Phase III trial, designated CHANGE (C1-Inhibitor in Hereditary Angioedema Nanofiltration Generation evaluating Efficacy), is a multi-center, placebo-controlled, double-blind study designed to examine the efficacy of the Company’s lead product candidate, nano-filtered C1-esterase inhibitor (“C1- INH”). The first part of the Phase III study, which began in March 2005 and is ongoing, is designed to examine the efficacy and safety of C1-INH in the treatment of acute inflammatory attacks in HAE. The second part of the study, which began in October 2005, is examining the efficacy of C1-INH in preventing the onset of such inflammatory attacks in severely affected patients. In 2004 LevPharma received orphan drug designation from the United States Food and Drug Administration for C1-esterase inhibitor (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.
Patients and physicians interested in obtaining more information about the Phase III trial should contact LevPharma directly at 212-682-3096, or visit the Company’s website at http://www.levpharma.com.
LevPharma is developing its C1-INH product through an agreement with Sanquin Blood Supply Foundation (“Sanquin”), an Amsterdam-based not-for-profit organization that provides blood and plasma products and related services, carries out research and provides education, primarily in the Netherlands. Sanquin has been producing and selling successive generations of C1-INH, prepared from human plasma, in the Netherlands for over 30 years for the treatment of HAE.
Continuous product development efforts at Sanquin have resulted in the product under investigation, a highly purified C1-INH that is the next generation of the product that has been available in the Netherlands since 1997. Despite its long record of use in Europe, however, C1-INH, has never been introduced in the United States. Through a supply and distribution agreement with Sanquin, LevPharma has the exclusive right to market and sell C1-INH prepared by Sanquin for the treatment of HAE in North America and certain other geographic regions.
About Hereditary Angioedema
HAE is a genetic disorder characterized by episodes of edema (swelling) in the extremities (the hands and feet), the face, the abdomen, and the larynx. There are thought to be 6,000 or more people with HAE in the United States. The majority of patients experience episodes of severe abdominal pain, nausea, and vomiting that is caused by swelling in the intestinal wall. Attacks that involve the face and throat can result in closure of the airway passages, and the mortality rate from untreated airway obstruction has been reported to be over 30% with death most frequently caused by asphyxiation due to airway closure. HAE is caused by a deficiency of C1-INH, and there are currently no approved treatments for acute attacks available in the United States.
About Lev Pharmaceuticals, Inc.
LevPharma is a biopharmaceutical company focused on developing and commercializing therapeutic products for the treatment of inflammatory diseases. LevPharma’s product candidates are based on C1-esterase inhibitor (“C1-INH”), a human plasma protein that mediates inflammation and is potentially applicable as a treatment for a range of medical indications. The Company initiated a Phase III clinical trial of its lead product candidate, C1-INH for the treatment of hereditary angioedema, in March 2005. LevPharma is also developing C1-INH for the treatment of acute myocardial infarction, or heart attack, and selective other diseases and disorders in which inflammation is known or believed to play an underlying role.
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 LevPharma’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 LevPharma 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 LevPharma will not obtain approval to market its products, the risk that LevPharma’s products will not gain market acceptance, the risks associated with dependence upon key personnel and the need for additional financing.
Contacts: Joshua D. Schein, Ph.D. Sharon Weinstein Chief Executive Officer Director of Investor Relations Lev Pharmaceuticals, Inc. Noonan Russo 212-682-3096 212-845-4271 jschein@levpharma.comsharon.weinstein@eurorscg.com
Lev Pharmaceuticals, Inc.
CONTACT: Joshua D. Schein, Ph.D., Chief Executive Officer, LevPharmaceuticals, Inc., +1-212-682-3096, jschein@levpharma.com; or SharonWeinstein, Director of Investor Relations, Noonan Russo, +1-212-845-4271,sharon.weinstein@eurorscg.com
Web site: http://www.levpharma.com/
